Clinical trial NCT05328401: To Evaluate the Therapeutic Effect of Laser Acupuncture in Patients with Acute or Subacute Post Stroke Shoulder Pain
Official title: To Evaluate the Therapeutic Effect of Laser Acupuncture in Patients with Acute or Subacute Post Stroke Shoulder Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post Stroke Shoulder Pain
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2022-04-14
Enrollment: 58
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Passive range of motion of shoulder
timeFrame: 3 weeks
measure: Numerical rating scale
timeFrame: 3 weeks
Secondary outcomes:
measure: Brief Pain Inventory - Short Form (BPI-sf)
timeFrame: 3 weeks
measure: Visual graphic rating scale (VGRS) of ShoulderQ
timeFrame: 3 weeks
measure: Meridian energy by Meridian Energy Analysis Devices
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Keelung
country: Taiwan
facility: Chang Gung Memorial Hospital, Keelung Medical Center
Study officials:
affiliation: Chang Gung Medical Foundation
name: Yu Wei Chang
role: STUDY_DIRECTOR
References: