An interventional study of Self-administered acupressure treatment group and Knee health education control group in Knee Osteoarthritis, sponsored by The Hong Kong Polytechnic University. Completed at 1 site in Hong Kong. Open to participants aged 50 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-04-15.
Sponsored by The Hong Kong Polytechnic University · Not applicable, Interventional, and Treatment
This is a randomized controlled trial comparing the short-term and medium-term effect of self-administered and knee health education for relieving knee pain in middle-aged and older adults with knee osteoarthritis.
Knee osteoarthritis (OA) is one of the major causes of physical disability commonly influencing people aged above 50 years. Acupressure is proposed for alleviating knee OA symptoms because of the low cost of intervention, accessibility, and safety.
Objectives: 1. To examine the short- and medium-term effectiveness of self-administered acupressure taught by a short training course on relieving knee OA pain in middle-aged and older adults. And to evaluate the subjects' compliance with self-administered acupressure for knee OA.
Hypothesis: self-administered acupressure group would have a greater pain relief compared to the knee health education control in subjects with knee OA at week 4 (short-term) and 12 (medium-term).
Design and subjects: A randomized, parallel-group, control trial. 314 subjects with knee OA will be recruited; 157 per group. All eligible subjects will be randomized to either self-administered acupressure or knee health education control group in 1:1 ratio.
Interventions: Subjects in the self-acupressure group will attend two 2-hour training sessions to learn self-acupressure and will practice self-acupressure twice a day for 12 weeks; subjects in the education control group will receive two 2-hour training sessions to learn the health information related to knee OA. They will be told to follow the knee health instructions for 12 weeks.
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 (WOMAC), Short-Form Six-Dimension (SF-6D), Timed Up \& Go Test (TUG) and Fast Gait Speed (FGS). Acceptability of two training courses will also be evaluated.
Data Analysis: Differences in the questionnaire scores will be examined using a linear mixed-effects model. Intention-to-treat analyses will be conducted. Effect sizes will be computed by dividing the difference in means by the pooled standard deviation. Incremental costs and incremental effects will be compared between the self-acupressure and knee health education groups and and plotted the results in a cost-effectiveness acceptability curve.
3,391 studies on the registry are indexed under Osteoarthritis, Knee; 628 are open to participants now.
This study's enrollment of 314 is above the median of 69 across 2,808 interventional studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →The Hong Kong Polytechnic University is the lead sponsor of 676 studies on the registry; 254 are open to participants now.
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Exclusion Criteria:
A training course will be offered to subjects in this group to train them to perform self-acupressure.
Other: Self-administered acupressure treatment group
A course regarding knee health will be offered to the subjects in this group.
Other: Knee health education control group
Subjects in the self-administered acupressure exercise group will receive two training sessions (2 hours each, 1-week apart). The self-administered acupressure treatment protocol was developed based on Chinese medicine meridian theory by previous studies and modified. The acupoints are indicated for knee pain and have been commonly used and tested for feasibility in pilot study. The training will be conducted in a group format with 4-6 subjects per group. Each subject will then receive a handout and an acupressure log. They will be told to perform the self-acupressure twice per day for 12 weeks.The capability of participants for self-administered acupressure will be inspected by the instructor with a competency checklist in each session. And a demonstration video will be sent to the participants via WhatsApp for their reference at home.
Subjects in the health education control group will receive knowledge related to knee OA symptom management. The health education will be conducted in a talk format for 2 hours for two sessions. The course content is developed from the course materials from the websites of Elderly Health Service, Department of Health, Hong Kong SAR and reviewed. Subjects in knee health education group will be told to follow the knee health instruction for 12 weeks.
Pain severity numerical rating scale
a single 11-point numeric scale ranges from 0 (no pain) to 10 (greatest pain imaginable) to indicate the pain severity in recent one week.
Time frame: Week 4
Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
The Western and McMaster Universities Osteoarthritis Index (WOMAC, Likert version 3.1). Its score ranges from 0 to 96.
Time frame: Baseline, Week 4, Week 8, Week 12
Short Form 6D (SF-6D)
A preference-based measure of health derived from a selection of SF-36 items for economic evaluation. It is used to measure quality of life.
Time frame: Baseline, Week 4, Week 8, Week 12
Timed Up & Go Test (TUG)
The TUG test was developed and modified from a clinical measure of balance, including stand up from armchair, walk for 3 meters, turn around, walk back and sit down. The unit will be expressed in m/s.
Time frame: Baseline, Week 4, Week 8, Week 12
Fast Gait Speed (FGS)
To tests the time of crossing a marked 10-meter distance at a speed "as quickly as possible but safe". The unit will be expressed in m/s.
Time frame: Baseline, Week 4, Week 8, Week 12
Pain severity numerical rating scale
a single 11-point numeric scale ranges from 0 (no pain) to 10 (greatest pain imaginable) to indicate the pain severity in recent one week.
Time frame: Week 8, Week 12
Self-report frequency of pain medication use
Participants were permitted to continue using routine medications and pain medications, and maintain their usual physician visits throughout the study. The unit will be expressed in no. of day taking pain medication.
Time frame: Baseline, Week 4, Week 8, Week 12
This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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