Heat and Acupuncture Randomised Controlled Trial to Manage Osteoarthritis of the Knee

Study Overview
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Brief Summary
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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

Official Title
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Heat and Acupuncture Randomised Controlled Trial to Manage Osteoarthritis of the Knee (HARMOKnee)

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Other: Acupuncture with Heat Therapy + Standard Care
* Other: Standard Care


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br> | Other: Standard Care<br>* Treatment as prescribed by orthopaedic surgeon routinely (e.g. physiotherapy, dietetics, pain management)<br>|
| Experimental: Intervention<br> | Other: Acupuncture with Heat Therapy + Standard Care<br>* Biweekly sessions of acupuncture with heat therapy over 6 weeks (total 12 sessions), in addition to standard care (e.g. physiotherapy, dietetics, pain management).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Osteoarthritis Outcome Score (KOOS-12) | 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. | Baseline, Change from Baseline to 6 weeks, Change from Baseline to 3 months, Change from Baseline to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Injury and Osteoarthritis Outcomes Score (KOOS) subscales - Pain, Function, QoL | The three subscales of KOOS-12 are scored separately: KOOS Pain (4 items); KOOS Function (4 items); KOOS QoL (4 items). A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the three scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems. | Baseline, Change from Baseline to 6 weeks, Change from Baseline to 3 months, Change from Baseline to 6 months | 
| EuroQol-5 Dimensions (EQ-5D-5L) | EuroQol-5 Dimensions (EQ-5D) consists of 2 dimensions, the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by selecting the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS will be used as a quantitative measure of health outcome. | Baseline, Change from Baseline to 6 weeks, Change from Baseline to 3 months, Change from Baseline to 6 months | 
| Patient Health Questionnaire 4 (PHQ-4) | Measurement for depression and anxiety rated on a 4 point Likert-type scale. 0 refers to 'Not at all', 3 refers 'Nearly everyday'. Total score is determined by adding together the scores of each of the 4 items. Scores are rated as normal (0-2), mild (3-5), moderate (6-8), and severe (9-12). Total score ≥3 for first 2 questions suggest anxiety. Total score ≥3 for last 2 questions suggest depression. | 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) | Measures the pain intensity and interference level using a three-item scale. Scale of 0 to 10 is used for each item. 0 refers 'no pain', 10 refers 'worse pain'. Add the responses to the three questions, then divide by three to get a mean score (out of 10) on overall impact of points. | Baseline, Change from Baseline to 6 weeks, Change from Baseline to 3 months, Change from Baseline to 6 months | 
| Functional Assessment - 30s chair stand test | To test leg strength and endurance. Total number of repetitions completed in 30 seconds is recorded. | Baseline, Change from Baseline to 3 months, Change from Baseline to 6 months | 
| Functional Assessment - 40m fast-paced walk test | Measure of patient's walking speed. Time taken to complete 40 meters walk will be recorded in seconds. | Baseline, Change from Baseline to 3 months, Change from Baseline to 6 months | 
| Functional Assessment - 4 stairs climb test | To assess the strength, balance and agility through ascending and descending a set number of steps. Time to ascend and descend steps (excluding turning around time) is recorded separately in seconds. Overall time taken (including the turn around time) to ascend and descend stairs is also recorded. | Baseline, Change from Baseline to 3 months, Change from Baseline to 6 months | 
| Functional Assessment - Timed up and go test | To assess patient's mobility and balance through the patient's ability to rise from a seated position to walk around a cone 3 meters away and return to the seated position. Time taken to perform the test in fast walking pace will be recorded in seconds. | Baseline, Change from Baseline to 3 months, Change from Baseline to 6 months | 
| TCM Evaluation Form | Used on intervention arm only. Form was designed after considering the progression and severity of KOA defined in TCM clinical guidelines published in China. TCM physician assists to administer the TCM-specific questions. | 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). | 
| VAS & ROM Evaluation Form | Used on intervention arm only. Form was designed after considering the progression and severity of KOA defined in TCM clinical guidelines published in China. Assess and completed by attending TCM physician. | Assess weekly for the first 6 weeks from the start of treatment |