Clinical trial NCT04034394: Electromoxibustion and Knee Health Education for Knee Osteoarthritis in Older Adults
Official title: Electromoxibustion and Knee Health Education for Knee Osteoarthritis in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Knee Osteoarthritis
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2019-07-26
Enrollment: 48
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized controlled trial comparing the short-term effect of electromoxibustion and knee health education for relieving knee pain in older adults with knee osteoarthritis.

Detailed description: Objective: This pilot randomized controlled trial (RCT) will preliminary examine the effects of an electromoxibustion device and knee health education on reliving knee osteoarthritis (OA) pain.

Method Design: This pilot RCT will embed a two-arm randomized control trial. The project will recruit 48 participants with knee OA. Eligible participants will be randomized into 2 groups - (1) Electromoxibustion, or (2) knee health education at 1:1 ratio.

Interventions: Participants in the electromoxibustion group will receive electromoxibustion using a knee-brace-like device which produces thermal stimulation with a moxa pad inside (Fort Mayer, Guangzhou, China); participants in the Knee health education group will attend 2 sessions (120 minutes each, 1-week apart) of health education related to knee OA symptom management.

Outcome measures: (1) Pain severity numerical rating scale (NRS) (Primary outcome); (2) Western Ontario and McMaster University Osteoarthritis Index (WOMAC) for pain, physical function, and stiffness related to knee osteoarthritis; (3) Short Form-6 Dimensions for quality of life; (4) Timed Up \& Go Test (TUG); (5) Fast Gait Speed (FGS) for knee functioning.

Statistical Analysis of quantitative data: Descriptive statistics will be used to describe the socio-demographic characteristics of the participants. A mixed-effects model with consideration of repeated measures and dropout by including all available data points (intention-to-treat analysis) to compare the electromoxibustion with the knee health education control group. SPSS version 23.0 will be used in this study.

Eligibility criteria: Inclusion Criteria:

1. ethnic Chinese;
2. aged 60 years or above;
3. ability to comprehend Chinese;
4. fulfilling any 3 of the following criteria: i. morning stiffness \</= 30 min; ii. crepitus on active joint motion; iii. bone tenderness; iv. bone enlargement; or v. no palpable joint warmth (This classification yielded 84% sensitivity and 89% specificity for OA knee diagnosis (Altman et al., 1986);
5. having knee pain for at least 3 months;
6. Knee pain ≥4 on a Likert pain scale from 1-10; and
7. willing to provide informed consent.

Exclusion Criteria:

1. medical diagnoses or conditions that preclude individuals from active participation (e.g. dementia, post-stroke syndrome, alcohol or drug abuse);
2. knee pain related to other conditions (cancer, fracture, rheumatoid arthritis, rheumatism) as screened according to the red flags for further investigation or referral in the National Clinical Guideline Centre 2014 Guidelines for Osteoarthritis of the knee (National Clinical Guideline Centre, 2014);
3. presence of skin lesions or infections at the treatment sites;
4. ever had knee replacement surgery or knee joint implant; and
5. ever received moxibustion, electromoxibustion or steroid injection for knee pain over the past 6 months; Further investigation or referral, either at the screening or during the study, will be made when necessary.

Primary outcomes:
measure: Pain severity numerical rating scale, NRS
timeFrame: Week 4
Secondary outcomes:
measure: Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
timeFrame: Week 4
measure: Short Form-6D
timeFrame: Week 4
measure: Timed Up & Go Test (TUG)
timeFrame: Week 4
measure: Fast Gait Speed (FGS)
timeFrame: Week 4
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Wing Fai YEUNG
Study officials:
References:
citation: Cheung T, Ho YS, Yuen CS, Lam CS, Chun-Lung So B, Chen SC, Leung DYP, Kwai-Ping Suen L, Tin-Yau So L, Chun-Hei Ho A, Yeung WF. Electromoxibustion for knee osteoarthritis in older adults: A pilot randomized controlled trial. Complement Ther Clin Pract. 2020 Nov;41:101254. doi: 10.1016/j.ctcp.2020.101254. Epub 2020 Nov 6.