Clinical trial NCT03155737: Self-administered Acupressure for Knee Osteoarthritis: A Pilot Randomized Controlled Trial
Official title: Self-administered Acupressure for Knee Osteoarthritis in Middle- and Older Adults: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Knee Osteoarthritis
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2017-05-16
Enrollment: 35
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Pain severity numerical rating scale
timeFrame: Week 6
Secondary outcomes:
measure: Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
timeFrame: Baseline, Week 2, Week 4, Week 6
measure: Range of motion (ROM)
timeFrame: Baseline, Week 6
measure: Short Form 6D (SF-6D)
timeFrame: Baseline, Week 6
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: School of Nursing, the Hong Kong Polytechnic University
Study officials:
References: