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Self-administered Acupressure for Knee Osteoarthritis in Middle- and Older-Aged Adults

Primary Purpose

Knee Osteoarthritis

Status
Unknown status
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Self-administered acupressure treatment group
Knee health education control group
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Knee Osteoarthritis

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ethnic Chinese;
  • aged 50 years or above;
  • ability to comprehend Chinese;
  • fulfilling any 3 of the following criteria: i. morning stiffness ≤ 30 min; ii. crepitus on active joint motion; iii. bone tenderness; iv. bone enlargement; or v. no palpable joint warmth (This classification yielded 84% sensitivity and 89% specificity for OA knee diagnosis);
  • having knee pain for at least 3 months;
  • Knee pain ≥3 on a Likert pain scale from 1-10;
  • having a smartphone (or a family member living together having a smartphone) that is compatible to WhatsApp (it is the investigator's experience in the pilot study that most of every subject had been used to using WhatsApp for social communication);
  • willing to provide informed consent

Exclusion Criteria:

  • medical diagnoses or conditions that preclude individuals from active participation (e.g. bleeding disorders, alcohol or drug abuse);
  • 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;
  • score < 22 in Hong Kong Montreal Cognitive Assessment (HK-MoCA) indicating cognitive impairment that may prevent understanding of training instructions;
  • body mass index over 30, the obese II criteria for Asians (it will be too difficult for the obese subjects to perform acupressure on the acupoints as physical pressure reaching the muscle is required);
  • presence of skin lesions or infections at the treatment sites;
  • ever had knee replacement surgery;
  • pregnancy or contemplating pregnancy;
  • ever received acupressure or steroid injection for knee pain over the past 6 months

Sites / Locations

  • School of Nursing, the Hong Kong Polytechnic UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Self-administered acupressure

Knee health education

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
September 17, 2019
Last Updated
July 30, 2020
Sponsor
The Hong Kong Polytechnic University
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1. Study Identification

Unique Protocol Identification Number
NCT04191837
Brief Title
Self-administered Acupressure for Knee Osteoarthritis in Middle- and Older-Aged Adults
Official Title
Self-administered Acupressure for Knee Osteoarthritis in Middle- and Older-Aged Adults: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 19, 2019 (Actual)
Primary Completion Date
April 2021 (Anticipated)
Study Completion Date
April 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Hong Kong Polytechnic University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Knee Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
314 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Self-administered acupressure
Arm Type
Experimental
Arm Description
A training course will be offered to subjects in this group to train them to perform self-acupressure.
Arm Title
Knee health education
Arm Type
Active Comparator
Arm Description
A course regarding knee health will be offered to the subjects in this group.
Intervention Type
Other
Intervention Name(s)
Self-administered acupressure treatment group
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Knee health education control group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain severity numerical rating scale
Description
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
Secondary Outcome Measure Information:
Title
Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
Description
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
Title
Short Form 6D (SF-6D)
Description
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
Title
Timed Up & Go Test (TUG)
Description
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
Title
Fast Gait Speed (FGS)
Description
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
Title
Pain severity numerical rating scale
Description
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
Other Pre-specified Outcome Measures:
Title
Self-report frequency of pain medication use
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ethnic Chinese; aged 50 years or above; ability to comprehend Chinese; fulfilling any 3 of the following criteria: i. morning stiffness ≤ 30 min; ii. crepitus on active joint motion; iii. bone tenderness; iv. bone enlargement; or v. no palpable joint warmth (This classification yielded 84% sensitivity and 89% specificity for OA knee diagnosis); having knee pain for at least 3 months; Knee pain ≥3 on a Likert pain scale from 1-10; having a smartphone (or a family member living together having a smartphone) that is compatible to WhatsApp (it is the investigator's experience in the pilot study that most of every subject had been used to using WhatsApp for social communication); willing to provide informed consent Exclusion Criteria: medical diagnoses or conditions that preclude individuals from active participation (e.g. bleeding disorders, alcohol or drug abuse); 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; score < 22 in Hong Kong Montreal Cognitive Assessment (HK-MoCA) indicating cognitive impairment that may prevent understanding of training instructions; body mass index over 30, the obese II criteria for Asians (it will be too difficult for the obese subjects to perform acupressure on the acupoints as physical pressure reaching the muscle is required); presence of skin lesions or infections at the treatment sites; ever had knee replacement surgery; pregnancy or contemplating pregnancy; ever received acupressure or steroid injection for knee pain over the past 6 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wing-Fai Yeung
Phone
27664151
Email
jerry-wf.yeung@polyu.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wing-Fai Yeung
Organizational Affiliation
School of Nursing, the Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Nursing, the Hong Kong Polytechnic University
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wing-Fai Yeung
Phone
27664151
Email
jerry-wf.yeung@polyu.edu.hk

12. IPD Sharing Statement

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Self-administered Acupressure for Knee Osteoarthritis in Middle- and Older-Aged Adults

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