Electromoxibustion and Knee Health Education for Knee Osteoarthritis in Older Adults

NCT ID: NCT04034394

Last Updated: 2024-04-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-20
• Study Completion Date: 2020-03-30

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.

Conditions

Knee Osteoarthritis

Study Design

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

Study Groups

Electromoxibustion

Participants in this group will receive electromoxibustion using a knee-brace-like device which produces thermal stimulation with a moxa pad inside (Fort Mayer, Guangzhou, China).

Group Type: EXPERIMENTAL

Electromoxibustion

Intervention Type: OTHER

Electromoxibustion is a electric device that mimic the burning or moxa. Subjects in this group will receive electromoxibustion using a knee-brace-like device which produces thermal stimulation with a moxa pad inside. The treatment will be delivered 3 times per week for 4 weeks.

Knee health education

Participants in this group will attend 2 sessions (120 minutes each, 1-week apart) of health education related to knee OA symptom management.

Group Type: ACTIVE_COMPARATOR

Knee health education

Intervention Type: OTHER

Subjects in this group will attend 2 lessons (120 minutes each) of health education related to knee OA symptom management in a small group of 5-7 subject. The course content is developed from the course materials from the websites of Elderly Health Service, Department of Health, Hong Kong SAR.

Interventions

Electromoxibustion

Electromoxibustion is a electric device that mimic the burning or moxa. Subjects in this group will receive electromoxibustion using a knee-brace-like device which produces thermal stimulation with a moxa pad inside. The treatment will be delivered 3 times per week for 4 weeks.

Intervention Type: OTHER

Knee health education

Subjects in this group will attend 2 lessons (120 minutes each) of health education related to knee OA symptom management in a small group of 5-7 subject. The course content is developed from the course materials from the websites of Elderly Health Service, Department of Health, Hong Kong SAR.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hong Kong Polytechnic University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Wing Fai YEUNG

Hong Kong, , Hong Kong

Countries

Hong Kong

References

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.

Reference Type: DERIVED

PMID: 33190009 (View on PubMed)

Other Identifiers

Emoxi Knee OA

Identifier Type: -

Identifier Source: org_study_id