Clinical trial NCT05507619: Heat and Acupuncture Randomised Controlled Trial to Manage Osteoarthritis of the Knee
Official title: Heat and Acupuncture Randomised Controlled Trial to Manage Osteoarthritis of the Knee (HARMOKnee)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis, Knee
Lead sponsor: Tan Tock Seng Hospital
Sponsor class: OTHER
Collaborators: name: National Healthcare Group, Singapore
name: Singapore Chung Hwa Medical Institution
First posted: 2022-08-19
Enrollment: 173
Sex: ALL
Minimum age (years): 45
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

1. 45 to 99 years old
2. Independent Community Mobilizers with or without walking aids
3. Conversant in English or Chinese
4. NICE clinical criteria for OA knee

Exclusion Criteria:

1. Alternative diagnosis to KOA e.g., referred pain from the spine or hip
2. Other forms of arthritis eg., inflammatory, post-traumatic
3. Inability to comply with study protocol e.g., cognitive impairment
4. Previous knee arthroplasty
5. Wheelchair-bound patients
6. Medical conditions that will medically interfere with study involvement e.g., decompensated heart failure, stroke, end-stage renal failure
7. Allergies to metal (needles)

Primary outcomes:
measure: Knee Osteoarthritis Outcome Score (KOOS-12)
timeFrame: Baseline, Change from Baseline to 6 weeks, Change from Baseline to 3 months, Change from Baseline to 6 months
Secondary outcomes:
measure: Knee Injury and Osteoarthritis Outcomes Score (KOOS) subscales - Pain, Function, QoL
timeFrame: Baseline, Change from Baseline to 6 weeks, Change from Baseline to 3 months, Change from Baseline to 6 months
measure: EuroQol-5 Dimensions (EQ-5D-5L)
timeFrame: Baseline, Change from Baseline to 6 weeks, Change from Baseline to 3 months, Change from Baseline to 6 months
measure: Patient Health Questionnaire 4 (PHQ-4)
timeFrame: Baseline, Change from Baseline to 6 weeks, Change from Baseline to 3 months, Change from Baseline to 6 months
measure: Pain, Enjoyment, General Activity Scale (PEG)
timeFrame: Baseline, Change from Baseline to 6 weeks, Change from Baseline to 3 months, Change from Baseline to 6 months
measure: Functional Assessment - 30s chair stand test
timeFrame: Baseline, Change from Baseline to 3 months, Change from Baseline to 6 months
measure: Functional Assessment - 40m fast-paced walk test
timeFrame: Baseline, Change from Baseline to 3 months, Change from Baseline to 6 months
measure: Functional Assessment - 4 stairs climb test
timeFrame: Baseline, Change from Baseline to 3 months, Change from Baseline to 6 months
measure: Functional Assessment - Timed up and go test
timeFrame: Baseline, Change from Baseline to 3 months, Change from Baseline to 6 months
measure: TCM Evaluation Form
timeFrame: 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).
measure: VAS & ROM Evaluation Form
timeFrame: Assess weekly for the first 6 weeks from the start of treatment
Other outcomes:
measure: University of California, Los Angeles (UCLA) activity score
timeFrame: Baseline, Change from Baseline to 6 weeks, Change from Baseline to 3 months, Change from Baseline to 6 months
measure: Global perceived effect (GPE)
timeFrame: Assess at 3 months, 6 months, 12 months
measure: Patient Acceptable Symptom State (PASS)
timeFrame: Assess at 3 months, 6 months, 12 months
measure: Self-reported treatment failure
timeFrame: Assess at 3 months, 6 months, 12 months
measure: Cumulative Analgesia Consumption Score (CACS)
timeFrame: Assess at 3 months, 6 months, 12 months
measure: Questionnaire measuring the direct and indirect costs
timeFrame: Assess at 3 months, 6 months, 12 months
measure: Adverse Events
timeFrame: Assess at 6 weeks, 3 months, 6 months, 12 months
Locations:
city: Singapore
country: Singapore
facility: Singapore Chung Hwa Medical Institution
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
Study officials:
affiliation: Woodlands Health
name: Bryan Tan
role: PRINCIPAL_INVESTIGATOR
References: