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 : December 26, 2017
This study is designed to:
- Determine the effectiveness (primarily measured by pain relief) of Coolief when used to create radiofrequency lesions of the genicular nerves compared to pain relief following corticosteroid injection; and
- Confirm the safety of Coolief when used to perform radiofrequency lesions of the genicular nerves in subjects to manage knee pain compared to safety of corticosteroid injection
|Condition or disease||Intervention/treatment|
|Osteoarthritis of the Knee||Device: Cooled Radiofrequency Drug: Corticosteroid injection|
This is a prospective, randomized, multicenter comparison study examining the outcomes of subjects having knee pain undergoing a procedure to create a radiofrequency lesion of the genicular nerves with the Coolief system compared to subjects receiving corticosteroid injection. A total of approximately 144 subjects will be enrolled into this study with subjects undergoing either radiofrequency neurotomy or corticosteroid injection in a 1:1 randomization scheme. Follow up will be conducted for a total of 12 months post Coolief procedure with the primary endpoint being completed at month 6. Subjects randomized to the comparison (corticosteroid) group will have the option to cross over to the neurotomy group after completing the 6 month endpoint assessment. They would then be followed for an additional 6 months. Pain, overall outcome, quality of life, pain medication use, and adverse events will be compared between the two treatment groups in order to determine success.
Primary Effectiveness Endpoint:
The proportion of subjects whose knee pain is reduced by ≥ 50% based on the NRS scale at 6 Months.
Primary Safety Endpoint:
The proportion of subjects experiencing adverse events through final follow up.
Secondary Effectiveness Endpoints:
- The proportion of subjects whose knee pain is reduced from baseline by ≥ 50% based on the Numeric Rating Scale (NRS) at 12 months.
- Improvement in global outcome from baseline as measured by the Oxford Knee Score at 6 months and 12 months.
Tertiary Effectiveness Endpoint:
Subject satisfaction as measured by the Global Perceived Effect Score at 6 months and 12 months.
Quaternary Effectiveness Endpoint:
Reduction in pain medication usage from baseline as measured by subject self-reported average daily dosage.
In addition, exploratory analyses of health economic indicators may be performed.
Subjects will participate in the study for up to 13 months (2 week roll-in period + treatment visit + 12 month follow up), except for subjects who participate in the optional crossover group. These crossover subjects will be on study for up to 15 months (2 week roll-in + treatment + 6 month follow-up and crossover + 6 month follow up). Enrollment is anticipated to take approximately 6-8 months.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||151 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Multi-Center, RCT Evaluating the Safety and Effectiveness of Coolief™ Cooled Radiofrequency Probe to Create Lesions of the Genicular Nerves and Comparing Corticosteroid Injection in the Management of Knee Pain|
|Actual Study Start Date :||January 2015|
|Primary Completion Date :||August 2016|
|Study Completion Date :||March 16, 2017|
Experimental: Cooled radiofrequency
Cooled radiofrequency energy will be delivered to study subjects' knees to ablate culprit sensory nerves and reduce knee pain
Device: Cooled Radiofrequency
Delivery of energy to ablate sensory nerves via cooled radiofrequency probe
Other Name: Coolief
Active Comparator: Corticosteroid injection
Corticosteroid injections will be administered to study subjects' knees to reduce knee pain
Drug: Corticosteroid injection
Delivery of corticosteroid into knee by injection with needle to reduce knee pain
- Numeric Rating Scale (NRS) [ Time Frame: 6 months ]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".
- Safety: Number of Subjects Experiencing Adverse Events Through Final Follow up. [ Time Frame: 6 months and 12 months ]Safety Endpoint: Number of subjects experiencing adverse events through final follow up.
- Numeric Rating Scale [ Time Frame: 12 months ]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".
- Oxford Knee Score [ Time Frame: 6 months and 12 months ]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".
- Subject Satisfaction - Number of Participants With a Global Perceived Effect Score of 5 or Greater [ Time Frame: 6 months and 12 months ]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".
- Medication Usage [ Time Frame: 6 months and 12 months ]Reduction in pain medication usage from baseline as measured by subject self-reported average daily dosage.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02343003
|United States, Arizona|
|Valley Anesthesiology Consultants - Estrella|
|Phoenix, Arizona, United States, 85037|
|Valley Anesthesiology Consultants/Valley Pain Consultants|
|Scottsdale, Arizona, United States, 85254|
|United States, California|
|Orthopedic Pain Specialists|
|Santa Monica, California, United States, 90403|
|United States, Illinois|
|Rush University Medical Center|
|Chicago, Illinois, United States, 60612|
|United States, Minnesota|
|MAPS Applied Research Center, Inc.|
|Maple Grove, Minnesota, United States, 55369|
|United States, New York|
|Ainsworth Institute of Pain Management|
|New York, New York, United States, 10022|
|United States, North Carolina|
|Center for Clinical Research|
|Winston-Salem, North Carolina, United States, 27103|
|United States, Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|United States, South Carolina|
|Piedmont Comprehensive Pain Management|
|Greenville, South Carolina, United States, 29622|
|United States, Virginia|
|Virginia iSpine Physicians|
|Richmond, Virginia, United States, 23235|
|United States, Wisconsin|
|Advanced Pain Management|
|Greenfield, Wisconsin, United States, 53221|
|Study Director:||David T Curd, MS||Halyard Health, Inc.|