NCT05507619: HARMOKnee

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

Status unknown NA Last updated 19 August 2022

What this trial tests

NA trial testing Acupuncture with Heat Therapy + Standard Care in Osteoarthritis, Knee in 173 participants. Status unknown.

Timeline

17 August 2022

Primary endpoint
31 July 2024

31 July 2024

Quick facts

Lead sponsor	Tan Tock Seng Hospital
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	173
Start date	17 August 2022
Primary completion	31 July 2024
Estimated completion	31 July 2024
Sites	2 locations across Singapore

Drugs / interventions tested

• Acupuncture with Heat Therapy + Standard Care
• Standard Care — full drug profile →

Conditions studied

• Osteoarthritis, Knee — all drugs for Osteoarthritis, Knee →

Sponsor

Tan Tock Seng Hospital

Who can join

Adults 45 to 99, any sex, with Osteoarthritis, Knee. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Heat and acupuncture restore mobility in knee osteoarthritis (HARMOKnee): A pragmatic integrated care, randomized controlled study.
   Ng HP, Tan CY, Lim CJ, Tan TL, et al · · 2025 · cited 1× · PMID 40769283 · DOI 10.1016/j.ctim.2025.103223
2. Heat and Acupuncture to Manage Osteoarthritis of the Knee (HARMOKnee): Protocol for an Effectiveness-Implementation Hybrid Randomized Controlled Trial.
   Tan BY, Tan CY, Tan TL, Yang SY, et al · · 2024 · cited 1× · PMID 38568718 · DOI 10.2196/54352