NCT07329023

Brief Summary

This study aims to evaluate the implementation and effectiveness of a self-administered acupressure (SAA) program for knee osteoarthritis (OA) among older adults in Hong Kong community centers. Using a pragmatic cluster randomized controlled trial (RCT) and mixed-methods approach, the research will assess the reach, adoption, implementation, maintenance, and effectiveness of the SAA program in real-world settings, with the goal of informing scalable interventions for knee OA management.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
368

participants targeted

Target at P75+ for not_applicable

Timeline
25mo left

Started Dec 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress16%
Dec 2025May 2028

First Submitted

Initial submission to the registry

September 19, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

December 20, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 9, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2028

Last Updated

January 9, 2026

Status Verified

December 1, 2025

Enrollment Period

1.9 years

First QC Date

September 19, 2025

Last Update Submit

December 28, 2025

Conditions

Keywords

knee OARCTpainosteoarthritisimplementation sciences

Outcome Measures

Primary Outcomes (1)

  • Numerical rating scale (NRS) for pain severity

    Numerical rating scale (NRS) for pain severity The NRS indicates the average pain intensity in the recent one week in the knee. NRS is a single Il-point numeric scale ranging from 0 (no pain) to 10 (greatest pain imaginable). The NRS is a valid and acceptable measure to detect changes in patients' improvement. NRS is chosen as primary outcome because our previous study suggests that the acupressure treatment protocol is more likely to improve global pain intensity. NRS has been used as the primary outcome in recent large-scale RCTs of acupuncture and procedural interventions for knee OA.

    Baseline, Week 4, Week 12, Week 24

Secondary Outcomes (6)

  • Western Ontario and McMaster University Osteoarthritis Index

    Baseline, Week 4, Week 12, Week 24

  • Short Form 6D (SF-6D)

    Baseline, Week 4, Week 12, Week 24

  • Timed Up and Go Test

    Baseline, Week 4, Week 12, Week 24

  • Fast Gait Speed test

    Baseline, Week 4, Week 12, Week 24

  • Analgesic Usage

    Baseline, Week 4, Week 12, Week 24

  • +1 more secondary outcomes

Other Outcomes (4)

  • Implementation outcome measures -Reach from District Elderly Centers (DEC)

    Week 24

  • Implementation outcome measures- Adoption

    Week 24

  • Implementation outcome measures - satisfaction

    Week 24

  • +1 more other outcomes

Study Arms (2)

Self-Administered Acupressure (SAA) Intervention for Knee Osteoarthritis Management

EXPERIMENTAL

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

Other: Experimental Group: Self-Administered Acupressure (SAA)

General Health Education

ACTIVE COMPARATOR

A booklet of general health education will be offered to the subjects in this group by the research personnel. The research staff will briefly explain the content covered by the booklet and instruct the subjects to read the booklet at home.

Other: Control Group: General Health Education

Interventions

Participants in this group will receive two acupressure training sessions (2 h each, 1 -week apart). The SAA treatment protocol was developed based on TCM meridian theory described in previous studies and modified by the PA and CO-A who is an experienced acupuncturist. The acupoints are indicated for knee pain and are commonly used tested for feasibility in RCT study. Participants will be asked to perform the acupressure at home in the morning (within 1 h after waking up) and at night (within 1 h after dinner) every day for 24 weeks. Participants will receive a follow-up phone call from the instructor during the first week to remind them to practice and answer their queries. During the intervention and follow-up period, the participants can communicate with the elderly staff/ our research ambassador to ask questions regarding acupressure.

Also known as: Self-Administered Acupressure(SAA) Intervention for KneeOsteoarthritis Management
Self-Administered Acupressure (SAA) Intervention for Knee Osteoarthritis Management

The participants of DEC centers in this group will be provided with the general health education booklets despite the same follow-up procedure. The booklets contains general health education information e.g. physical health, sleep health, for the participants' self-reading. The content is based on our previous studies for lifestyle intervention and health information from the government website. They will be told to read the booklet and follow the suggestions in the booklet. They will have the same program after outcome evaluation at 24 weeks.

Also known as: General Health Education
General Health Education

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ethnic Chinese;
  • aged 60 years or above;
  • able to read Chinese and comprehend Mandarin or Cantonese;
  • 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 on those with age \>50 years yielded 84% sensitivity, and 89% specificity for OA knee diagnosis (25));
  • having knee pain for at least 3 months (26);
  • knee pain 23 on a Likert pain scale from 1-10;
  • having a smartphone (or a family member living together having a smartphone) that is compatible with WhatsApp (based on our previous studies, almost every eligible subject is used to using WhatsApp for social communication); and
  • willing to provide informed consent.

You may not qualify if:

  • 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, and rheumatism) as screened according to the red flags for further investigation or referral in the NICE 2014 Guidelines for Osteoarthritis of the knee (27);
  • score \< 22 in Hong Kong Montreal Cognitive Assessment (HK-MoCA) indicating cognitive impairment that may prevent the understanding of training instructions (28);
  • body mass index over 30, the obese Il criteria for Asians (29) (obese subjects will find great difficulty in performing acupressure on acupoints because physical pressure reaching the muscle is required); and
  • ever had knee-replacement surgery
  • Further investigation or referral, either at the screening or during the study, will be made whenever necessary.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hong Kong Polytechnic University

Kowloon, Hong Kong

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, KneePainOsteoarthritis

Interventions

Methods

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • WIng-Fai YEUNG, Phd

    School of Nursing. the Hong Kong Polytechnic University, Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wing-Fai YEUNG, PhD

CONTACT

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
SPONSOR

Study Record Dates

First Submitted

September 19, 2025

First Posted

January 9, 2026

Study Start

December 20, 2025

Primary Completion (Estimated)

November 30, 2027

Study Completion (Estimated)

May 30, 2028

Last Updated

January 9, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

We did not obtain consent from the participants regarding sharing data.

Locations