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NCT Number: NCT05328401

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chang Gung Memorial Hospital, Keelung Medical Center

Keelung, Taiwan

Location status: Recruiting

Location contact

Yu Wei Chang

CONTACT

+886 975360678

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Verum laser acupuncture

Device

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

Sham laser acupuncture

Device

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

Primary outcomes

  1. Passive range of motion of shoulder

    Time frame: 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.

  2. Numerical rating scale

    Time frame: 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.

Secondary outcomes

  1. Brief Pain Inventory - Short Form (BPI-sf)

    Time frame: 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.

  2. Visual graphic rating scale (VGRS) of ShoulderQ

    Time frame: 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.

  3. Meridian energy by Meridian Energy Analysis Devices

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yu Wei Chang

CONTACT

[email protected]

+886 975360678

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
Apr 14, 2022
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.