Comparing Pain Outcomes of Treatment Strategies for Osteoarthritis Knee Patients

NCT05700253 | Unknown

• 1 other identifier: Osteoarthritis01
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

cooled radiofrequency ablation; hyaluronic acid injection

Outcome Measures

Primary Outcomes (1)

• Extent of reduction of pain score

  11-point Visual Analogue Scale

  6 months

Secondary Outcomes (5)

• Proportion of subjects ("responders") whose knee pain is reduced by at least 50% from baseline up to 6 months after treatment.

  6 months

• Overall knee pain score

  6 months

• Opinion of knee injury and treatment outcomes

  6 months

• Perception of treatment effect

  6 months

• Health related quality of life

  6 months

Study Arms (2)

Cooled Radiofrequency Ablation

EXPERIMENTAL

Relieves pain by blocking pain signals via the deactivation of nerve structures using radiofrequency energy.

Device: Cooled Radiofrequency Ablation

Hyaluronic Acid Injection

ACTIVE COMPARATOR

Injection of hyaluronic acid into the affected knee provides lubrication and shock absorption.

Device: Hyaluronic Acid Injection

Interventions

Cooled Radiofrequency Ablation DEVICE

Image-guided genicular nerve ablation will be performed with the Coolief System (COOLIEF\* CRFA; Avanos Medical).

Cooled Radiofrequency Ablation

Hyaluronic Acid Injection DEVICE

Synvisc-One (\[Hylan G-F 20\]; Sanofi) will be administered as a single intra-articular dose (6 mL).

Hyaluronic Acid Injection

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 21 years
• Able to understand the informed consent form and provide written informed consent and able to complete outcome measures
• Chronic knee pain for longer than 3 months that interferes with functional activities (for example, ambulation, prolonged standing, etc.)
• 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.)
• Positive response (defined as a decrease in numeric pain scores of at least 50%) to a single genicular nerve block of the index knee
• Pain on VAS ≥ 6 on an 11-point scale for the index knee
• 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
• An intra-articular HA injection is indicated as an appropriate treatment option
• 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
• Agree to see one physician (study physician) for knee pain during the study period
• Willing to delay any surgical intervention for the index knee for the period of the study follow up
• Willing to comply with the requirements of this protocol for the full duration of the study

You may not qualify if:

• Evidence of inflammatory arthritis (for example, rheumatoid arthritis) or other systemic inflammatory condition (for example, gout, fibromyalgia) that could cause knee pain
• Evidence of neuropathic pain secondary to other causes (e.g., sciatica), apart from OA knee, affecting the index knee
• Previous or pending lower limb amputation
• Intra-articular steroid or PRP injection or Radiofrequency lesioning into the index knee within 180 days from randomization
• Hyaluronic acid injection, PRP injection, stem cell, or arthroscopic debridement/lavage injection into the index knee within 180 days from randomization
• Prior partial, resurfacing, or total knee arthroplasty of the index knee (residual hardware)
• Clinically significant ligamentous laxity of the index knee
• 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
• Body mass index (BMI) \> 45 kg/m2 or \< 18 kg/m2
• Extremely thin patients and those with minimal subcutaneous tissue thickness that would not accommodate a radiofrequency lesion of up to 14 mm in diameter to limit the risk of skin burns
• Pending or active compensation claim, litigation, or disability remuneration (secondary gain)
• Pregnant, nursing or intent of becoming pregnant during the study period
• Chronic pain associated with significant psychosocial dysfunction
• Patients with known psychiatric history including severe mental health issues.
• Allergies to any of the medications to be used during the procedures, including known hypersensitivity (allergy) to hyaluronate preparations or allergies to avian or avian-derived products (including eggs, feathers, or poultry)

Sponsors & Collaborators

• Changi General Hospital: lead

Study Sites (1)

Changi General Hospital

Singapore, 529889, Singapore

Location

Related Publications (5)

• Wu L, Li Y, Si H, Zeng Y, Li M, Liu Y, Shen B. Radiofrequency Ablation in Cooled Monopolar or Conventional Bipolar Modality Yields More Beneficial Short-Term Clinical Outcomes Versus Other Treatments for Knee Osteoarthritis: A Systematic Review and Network Meta-Analysis of Randomized Controlled Trials. Arthroscopy. 2022 Jul;38(7):2287-2302. doi: 10.1016/j.arthro.2022.01.048. Epub 2022 Feb 12.

  PMID: 35157969 BACKGROUND

• Oladeji LO, Cook JL. Cooled Radio Frequency Ablation for the Treatment of Osteoarthritis-Related Knee Pain: Evidence, Indications, and Outcomes. J Knee Surg. 2019 Jan;32(1):65-71. doi: 10.1055/s-0038-1675418. Epub 2018 Nov 5.

  PMID: 30396206 BACKGROUND

• Chen AF, Khalouf F, Zora K, DePalma M, Kohan L, Guirguis M, Beall D, Loudermilk E, Pingree MJ, Badiola I, Lyman J. Cooled radiofrequency ablation provides extended clinical utility in the management of knee osteoarthritis: 12-month results from a prospective, multi-center, randomized, cross-over trial comparing cooled radiofrequency ablation to a single hyaluronic acid injection. BMC Musculoskelet Disord. 2020 Jun 9;21(1):363. doi: 10.1186/s12891-020-03380-5.

  PMID: 32517739 BACKGROUND

• Chen AF, Khalouf F, Zora K, DePalma M, Kohan L, Guirguis M, Beall D, Loudermilk E, Pingree M, Badiola I, Lyman J. Cooled Radiofrequency Ablation Compared with a Single Injection of Hyaluronic Acid for Chronic Knee Pain: A Multicenter, Randomized Clinical Trial Demonstrating Greater Efficacy and Equivalent Safety for Cooled Radiofrequency Ablation. J Bone Joint Surg Am. 2020 Sep 2;102(17):1501-1510. doi: 10.2106/JBJS.19.00935.

  PMID: 32898379 BACKGROUND

• Lyman J, Khalouf F, Zora K, DePalma M, Loudermilk E, Guiguis M, Beall D, Kohan L, Chen AF. Cooled radiofrequency ablation of genicular nerves provides 24-Month durability in the management of osteoarthritic knee pain: Outcomes from a prospective, multicenter, randomized trial. Pain Pract. 2022 Jul;22(6):571-581. doi: 10.1111/papr.13139. Epub 2022 Jun 29.

  PMID: 35716058 BACKGROUND

Related Links

• Avanos Coolief System

MeSH Terms

Conditions

Osteoarthritis, Knee; Pain

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Prit Anand Singh

  Changi General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Seok Hwee Koo, PhD

CONTACT

+6568504929; seok_hwee_koo@cgh.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant, Department of Anaesthesia and Surgical Intensive Care

Study Record Dates

• First Submitted: January 17, 2023
• First Posted: January 26, 2023
• Study Start: February 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: January 26, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)