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

NCT03155737 | Completed

• 1 other identifier: AcupKneeOA
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Keywords

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Western Ontario and McMaster University Osteoarthritis Index (WOMAC)

  Baseline, Week 2, Week 4, Week 6

• Range of motion (ROM)

  Baseline, Week 6

• Short Form 6D (SF-6D)

  Baseline, Week 6

Study Arms (2)

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.

Other: Self-acupressure

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.

Other: Knee health education

Interventions

Self-acupressure OTHER

A training course will be offered to subjects in this group to train them to perform self-acupressure.

Self-acupressure Training

Knee health education OTHER

A course regarding knee health will be offered to the subjects in this group.

Knee Health Education

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

School of Nursing, the Hong Kong Polytechnic University

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 14, 2017
• First Posted: May 16, 2017
• Study Start: June 1, 2017
• Primary Completion: October 31, 2017
• Study Completion: March 31, 2018
• Last Updated: September 22, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)