Post Stroke Shoulder PainNCT05328401
To Evaluate the Therapeutic Effect of Laser Acupuncture in Patients With Acute or Subacute Post Stroke Shoulder Pain
A study testing Verum laser acupuncture in people with Post Stroke Shoulder Pain, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Investigators propose a research design protocol to evaluate the efficacy of laser acupuncture in improving shoulder pain and improving shoulder function recovery after stroke. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Post Stroke Shoulder Pain
- What is being tested?
- Verum laser acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteTaiwan
- Study dates
- 16 Apr 2022to 15 Mar 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Beyond the age of 20.
- Normal consciousness before and after stroke who can reply and fill in the questionnaire.
- Subacute (subacute phase: 7 days to 6 months after stroke) and Chronic (chronic phase: more than 6 months after stroke) with shoulder pain after stroke and in post- stroke recovery period.
- Stop taking painkillers for more than 1 day,
- Without received intramuscular drugs (steroids, botulinum toxin, glucose, etc.) injections in the shoulder joint or around the shoulder for more than 2 weeks
- Those willing to sign the written subject consent form.
Who cannot join
- Participants with shoulder pain symptoms before the stroke
- Acute shoulder trauma on the affected side of shoulder pain in the past.
- Surgery on the affected side of shoulder pain in the past.
- Those who cannot complete the scale assessment due to aphasia, post-stroke depression, and obvious cognitive impairment.
- Women who are pregnant or planning to become pregnant.
- Those who have a history of epilepsy and are receiving anti-epileptic drug treatment.
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- Who are receiving any herbal or folk remedies related to shoulder pain.
- Any other conditions deemed unsuitable in the assessment of the responsible physician.
- Those who have not signed the written subject consent form.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital, Keelung Medical Center
Keelung, Taiwan
Yu Wei Chang, +886 975360678
About this study
Investigators propose a research design protocol to evaluate the efficacy of laser acupuncture in improving shoulder pain and improving shoulder function recovery after stroke.
Read the detailed description
Shoulder pain after stroke, also known as hemiplegic shoulder pain, is one of the common complications after stroke. The overall incidence rate increases with the time after stroke.The existing treatment methods for shoulder pain after stroke are divided into non-drug and drug. Investigators propose a research design protocol to evaluate the efficacy of laser acupuncture in improving shoulder pain and improving shoulder function recovery after stroke.
- Conditions
- Post Stroke Shoulder Pain
- Being tested
- Verum laser acupuncture, Sham laser acupuncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Verum laser acupunctureDevice
Applied verum laser acupuncture on specific acupoints in patient with post stroke shoulder pain.
Sham laser acupunctureDevice
Applied sham laser acupuncture on specific acupoints in patient with post stroke shoulder pain.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group (verum laser acupuncture group ) | Experimental | After blind random allocation, investigators applied verum laser acupuncture on patient with shoulder pain after stroke. Receives: Device: Verum laser acupuncture |
| Control group (sham laser acupuncture group) | Sham comparator | After blind random allocation, investigators applied sham laser acupuncture on patient with shoulder pain after stroke. Receives: Device: Sham laser acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Passive range of motion of shoulder
Measuring the passive range of motion (Scale unit: angular degree) of shoulder (Abduction ranged from 0-180 degree, flexion ranged from 0-180 degree, external rotation ranged from 0-90 degree) of patient with shoulder pain. The higher degree of range of motion mean the better outcome.
Measured: 3 weeks
Numerical rating scale
Measuring the pain level by Numerical rating scale (scale unit: point). The scales ranged form 1 to 10 and the higher scores mean the worse outcome.
Measured: 3 weeks
Secondary outcomes (3)
Brief Pain Inventory - Short Form (BPI-sf)
Measuring the level of daily life effect by shoulder pain by Visual graphic rating scale (scale unit: point) of BPI-sf. The scales ranged form 1 to 10 and the higher scores mean the worse outcome.
Measured: 3 weeks
Visual graphic rating scale (VGRS) of ShoulderQ
Measuring the pain level on deferent time points by Visual graphic rating scale (scale unit: point) of ShoulderQ. The scales ranged form 1 to 10 and the higher scores mean the worse outcome.
Measured: 3 weeks
Meridian energy by Meridian Energy Analysis Devices
Meridian Energy Analysis Devices (MEADs) is a non-invasive meridian energy measurement tool used to Measure the meridian energy of patient. By measuring the current value (scale unit: micro ampere, uA) in the subject's limbs, investigators estimate the energy meridian energy. The higher the current energy value, the higher the meridian energy.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start16 Apr 2022
- Primary completion15 Mar 2028 (estimated)
- Study completion15 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Stroke Shoulder PainStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu Wei Chang, Study director, Chang Gung Medical Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05328401
- Sponsor's protocol ID
- 202200086A3
- Other IDs
- 202200086A3C502
- Status last verified
- Feb 2026
- First submitted
- 22 Mar 2022
- Last updated
- 6 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not share the data of this study.
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Therapeutic Effect of Laser Acupuncture in Patients With Acute or Subacute Post Stroke Shoulder Pain
- ClinicalTrials.gov ID
- NCT05328401
- Acronym / sponsor ID
- 202200086A3
- Conditions
- Post Stroke Shoulder Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 16 Apr 2022 (actual)
- Primary completion
- 15 Mar 2028 (estimated)
- Study completion
- 15 Mar 2028 (estimated)
- First posted
- 14 Apr 2022 (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.
Investigators propose a research design protocol to evaluate the efficacy of laser acupuncture in improving shoulder pain and improving shoulder function recovery after stroke.
Detailed description
Shoulder pain after stroke, also known as hemiplegic shoulder pain, is one of the common complications after stroke. The overall incidence rate increases with the time after stroke.The existing treatment methods for shoulder pain after stroke are divided into non-drug and drug. Investigators propose a research design protocol to evaluate the efficacy of laser acupuncture in improving shoulder pain and improving shoulder function recovery after stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group (verum laser acupuncture group ) | Experimental | Device: Verum laser acupunctureAfter blind random allocation, investigators applied verum laser acupuncture on patient with shoulder pain after stroke. |
| Control group (sham laser acupuncture group) | Sham comparator | Device: Sham laser acupunctureAfter blind random allocation, investigators applied sham laser acupuncture on patient with shoulder pain after stroke. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Beyond the age of 20.
- Normal consciousness before and after stroke who can reply and fill in the questionnaire.
- Subacute (subacute phase: 7 days to 6 months after stroke) and Chronic (chronic phase: more than 6 months after stroke) with shoulder pain after stroke and in post- stroke recovery period.
- Stop taking painkillers for more than 1 day,
- Without received intramuscular drugs (steroids, botulinum toxin, glucose, etc.) injections in the shoulder joint or around the shoulder for more than 2 weeks
Key exclusion criteria (9 listed)
- Participants with shoulder pain symptoms before the stroke
- Acute shoulder trauma on the affected side of shoulder pain in the past.
- Surgery on the affected side of shoulder pain in the past.
- Those who cannot complete the scale assessment due to aphasia, post-stroke depression, and obvious cognitive impairment.
- Women who are pregnant or planning to become pregnant.
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 |
|---|---|---|
| Verum laser acupunctureApplied verum laser acupuncture on specific acupoints in patient with post stroke shoulder pain. | Device | Intervention group (verum laser acupuncture group ) |
| Sham laser acupunctureApplied sham laser acupuncture on specific acupoints in patient with post stroke shoulder pain. | Device | Control group (sham laser acupuncture group) |
Primary outcome
Passive range of motion of shoulder
Time frame: 3 weeks
Measuring the passive range of motion (Scale unit: angular degree) of shoulder (Abduction ranged from 0-180 degree, flexion ranged from 0-180 degree, external rotation ranged from 0-90 degree) of patient with shoulder pain. The higher degree of range of motion mean the better outcome.
Numerical rating scale
Time frame: 3 weeks
Measuring the pain level by Numerical rating scale (scale unit: point). The scales ranged form 1 to 10 and the higher scores mean the worse outcome.
3 secondary outcomes
Brief Pain Inventory - Short Form (BPI-sf)
Time frame: 3 weeks
Visual graphic rating scale (VGRS) of ShoulderQ
Time frame: 3 weeks
Meridian energy by Meridian Energy Analysis Devices
Time frame: 3 weeks
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 6 Mar 2026.
- Individual participant dataSharing planned: No. We do not share the data of this study.
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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.
Yu Wei Chang study director
Chang Gung Medical Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Verum laser acupuncture in people with Post Stroke Shoulder Pain, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 6 inclusion and 9 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 6 Mar 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 Taiwan. 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. Some participants in this study may receive a placebo. 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 Yu Wei Chang (+886 975360678, yahwehmax@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Passive range of motion of shoulder (time frame: 3 weeks). The study lists 2 primary outcomes in all. 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 6 Mar 2026.