Knee Osteoarthritis (Knee OA)NCT07329023
An Implementation Science Approach to Evaluating Self-Administered Acupressure for Knee Osteoarthritis in Older-Aged Adults in the Community
A study testing Experimental Group: Self-Administered Acupressure (SAA) in people with Knee Osteoarthritis (Knee OA), run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Knee Osteoarthritis (Knee OA)
- What is being tested?
- Experimental Group: Self-Administered Acupressure (SAA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 368 participants
- Where
- 1 siteHong Kong
- Study dates
- 20 Dec 2025to 30 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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, 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
The Hong Kong Polytechnic University
Kowloon
About this study
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.
Read the detailed 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:
- To explore the reach, adoption, implementation, and maintenance of the SAA program among community service units.
- 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.
- 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.
- Conditions
- Knee Osteoarthritis (Knee OA)
- Being tested
- Experimental Group: Self-Administered Acupressure (SAA), Control Group: General Health Education
- Keywords
- knee OA, RCT, pain, osteoarthritis, implementation sciences
- Medical subject headings
- Osteoarthritis, Knee, Pain, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental Group: Self-Administered Acupressure (SAA)Other
Also called Self-Administered Acupressure(SAA) Intervention for KneeOsteoarthritis Management
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.
Control Group: General Health EducationOther
Also called General Health Education
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Control Group: General Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 4, Week 12, Week 24
Secondary outcomes (6)
Western Ontario and McMaster University Osteoarthritis Index
Western Ontario and McMaster University Osteoarthritis Index (WOMAC): Assesses pain, physical function, and stiffness. A total raw score ranges from 0-96. Scores are often converted to a 0-100 scale (0=best, 100=worst) for standardized reporting, with higher numbers indicating greater disability.
Measured: Baseline, Week 4, Week 12, Week 24
Short Form 6D (SF-6D)
Short Form 6D (SF-6D): Measures quality of life. It is a standard tool used to measure health-related quality of life (HRQoL) by assessing six key areas (physical functioning, role limitations, social functioning, pain, mental health, vitality) from the SF-36. The score ranges from 0 (worst quality of life) to 1 (perfect quality of life).
Measured: Baseline, Week 4, Week 12, Week 24
Timed Up and Go Test
Functional Test: the Timed Up and Go Test to evaluate knee function. It is a assessment of functional mobility and fall risk, especially for older adults, involving timing how long it takes to stand from a chair, walk 3 meters, turn, walk back, and sit down. The time will be recorded (in seconds) for completing the task.
Measured: Baseline, Week 4, Week 12, Week 24
Fast Gait Speed test
Functional Test: Fast Gait Speed test to evaluate knee function. It measures how fast the subject walks by timing them over a 10 m distance where you accelerate for 2m, walk quickly (safely) for 6m , and decelerate for 2m. The time, in seconds, will be recorded for completing the task.
Measured: Baseline, Week 4, Week 12, Week 24
Analgesic Usage
Medication Use:
Participants may continue their usual medications, with analgesic use recorded during follow-up. They will be asked to fill in a daily log to record their frequency (in times) of analgesic used.
Measured: Baseline, Week 4, Week 12, Week 24
Compliance Assessment
Compliance Assessment:
Attendance at training and daily practice logged in acupressure logbooks. They are required to fill in their number of practice in the logbook daily.
Measured: Baseline, Week 4, Week 12, Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start20 Dec 2025
- Primary completion30 Nov 2027 (estimated)
- Study completion30 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Osteoarthritis (Knee OA)Studies 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
- 368 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- WIng-Fai YEUNG, Phd, Principal investigator, School of Nursing. the Hong Kong Polytechnic University, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07329023
- Sponsor's protocol ID
- KOIS
- Status last verified
- Dec 2025
- First submitted
- 19 Sep 2025
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We did not obtain consent from the participants regarding sharing data.
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Implementation Science Approach to Evaluating Self-Administered Acupressure for Knee Osteoarthritis in Older-Aged Adults in the Community
- ClinicalTrials.gov ID
- NCT07329023
- Acronym / sponsor ID
- KOIS
- Conditions
- Knee Osteoarthritis (Knee OA)
- Keywords
- knee OA, RCT, pain, osteoarthritis, implementation sciences
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 368 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 20 Dec 2025 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 May 2028 (estimated)
- First posted
- 9 Jan 2026 (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 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.
Detailed 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:
- To explore the reach, adoption, implementation, and maintenance of the SAA program among community service units.
- 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.
- 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.
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 (SAA) Intervention for Knee Osteoarthritis Management | Experimental | Other: Experimental Group: Self-Administered Acupressure (SAA)A training course will be offered to subjects in this group to train them to perform self-acupressure. |
| General Health Education | Active comparator | Other: Control Group: General Health EducationA 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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);
Key exclusion criteria (6 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, 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
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 |
|---|---|---|
| Experimental Group: Self-Administered Acupressure (SAA)Also: Self-Administered Acupressure(SAA) Intervention for KneeOsteoarthritis ManagementParticipants 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. | Other | Self-Administered Acupressure (SAA) Intervention for Knee Osteoarthritis Management |
| Control Group: General Health EducationAlso: General Health EducationThe 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. | Other | General Health Education |
Primary outcome
Numerical rating scale (NRS) for pain severity
Time frame: Baseline, Week 4, Week 12, Week 24
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.
6 secondary outcomes
Western Ontario and McMaster University Osteoarthritis Index
Time frame: Baseline, Week 4, Week 12, Week 24
Short Form 6D (SF-6D)
Time frame: Baseline, Week 4, Week 12, Week 24
Timed Up and Go Test
Time frame: Baseline, Week 4, Week 12, Week 24
Fast Gait Speed test
Time frame: Baseline, Week 4, Week 12, Week 24
Analgesic Usage
Time frame: Baseline, Week 4, Week 12, Week 24
Compliance Assessment
Time frame: Baseline, Week 4, Week 12, Week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: No. We did not obtain consent from the participants regarding sharing data.
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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.
WIng-Fai YEUNG, Phd principal investigator
School of Nursing. the Hong Kong Polytechnic University, Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Group: Self-Administered Acupressure (SAA) in people with Knee Osteoarthritis (Knee OA), 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 6 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: looking for participants now, as of the sponsor's last update on 21 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wing-Fai YEUNG, PhD (27664151, jerry-wf.yeung@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical rating scale (NRS) for pain severity (time frame: Baseline, Week 4, Week 12, Week 24). 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 21 Sep 2026.