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

Tan Tock Seng Hospital

Status: Not yet enrolling

Conditions: Osteoarthritis, Knee

Treatments: Other: Acupuncture with Heat Therapy + Standard Care; Other: Standard Care

Study type: Interventional

Funder types: Other

Identifiers

NCT05507619

2021/01106

Details and patient eligibility

About

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

Enrollment: 173 estimated patients

Sex: All

Ages: 45 to 99 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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173 participants in 2 patient groups

Control

Active Comparator group

Treatment:

Other: Standard Care

Intervention

Experimental group

Treatment:

Other: Acupuncture with Heat Therapy + Standard Care