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

NCT05507619 | Unknown

• 1 other identifier: 2021/01106
• Study Type: interventional
• Target: 173
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Knee Osteoarthritis Outcome Score (KOOS-12)

  Derived from the original 42-item Knee injury and Osteoarthritis Outcome Score (KOOS), KOOS-12 reduces respondent burden by 70% from the original KOOS while providing scale scores for knee-specific Pain, Function and QOL, along with a summary measure of overall knee impact. The KOOS sub scales are scored using the method of summated ratings and transformed to range from 0 to 100, with 0 representing extreme knee problems and 100 representing no knee problem. The KOOS-12 Summary knee impact score is calculated as the average of the KOOS-12 Pain, KOOS-12 Function and KOOS-12 QOL scale scores. It also ranges from 0 to 100, where 0 is the worst possible and 100 is the best possible score.

  Baseline, Change from Baseline to 6 weeks, Change from Baseline to 3 months, Change from Baseline to 6 months

Secondary Outcomes (10)

• Knee Injury and Osteoarthritis Outcomes Score (KOOS) subscales - Pain, Function, QoL

  Baseline, Change from Baseline to 6 weeks, Change from Baseline to 3 months, Change from Baseline to 6 months

• EuroQol-5 Dimensions (EQ-5D-5L)

  Baseline, Change from Baseline to 6 weeks, Change from Baseline to 3 months, Change from Baseline to 6 months

• Patient Health Questionnaire 4 (PHQ-4)

  Baseline, Change from Baseline to 6 weeks, Change from Baseline to 3 months, Change from Baseline to 6 months

• Pain, Enjoyment, General Activity Scale (PEG)

  Baseline, Change from Baseline to 6 weeks, Change from Baseline to 3 months, Change from Baseline to 6 months

• Functional Assessment - 30s chair stand test

  Baseline, Change from Baseline to 3 months, Change from Baseline to 6 months

Other Outcomes (7)

• University of California, Los Angeles (UCLA) activity score

  Baseline, Change from Baseline to 6 weeks, Change from Baseline to 3 months, Change from Baseline to 6 months

• Global perceived effect (GPE)

  Assess at 3 months, 6 months, 12 months

• Patient Acceptable Symptom State (PASS)

  Assess at 3 months, 6 months, 12 months

Study Arms (2)

Control

ACTIVE COMPARATOR

Other: Standard Care

Intervention

EXPERIMENTAL

Other: Acupuncture with Heat Therapy + Standard Care

Interventions

Acupuncture with Heat Therapy + Standard Care 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).

Intervention

Standard Care OTHER

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

Control

Eligibility Criteria

• Age: 45 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 99 years old
• Independent Community Mobilizers with or without walking aids
• Conversant in English or Chinese
• NICE clinical criteria for OA knee

You may not qualify if:

• Alternative diagnosis to KOA e.g., referred pain from the spine or hip
• Other forms of arthritis eg., inflammatory, post-traumatic
• Inability to comply with study protocol e.g., cognitive impairment
• Previous knee arthroplasty
• Wheelchair-bound patients
• Medical conditions that will medically interfere with study involvement e.g., decompensated heart failure, stroke, end-stage renal failure
• Allergies to metal (needles)

Sponsors & Collaborators

• Tan Tock Seng Hospital: lead
• National Healthcare Group, Singapore: collaborator
• Singapore Chung Hwa Medical Institution: collaborator

Study Sites (2)

Singapore Chung Hwa Medical Institution

Singapore, Singapore

Location

Tan Tock Seng Hospital

Singapore, Singapore

Location

Related Publications (1)

• 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.

  PMID: 38568718 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Acupuncture Therapy; Diathermy; Standard of Care

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Hyperthermia, Induced; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Bryan Tan

  Woodlands Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bryan Tan

CONTACT

63633000; bryan_tan@whc.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Study Record Dates

• First Submitted: August 16, 2022
• First Posted: August 19, 2022
• Study Start: August 17, 2022
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: August 19, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

SG (2)