Comparing Pain Outcomes of Treatment Strategies for Osteoarthritis Knee Patients

Sponsor

Changi General Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05700253

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis, Knee Pain	Device: Cooled Radiofrequency Ablation Device: Hyaluronic Acid Injection	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

76 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2024

Anticipated Study Completion Date :

Sep 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cooled Radiofrequency Ablation Relieves pain by blocking pain signals via the deactivation of nerve structures using radiofrequency energy.	Device: Cooled Radiofrequency Ablation Image-guided genicular nerve ablation will be performed with the Coolief System (COOLIEF* CRFA; Avanos Medical).
Active Comparator: Hyaluronic Acid Injection Injection of hyaluronic acid into the affected knee provides lubrication and shock absorption.	Device: Hyaluronic Acid Injection Synvisc-One ([Hylan G-F 20]; Sanofi) will be administered as a single intra-articular dose (6 mL).

Arm

Intervention/Treatment

Experimental: Cooled Radiofrequency Ablation

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

Device: Cooled Radiofrequency Ablation

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

Active Comparator: Hyaluronic Acid Injection

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

Device: Hyaluronic Acid Injection

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

Outcome Measures

Primary Outcome Measures

Extent of reduction of pain score [6 months]
11-point Visual Analogue Scale

Secondary Outcome Measures

Proportion of subjects ("responders") whose knee pain is reduced by at least 50% from baseline up to 6 months after treatment. [6 months]
11-point Visual Analogue Scale
Overall knee pain score [6 months]
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Opinion of knee injury and treatment outcomes [6 months]
Knee injury and Osteoarthritis Outcome Score (KOOS)
Perception of treatment effect [6 months]
Global Perceived Effect (GPE) score
Health related quality of life [6 months]
EuroQol-5 Dimensions 5 Level (EQ-5D-5L)

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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)
Active joint infection or systemic or localized infection at needle entry sites (subject may be considered for inclusion once infection is resolved)
History of uncontrolled coagulopathy, ongoing coagulation treatment that cannot be safely interrupted for procedure, or unexplained or uncontrollable bleeding that is not correctable
Identifiable anatomical variability that would materially alter the procedure as described in the protocol
Within the preceding 2 years, subject has suffered from active narcotic addiction, substance, or alcohol abuse
Current prescribed opioid medications greater than 60 milligrams morphine equivalent daily opioid dose
Uncontrolled immunosuppression (e.g., AIDS, cancer, diabetes, etc.)
Subject currently implanted with pacemaker, stimulator or defibrillator
Participating in another clinical trial/investigation within 30 days prior to signing informed consent
Subject unwilling or unable to comply with follow up schedule or protocol requirements