NCT05507619

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 173 (estimated)
• Sponsor: Tan Tock Seng Hospital · Academic / Other
• Sex: All
• Age: 45 Years – 99 Years
• Healthy volunteers: Not accepted

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

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
OTHER	Acupuncture with Heat Therapy + Standard Care	Biweekly sessions of acupuncture with heat therapy over 6 weeks (total 12 sessions), in addition to standard care (e.g. physiotherapy, dietetics, pain management).
OTHER	Standard Care	Treatment as prescribed by orthopaedic surgeon routinely (e.g. physiotherapy, dietetics, pain management)

Timeline

• Start date: 2022-08-17
• Primary completion: 2024-07-31
• Completion: 2024-07-31
• First posted: 2022-08-19
• Last updated: 2022-08-19

Locations

2 sites across 1 country: Singapore