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Nerve Ablation by Cooled Radiofrequency Compared to Corticosteroid Injection for Management of Knee Pain

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ClinicalTrials.gov Identifier: NCT02343003
Recruitment Status : Completed
First Posted : January 21, 2015
Results First Posted : October 9, 2017
Last Update Posted : May 13, 2019
Sponsor:
Information provided by (Responsible Party):
Halyard Health

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Osteoarthritis of the Knee
Interventions Device: Cooled Radiofrequency
Drug: Corticosteroid injection
Enrollment 151
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cooled Radiofrequency Corticosteroid Injection
Hide Arm/Group Description

Cooled radiofrequency energy will be delivered to study subjects' knees to ablate culprit sensory nerves and reduce knee pain

Cooled Radiofrequency: Delivery of energy to ablate sensory nerves via cooled radiofrequency probe

Corticosteroid injections will be administered to study subjects' knees to reduce knee pain

Corticosteroid injection: Delivery of corticosteroid into knee by injection with needle to reduce knee pain

Period Title: Overall Study
Started 76 75
Completed [1] 58 68
Not Completed 18 7
Reason Not Completed
Withdrawal by Subject             9             4
Lost to Follow-up             5             1
Protocol Violation             1             0
Death             0             1
exclusion criteria met             1             1
terminated by sponsor             2             0
[1]
Completion is with respect to the 6-month primary outcome.
Arm/Group Title Cooled Radiofrequency Corticosteroid Injection Total
Hide Arm/Group Description

Cooled radiofrequency energy will be delivered to study subjects' knees to ablate culprit sensory nerves and reduce knee pain

Cooled Radiofrequency: Delivery of energy to ablate sensory nerves via cooled radiofrequency probe

Corticosteroid injections will be administered to study subjects' knees to reduce knee pain

Corticosteroid injection: Delivery of corticosteroid into knee by injection with needle to reduce knee pain

Total of all reporting groups
Overall Number of Baseline Participants 76 75 151
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 76 participants 75 participants 151 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
45
  59.2%
30
  40.0%
75
  49.7%
>=65 years
31
  40.8%
45
  60.0%
76
  50.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 76 participants 75 participants 151 participants
63  (11.9) 66.1  (13.1) 64.6  (12.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 76 participants 75 participants 151 participants
Female
50
  65.8%
49
  65.3%
99
  65.6%
Male
26
  34.2%
26
  34.7%
52
  34.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 76 participants 75 participants 151 participants
76 75 151
1.Primary Outcome
Title Numeric Rating Scale (NRS)
Hide Description The number of subjects whose knee pain is reduced by ≥ 50% based on the Numeric Rating Scale (NRS). The NRS is an 11-point scale (0 points to 10 points), where 0 points equals "no pain" and 10 points equals the "worst pain".
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
58 of the 76 originally-randomized study subjects in the Cooled radiofrequency group completed this 6 month outcome. 68 of the originally-randomized 75 study subjects in the Corticosteroid injection group completed this 6 month outcome.
Arm/Group Title Cooled Radiofrequency Corticosteroid Injection
Hide Arm/Group Description:

Cooled radiofrequency energy will be delivered to study subjects' knees to ablate culprit sensory nerves and reduce knee pain

Cooled Radiofrequency: Delivery of energy to ablate sensory nerves via cooled radiofrequency probe

Corticosteroid injections will be administered to study subjects' knees to reduce knee pain

Corticosteroid injection: Delivery of corticosteroid into knee by injection with needle to reduce knee pain

Overall Number of Participants Analyzed 58 68
Measure Type: Count of Participants
Unit of Measure: Participants
43
  74.1%
11
  16.2%
2.Primary Outcome
Title Safety: Number of Subjects Experiencing Adverse Events Through Final Follow up.
Hide Description Safety Endpoint: Number of subjects experiencing adverse events through final follow up.
Time Frame 6 months and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cooled Radiofrequency Corticosteroid Injection
Hide Arm/Group Description:

Cooled radiofrequency energy will be delivered to study subjects' knees to ablate culprit sensory nerves and reduce knee pain

Cooled Radiofrequency: Delivery of energy to ablate sensory nerves via cooled radiofrequency probe

Corticosteroid injections will be administered to study subjects' knees to reduce knee pain

Corticosteroid injection: Delivery of corticosteroid into knee by injection with needle to reduce knee pain

Overall Number of Participants Analyzed 76 75
Measure Type: Count of Participants
Unit of Measure: Participants
6 months post-intervention
34
  44.7%
31
  41.3%
12 months post-intervention
12
  15.8%
3
   4.0%
3.Secondary Outcome
Title Numeric Rating Scale
Hide Description The number of subjects whose knee pain is reduced from baseline by ≥ 50% based on the Numeric Rating Scale (NRS) at 12 months. The NRS is an 11-point scale (0 points to 10 points), where 0 points equals "no pain" and 10 points equals the "worst pain".
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
52 of the 76 originally-randomized study subjects in the Cooled radiofrequency group completed this 12 month outcome. 4 of the originally-randomized 75 study subjects in the Corticosteroid injection group completed this 12 month outcome.
Arm/Group Title Cooled Radiofrequency Corticosteroid Injection
Hide Arm/Group Description:

Cooled radiofrequency energy will be delivered to study subjects' knees to ablate culprit sensory nerves and reduce knee pain

Cooled Radiofrequency: Delivery of energy to ablate sensory nerves via cooled radiofrequency probe

Corticosteroid injections will be administered to study subjects' knees to reduce knee pain

Corticosteroid injection: Delivery of corticosteroid into knee by injection with needle to reduce knee pain

Overall Number of Participants Analyzed 52 4
Measure Type: Count of Participants
Unit of Measure: Participants
34
  65.4%
2
  50.0%
4.Secondary Outcome
Title Oxford Knee Score
Hide Description Improvement in global outcome from baseline as measured by the Oxford Knee Score at 6 months and 12 months. The Oxford Knee Score is determined by a 12-question survey that measures knee function, and is scored on a scale that ranges from 0 - 48 points, with scores of 0 - 19 = "severe arthritis", 20 - 29 = "moderate to severe arthritis", 30 - 39 = "mild to moderate arthritis", and 40 - 48 = "satisfactory joint function".
Time Frame 6 months and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
58 of the 76 originally-randomized study subjects in the Cooled radiofrequency group completed this 6 month outcome. 67 of the originally-randomized 75 study subjects in the Corticosteroid injection group completed this 6 month outcome. 12 months: 52/76 in Cooled radiofrequency group and 3/75 in Corticosteroid injection group completed.
Arm/Group Title Cooled Radiofrequency Corticosteroid Injection
Hide Arm/Group Description:

Cooled radiofrequency energy will be delivered to study subjects' knees to ablate culprit sensory nerves and reduce knee pain

Cooled Radiofrequency: Delivery of energy to ablate sensory nerves via cooled radiofrequency probe

Corticosteroid injections will be administered to study subjects' knees to reduce knee pain

Corticosteroid injection: Delivery of corticosteroid into knee by injection with needle to reduce knee pain

Overall Number of Participants Analyzed 58 67
Mean (Standard Deviation)
Unit of Measure: units on a scale
6 months post-intervention Number Analyzed 58 participants 67 participants
18.5  (9.9) 5.7  (8.9)
12 months post-intervention Number Analyzed 52 participants 3 participants
17.3  (12) 8.7  (9.9)
5.Other Pre-specified Outcome
Title Subject Satisfaction - Number of Participants With a Global Perceived Effect Score of 5 or Greater
Hide Description Subject satisfaction as measured by the Global Perceived Effect Score at 6 months and 12 months. The study subjects' perception of treatment effect was reflected by the Global Perceived Effect (GPE). The Global Perceived Effect is a 7-point scale: 1 point = "worst ever", 2 points = "much worse", 3 points = "worse", 4 points = "not improved but not worse", 5 points = "improved", 6 points = "much improved", 7 points = "best ever".
Time Frame 6 months and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
58 of the 76 originally-randomized study subjects in the Cooled radiofrequency group completed this 6 month outcome. 67 of the originally-randomized 75 study subjects in the Corticosteroid injection group completed this 6 month outcome. 12 months: 52/76 in Cooled radiofrequency group and 4/75 in Corticosteroid injection group completed.
Arm/Group Title Cooled Radiofrequency Corticosteroid Injection
Hide Arm/Group Description:

Cooled radiofrequency energy will be delivered to study subjects' knees to ablate culprit sensory nerves and reduce knee pain

Cooled Radiofrequency: Delivery of energy to ablate sensory nerves via cooled radiofrequency probe

Corticosteroid injections will be administered to study subjects' knees to reduce knee pain

Corticosteroid injection: Delivery of corticosteroid into knee by injection with needle to reduce knee pain

Overall Number of Participants Analyzed 58 67
Measure Type: Count of Participants
Unit of Measure: Participants
6 months post-intervention Number Analyzed 58 participants 67 participants
53
  91.4%
16
  23.9%
12 months post-intervention Number Analyzed 52 participants 4 participants
39
  75.0%
2
  50.0%
6.Other Pre-specified Outcome
Title Medication Usage
Hide Description Reduction in pain medication usage from baseline as measured by subject self-reported average daily dosage.
Time Frame 6 months and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
17 of the 76 originally-randomized study subjects in the Cooled radiofrequency group completed this 6 month outcome. 25 of the originally-randomized 75 study subjects in the Corticosteroid injection group completed this 6 month outcome. 12 months: 17/76 in Cooled radiofrequency group and 2/75 in Corticosteroid injection group completed.
Arm/Group Title Cooled Radiofrequency Corticosteroid Injection
Hide Arm/Group Description:

Cooled radiofrequency energy will be delivered to study subjects' knees to ablate culprit sensory nerves and reduce knee pain

Cooled Radiofrequency: Delivery of energy to ablate sensory nerves via cooled radiofrequency probe

Corticosteroid injections will be administered to study subjects' knees to reduce knee pain

Corticosteroid injection: Delivery of corticosteroid into knee by injection with needle to reduce knee pain

Overall Number of Participants Analyzed 17 25
Mean (Standard Deviation)
Unit of Measure: milligrams
6 months post-intervention Number Analyzed 17 participants 25 participants
2.4  (8.3) -0.6  (9.8)
12 months post-intervention Number Analyzed 17 participants 2 participants
1  (10.3) 2.5  (17.7)
Time Frame 12 months
Adverse Event Reporting Description A protocol-directed review of adverse events at pre-specified time points was conducted to collect the adverse events.
 
Arm/Group Title Cooled Radiofrequency Corticosteroid Injection
Hide Arm/Group Description

Cooled radiofrequency energy will be delivered to study subjects' knees to ablate culprit sensory nerves and reduce knee pain

Cooled Radiofrequency: Delivery of energy to ablate sensory nerves via cooled radiofrequency probe

Corticosteroid injections will be administered to study subjects' knees to reduce knee pain

Corticosteroid injection: Delivery of corticosteroid into knee by injection with needle to reduce knee pain

All-Cause Mortality
Cooled Radiofrequency Corticosteroid Injection
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Cooled Radiofrequency Corticosteroid Injection
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/76 (3.95%)      9/75 (12.00%)    
Cardiac disorders     
cardiovascular   0/76 (0.00%)  0 2/75 (2.67%)  2
Gastrointestinal disorders     
gastrointestinal   0/76 (0.00%)  0 3/75 (4.00%)  4
General disorders     
other  [1]  0/76 (0.00%)  0 2/75 (2.67%)  2
Infections and infestations     
infection   1/76 (1.32%)  1 0/75 (0.00%)  0
Musculoskeletal and connective tissue disorders     
procedure   1/76 (1.32%)  1 1/75 (1.33%)  1
Renal and urinary disorders     
urogenital   1/76 (1.32%)  1 1/75 (1.33%)  1
Respiratory, thoracic and mediastinal disorders     
respiratory   1/76 (1.32%)  3 0/75 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Adverse events were monitored/assessed without regard to the specific adverse event term
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cooled Radiofrequency Corticosteroid Injection
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   43/76 (56.58%)      25/75 (33.33%)    
Blood and lymphatic system disorders     
blood/lymphatic   0/76 (0.00%)  0 1/75 (1.33%)  1
Endocrine disorders     
endocrine/metabolic   1/76 (1.32%)  1 1/75 (1.33%)  1
Gastrointestinal disorders     
gastrointestinal   3/76 (3.95%)  3 2/75 (2.67%)  5
General disorders     
extremities  [1]  36/76 (47.37%)  46 18/75 (24.00%)  24
head, eyes, ears, nose, throat   1/76 (1.32%)  1 2/75 (2.67%)  2
other  [2]  4/76 (5.26%)  6 6/75 (8.00%)  10
Musculoskeletal and connective tissue disorders     
musculoskeletal   8/76 (10.53%)  10 3/75 (4.00%)  5
Nervous system disorders     
neurological   2/76 (2.63%)  2 1/75 (1.33%)  3
Renal and urinary disorders     
urogenital   0/76 (0.00%)  0 2/75 (2.67%)  2
Respiratory, thoracic and mediastinal disorders     
respiratory   0/76 (0.00%)  0 7/75 (9.33%)  7
Skin and subcutaneous tissue disorders     
skin   2/76 (2.63%)  2 2/75 (2.67%)  2
Indicates events were collected by systematic assessment
[1]
infection, pain: treated knee, contralateral knee, both knees
[2]
Adverse events were monitored/assessed without regard to the specific adverse event term
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 Curd
Organization: Halyard Health
Phone: 470-448-5178
EMail: david.curd@hyh.com
Layout table for additonal information
Responsible Party: Halyard Health
ClinicalTrials.gov Identifier: NCT02343003    
Other Study ID Numbers: 105-14-0001
First Submitted: January 15, 2015
First Posted: January 21, 2015
Results First Submitted: August 8, 2017
Results First Posted: October 9, 2017
Last Update Posted: May 13, 2019