A clinical trial to study the effect of nerve ablation for pain on knee muscle strength in patients with osteoarthritis
- Conditions
- Unilateral primary osteoarthritisof knee,
- Registration Number
- CTRI/2020/05/025363
- Lead Sponsor
- Post Graduate Institute of Medical Education and Research
- Brief Summary
A double blinded randomised clinical trial planned for assessing the effect of radio frequency ablation of genicular nerves on the isokinetic muscle strength of knee joint in patients with osteoarthritis knee. Patients with chronic pain from osteoarthritis knee not responding to oral analgesics or physiotherapy will be recruited into the trial. They will be randomised into either the intervention group or the control group based on computer generated random number envelopes.Baseline isokinetic muscle strength of knee, VNRS and WOMAC will be recorded for all patients.Patients belonging to the intervention group will receive thermal radio frequency ablation to SMGN, IMGN, SLGN. Patients in the control group will undergo a sham procedure wherein the radio frequency cannulas will be placed but no ablation will be delivered. Both groups will be followed up after 2 weeks, 1 month and 3 months of procedure. Isokinetic muscle strength, VNRS, WOMAC, Global perceived effects, Likert scale for compliance to physiotherapy will be assessed at each time point. Final data will be analysed to look for any improvement in muscle strength in patients who have received GNRF over those who did not.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- All
- Target Recruitment
- 60
patients having chronic knee osteoarthritis pain having VNRS > 50, KL grading of 2 or more, not responding to physiotherapy or oral analgesics.
patients with acute knee pain, history of trauma to the knees, prior knee surgery, connective tissue disorders, neurological or psychiatric disorders, received intraarticular injection with steroid or hyaluronic acid within 3 months, radicular leg pain, taking anticoagulant medications.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Effects of Radiofrequency ablation of genicular nerves on isokinetic strength of knee joint Baseline, 2 weeks, 1 month, 3 months
- Secondary Outcome Measures
Name Time Method Reduction in VNRS of knee pain in response to radio frequency ablation baseline, 2 weeks, 1 month and 3 months improvement in functionality assessed by WOMAC scale in response to radio frequency ablation baseline, 2 weeks, 1 month, 3 months patient perception of effect as assessed by GPE scale 2 weeks, 1 month, 3 months Compliance to the suggested physiotherapy regimen assessed by a Likert scale 2 weeks, 1 month, 3 months
Trial Locations
- Locations (1)
Post Graduate institute for Medical Education and Research
🇮🇳Chandigarh, CHANDIGARH, India
Post Graduate institute for Medical Education and Research🇮🇳Chandigarh, CHANDIGARH, IndiaJeetinder kaur MakkarPrincipal investigator7087009510jeet1516@gmail.com