Heat and Acupuncture Randomised Controlled Trial to Manage Osteoarthritis of the Knee (HARMOKnee)
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 173
- Locations
- 2
- Primary Endpoint
- Knee Osteoarthritis Outcome Score (KOOS-12)
Study Overview
Brief Summary
Knee osteoarthritis (KOA) is one of the largest and fast-growing causes of pain, impaired mobility, and poor quality of life in the elderly worldwide. Despite a significant increase in Traditional Chinese Medicine (TCM) utilisation, in particular acupuncture, as first or second-line treatment among local KOA patients, there exists a lack of high-quality evidence on its efficacy and local practice guidelines for TCM use in KOA tailored to our specific population demographic.
HarmoKNEE trial aims to address these gaps by evaluating the short and medium-term clinical and cost-effectiveness of TCM acupuncture with far-infrared heat therapy in addition to standard care, compared to standard care alone. Through a robust process and economic evaluation, the investigators aim to inform evidence-based practice for KOA patients in Singapore to facilitate the large-scale implementation of a comprehensive and holistic model of care which harmonises elements from Western medicine and TCM.
The investigators hypothesize that acupuncture with heat therapy as an adjunct to standard care is clinically more effective than standard care alone.
This will be a multi-centre pragmatic, parallel-arm, single-blinded, effectiveness-implementation hybrid randomised control trial. KOA patients will be randomised to either the control arm (standard care only) or intervention arm (biweekly sessions of acupuncture with heat therapy over 6 weeks, in addition to standard care).
A mixed-method approach through an embedded process evaluation will facilitate large scale implementation. An economic evaluation will be performed to evaluate financial sustainability
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 45 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •45 to 99 years old
- •Independent Community Mobilizers with or without walking aids
- •Conversant in English or Chinese
- •NICE clinical criteria for OA knee
Exclusion Criteria
- •Alternative diagnosis to KOA e.g., referred pain from the spine or hip
- •Other forms of arthritis eg., inflammatory, post-traumatic
- •Inability to comply with study protocol e.g., cognitive impairment
- •Previous knee arthroplasty
- •Wheelchair-bound patients
- •Medical conditions that will medically interfere with study involvement e.g., decompensated heart failure, stroke, end-stage renal failure
- •Allergies to metal (needles)
Outcomes
Primary Outcomes
Knee Osteoarthritis Outcome Score (KOOS-12)
Time Frame: Baseline, Change from Baseline to 6 weeks, Change from Baseline to 3 months, Change from Baseline to 6 months
Derived from the original 42-item Knee injury and Osteoarthritis Outcome Score (KOOS), KOOS-12 reduces respondent burden by 70% from the original KOOS while providing scale scores for knee-specific Pain, Function and QOL, along with a summary measure of overall knee impact. The KOOS sub scales are scored using the method of summated ratings and transformed to range from 0 to 100, with 0 representing extreme knee problems and 100 representing no knee problem. The KOOS-12 Summary knee impact score is calculated as the average of the KOOS-12 Pain, KOOS-12 Function and KOOS-12 QOL scale scores. It also ranges from 0 to 100, where 0 is the worst possible and 100 is the best possible score.
Secondary Outcomes
- Knee Injury and Osteoarthritis Outcomes Score (KOOS) subscales - Pain, Function, QoL(Baseline, Change from Baseline to 6 weeks, Change from Baseline to 3 months, Change from Baseline to 6 months)
- TCM Evaluation Form(Assess at Week 1 (start of treatment, before the 1st acupuncture session), Week 4 (mid-treatment, before the 7th acupuncture session) and Week 6 (end of treatment, after the 12th / last acupuncture session).)
- Patient Health Questionnaire 4 (PHQ-4)(Baseline, Change from Baseline to 6 weeks, Change from Baseline to 3 months, Change from Baseline to 6 months)
- Functional Assessment - Timed up and go test(Baseline, Change from Baseline to 3 months, Change from Baseline to 6 months)
- EuroQol-5 Dimensions (EQ-5D-5L)(Baseline, Change from Baseline to 6 weeks, Change from Baseline to 3 months, Change from Baseline to 6 months)
- Pain, Enjoyment, General Activity Scale (PEG)(Baseline, Change from Baseline to 6 weeks, Change from Baseline to 3 months, Change from Baseline to 6 months)
- VAS & ROM Evaluation Form(Assess weekly for the first 6 weeks from the start of treatment)
- Functional Assessment - 30s chair stand test(Baseline, Change from Baseline to 3 months, Change from Baseline to 6 months)
- Functional Assessment - 40m fast-paced walk test(Baseline, Change from Baseline to 3 months, Change from Baseline to 6 months)
- Functional Assessment - 4 stairs climb test(Baseline, Change from Baseline to 3 months, Change from Baseline to 6 months)
Investigators
Bryan Tan
Consultant
National Healthcare Group, Singapore