Knee OsteoarthritisNCT04191837
Self-administered Acupressure for Knee Osteoarthritis in Middle- and Older-Aged Adults
A study testing Self-administered acupressure treatment group in people with Knee Osteoarthritis, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Self-administered acupressure treatment group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 314 participants
- Where
- 1 siteHong Kong
- Study dates
- 19 Aug 2019to 30 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
School of Nursing, the Hong Kong Polytechnic University
Hong Kong
About this study
Official title: Self-administered Acupressure for Knee Osteoarthritis in Middle- and Older-Aged Adults: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Self-administered acupressure treatment group, Knee health education control group
- Keywords
- Knee Osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-administered acupressure treatment groupOther
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.
Knee health education control groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Self-administered acupressure | Experimental | A training course will be offered to subjects in this group to train them to perform self-acupressure. Receives: Other: Self-administered acupressure treatment group |
| Knee health education | Active comparator | A course regarding knee health will be offered to the subjects in this group. Receives: Other: Knee health education control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 4
Secondary outcomes (5)
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.
Measured: Baseline, Week 4, Week 8, Week 12
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.
Measured: Baseline, Week 4, Week 8, Week 12
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.
Measured: Baseline, Week 4, Week 8, Week 12
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.
Measured: Baseline, Week 4, Week 8, Week 12
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.
Measured: Week 8, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start19 Aug 2019
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 314 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wing-Fai Yeung, Principal investigator, School of Nursing, the Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04191837
- Sponsor's protocol ID
- Self-Acup KneeOA
- Status last verified
- Jul 2020
- First submitted
- 17 Sep 2019
- Last updated
- 15 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yeung WF, Chen SC, Cheung DST, Wong CK, Chong TC, Ho YS, Suen LKP, Ho LM, Lao L. Self-Administered Acupressure for Probable Knee Osteoarthritis in Middle-Aged and Older Adults: A Randomized Clinical Trial. JAMA Netw Open. 2024 Apr 1;7(4):e245830. doi: 10.1001/jamanetworkopen.2024.5830.
PubMed 38639940
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-administered Acupressure for Knee Osteoarthritis in Middle- and Older-Aged Adults: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04191837
- Acronym / sponsor ID
- Self-Acup KneeOA
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 314 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 19 Aug 2019 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 10 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-administered acupressure | Experimental | Other: Self-administered acupressure treatment groupA training course will be offered to subjects in this group to train them to perform self-acupressure. |
| Knee health education | Active comparator | Other: Knee health education control groupA course regarding knee health will be offered to the subjects in this group. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-administered acupressure treatment groupSubjects 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. | Other | Self-administered acupressure |
| Knee health education control groupSubjects 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. | Other | Knee health education |
Primary outcome
Pain severity numerical rating scale
Time frame: Week 4
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.
5 secondary outcomes
Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
Time frame: Baseline, Week 4, Week 8, Week 12
Short Form 6D (SF-6D)
Time frame: Baseline, Week 4, Week 8, Week 12
Timed Up & Go Test (TUG)
Time frame: Baseline, Week 4, Week 8, Week 12
Fast Gait Speed (FGS)
Time frame: Baseline, Week 4, Week 8, Week 12
Pain severity numerical rating scale
Time frame: Week 8, Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2024.
- Derived from this study: PubMed 38639940Yeung WF, Chen SC, Cheung DST, Wong CK, Chong TC, Ho YS, Suen LKP, Ho LM, Lao L. Self-Administered Acupressure for Probable Knee Osteoarthritis in Middle-Aged and Older Adults: A Randomized Clinical Trial. JAMA Netw Open. 2024 Apr 1;7(4):e245830. doi: 10.1001/jamanetworkopen.2024.5830.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wing-Fai Yeung principal investigator
School of Nursing, the Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-administered acupressure treatment group in people with Knee Osteoarthritis, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain severity numerical rating scale (time frame: Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04191837, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2024.