Knee OsteoarthritisNCT03155737
Self-administered Acupressure for Knee Osteoarthritis: A Pilot Randomized Controlled Trial
A study testing Self-acupressure and Knee health education in people with Knee Osteoarthritis, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial 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… 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-acupressure and Knee health education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jun 2017to 31 Mar 2018
- 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 -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
Who cannot join
- 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;
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- 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.
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 Adults: A Pilot Randomized Controlled Trial
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.
Read more
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
- Being tested
- Self-acupressure, Knee health education
- 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-acupressureOther
A training course will be offered to subjects in this group to train them to perform self-acupressure.
Knee health educationOther
A course regarding knee health will be offered to the subjects in this group.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Knee health education |
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 to 10 in 1 cm intervals (zero: no pain, 10: greatest pain imaginable).
Measured: Week 6
Secondary outcomes (3)
Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
The Western and McMaster Universities Osteoarthritis Index (WOMAC, Likert version 3.1) covered pain, physical function, and stiffness related to knee osteoarthritis. The physical function subscale (consisting of 17 items) will be adopted to assess the level of physical function in patients with knee osteoarthritis under different activities.
Measured: Baseline, Week 2, Week 4, Week 6
Range of motion (ROM)
Range of motion is recorded in degrees by using a goniometer. ROM can be used to address the inter-relationship between ROMs of joint action and disability in patient with knee OA.
Measured: Baseline, Week 6
Short Form 6D (SF-6D)
The Short Form -6D is a preference-based measure of health derived from a selection of SF-36 items for economic evaluation.
Measured: Baseline, Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2017
- Study start1 Jun 2017
- Primary completion31 Oct 2017
- Study completion31 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- 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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YEUNG Wing Fai, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03155737
- Sponsor's protocol ID
- AcupKneeOA
- Status last verified
- Sep 2023
- First submitted
- 14 May 2017
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. 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 Adults: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03155737
- Acronym / sponsor ID
- AcupKneeOA
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 31 Oct 2017 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 16 May 2017 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-acupressure Training | Experimental | Other: Self-acupressureSubjects 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. |
| Knee Health Education | Active comparator | Other: Knee health educationSubjects 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. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (10 listed)
- 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);
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-acupressureA training course will be offered to subjects in this group to train them to perform self-acupressure. | Other | Self-acupressure Training |
| Knee health educationA course regarding knee health will be offered to the subjects in this group. | Other | Knee Health Education |
Primary outcome
Pain severity numerical rating scale
Time frame: Week 6
A single 11-point numeric scale ranges from 0 to 10 in 1 cm intervals (zero: no pain, 10: greatest pain imaginable).
3 secondary outcomes
Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
Time frame: Baseline, Week 2, Week 4, Week 6
Range of motion (ROM)
Time frame: Baseline, Week 6
Short Form 6D (SF-6D)
Time frame: Baseline, Week 6
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 22 Sep 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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-acupressure and Knee health education 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 7 inclusion and 10 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 22 Sep 2023. 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 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Sep 2023.