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

NCT ID: NCT05507619

Last Updated: 2022-08-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 173 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-17
• Study Completion Date: 2024-07-31

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

Conditions

Osteoarthritis, Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control

Group Type: ACTIVE_COMPARATOR

Standard Care

Intervention Type: OTHER

Treatment as prescribed by orthopaedic surgeon routinely (e.g. physiotherapy, dietetics, pain management)

Intervention

Group Type: EXPERIMENTAL

Acupuncture with Heat Therapy + Standard Care

Intervention Type: OTHER

Biweekly sessions of acupuncture with heat therapy over 6 weeks (total 12 sessions), in addition to standard care (e.g. physiotherapy, dietetics, pain management).

Interventions

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).

Intervention Type: OTHER

Standard Care

Treatment as prescribed by orthopaedic surgeon routinely (e.g. physiotherapy, dietetics, pain management)

Intervention Type: OTHER

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)

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Healthcare Group, Singapore

OTHER_GOV

Sponsor Role: collaborator

Singapore Chung Hwa Medical Institution

OTHER

Sponsor Role: collaborator

Tan Tock Seng Hospital

OTHER

Sponsor Role: lead

Responsible Party

Bryan Tan

Consultant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bryan Tan

Role: PRINCIPAL_INVESTIGATOR

Woodlands Health

Locations

Singapore Chung Hwa Medical Institution

Singapore, , Singapore

Tan Tock Seng Hospital

Singapore, , Singapore

Countries

Singapore

Central Contacts

Bryan Tan

Role: CONTACT

bryan_tan@whc.sg

63633000

Facility Contacts

Hui Ping Ng

Role: primary

Tong Leng Tan

Role: primary

63577713

References

Tan BY, Tan CY, Tan TL, Yang SY, Chew GLS, Tan SI, Chua YC, Yan YW, Soh DBQ, Goh TH, Ng PJ, Ng YT, Kuan SB, Teo BS, Kong KH, Pereira MJ, Ng HP. Heat and Acupuncture to Manage Osteoarthritis of the Knee (HARMOKnee): Protocol for an Effectiveness-Implementation Hybrid Randomized Controlled Trial. JMIR Res Protoc. 2024 Apr 3;13:e54352. doi: 10.2196/54352.

Reference Type: DERIVED

PMID: 38568718 (View on PubMed)

Other Identifiers

2021/01106

Identifier Type: -

Identifier Source: org_study_id