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

September 21, 2023 updated by: YEUNG Wing Fai, The Hong Kong Polytechnic University

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • School of Nursing, The Hong Kong Polytechnic University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain severity numerical rating scale
Time Frame: Week 6
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)
Time Frame: Baseline, Week 2, Week 4, Week 6
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)
Time Frame: Baseline, Week 6
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)
Time Frame: Baseline, Week 6
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hong Kong Polytechnic University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2017

Primary Completion (Actual)

October 31, 2017

Study Completion (Actual)

March 31, 2018

Study Registration Dates

First Submitted

May 14, 2017

First Submitted That Met QC Criteria

May 15, 2017

First Posted (Actual)

May 16, 2017

Study Record Updates

Last Update Posted (Actual)

September 22, 2023

Last Update Submitted That Met QC Criteria

September 21, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AcupKneeOA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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