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Comparing Pain Outcomes of Treatment Strategies for Osteoarthritis Knee Patients

Unknown statusNot applicableNCT05700253
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

The goal of this clinical trial is to compare two different pain relief techniques (cooled radiofrequency ablation (CRFA) and hyaluronic acid (HA) injection) for patients with knee osteoarthritis (OA) over a period of 6 months. The main questions it aims to answer are: * the extent of reduction of pain score and the proportion of subjects ("responders") whose knee pain is reduced by at least 50% from baseline up to 6 months after treatment in the two treatment groups. * the safety of the two treatment modalities. Participants will undergo a nerve block test to determine if they would experience pain relief from blocking of nerve signals. Responders will be randomised to receive one of the two treatments for their knee pain. Researchers will compare the pain intensity of CRFA and HA injection groups at baseline, 2 weeks, 1 month, 3 months and 6 months post-treatment using validated questionnaires.

Study details

Official title
Comparing Pain Outcomes of Cooled Radiofrequency Ablation and Hyaluronic Acid Therapies for Chronic Osteoarthritis Knee Patients
Interventions
  • Device: Cooled Radiofrequency Ablation
  • Device: Hyaluronic Acid Injection
Sponsor
Changi General Hospital
Start date
2023-02
Primary completion
2024-09
Sex
All
Age range
from 21 Years to 99 Years
Results posted
No results posted in this snapshot
Countries
Singapore
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Age ≥ 21 years 2. Able to understand the informed consent form and provide written informed consent and able to complete outcome measures 3. Chronic knee pain for longer than 3 months that interferes with functional activities (for example, ambulation, prolonged standing, etc.) 4. Continued pain in the target knee despite at least 3 months of conservative treatments, including activity modification, home exercise, protective weight bearing, and/or analgesics (for example, acetaminophen or non-steroidal anti-inflammatory drugs \[NSAIDs\] etc.) 5. Positive response (defined as a decrease in numeric pain scores of at least 50%) to a single genicular nerve block of the index knee 6. Pain on VAS ≥ 6 on an 11-point scale for the index knee 7. Radiologic confirmation of arthritis (x-ray/MRI/CT) of OA grade of 2 (mild), 3 (moderate) or 4 (severe) noted within 6 months for the index knee 8. An intra-articular HA injection is indicated as an appropriate treatment option 9. WOMAC Knee Score group at baseline of Score of ≥ 2 (0 to 4 scale) on WOMAC question 1 (Pain) and a mean score of ≥ 1.5 on all five questions of the WOMAC pain subscale 10. Agree to see one physician (study physician) for knee pain during the study period 11. Willing to delay any surgical intervention for the index knee for the period of the study follow up 12. Willing to comply with the requirements of this protocol for the full duration of the study Exclusion Criteria: 1. Evidence of inflammatory arthritis (for example, rheumatoid arthritis) or other systemic inflammatory condition (for example, gout, fibromyalgia) that could cause knee pain 2. Evidence of neuropathic pain secondary to other causes (e.g., sciatica), apart from OA knee, affecting the index knee 3. Previous or pending lower limb amputation 4. Intra-articular steroid or PRP injection or Radiofrequency lesioning into the index knee within 180 days from randomization 5. Hyaluronic acid injection, PRP injection, stem cell, or arthroscopic debridement/lavage injection into the index knee within 180 days from randomization 6. Prior partial, resurfacing, or total knee arthroplasty of the index knee (residual hardware) 7. Clinically significant ligamentous laxity of the index knee 8. Clinically significant valgus/varus deformities or evidence of pathology (other than osteoarthritis of knee) that materially affects gait or function of the knee or is the underlying cause of the knee pain and/or functional limitations 9…

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05700253