Self-administered Acupressure for Knee Osteoarthritis: A Pilot Randomized Controlled Trial

The Hong Kong Polytechnic University

Status: Completed

Conditions: Knee Osteoarthritis

Treatments: Other: Self-acupressure; Other: Knee health education

Study type: Interventional

Funder types: Other

Identifiers

NCT03155737

AcupKneeOA

Details and patient eligibility

About

Objectives: To test the feasibility of the study design and clinical effects of self-administered acupressure on relieving knee osteoarthritis (OA) pain.

Hypothesis: self-administered acupressure would have a superior beneficial effect compared to health education control group in terms of pain relief in patients with knee osteoarthritis across the 6-week study period.

Design and subjects: A pilot randomized controlled trial. 36 subjects with knee OA will be recruited; 18 per group. All eligible subjects will be randomized to either self-administered acupressure or health education control group in 1:1 ratio.

Interventions: Subjects in the self-acupressure group will attend two 1.5 hours training sessions to learn self-acupressure and will practice self-acupressure every morning and night for 6 weeks; subjects in the education control group will receive two 1.5 hours training sessions to learn the health information related to knee OA.

Main outcome measures: The primary outcome measure is the numerical rating scale for knee pain. Other measures include Western Ontario and McMaster University Osteoarthritis Index, knees' range of motion (ROM), and SF-6D. Acceptability of the self-acupressure training course will also be evaluated.

Data Analysis: Differences in the questionnaire scores and ROM will be examined using a mixed-effects model. Both completer and intention-to-treat analyses will be conducted. Effect sizes will be computed by dividing the difference in means by the pooled standard deviation.

Enrollment: 35 patients

Sex: All

Ages: 50 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ethnic Chinese;
• aged 50 -70 years
• fulfills any 3 of the following criteria proposed by Altman et al., (1986): ( I. morning stiffness</= 30 min; ii. crepitus on active joint motion; iii. bone tenderness; iv. bone enlargement; or v. no palpable joint warmth);
• having knee pain for at least 3 months;
• ability to provide informed consent;
• ability to comprehend Chinese; and
• Knee pain ≥3/10 and </= 7 on a Likert pain scale from 1-10

Exclusion criteria

• medical diagnoses or conditions that preclude individuals from active participation (bleeding disorders, alcohol or drug abuse);
• presence of skin lesions or infections at the treatment sites;
• currently participating in other interventional research studies for knee OA;
• cognitive impairment preventing informed consent or understanding of instructions
• body mass index over 25, the obese criteria for Asians (Anuurad et al., 2003);
• 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 NICE 2014 Guidelines for Osteoarthritis of the knee;
• had previous foot injury or trauma;
• using of steroid for knee pain;
• pregnancy or contemplating pregnancy;
• ever received acupressure for knee OA over the past 6 months.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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35 participants in 2 patient groups

Self-acupressure Training

Experimental group

Description:

Subjects in the self-administered acupressure exercise group will receive two 1.5 hours acupressure training sessions. The training will be conducted in a group format with 4-7 subjects per group. Each subject will then receive a handout and an acupressure log. The handout includes a picture-illustrating acupressure step-by-step protocol. They will be told to perform the self-acupressure twice per day for 6 weeks.

Treatment:

Other: Self-acupressure

Knee Health Education

Active Comparator group

Description:

Subjects in the health education control group will receive knowledge related to knee OA. The health education will be conducted in a talk format for 1.5 hours for two sessions.

Treatment:

Other: Knee health education