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

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 Overview

• Status: Recruiting
• Conditions: Post Stroke Shoulder Pain
• Intervention / Treatment: Device: Verum laser acupuncture; Device: Sham laser acupuncture

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 Type: Interventional
• Enrollment (Estimated): 58
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yu Wei Chang; Phone Number: +886 975360678; Email: yahwehmax@cgmh.org.tw

Study Locations

• Taiwan
  • Taiwan
    • Keelung, Taiwan, Taiwan
      • Recruiting
      • Chang Gung Memorial Hospital, Keelung Medical Center
      • Contact: Yu Wei Chang; Phone Number: +886 975360678

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group (verum laser acupuncture group ); After blind random allocation, investigators applied verum laser acupuncture on patient with shoulder pain after stroke.	Device: Verum laser acupuncture; Applied verum laser acupuncture on specific acupoints in patient with post stroke shoulder pain.
Sham Comparator: Control group (sham laser acupuncture group); After blind random allocation, investigators applied sham laser acupuncture on patient with shoulder pain after stroke.	Device: Sham laser acupuncture; Applied sham laser acupuncture on specific acupoints in patient with post stroke shoulder pain.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	3 weeks

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Study Director: Yu Wei Chang, Chang Gung Medical Foundation

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2022
• Primary Completion (Estimated): March 15, 2028
• Study Completion (Estimated): March 15, 2028

Study Registration Dates

• First Submitted: March 22, 2022
• First Submitted That Met QC Criteria: April 13, 2022
• First Posted (Actual): April 14, 2022

Study Record Updates

• Last Update Posted (Actual): March 6, 2026
• Last Update Submitted That Met QC Criteria: March 4, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Joint Diseases; Arthralgia; Stroke; Shoulder Pain
• Other Study ID Numbers: 202200086A3; 202200086A3C502 (Other Identifier: ChangGungMH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We do not share the data of this study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No