JMIR Publications

ABSTRACT

Background:

Background:

Knee osteoarthritis (KOA) is one of most prevalent and fast-growing causes of pain, impaired mobility, and poor quality of life in the rapidly ageing population worldwide. There is a lack of high-quality evidence on the efficacy of Traditional Chinese Medicine (TCM), particularly acupuncture, as well as KOA practice guidelines that are tailored to the unique population demographics and tropical climates.

Objective:

Objectives: Our HarmoKNEE trial aims to address these gaps by evaluating the short and medium-term clinical and cost-effectiveness of acupuncture with heat therapy in addition to standard care, compared to standard care alone. Through a robust process and economic evaluation, we aim to inform evidence-based practice for KOA patients to facilitate the large-scale implementation of a comprehensive and holistic model of care which harmonises elements from Western medicine and TCM. We hypothesize that acupuncture with heat therapy as an adjunct to standard care is clinically more effective than standard care alone.

Methods:

Methods:

A multi-centre pragmatic, parallel-arm, single-blinded, effectiveness-implementation hybrid randomised control trial will be conducted. We intend to recruit 100 KOA patients and randomised to either the control arm (standard care only) or intervention arm (acupuncture with heat therapy, in addition to standard care). Inclusion criteria are community ambulators with primary KOA, excluding patients with secondary arthritis or previous knee replacements. Primary outcome measure is Knee Osteoarthritis Outcome Score at 6 weeks. Secondary outcome measures include psychological, physical, quality of life, satisfaction and global outcome measures measured at 6, 12 and 24 weeks. A mixed-method approach through an embedded process evaluation will facilitate large scale implementation. An economic evaluation will be performed to assess financial sustainability.

Results:

Results:

Patient enrolment has been ongoing since August 2022. The recruitment process is anticipated to conclude by July 2024, and the findings will be analysed and publicised as they are obtainable. As of 6 November 2023, our patient enrolment stands at 65 individuals.

Conclusions:

Conclusions:

Our HARMOKnee study aims to (1) add high-quality evidence for acupuncture treatment of KOA to the existing literature on a broader scale; (2) support the development of locally standardised national evidence-based practice guidelines tailored to the unique population demographics; and (3) support the implementation and integration of acupuncture and heat therapy into current treatment models supported by process and economic evaluation; (4) establish the foundation that pave the way for the development of an integrated model of care which harmonises both Western and Eastern care components. Clinical Trial: ClinicalTrials.gov (NCT05507619), registered on August 19, 2022.