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Does Radiofrequency Ablation of the Articular Nerves of the Knee Prior to Total Knee Replacement Improve Pain Outcomes

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ClinicalTrials.gov Identifier: NCT02746874
Recruitment Status : Completed
First Posted : April 21, 2016
Results First Posted : February 2, 2021
Last Update Posted : February 2, 2021
Sponsor:
Information provided by (Responsible Party):
David Walega, Northwestern University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition Arthroplasty, Replacement, Knee
Interventions Procedure: Radiofrequency Ablation (RFA)
Procedure: Simulated Radiofrequency Ablation (RFA)
Enrollment 70
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Active Group Placebo Group
Hide Arm/Group Description

Radiofrequency ablation procedure of the three articular branches of the knee joint. The targets will be thermally lesioned for 2 minutes 30 seconds thereby causing neurolysis.

Radiofrequency Ablation (RFA): The radiofrequency generator which will be turned on but will not be in the patient's view. The skin overlying the target sites identified with image guidance will be numb using lidocaine 1%. A needle will be placed through the skin to be optimally positioned according to the three targets. Sensory and motor testing will be performed to confirm appropriate placement. Lidocaine 2% 1-2cc will be injected prior to lesioning.

Simulated Radiofrequency Ablation procedure of the three articular branches of the knee joint.The targets will be not be thermally lesioned for 2 minutes 30 seconds therefore not causing neurolysis.

Simulated Radiofrequency Ablation (RFA): The radiofrequency generator which will be turned on but will not be in the patient's view. The skin overlying the target sites identified with image guidance will be numb using lidocaine 1%. A needle will be placed through the skin to be optimally positioned according to the three targets. Sensory and motor testing will be performed to confirm appropriate placement. Lidocaine 2% 1-2cc will be injected. A simulate sham lesion will be performed at each target site.

Period Title: Overall Study
Started 35 35
Completed 35 32
Not Completed 0 3
Reason Not Completed
Withdrawal by Subject             0             1
Surgery Date Changed             0             2
Arm/Group Title Active Group Placebo Group Total
Hide Arm/Group Description

Radiofrequency ablation procedure of the three articular branches of the knee joint. The targets will be thermally lesioned for 2 minutes 30 seconds thereby causing neurolysis.

Radiofrequency Ablation (RFA): The radiofrequency generator which will be turned on but will not be in the patient's view. The skin overlying the target sites identified with image guidance will be numb using lidocaine 1%. A needle will be placed through the skin to be optimally positioned according to the three targets. Sensory and motor testing will be performed to confirm appropriate placement. Lidocaine 2% 1-2cc will be injected prior to lesioning.

Simulated Radiofrequency Ablation procedure of the three articular branches of the knee joint.The targets will be not be thermally lesioned for 2 minutes 30 seconds therefore not causing neurolysis.

Simulated Radiofrequency Ablation (RFA): The radiofrequency generator which will be turned on but will not be in the patient's view. The skin overlying the target sites identified with image guidance will be numb using lidocaine 1%. A needle will be placed through the skin to be optimally positioned according to the three targets. Sensory and motor testing will be performed to confirm appropriate placement. Lidocaine 2% 1-2cc will be injected. A simulate sham lesion will be performed at each target site.

Total of all reporting groups
Overall Number of Baseline Participants 35 32 67
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Standard Deviation)
Unit of measure:  Years
Number Analyzed 35 participants 32 participants 67 participants
66  (7) 66  (9) 66  (8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 32 participants 67 participants
Female
20
  57.1%
20
  62.5%
40
  59.7%
Male
15
  42.9%
12
  37.5%
27
  40.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 32 participants 67 participants
Hispanic or Latino
3
   8.6%
4
  12.5%
7
  10.4%
Not Hispanic or Latino
32
  91.4%
28
  87.5%
60
  89.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 32 participants 67 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
5
  14.3%
8
  25.0%
13
  19.4%
White
27
  77.1%
20
  62.5%
47
  70.1%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
3
   8.6%
4
  12.5%
7
  10.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 35 participants 32 participants 67 participants
35 32 67
Operative site  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 32 participants 67 participants
Left Side
19
  54.3%
14
  43.8%
33
  49.3%
Right Side
16
  45.7%
18
  56.3%
34
  50.7%
BMI (kg/m^2)   [1] 
Median (Standard Deviation)
Unit of measure:  BMI (kg/m^2)
Number Analyzed 35 participants 32 participants 67 participants
32.0  (5.4) 30.5  (5.3) 31  (5.3)
[1]
Measure Description: Body mass index (BMI) index is a value derived from the mass (weight) and height.BMI is defined as the body mass divided by the square of the body height, and is universally expressed in units of kg/m2
1.Primary Outcome
Title Opioid Consumption After Surgery
Hide Description Pain medication will be calculated into oral morphine equivalents (ME) for the first 48 hours after surgery. Morphine equivalents determine a patient's cumulative intake of any drugs in the opioid class.
Time Frame 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Group Placebo Group
Hide Arm/Group Description:

Radiofrequency ablation procedure of the three articular branches of the knee joint. The targets will be thermally lesioned for 2 minutes 30 seconds thereby causing neurolysis.

Radiofrequency Ablation (RFA): The radiofrequency generator which will be turned on but will not be in the patient's view. The skin overlying the target sites identified with image guidance will be numb using lidocaine 1%. A needle will be placed through the skin to be optimally positioned according to the three targets. Sensory and motor testing will be performed to confirm appropriate placement. Lidocaine 2% 1-2cc will be injected prior to lesioning.

Simulated Radiofrequency Ablation procedure of the three articular branches of the knee joint.The targets will be not be thermally lesioned for 2 minutes 30 seconds therefore not causing neurolysis.

Simulated Radiofrequency Ablation (RFA): The radiofrequency generator which will be turned on but will not be in the patient's view. The skin overlying the target sites identified with image guidance will be numb using lidocaine 1%. A needle will be placed through the skin to be optimally positioned according to the three targets. Sensory and motor testing will be performed to confirm appropriate placement. Lidocaine 2% 1-2cc will be injected. A simulate sham lesion will be performed at each target site.

Overall Number of Participants Analyzed 35 32
Median (Inter-Quartile Range)
Unit of Measure: Morphine Equivalents (ME)
192
(105 to 274)
144
(112 to 314)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active Group, Placebo Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .978
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Secondary Outcome
Title Oral Morphine Equivalent Milligrams at Baseline.
Hide Description The total morphine equivalent (milligrams) reported by the subject at baseline.
Time Frame Pre operative
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Group Placebo Group
Hide Arm/Group Description:

Radiofrequency ablation procedure of the three articular branches of the knee joint. The targets will be thermally lesioned for 2 minutes 30 seconds thereby causing neurolysis.

Radiofrequency Ablation (RFA): The radiofrequency generator which will be turned on but will not be in the patient's view. The skin overlying the target sites identified with image guidance will be numb using lidocaine 1%. A needle will be placed through the skin to be optimally positioned according to the three targets. Sensory and motor testing will be performed to confirm appropriate placement. Lidocaine 2% 1-2cc will be injected prior to lesioning.

Simulated Radiofrequency Ablation procedure of the three articular branches of the knee joint.The targets will be not be thermally lesioned for 2 minutes 30 seconds therefore not causing neurolysis.

Simulated Radiofrequency Ablation (RFA): The radiofrequency generator which will be turned on but will not be in the patient's view. The skin overlying the target sites identified with image guidance will be numb using lidocaine 1%. A needle will be placed through the skin to be optimally positioned according to the three targets. Sensory and motor testing will be performed to confirm appropriate placement. Lidocaine 2% 1-2cc will be injected. A simulate sham lesion will be performed at each target site.

Overall Number of Participants Analyzed 35 32
Median (Inter-Quartile Range)
Unit of Measure: milligrams
0
(0 to 0)
0
(0 to 0)
3.Secondary Outcome
Title Oral Morphine Equivalents at Baseline Compared to 48 Hours Post-operative.
Hide Description Total oral morphine equivalents at baseline compared to oral morphine equivalents at 48 hours post-operative.
Time Frame 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Group Placebo Group
Hide Arm/Group Description:

Radiofrequency ablation procedure of the three articular branches of the knee joint. The targets will be thermally lesioned for 2 minutes 30 seconds thereby causing neurolysis.

Radiofrequency Ablation (RFA): The radiofrequency generator which will be turned on but will not be in the patient's view. The skin overlying the target sites identified with image guidance will be numb using lidocaine 1%. A needle will be placed through the skin to be optimally positioned according to the three targets. Sensory and motor testing will be performed to confirm appropriate placement. Lidocaine 2% 1-2cc will be injected prior to lesioning.

Simulated Radiofrequency Ablation procedure of the three articular branches of the knee joint.The targets will be not be thermally lesioned for 2 minutes 30 seconds therefore not causing neurolysis.

Simulated Radiofrequency Ablation (RFA): The radiofrequency generator which will be turned on but will not be in the patient's view. The skin overlying the target sites identified with image guidance will be numb using lidocaine 1%. A needle will be placed through the skin to be optimally positioned according to the three targets. Sensory and motor testing will be performed to confirm appropriate placement. Lidocaine 2% 1-2cc will be injected. A simulate sham lesion will be performed at each target site.

Overall Number of Participants Analyzed 35 32
Median (Inter-Quartile Range)
Unit of Measure: Morphine Equivalents (ME)
-187
(-233 to -148)
-191
(-254 to -133)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active Group, Placebo Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .978
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
4.Secondary Outcome
Title Medication Quantification Scale III (MQSIII) Score 48 Hours Post-operative.
Hide Description Medication Quantification Scale III (MQSIII) is a method of quantifying different pain drug regimens by evaluating the use of 22 distinct drug classes (e.g., nonsteroidal anti-inflammatory drugs [NSAIDs], antidepressants, benzodiazepines, opiates). A single value is calculated based on a patient's pain medication profile, taking into account dosages, and the types of pain medications prescribed. The score is calculated for a given pharmacologic class by taking its detriment weight, as determined by the physician, multiplied by a score given for dosage. The scores for each pharmacologic class prescribed to a patient are then summed to determine the overall score of a given pain medication regimen. The scale ranges from (0 low (good) 500 high (poor).
Time Frame 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Group Placebo Group
Hide Arm/Group Description:

Radiofrequency ablation procedure of the three articular branches of the knee joint. The targets will be thermally lesioned for 2 minutes 30 seconds thereby causing neurolysis.

Radiofrequency Ablation (RFA): The radiofrequency generator which will be turned on but will not be in the patient's view. The skin overlying the target sites identified with image guidance will be numb using lidocaine 1%. A needle will be placed through the skin to be optimally positioned according to the three targets. Sensory and motor testing will be performed to confirm appropriate placement. Lidocaine 2% 1-2cc will be injected prior to lesioning.

Simulated Radiofrequency Ablation procedure of the three articular branches of the knee joint.The targets will be not be thermally lesioned for 2 minutes 30 seconds therefore not causing neurolysis.

Simulated Radiofrequency Ablation (RFA): The radiofrequency generator which will be turned on but will not be in the patient's view. The skin overlying the target sites identified with image guidance will be numb using lidocaine 1%. A needle will be placed through the skin to be optimally positioned according to the three targets. Sensory and motor testing will be performed to confirm appropriate placement. Lidocaine 2% 1-2cc will be injected. A simulate sham lesion will be performed at each target site.

Overall Number of Participants Analyzed 35 32
Median (Standard Deviation)
Unit of Measure: score on a scale
33  (8) 35  (7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active Group, Placebo Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .371
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
5.Secondary Outcome
Title Number of Stairs Climbed on Post-operative Day 2.
Hide Description Number of stairs climbed on post-operative day 2 prior to discharge from the hospital.
Time Frame Post operative day 2
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Group Placebo Group
Hide Arm/Group Description:

Radiofrequency ablation procedure of the three articular branches of the knee joint. The targets will be thermally lesioned for 2 minutes 30 seconds thereby causing neurolysis.

Radiofrequency Ablation (RFA): The radiofrequency generator which will be turned on but will not be in the patient's view. The skin overlying the target sites identified with image guidance will be numb using lidocaine 1%. A needle will be placed through the skin to be optimally positioned according to the three targets. Sensory and motor testing will be performed to confirm appropriate placement. Lidocaine 2% 1-2cc will be injected prior to lesioning.

Simulated Radiofrequency Ablation procedure of the three articular branches of the knee joint.The targets will be not be thermally lesioned for 2 minutes 30 seconds therefore not causing neurolysis.

Simulated Radiofrequency Ablation (RFA): The radiofrequency generator which will be turned on but will not be in the patient's view. The skin overlying the target sites identified with image guidance will be numb using lidocaine 1%. A needle will be placed through the skin to be optimally positioned according to the three targets. Sensory and motor testing will be performed to confirm appropriate placement. Lidocaine 2% 1-2cc will be injected. A simulate sham lesion will be performed at each target site.

Overall Number of Participants Analyzed 35 32
Mean (Standard Deviation)
Unit of Measure: stairs
7  (4) 8  (5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active Group, Placebo Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .325
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
6.Secondary Outcome
Title Distance Walked on Post-operative Day 2.
Hide Description Distance in feet walked on post-operative day 2 prior to discharge from the hospital.
Time Frame Post operative day 2
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Group Placebo Group
Hide Arm/Group Description:

Radiofrequency ablation procedure of the three articular branches of the knee joint. The targets will be thermally lesioned for 2 minutes 30 seconds thereby causing neurolysis.

Radiofrequency Ablation (RFA): The radiofrequency generator which will be turned on but will not be in the patient's view. The skin overlying the target sites identified with image guidance will be numb using lidocaine 1%. A needle will be placed through the skin to be optimally positioned according to the three targets. Sensory and motor testing will be performed to confirm appropriate placement. Lidocaine 2% 1-2cc will be injected prior to lesioning.

Simulated Radiofrequency Ablation procedure of the three articular branches of the knee joint.The targets will be not be thermally lesioned for 2 minutes 30 seconds therefore not causing neurolysis.

Simulated Radiofrequency Ablation (RFA): The radiofrequency generator which will be turned on but will not be in the patient's view. The skin overlying the target sites identified with image guidance will be numb using lidocaine 1%. A needle will be placed through the skin to be optimally positioned according to the three targets. Sensory and motor testing will be performed to confirm appropriate placement. Lidocaine 2% 1-2cc will be injected. A simulate sham lesion will be performed at each target site.

Overall Number of Participants Analyzed 35 32
Mean (Standard Deviation)
Unit of Measure: feet
216  (134) 232  (115)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active Group, Placebo Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .466
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
7.Secondary Outcome
Title Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score 6 Months Post Operative
Hide Description Western Ontario and McMaster Universities Arthritis Index (WOMAC) score 6 months post operative. The WOMAC score is a survey comprised of 24 items divided into three subscales: Pain (5 items), stiffness (2 items), and physical function (17 items). Subjects are asked a range of questions about their ability to carry out daily activities such as using the stairs, rising from sitting, lying in bed and conducting light or heavy domestic duties. Items are scored on a scale of 0-4 (lower scores indicate lower levels of symptoms or physical disability). Values are summed up for a combined WOMAC score of 0 (low) to 96 (high) Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitation.
Time Frame 6 months post operative
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Group Placebo Group
Hide Arm/Group Description:

Radiofrequency ablation procedure of the three articular branches of the knee joint. The targets will be thermally lesioned for 2 minutes 30 seconds thereby causing neurolysis.

Radiofrequency Ablation (RFA): The radiofrequency generator which will be turned on but will not be in the patient's view. The skin overlying the target sites identified with image guidance will be numb using lidocaine 1%. A needle will be placed through the skin to be optimally positioned according to the three targets. Sensory and motor testing will be performed to confirm appropriate placement. Lidocaine 2% 1-2cc will be injected prior to lesioning.

Simulated Radiofrequency Ablation procedure of the three articular branches of the knee joint.The targets will be not be thermally lesioned for 2 minutes 30 seconds therefore not causing neurolysis.

Simulated Radiofrequency Ablation (RFA): The radiofrequency generator which will be turned on but will not be in the patient's view. The skin overlying the target sites identified with image guidance will be numb using lidocaine 1%. A needle will be placed through the skin to be optimally positioned according to the three targets. Sensory and motor testing will be performed to confirm appropriate placement. Lidocaine 2% 1-2cc will be injected. A simulate sham lesion will be performed at each target site.

Overall Number of Participants Analyzed 35 32
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
8
(4 to 22)
9
(2 to 14)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active Group, Placebo Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .368
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
8.Post-Hoc Outcome
Title Medication Quantification Scale Version III (MSQVIII) at Baseline in Patients With Hospital Anxiety and Depression Scores of Less Than 11.
Hide Description Medication Quantification Scale Version III (MQSVIII) is a single value calculated based on a patient's pain medication profile, taking into account dosages, and the types of pain medications prescribed. The score is calculated for a given pharmacologic class by taking its detriment weight, as determined by the physician, multiplied by a score given for dosage. The scores for each pharmacologic class prescribed to a patient are then summed to determine the overall score of a given pain medication regimen at baseline in patients (the scale ranges from (0 low (good) 500 high) with Hospital Anxiety and Depression Scores (HADS) of less than 11.The Hospital Anxiety and Depression Scores (HADS) is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. The questionnaire is scored from 0-3 and this means that a person can score between 0 (low) and 21 (high) for either anxiety or depression.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Group Placebo Group
Hide Arm/Group Description:

Radiofrequency ablation procedure of the three articular branches of the knee joint. The targets will be thermally lesioned for 2 minutes 30 seconds thereby causing neurolysis.

Radiofrequency Ablation (RFA): The radiofrequency generator which will be turned on but will not be in the patient's view. The skin overlying the target sites identified with image guidance will be numb using lidocaine 1%. A needle will be placed through the skin to be optimally positioned according to the three targets. Sensory and motor testing will be performed to confirm appropriate placement. Lidocaine 2% 1-2cc will be injected prior to lesioning.

Simulated Radiofrequency Ablation procedure of the three articular branches of the knee joint.The targets will be not be thermally lesioned for 2 minutes 30 seconds therefore not causing neurolysis.

Simulated Radiofrequency Ablation (RFA): The radiofrequency generator which will be turned on but will not be in the patient's view. The skin overlying the target sites identified with image guidance will be numb using lidocaine 1%. A needle will be placed through the skin to be optimally positioned according to the three targets. Sensory and motor testing will be performed to confirm appropriate placement. Lidocaine 2% 1-2cc will be injected. A simulate sham lesion will be performed at each target site.

Overall Number of Participants Analyzed 32 29
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
6.5
(3 to 10)
4
(2 to 10)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active Group, Placebo Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .509
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
9.Post-Hoc Outcome
Title Medication Quantification Scale Version III (MSQVIII) at 48 Hours in Patients With Hospital Anxiety and Depression Scores of Less Than 11.
Hide Description Medication Quantification Scale Version III (MQSVIII) is a single value calculated based on a patient's pain medication profile, taking into account dosages, and the types of pain medications prescribed. The score is calculated for a given pharmacologic class by taking its detriment weight, as determined by the physician, multiplied by a score given for dosage. The scores for each pharmacologic class prescribed to a patient are then summed to determine the overall score of a given pain medication regimen score on a scale of 0 good-500 poor at baseline in patients with Hospital Anxiety and Depression Scores (HADS) of less than 11.The Hospital Anxiety and Depression Scores (HADS) is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. The questionnaire is scored from 0-3 and this means that a person can score between 0 (low) and 21 (high) for either anxiety or depression.
Time Frame 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Group Placebo Group
Hide Arm/Group Description:

Radiofrequency ablation procedure of the three articular branches of the knee joint. The targets will be thermally lesioned for 2 minutes 30 seconds thereby causing neurolysis.

Radiofrequency Ablation (RFA): The radiofrequency generator which will be turned on but will not be in the patient's view. The skin overlying the target sites identified with image guidance will be numb using lidocaine 1%. A needle will be placed through the skin to be optimally positioned according to the three targets. Sensory and motor testing will be performed to confirm appropriate placement. Lidocaine 2% 1-2cc will be injected prior to lesioning.

Simulated Radiofrequency Ablation procedure of the three articular branches of the knee joint.The targets will be not be thermally lesioned for 2 minutes 30 seconds therefore not causing neurolysis.

Simulated Radiofrequency Ablation (RFA): The radiofrequency generator which will be turned on but will not be in the patient's view. The skin overlying the target sites identified with image guidance will be numb using lidocaine 1%. A needle will be placed through the skin to be optimally positioned according to the three targets. Sensory and motor testing will be performed to confirm appropriate placement. Lidocaine 2% 1-2cc will be injected. A simulate sham lesion will be performed at each target site.

Overall Number of Participants Analyzed 32 27
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
33.5
(28 to 37)
34
(30 to 38)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active Group, Placebo Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .593
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
10.Post-Hoc Outcome
Title Medication Quantification Scale Version III (MSQVIII) at 1 Month in Patients With Hospital Anxiety and Depression Scores of Less Than 11.
Hide Description Medication Quantification Scale Version III (MQSVIII) is a single value calculated based on a patient's pain medication profile, taking into account dosages, and the types of pain medications prescribed. The score is calculated for a given pharmacologic class by taking its detriment weight, as determined by the physician, multiplied by a score given for dosage. The scores for each pharmacologic class prescribed to a patient are then summed to determine the overall score of a given pain medication regimen (score on a scale 0 good-500 poor) at baseline in patients with Hospital Anxiety and Depression Scores (HADS) of less than 11.The Hospital Anxiety and Depression Scores (HADS) is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. The questionnaire is scored from 0-3 and this means that a person can score between 0 (low) and 21 (high) for either anxiety or depression.
Time Frame 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Group Placebo Group
Hide Arm/Group Description:

Radiofrequency ablation procedure of the three articular branches of the knee joint. The targets will be thermally lesioned for 2 minutes 30 seconds thereby causing neurolysis.

Radiofrequency Ablation (RFA): The radiofrequency generator which will be turned on but will not be in the patient's view. The skin overlying the target sites identified with image guidance will be numb using lidocaine 1%. A needle will be placed through the skin to be optimally positioned according to the three targets. Sensory and motor testing will be performed to confirm appropriate placement. Lidocaine 2% 1-2cc will be injected prior to lesioning.

Simulated Radiofrequency Ablation procedure of the three articular branches of the knee joint.The targets will be not be thermally lesioned for 2 minutes 30 seconds therefore not causing neurolysis.

Simulated Radiofrequency Ablation (RFA): The radiofrequency generator which will be turned on but will not be in the patient's view. The skin overlying the target sites identified with image guidance will be numb using lidocaine 1%. A needle will be placed through the skin to be optimally positioned according to the three targets. Sensory and motor testing will be performed to confirm appropriate placement. Lidocaine 2% 1-2cc will be injected. A simulate sham lesion will be performed at each target site.

Overall Number of Participants Analyzed 32 27
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
7
(3 to 7.5)
5
(0 to 9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active Group, Placebo Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.687
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
11.Post-Hoc Outcome
Title Medication Quantification Scale Version III (MSQVIII) at 6 Months in Patients With Hospital Anxiety and Depression Scores of Less Than 11.
Hide Description Medication Quantification Scale Version III (MQSVIII) is a single value calculated based on a patient's pain medication profile, taking into account dosages, and the types of pain medications prescribed. The score is calculated for a given pharmacologic class by taking its detriment weight, as determined by the physician, multiplied by a score given for dosage. The scores for each pharmacologic class prescribed to a patient are then summed to determine the overall score of a given pain medication regimen (the scale ranges from (0 low (good) 500 high) at baseline in patients with Hospital Anxiety and Depression Scores (HADS) of less than 11.The Hospital Anxiety and Depression Scores (HADS) is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. The questionnaire is scored from 0-3 and this means that a person can score between 0 (low) and 21 (high) for either anxiety or depression.
Time Frame 6 month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Group Placebo Group
Hide Arm/Group Description:

Radiofrequency ablation procedure of the three articular branches of the knee joint. The targets will be thermally lesioned for 2 minutes 30 seconds thereby causing neurolysis.

Radiofrequency Ablation (RFA): The radiofrequency generator which will be turned on but will not be in the patient's view. The skin overlying the target sites identified with image guidance will be numb using lidocaine 1%. A needle will be placed through the skin to be optimally positioned according to the three targets. Sensory and motor testing will be performed to confirm appropriate placement. Lidocaine 2% 1-2cc will be injected prior to lesioning.

Simulated Radiofrequency Ablation procedure of the three articular branches of the knee joint.The targets will be not be thermally lesioned for 2 minutes 30 seconds therefore not causing neurolysis.

Simulated Radiofrequency Ablation (RFA): The radiofrequency generator which will be turned on but will not be in the patient's view. The skin overlying the target sites identified with image guidance will be numb using lidocaine 1%. A needle will be placed through the skin to be optimally positioned according to the three targets. Sensory and motor testing will be performed to confirm appropriate placement. Lidocaine 2% 1-2cc will be injected. A simulate sham lesion will be performed at each target site.

Overall Number of Participants Analyzed 29 27
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
0
(0 to 0)
0
(0 to 0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active Group, Placebo Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .813
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
12.Post-Hoc Outcome
Title Medication Quantification Scale Version III (MSQVIII) at 3 Months in Patients With Hospital Anxiety and Depression Scores of Less Than 11.
Hide Description Medication Quantification Scale Version III (MQSVIII) is a single value calculated based on a patient's pain medication profile, taking into account dosages, and the types of pain medications prescribed. The score is calculated for a given pharmacologic class by taking its detriment weight, as determined by the physician, multiplied by a score given for dosage. The scores for each pharmacologic class prescribed to a patient are then summed to determine the overall score of a given pain medication regimen (score on a scale 0 good-500 poor) at baseline in patients with Hospital Anxiety and Depression Scores (HADS) of less than 11.The Hospital Anxiety and Depression Scores (HADS) is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. The questionnaire is scored from 0-3 and this means that a person can score between 0 (low) and 21 (high) for either anxiety or depression.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Group Placebo Group
Hide Arm/Group Description:

Radiofrequency ablation procedure of the three articular branches of the knee joint. The targets will be thermally lesioned for 2 minutes 30 seconds thereby causing neurolysis.

Radiofrequency Ablation (RFA): The radiofrequency generator which will be turned on but will not be in the patient's view. The skin overlying the target sites identified with image guidance will be numb using lidocaine 1%. A needle will be placed through the skin to be optimally positioned according to the three targets. Sensory and motor testing will be performed to confirm appropriate placement. Lidocaine 2% 1-2cc will be injected prior to lesioning.

Simulated Radiofrequency Ablation procedure of the three articular branches of the knee joint.The targets will be not be thermally lesioned for 2 minutes 30 seconds therefore not causing neurolysis.

Simulated Radiofrequency Ablation (RFA): The radiofrequency generator which will be turned on but will not be in the patient's view. The skin overlying the target sites identified with image guidance will be numb using lidocaine 1%. A needle will be placed through the skin to be optimally positioned according to the three targets. Sensory and motor testing will be performed to confirm appropriate placement. Lidocaine 2% 1-2cc will be injected. A simulate sham lesion will be performed at each target site.

Overall Number of Participants Analyzed 32 27
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
0
(0 to 4.5)
0
(0 to 6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active Group, Placebo Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .687
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
13.Post-Hoc Outcome
Title Total Oral Morphine Equivalents in Milligrams at Baseline in Patients With Hospital Anxiety and Depression Scores (HADS) of Less Than 11.
Hide Description Total oral morphine equivalents in milligrams at baseline in patients with Hospital Anxiety and Depression Scores (HADS) of less than 11.The Hospital Anxiety and Depression Scores (HADS) is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. The questionnaire is scored from 0-3 and this means that a person can score between 0 (low) and 21 (high) for either anxiety or depression.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Group Placebo Group
Hide Arm/Group Description:

Radiofrequency ablation procedure of the three articular branches of the knee joint. The targets will be thermally lesioned for 2 minutes 30 seconds thereby causing neurolysis.

Radiofrequency Ablation (RFA): The radiofrequency generator which will be turned on but will not be in the patient's view. The skin overlying the target sites identified with image guidance will be numb using lidocaine 1%. A needle will be placed through the skin to be optimally positioned according to the three targets. Sensory and motor testing will be performed to confirm appropriate placement. Lidocaine 2% 1-2cc will be injected prior to lesioning.

Simulated Radiofrequency Ablation procedure of the three articular branches of the knee joint.The targets will be not be thermally lesioned for 2 minutes 30 seconds therefore not causing neurolysis.

Simulated Radiofrequency Ablation (RFA): The radiofrequency generator which will be turned on but will not be in the patient's view. The skin overlying the target sites identified with image guidance will be numb using lidocaine 1%. A needle will be placed through the skin to be optimally positioned according to the three targets. Sensory and motor testing will be performed to confirm appropriate placement. Lidocaine 2% 1-2cc will be injected. A simulate sham lesion will be performed at each target site.

Overall Number of Participants Analyzed 32 29
Median (Inter-Quartile Range)
Unit of Measure: milligrams
0
(0 to 0)
0
(0 to 0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active Group, Placebo Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.840
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
14.Post-Hoc Outcome
Title Total Oral Morphine Equivalents in Milligrams at 48 Hours in Patients With Hospital Anxiety and Depression Scores (HADS) of Less Than 11.
Hide Description Total oral morphine equivalents in milligrams at 48 hours in patients with Hospital Anxiety and Depression Scores (HADS) of less than 11.The Hospital Anxiety and Depression Scores (HADS) is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. The questionnaire is scored from 0-3 and this means that a person can score between 0 (low) and 21 (high) for either anxiety or depression.
Time Frame 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Group Placebo Group
Hide Arm/Group Description:

Radiofrequency ablation procedure of the three articular branches of the knee joint. The targets will be thermally lesioned for 2 minutes 30 seconds thereby causing neurolysis.

Radiofrequency Ablation (RFA): The radiofrequency generator which will be turned on but will not be in the patient's view. The skin overlying the target sites identified with image guidance will be numb using lidocaine 1%. A needle will be placed through the skin to be optimally positioned according to the three targets. Sensory and motor testing will be performed to confirm appropriate placement. Lidocaine 2% 1-2cc will be injected prior to lesioning.

Simulated Radiofrequency Ablation procedure of the three articular branches of the knee joint.The targets will be not be thermally lesioned for 2 minutes 30 seconds therefore not causing neurolysis.

Simulated Radiofrequency Ablation (RFA): The radiofrequency generator which will be turned on but will not be in the patient's view. The skin overlying the target sites identified with image guidance will be numb using lidocaine 1%. A needle will be placed through the skin to be optimally positioned according to the three targets. Sensory and motor testing will be performed to confirm appropriate placement. Lidocaine 2% 1-2cc will be injected. A simulate sham lesion will be performed at each target site.

Overall Number of Participants Analyzed 32 29
Median (Inter-Quartile Range)
Unit of Measure: milligrams
178.5
(92.5 to 267)
138
(110 to 328)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active Group, Placebo Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .913
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
15.Post-Hoc Outcome
Title Total Oral Morphine Equivalents in Milligrams at 1 Month in Patients With Hospital Anxiety and Depression Scores (HADS) of Less Than 11.
Hide Description Total oral morphine equivalents in milligrams at 1 month in patients with Hospital Anxiety and Depression Scores (HADS) of less than 11.The Hospital Anxiety and Depression Scores (HADS) is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. The questionnaire is scored from 0-3 and this means that a person can score between 0 (low) and 21 (high) for either anxiety or depression.
Time Frame 1 month post operative
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Group Placebo Group
Hide Arm/Group Description:

Radiofrequency ablation procedure of the three articular branches of the knee joint. The targets will be thermally lesioned for 2 minutes 30 seconds thereby causing neurolysis.

Radiofrequency Ablation (RFA): The radiofrequency generator which will be turned on but will not be in the patient's view. The skin overlying the target sites identified with image guidance will be numb using lidocaine 1%. A needle will be placed through the skin to be optimally positioned according to the three targets. Sensory and motor testing will be performed to confirm appropriate placement. Lidocaine 2% 1-2cc will be injected prior to lesioning.

Simulated Radiofrequency Ablation procedure of the three articular branches of the knee joint.The targets will be not be thermally lesioned for 2 minutes 30 seconds therefore not causing neurolysis.

Simulated Radiofrequency Ablation (RFA): The radiofrequency generator which will be turned on but will not be in the patient's view. The skin overlying the target sites identified with image guidance will be numb using lidocaine 1%. A needle will be placed through the skin to be optimally positioned according to the three targets. Sensory and motor testing will be performed to confirm appropriate placement. Lidocaine 2% 1-2cc will be injected. A simulate sham lesion will be performed at each target site.

Overall Number of Participants Analyzed 32 27
Median (Inter-Quartile Range)
Unit of Measure: milligrams
10
(1 to 20)
5
(0 to 10)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active Group, Placebo Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.301
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
16.Post-Hoc Outcome
Title Total Oral Morphine Equivalents in Milligrams at 3 Months in Patients With Hospital Anxiety and Depression Scores (HADS) of Less Than 11.
Hide Description Total oral morphine equivalents in milligrams at 3 months in patients with Hospital Anxiety and Depression Scores (HADS) of less than 11.The Hospital Anxiety and Depression Scores (HADS) is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. The questionnaire is scored from 0-3 and this means that a person can score between 0 (low) and 21 (high) for either anxiety or depression.
Time Frame 3 month post operative
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Group Placebo Group
Hide Arm/Group Description:

Radiofrequency ablation procedure of the three articular branches of the knee joint. The targets will be thermally lesioned for 2 minutes 30 seconds thereby causing neurolysis.

Radiofrequency Ablation (RFA): The radiofrequency generator which will be turned on but will not be in the patient's view. The skin overlying the target sites identified with image guidance will be numb using lidocaine 1%. A needle will be placed through the skin to be optimally positioned according to the three targets. Sensory and motor testing will be performed to confirm appropriate placement. Lidocaine 2% 1-2cc will be injected prior to lesioning.

Simulated Radiofrequency Ablation procedure of the three articular branches of the knee joint.The targets will be not be thermally lesioned for 2 minutes 30 seconds therefore not causing neurolysis.

Simulated Radiofrequency Ablation (RFA): The radiofrequency generator which will be turned on but will not be in the patient's view. The skin overlying the target sites identified with image guidance will be numb using lidocaine 1%. A needle will be placed through the skin to be optimally positioned according to the three targets. Sensory and motor testing will be performed to confirm appropriate placement. Lidocaine 2% 1-2cc will be injected. A simulate sham lesion will be performed at each target site.

Overall Number of Participants Analyzed 32 27
Median (Inter-Quartile Range)
Unit of Measure: milligrams
0
(0 to 4)
0
(0 to 2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active Group, Placebo Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.826
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
17.Post-Hoc Outcome
Title Total Oral Morphine Equivalents in Milligrams at 6 Months in Patients With Hospital Anxiety and Depression Scores (HADS) of Less Than 11.
Hide Description Total oral morphine equivalents in milligrams at 6 months in patients with Hospital Anxiety and Depression Scores (HADS) of less than 11.The Hospital Anxiety and Depression Scores (HADS) is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. The questionnaire is scored from 0-3 and this means that a person can score between 0 (low) and 21 (high) for either anxiety or depression.
Time Frame 6 month post operative
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Group Placebo Group
Hide Arm/Group Description:

Radiofrequency ablation procedure of the three articular branches of the knee joint. The targets will be thermally lesioned for 2 minutes 30 seconds thereby causing neurolysis.

Radiofrequency Ablation (RFA): The radiofrequency generator which will be turned on but will not be in the patient's view. The skin overlying the target sites identified with image guidance will be numb using lidocaine 1%. A needle will be placed through the skin to be optimally positioned according to the three targets. Sensory and motor testing will be performed to confirm appropriate placement. Lidocaine 2% 1-2cc will be injected prior to lesioning.

Simulated Radiofrequency Ablation procedure of the three articular branches of the knee joint.The targets will be not be thermally lesioned for 2 minutes 30 seconds therefore not causing neurolysis.

Simulated Radiofrequency Ablation (RFA): The radiofrequency generator which will be turned on but will not be in the patient's view. The skin overlying the target sites identified with image guidance will be numb using lidocaine 1%. A needle will be placed through the skin to be optimally positioned according to the three targets. Sensory and motor testing will be performed to confirm appropriate placement. Lidocaine 2% 1-2cc will be injected. A simulate sham lesion will be performed at each target site.

Overall Number of Participants Analyzed 29 27
Median (Inter-Quartile Range)
Unit of Measure: Milligrams
0
(0 to 0)
0
(0 to 0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active Group, Placebo Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .813
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
18.Post-Hoc Outcome
Title Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at Baseline in Patients With Hospital Anxiety and Depression Scale (HADS) Scores of Less Than 11.
Hide Description WOMAC score at baseline in patients with Hospital Anxiety and Depression Scale (HADS) Scores of less than 11.The WOMAC score is a survey comprised of 24 items divided into three subscales:Pain (5 items), stiffness (2 items), and physical function (17 items). Subjects are asked a range of questions about their ability to carry out daily activities such as using the stairs, rising from sitting, lying in bed and conducting light or heavy domestic duties. Items are scored on a scale of 0-4 (lower scores indicate lower levels of symptoms or physical disability). Summed for a combined WOMAC score of 0 (low) to 96 (high) Higher scores indicate worse pain, stiffness, and functional limitation. The Hospital Anxiety and Depression Scores (HADS) is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression.The questionnaire is scored from 0-3 and this means that a person can score between 0 (low) and 21 (high) for either anxiety or depression.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Group Placebo Group
Hide Arm/Group Description:

Radiofrequency ablation procedure of the three articular branches of the knee joint. The targets will be thermally lesioned for 2 minutes 30 seconds thereby causing neurolysis.

Radiofrequency Ablation (RFA): The radiofrequency generator which will be turned on but will not be in the patient's view. The skin overlying the target sites identified with image guidance will be numb using lidocaine 1%. A needle will be placed through the skin to be optimally positioned according to the three targets. Sensory and motor testing will be performed to confirm appropriate placement. Lidocaine 2% 1-2cc will be injected prior to lesioning.

Simulated Radiofrequency Ablation procedure of the three articular branches of the knee joint.The targets will be not be thermally lesioned for 2 minutes 30 seconds therefore not causing neurolysis.

Simulated Radiofrequency Ablation (RFA): The radiofrequency generator which will be turned on but will not be in the patient's view. The skin overlying the target sites identified with image guidance will be numb using lidocaine 1%. A needle will be placed through the skin to be optimally positioned according to the three targets. Sensory and motor testing will be performed to confirm appropriate placement. Lidocaine 2% 1-2cc will be injected. A simulate sham lesion will be performed at each target site.

Overall Number of Participants Analyzed 32 29
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
39.5
(32.5 to 52)
40
(22 to 48)
19.Post-Hoc Outcome
Title Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 1 Month in Patients With Hospital Anxiety and Depression Scale (HADS) Scores of Less Than 11.
Hide Description WOMAC score at 1 month in patients with Hospital Anxiety and Depression Scale (HADS) Scores of less than 11.The WOMAC score is a survey comprised of 24 items divided into three subscales:Pain (5 items), stiffness (2 items), and physical function (17 items). Subjects are asked a range of questions about their ability to carry out daily activities such as using the stairs, rising from sitting, lying in bed and conducting light or heavy domestic duties. Items are scored on a scale of 0-4 (lower scores indicate lower levels of symptoms or physical disability). Summed for a combined WOMAC score of 0 (low) to 96 (high) Higher scores indicate worse pain, stiffness, and functional limitation. The Hospital Anxiety and Depression Scores (HADS) is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression.The questionnaire is scored from 0-3 and this means that a person can score between 0 (low) and 21 (high) for either anxiety or depression.
Time Frame 1 month post operative
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Group Placebo Group
Hide Arm/Group Description:

Radiofrequency ablation procedure of the three articular branches of the knee joint. The targets will be thermally lesioned for 2 minutes 30 seconds thereby causing neurolysis.

Radiofrequency Ablation (RFA): The radiofrequency generator which will be turned on but will not be in the patient's view. The skin overlying the target sites identified with image guidance will be numb using lidocaine 1%. A needle will be placed through the skin to be optimally positioned according to the three targets. Sensory and motor testing will be performed to confirm appropriate placement. Lidocaine 2% 1-2cc will be injected prior to lesioning.

Simulated Radiofrequency Ablation procedure of the three articular branches of the knee joint.The targets will be not be thermally lesioned for 2 minutes 30 seconds therefore not causing neurolysis.

Simulated Radiofrequency Ablation (RFA): The radiofrequency generator which will be turned on but will not be in the patient's view. The skin overlying the target sites identified with image guidance will be numb using lidocaine 1%. A needle will be placed through the skin to be optimally positioned according to the three targets. Sensory and motor testing will be performed to confirm appropriate placement. Lidocaine 2% 1-2cc will be injected. A simulate sham lesion will be performed at each target site.

Overall Number of Participants Analyzed 32 27
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
21
(14 to 28)
13
(8 to 22)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active Group, Placebo Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .047
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
20.Post-Hoc Outcome
Title Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 3 Month in Patients With Hospital Anxiety and Depression Scale (HADS) Scores of Less Than 11.
Hide Description WOMAC score at 3 months in patients with Hospital Anxiety and Depression Scale (HADS) Scores of less than 11.The WOMAC score is a survey comprised of 24 items divided into three subscales:Pain (5 items), stiffness (2 items), and physical function (17 items). Subjects are asked a range of questions about their ability to carry out daily activities such as using the stairs, rising from sitting, lying in bed and conducting light or heavy domestic duties. Items are scored on a scale of 0-4 (lower scores indicate lower levels of symptoms or physical disability). Summed for a combined WOMAC score of 0 (low) to 96 (high) Higher scores indicate worse pain, stiffness, and functional limitation. The Hospital Anxiety and Depression Scores (HADS) is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression.The questionnaire is scored from 0-3 and this means that a person can score between 0 (low) and 21 (high) for either anxiety or depression.
Time Frame 3 month post operative
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Group Placebo Group
Hide Arm/Group Description:

Radiofrequency ablation procedure of the three articular branches of the knee joint. The targets will be thermally lesioned for 2 minutes 30 seconds thereby causing neurolysis.

Radiofrequency Ablation (RFA): The radiofrequency generator which will be turned on but will not be in the patient's view. The skin overlying the target sites identified with image guidance will be numb using lidocaine 1%. A needle will be placed through the skin to be optimally positioned according to the three targets. Sensory and motor testing will be performed to confirm appropriate placement. Lidocaine 2% 1-2cc will be injected prior to lesioning.

Simulated Radiofrequency Ablation procedure of the three articular branches of the knee joint.The targets will be not be thermally lesioned for 2 minutes 30 seconds therefore not causing neurolysis.

Simulated Radiofrequency Ablation (RFA): The radiofrequency generator which will be turned on but will not be in the patient's view. The skin overlying the target sites identified with image guidance will be numb using lidocaine 1%. A needle will be placed through the skin to be optimally positioned according to the three targets. Sensory and motor testing will be performed to confirm appropriate placement. Lidocaine 2% 1-2cc will be injected. A simulate sham lesion will be performed at each target site.

Overall Number of Participants Analyzed 29 27
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
11.5
(6 to 23.5)
8
(2 to 17)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active Group, Placebo Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .115
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
21.Post-Hoc Outcome
Title Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 6 Month in Patients With Hospital Anxiety and Depression Scale (HADS) Scores of Less Than 11.
Hide Description WOMAC score at 6 months in patients with Hospital Anxiety and Depression Scale (HADS) Scores of less than 11.The WOMAC score is a survey comprised of 24 items divided into three subscales:Pain (5 items), stiffness (2 items), and physical function (17 items). Subjects are asked a range of questions about their ability to carry out daily activities such as using the stairs, rising from sitting, lying in bed and conducting light or heavy domestic duties. Items are scored on a scale of 0-4 (lower scores indicate lower levels of symptoms or physical disability). Summed for a combined WOMAC score of 0 (low) to 96 (high) Higher scores indicate worse pain, stiffness, and functional limitation. The Hospital Anxiety and Depression Scores (HADS) is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression.The questionnaire is scored from 0-3 and this means that a person can score between 0 (low) and 21 (high) for either anxiety or depression.
Time Frame 6 month post operative
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Group Placebo Group
Hide Arm/Group Description:

Radiofrequency ablation procedure of the three articular branches of the knee joint. The targets will be thermally lesioned for 2 minutes 30 seconds thereby causing neurolysis.

Radiofrequency Ablation (RFA): The radiofrequency generator which will be turned on but will not be in the patient's view. The skin overlying the target sites identified with image guidance will be numb using lidocaine 1%. A needle will be placed through the skin to be optimally positioned according to the three targets. Sensory and motor testing will be performed to confirm appropriate placement. Lidocaine 2% 1-2cc will be injected prior to lesioning.

Simulated Radiofrequency Ablation procedure of the three articular branches of the knee joint.The targets will be not be thermally lesioned for 2 minutes 30 seconds therefore not causing neurolysis.

Simulated Radiofrequency Ablation (RFA): The radiofrequency generator which will be turned on but will not be in the patient's view. The skin overlying the target sites identified with image guidance will be numb using lidocaine 1%. A needle will be placed through the skin to be optimally positioned according to the three targets. Sensory and motor testing will be performed to confirm appropriate placement. Lidocaine 2% 1-2cc will be injected. A simulate sham lesion will be performed at each target site.

Overall Number of Participants Analyzed 29 27
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
9
(4 to 20)
9
(1 to 14)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active Group, Placebo Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .349
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame Collection of adverse events 48 hours after total knee arthroplasty.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Active Group Placebo Group
Hide Arm/Group Description

Radiofrequency ablation procedure of the three articular branches of the knee joint. The targets will be thermally lesioned for 2 minutes 30 seconds thereby causing neurolysis.

Radiofrequency Ablation (RFA): The radiofrequency generator which will be turned on but will not be in the patient's view. The skin overlying the target sites identified with image guidance will be numb using lidocaine 1%. A needle will be placed through the skin to be optimally positioned according to the three targets. Sensory and motor testing will be performed to confirm appropriate placement. Lidocaine 2% 1-2cc will be injected prior to lesioning.

Simulated Radiofrequency Ablation procedure of the three articular branches of the knee joint.The targets will be not be thermally lesioned for 2 minutes 30 seconds therefore not causing neurolysis.

Simulated Radiofrequency Ablation (RFA): The radiofrequency generator which will be turned on but will not be in the patient's view. The skin overlying the target sites identified with image guidance will be numb using lidocaine 1%. A needle will be placed through the skin to be optimally positioned according to the three targets. Sensory and motor testing will be performed to confirm appropriate placement. Lidocaine 2% 1-2cc will be injected. A simulate sham lesion will be performed at each target site.

All-Cause Mortality
Active Group Placebo Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/35 (0.00%)      0/32 (0.00%)    
Hide Serious Adverse Events
Active Group Placebo Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/35 (0.00%)      0/32 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Active Group Placebo Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/35 (22.86%)      9/32 (28.13%)    
Gastrointestinal disorders     
Nausea  1  8/35 (22.86%)  8 9/32 (28.13%)  9
Skin and subcutaneous tissue disorders     
Puritis  2 [1]  8/35 (22.86%)  8 9/32 (28.13%)  9
1
Term from vocabulary, Nausea
2
Term from vocabulary, Puritis
Indicates events were collected by systematic assessment
[1]
Puritis experienced up to 48 hours after surgery.
During the study 2016-2018 there was increased patient and physician awareness of opioid abuse epidemic in the US. Fear of opioid addiction and increased pressure on physician may have influenced post operative opioid use and primary outcome
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: David Walega, MD
Organization: Northwestern University
Phone: 312-695-0061
EMail: d-walega@northwestern.edu
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Responsible Party: David Walega, Northwestern University
ClinicalTrials.gov Identifier: NCT02746874    
Other Study ID Numbers: STU00200439
First Submitted: April 18, 2016
First Posted: April 21, 2016
Results First Submitted: August 20, 2019
Results First Posted: February 2, 2021
Last Update Posted: February 2, 2021