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

Chang Gung Medical Foundation

Status: Enrolling

Conditions: Post Stroke Shoulder Pain

Treatments: Device: Verum laser acupuncture; Device: Sham laser acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT05328401

202200086A3

Details and patient eligibility

About

Investigators propose a research design protocol to evaluate the efficacy of laser acupuncture in improving shoulder pain and improving shoulder function recovery after stroke.

Full 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.

Enrollment: 58 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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58 participants in 2 patient groups

Intervention group (verum laser acupuncture group )

Experimental group

Description:

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

Treatment:

Device: Verum laser acupuncture

Control group (sham laser acupuncture group)

Sham Comparator group

Description:

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

Treatment:

Device: Sham laser acupuncture