NCT05700253

Comparing Pain Outcomes of Treatment Strategies for Osteoarthritis Knee Patients

Comparing Pain Outcomes of Cooled Radiofrequency Ablation and Hyaluronic Acid Therapies for Chronic Osteoarthritis Knee Patients

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 76 (estimated)
• Sponsor: Changi General Hospital · Academic / Other
• Sex: All
• Age: 21 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This study will be a single-centred, open-label, prospective randomized controlled study to compare the extent of OA-related knee pain relief between subjects who undergo radiofrequency lesioning (COOLIEF\* CRFA; Avanos Medical) of the genicular nerves and subjects who receive a single intra-articular HA injection (Synvisc-One \[Hylan G-F 20\]; Sanofi). Study subjects will receive CRFA or HA injection in a 1:1 randomization scheme, with post-treatment data collection at 2 weeks, 1 month, 3 months and 6 months. Six months was chosen as the duration of follow-up as that is the expected duration of medical improvement following HA injection for chronic knee pain. Knee pain, function, overall subject impressions of treatment, quality of life, pain medication use, and adverse events will be compared among the treatment cohorts. The study is open-label as blinding is not possible due to the differences in administration of injection and CRFA, hence both the patient and the investigator will be aware of the treatment type. The primary endpoints will be the extent of reduction of pain score measured via 11-point visual analogue scale (VAS). Secondary outcomes will include proportion of subjects ("responders") whose knee pain is reduced by at least 50% from baseline up to 6 months after treatment, patients' overall knee pain score as measured via Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), subjects' perception of treatment effect as measured via Knee injury and Osteoarthritis Outcome Score (KOOS), patients' perception of treatment effect via Global Perceived Effect (GPE) score and health related quality of life via EuroQol-5 Dimensions 5 Level (EQ-5D-5L). Assessments of these study endpoints will be made at baseline, 2 weeks, 1 month, 3 months and 6 months following treatment.

Conditions

• Osteoarthritis, Knee
• Pain

Interventions

Type	Name	Description
DEVICE	Cooled Radiofrequency Ablation	Image-guided genicular nerve ablation will be performed with the Coolief System (COOLIEF\* CRFA; Avanos Medical).
DEVICE	Hyaluronic Acid Injection	Synvisc-One (\[Hylan G-F 20\]; Sanofi) will be administered as a single intra-articular dose (6 mL).

Timeline

• Start date: 2023-02-01
• Primary completion: 2024-09-01
• Completion: 2024-09-01
• First posted: 2023-01-26
• Last updated: 2023-01-26

Locations

1 site across 1 country: Singapore