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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Self-acupressure Training | Experimental | 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. |
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| Knee Health Education | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self-acupressure | Other | A training course will be offered to subjects in this group to train them to perform self-acupressure. |
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| 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 |
| 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. |
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Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Nursing, the Hong Kong Polytechnic University | Hong Kong | Hong Kong |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| Knee health education | Other | A course regarding knee health will be offered to the subjects in this group. |
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| 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 |
| D012216 |
| Rheumatic Diseases |