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Comparing Pain Outcomes of Treatment Strategies for Osteoarthritis Knee Patients

NCT05700253 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2023-01-26

No results posted yet for this study

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.

Conditions

  • Osteoarthritis, Knee
  • Pain

Interventions

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).

Sponsors & Collaborators

  • Changi General Hospital

    lead OTHER

Principal Investigators

  • Prit Anand Singh · Changi General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-28
Primary Completion
2024-09-30
Completion
2024-09-30

Countries

  • Singapore

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05700253 on ClinicalTrials.gov