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

Not Applicable

Recruiting

• Conditions: Post Stroke Shoulder Pain
• Interventions: Device: Verum laser acupuncture; Device: Sham laser acupuncture

• Registration Number: NCT05328401
• Lead Sponsor: Chang Gung Memorial Hospital

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.

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 Timeline

• Study First Submitted: 2022-03-22
• Study First Submitted QC: 2022-04-13
• Study First Posted: 2022-04-14
• Study Start: 2022-04-16
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-05
• Last Update Posted: 2025-02-07
• Primary Completion: 2028-03-15
• Study Completion: 2028-03-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 58

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group (verum laser acupuncture group )	Verum laser acupuncture	After blind random allocation, investigators applied verum laser acupuncture on patient with shoulder pain after stroke.
Control group (sham laser acupuncture group)	Sham laser acupuncture	After blind random allocation, investigators applied sham laser acupuncture on patient with shoulder pain after stroke.

Primary Outcome Measures

Name	Time	Method
Numerical rating scale	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.
Passive range of motion of shoulder	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.

Secondary Outcome Measures

Name	Time	Method
Brief Pain Inventory - Short Form (BPI-sf)	3 weeks	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.
Meridian energy by Meridian Energy Analysis Devices	3 weeks	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.
Visual graphic rating scale (VGRS) of ShoulderQ	3 weeks	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.

Trial Locations

Locations (1)

Chang Gung Memorial Hospital, Keelung Medical Center; 🇨🇳 Keelung, Taiwan