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

The Hong Kong Polytechnic University35 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Knee Osteoarthritis

Eligibility

Sex: ALLMin age: 50 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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).

Time frame: Week 6

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.