To Evaluate the Therapeutic Effect of Laser Acupuncture in Patients With Acute or Subacute Post Stroke Shoulder Pain

NCT05328401 | Recruiting

• 2 other identifiers: 202200086A3202200086A3C502
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Post Stroke Shoulder Pain

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  3 weeks

Secondary Outcomes (3)

• Brief Pain Inventory - Short Form (BPI-sf)

  3 weeks

• Visual graphic rating scale (VGRS) of ShoulderQ

  3 weeks

• Meridian energy by Meridian Energy Analysis Devices

  3 weeks

Study Arms (2)

Intervention group (verum laser acupuncture group )

EXPERIMENTAL

After blind random allocation, investigators applied verum laser acupuncture on patient with shoulder pain after stroke.

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.

Device: Sham laser acupuncture

Interventions

Sham laser acupuncture DEVICE

Applied sham laser acupuncture on specific acupoints in patient with post stroke shoulder pain.

Control group (sham laser acupuncture group)

Verum laser acupuncture DEVICE

Applied verum laser acupuncture on specific acupoints in patient with post stroke shoulder pain.

Intervention group (verum laser acupuncture group )

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital, Keelung Medical Center

Keelung, Taiwan, Taiwan

RECRUITING

Study Officials

• Yu Wei Chang

  Chang Gung Medical Foundation

  STUDY DIRECTOR

Central Study Contacts

Yu Wei Chang

CONTACT

+886 975360678; yahwehmax@cgmh.org.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2022
• First Posted: April 14, 2022
• Study Start: April 16, 2022
• Primary Completion (Estimated): March 15, 2028
• Study Completion (Estimated): March 15, 2028
• Last Updated: March 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)