Electromoxibustion and Knee Health Education for Knee Osteoarthritis in Older Adults

NCT04034394 | Completed

• 1 other identifier: Emoxi Knee OA
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Keywords

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Pain severity numerical rating scale, NRS

  The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain). It has been shown that a composite scoring system including best, worse, and current level of pain over the last 24 hours was sufficient to pick up changes in pain intensity with maximal reliability.

  Week 4

Secondary Outcomes (4)

• Western Ontario and McMaster University Osteoarthritis Index (WOMAC)

  Week 4

• Short Form-6D

  Week 4

• Timed Up & Go Test (TUG)

  Week 4

• Fast Gait Speed (FGS)

  Week 4

Study Arms (2)

Electromoxibustion

EXPERIMENTAL

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).

Other: Electromoxibustion

Knee health education

ACTIVE COMPARATOR

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

Other: Knee health education

Interventions

Electromoxibustion 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.

Electromoxibustion

Knee health education 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.

Knee health education

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ethnic Chinese;
• aged 60 years or above;
• ability to comprehend Chinese;
• 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);
• having knee pain for at least 3 months;
• Knee pain ≥4 on a Likert pain scale from 1-10; and
• willing to provide informed consent.

You may not qualify if:

• medical diagnoses or conditions that preclude individuals from active participation (e.g. dementia, post-stroke syndrome, alcohol or drug abuse);
• 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);
• presence of skin lesions or infections at the treatment sites;
• ever had knee replacement surgery or knee joint implant; and
• 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.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

Wing Fai YEUNG

Hong Kong, 000000, Hong Kong

Location

Related Publications (1)

• 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.

  PMID: 33190009 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors will be blinded to the group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2019
• First Posted: July 26, 2019
• Study Start: September 20, 2019
• Primary Completion: December 30, 2019
• Study Completion: March 30, 2020
• Last Updated: April 15, 2024

Record last verified: 2019-07

Locations

HK (1)