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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Other: Standard Care; Other: Acupuncture with Heat Therapy + Standard Care

• Study Type: Interventional
• Enrollment (Anticipated): 173
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bryan Tan; Phone Number: 63633000; Email: bryan_tan@whc.sg

Study Locations

• Singapore
  • Singapore, Singapore
    • Tan Tock Seng Hospital
    • Contact: Tong Leng Tan; Phone Number: 63577713
    • Sub-Investigator: Keng He Kong
    • Sub-Investigator: Su-Yin Yang
    • Sub-Investigator: Yu Chun Chua
    • Sub-Investigator: Siang-Ing Tan
    • Sub-Investigator: Yew Wai Yan
  • Singapore, Singapore
    • Singapore Chung Hwa Medical Institution
    • Contact: Hui Ping Ng

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention	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).
Active Comparator: Control	Other: Standard Care; Treatment as prescribed by orthopaedic surgeon routinely (e.g. physiotherapy, dietetics, pain management)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee Injury and Osteoarthritis Outcomes Score (KOOS) subscales - Pain, Function, QoL	The three subscales of KOOS-12 are scored separately: KOOS Pain (4 items); KOOS Function (4 items); KOOS QoL (4 items). A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the three scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems.	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)	EuroQol-5 Dimensions (EQ-5D) consists of 2 dimensions, the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by selecting the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS will be used as a quantitative measure of health outcome.	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)	Measurement for depression and anxiety rated on a 4 point Likert-type scale. 0 refers to 'Not at all', 3 refers 'Nearly everyday'. Total score is determined by adding together the scores of each of the 4 items. Scores are rated as normal (0-2), mild (3-5), moderate (6-8), and severe (9-12). Total score ≥3 for first 2 questions suggest anxiety. Total score ≥3 for last 2 questions suggest depression.	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)	Measures the pain intensity and interference level using a three-item scale. Scale of 0 to 10 is used for each item. 0 refers 'no pain', 10 refers 'worse pain'. Add the responses to the three questions, then divide by three to get a mean score (out of 10) on overall impact of points.	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	To test leg strength and endurance. Total number of repetitions completed in 30 seconds is recorded.	Baseline, Change from Baseline to 3 months, Change from Baseline to 6 months
Functional Assessment - 40m fast-paced walk test	Measure of patient's walking speed. Time taken to complete 40 meters walk will be recorded in seconds.	Baseline, Change from Baseline to 3 months, Change from Baseline to 6 months
Functional Assessment - 4 stairs climb test	To assess the strength, balance and agility through ascending and descending a set number of steps. Time to ascend and descend steps (excluding turning around time) is recorded separately in seconds. Overall time taken (including the turn around time) to ascend and descend stairs is also recorded.	Baseline, Change from Baseline to 3 months, Change from Baseline to 6 months
Functional Assessment - Timed up and go test	To assess patient's mobility and balance through the patient's ability to rise from a seated position to walk around a cone 3 meters away and return to the seated position. Time taken to perform the test in fast walking pace will be recorded in seconds.	Baseline, Change from Baseline to 3 months, Change from Baseline to 6 months
TCM Evaluation Form	Used on intervention arm only. Form was designed after considering the progression and severity of KOA defined in TCM clinical guidelines published in China. TCM physician assists to administer the TCM-specific questions.	Assess at Week 1 (start of treatment, before the 1st acupuncture session), Week 4 (mid-treatment, before the 7th acupuncture session) and Week 6 (end of treatment, after the 12th / last acupuncture session).
VAS & ROM Evaluation Form	Used on intervention arm only. Form was designed after considering the progression and severity of KOA defined in TCM clinical guidelines published in China. Assess and completed by attending TCM physician.	Assess weekly for the first 6 weeks from the start of treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
University of California, Los Angeles (UCLA) activity score	1 question survey to understands patient physical activity level from a scale of 1 (wholly inactive) to 10 (regular participation in impact sports).	Baseline, Change from Baseline to 6 weeks, Change from Baseline to 3 months, Change from Baseline to 6 months
Global perceived effect (GPE)	Patient will be asked to rate thier overall recovery on a 7-point Likert scale. 1 refers to 'Very much improved'; 7 refers to 'Very much deteriorated'.	Assess at 3 months, 6 months, 12 months
Patient Acceptable Symptom State (PASS)	A single-question used to assess patient's satisfaction in the treatment. Response will be either yes or no. "When you think of your knee function, will you consider your current condition as satisfying? By knee function, you should take into account your activities of daily living, sport and recreational activities, your pain and other symptoms and your quality of life."	Assess at 3 months, 6 months, 12 months
Self-reported treatment failure	Patient who answers 'no' to PASS will be asked to determine if they consider the treatment to have failed. Response will be 'yes' or 'no'. "Would you consider your current state as being so unsatisfactory that you consider the treatment to have failed?"	Assess at 3 months, 6 months, 12 months
Cumulative Analgesia Consumption Score (CACS)	Objective measurement of patient's analgesics average weekly consumption based on the quantity multiplied by the category of analgesic medication according to the WHO pain relief ladder (1 point - non-opioid, 2 points - mild opioid, 3 points - strong opioid) in order to calculate a total score.	Assess at 3 months, 6 months, 12 months
Questionnaire measuring the direct and indirect costs	Cost questionnaire	Assess at 3 months, 6 months, 12 months
Adverse Events	Adverse events (AE) and serious adverse events (SAE) will be recorded at all follow-ups by asking the participants about potential AEs using open-probe questioning to ensure that all AEs are recorded. AEs will be categorized into index knee or other sites and will be recorded and assessed for severity independent of whether or not there is a causal relationship with study treatments.	Assess at 6 weeks, 3 months, 6 months, 12 months

Collaborators and Investigators

• Sponsor: Tan Tock Seng Hospital
• Collaborators: National Healthcare Group, Singapore; Singapore Chung Hwa Medical Institution
• Investigators: Principal Investigator: Bryan Tan, Woodlands Health

Study record dates

Study Major Dates

• Study Start (Anticipated): August 17, 2022
• Primary Completion (Anticipated): July 31, 2024
• Study Completion (Anticipated): July 31, 2024

Study Registration Dates

• First Submitted: August 16, 2022
• First Submitted That Met QC Criteria: August 17, 2022
• First Posted (Actual): August 19, 2022

Study Record Updates

• Last Update Posted (Actual): August 19, 2022
• Last Update Submitted That Met QC Criteria: August 17, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 2021/01106

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No