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

NCT ID: NCT05328401

Last Updated: 2025-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-16

Study Completion Date

2028-03-15

Brief Summary

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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

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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

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Post Stroke Shoulder Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Intervention group (verum laser acupuncture group )

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

Group Type EXPERIMENTAL

Verum laser acupuncture

Intervention Type DEVICE

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

Control group (sham laser acupuncture group)

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

Group Type SHAM_COMPARATOR

Sham laser acupuncture

Intervention Type DEVICE

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

Interventions

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Verum laser acupuncture

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

Intervention Type DEVICE

Sham laser acupuncture

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yu Wei Chang

Role: STUDY_DIRECTOR

Chang Gung Medical Foundation

Locations

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Chang Gung Memorial Hospital, Keelung Medical Center

Keelung, Taiwan, Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Yu Wei Chang

Role: CONTACT

+886 975360678

Facility Contacts

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Yu Wei Chang

Role: primary

+886 975360678

Other Identifiers

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202200086A3

Identifier Type: -

Identifier Source: org_study_id

202200086A3C502

Identifier Type: OTHER

Identifier Source: secondary_id

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