An Implementation Science Approach to Evaluating Self-Administered Acupressure for Knee Osteoarthritis in Older-Aged Adults in the Community

The Hong Kong Polytechnic University

Status: Enrolling

Conditions: Knee Osteoarthritis (Knee OA)

Treatments: Other: Experimental Group: Self-Administered Acupressure (SAA); Other: Control Group: General Health Education

Study type: Interventional

Funder types: Other

Identifiers

NCT07329023

KOIS

Details and patient eligibility

About

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.

Full description

Knee OA is a prevalent and debilitating condition in older adults, often managed with medications that have side effects or nonpharmacological interventions requiring significant behavioral change. Acupressure, a variant of acupuncture, can be self-administered after appropriate training and has shown efficacy in previous RCTs for knee OA. This study will implement the SAA program in district elderly community (DEC) centers across Hong Kong, training frontline workers and older adults to deliver and practice acupressure. The intervention includes two training sessions, ongoing support, and a 24-week follow-up. Effectiveness will be measured by pain reduction, improved knee function, and quality of life, while implementation outcomes will be evaluated using the RE-AIM framework. Qualitative interviews will explore facilitators and barriers to adoption and sustainability.

Objectives:

1. To explore the reach, adoption, implementation, and maintenance of the SAA program among community service units.
2. To examine the effectiveness of the SAA program in relieving pain and improving knee function in middle-aged and older adults in real-world settings.
3. To explore the experiences (facilitators and barriers) of adopting SAA in routine services through qualitative interviews.

Hypothesis

• The SAA program will be effectively implemented in community settings, achieving high reach, adoption, fidelity, and sustainability.
• Participants in the SAA group will experience greater reductions in knee pain and improvements in knee function and quality of life compared to the control group.

Design and subjects:

• Design: Pragmatic cluster randomized controlled trial (RCT) with mixed-methods (quantitative and qualitative).

• Setting: District Elderly Community (DEC) centers in Hong Kong.

• Subjects:

  • Sample Size: 368 older adults (aged ≥60), recruited from DEC centers (8 clusters per group, 23 participants per cluster).
  • Inclusion Criteria: Ethnic Chinese, aged ≥60, able to read Chinese and comprehend Mandarin/Cantonese, probable knee OA (based on clinical criteria), knee pain ≥3 months, pain score ≥3/10, smartphone access, consent.
  • Exclusion Criteria: Medical conditions precluding participation, knee pain from other causes, cognitive impairment, BMI >30, prior knee replacement.

Interventions:

• SAA Group (Focus Group):

  • Two acupressure training sessions (2 hours each, 1 week apart) led by trained instructors.
  • Training includes acupressure technique, knee-health education, practice with feedback, and provision of materials (handouts, rods, logbook).
  • Daily home practice (morning and night) for 24 weeks, with ongoing support via WhatsApp and phone calls.

• General Health Education Group (Control Group):

  • A general health education booklet will be provided during the study period; will receive the SAA program after 24-week outcome evaluation.

Main outcome measures:

The outcome measures will include treatment effectiveness and implementation.

Effectiveness Outcome 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).

Implementation Outcome RE-AIM framework will be used to evaluate the project, which covers five aspects of reach, effectiveness, adoption, implementation, and maintenance.

Data Analysis

• Quantitative:

  • Double data entry; analysis in SPSS 28.0.
  • Baseline differences controlled as covariates.
  • Linear mixed-effect models to compare changes in primary (NRS pain score) and secondary outcomes (WOMAC, SF-6D, functional tests) over time.
  • Compliance and clinical significance assessed (≥2-point or ≥30% reduction in NRS).
  • Intention-to-treat analysis.

• Qualitative:

  • Thematic content analysis of interview transcripts using NVivo 12.0.
  • Open coding by two independent researchers; themes reviewed for sufficiency and coherence.

• Cost-Effectiveness:

  • QALYs calculated from SF-6D.
  • Incremental cost-effectiveness ratio (ICER) computed.
  • Bootstrapping (5,000 iterations) for uncertainty; cost-effectiveness acceptability curve generated.

Enrollment: 368 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. ethnic Chinese;
2. aged 60 years or above;
3. able to read Chinese and comprehend Mandarin or Cantonese;
4. 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));
5. having knee pain for at least 3 months (26);
6. knee pain 23 on a Likert pain scale from 1-10;
7. 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
8. willing to provide informed consent.

Exclusion criteria

1. medical diagnoses or conditions that preclude individuals from active participation (e.g., bleeding disorders, alcohol, or drug abuse);
2. 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);
3. score < 22 in Hong Kong Montreal Cognitive Assessment (HK-MoCA) indicating cognitive impairment that may prevent the understanding of training instructions (28);
4. 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
5. ever had knee-replacement surgery

Further investigation or referral, either at the screening or during the study, will be made whenever necessary.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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368 participants in 2 patient groups

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

Experimental group

Description:

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

Treatment:

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

General Health Education

Active Comparator group

Description:

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.

Treatment:

Other: Control Group: General Health Education