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

Study Overview
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Brief Summary
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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.

Official Title
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Self-administered Acupressure for Knee Osteoarthritis in Middle- and Older Adults: A Pilot Randomized Controlled Trial

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Other: Self-acupressure
* Other: Knee health education


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Self-acupressure Training<br>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. | Other: Self-acupressure<br>* A training course will be offered to subjects in this group to train them to perform self-acupressure.<br>|
| Active Comparator: Knee Health Education<br>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. | Other: Knee health education<br>* A course regarding knee health will be offered to the subjects in this group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain severity numerical rating scale | A single 11-point numeric scale ranges from 0 to 10 in 1 cm intervals (zero: no pain, 10: greatest pain imaginable). | Week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Western Ontario and McMaster University Osteoarthritis Index (WOMAC) | The Western and McMaster Universities Osteoarthritis Index (WOMAC, Likert version 3.1) covered pain, physical function, and stiffness related to knee osteoarthritis. The physical function subscale (consisting of 17 items) will be adopted to assess the level of physical function in patients with knee osteoarthritis under different activities. | Baseline, Week 2, Week 4, Week 6 | 
| Range of motion (ROM) | Range of motion is recorded in degrees by using a goniometer. ROM can be used to address the inter-relationship between ROMs of joint action and disability in patient with knee OA. | Baseline, Week 6 | 
| Short Form 6D (SF-6D) | The Short Form -6D is a preference-based measure of health derived from a selection of SF-36 items for economic evaluation. | Baseline, Week 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Knee Osteoarthritis