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

• 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: Halyard Health
• 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

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Cooled Radiofrequency	Corticosteroid Injection
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.

Baseline Characteristics

Arm/Group Title		Cooled Radiofrequency	Corticosteroid Injection	Total
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
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

Outcome Measures

1. Primary Outcome

Title	Numeric Rating Scale (NRS)
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

Outcome Measure Data

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
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.
Description	Safety Endpoint: Number of subjects experiencing adverse events through final follow up.
Time Frame	6 months and 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cooled Radiofrequency	Corticosteroid Injection
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
Description	Reduction in pain medication usage from baseline as measured by subject self-reported average daily dosage.
Time Frame	6 months and 12 months

Outcome Measure Data

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
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)

Adverse Events

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
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	--/--		--/--
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
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

Limitations and Caveats

[Not Specified]

More Information

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

• Name/Title: David Curd
• Organization: Halyard Health
• Phone: 470-448-5178
• EMail: david.curd@hyh.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Davis T, Loudermilk E, DePalma M, Hunter C, Lindley DA, Patel N, Choi D, Soloman M, Gupta A, Desai M, Cook E, Kapural L. Twelve-month analgesia and rescue, by cooled radiofrequency ablation treatment of osteoarthritic knee pain: results from a prospective, multicenter, randomized, cross-over trial. Reg Anesth Pain Med. 2019 Feb 16. pii: rapm-2018-100051. doi: 10.1136/rapm-2018-100051. [Epub ahead of print]

Davis T, Loudermilk E, DePalma M, Hunter C, Lindley D, Patel N, Choi D, Soloman M, Gupta A, Desai M, Buvanendran A, Kapural L. Prospective, Multicenter, Randomized, Crossover Clinical Trial Comparing the Safety and Effectiveness of Cooled Radiofrequency Ablation With Corticosteroid Injection in the Management of Knee Pain From Osteoarthritis. Reg Anesth Pain Med. 2018 Jan;43(1):84-91. doi: 10.1097/AAP.0000000000000690.

• 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