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

Primary Purpose

Post Stroke Shoulder Pain

Status

Recruiting

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

Verum laser acupuncture

Sham laser acupuncture

About this trial

This is an interventional treatment trial for Post Stroke Shoulder Pain

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Chang Gung Memorial Hospital, Keelung Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Intervention group (verum laser acupuncture group )

Control group (sham laser acupuncture group)

Arm Description

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

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

Outcomes

Primary Outcome Measures

Passive range of motion of shoulder

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.

Numerical rating scale

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 Outcome Measures

Brief Pain Inventory - Short Form (BPI-sf)

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.

Visual graphic rating scale (VGRS) of ShoulderQ

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.

Meridian energy by Meridian Energy Analysis Devices

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.

Full Information

NCT ID

NCT05328401

First Posted

March 22, 2022

Last Updated

August 2, 2022

Sponsor

Chang Gung Memorial Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05328401

Brief Title

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

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Recruiting

Study Start Date

April 16, 2022 (Actual)

Primary Completion Date

March 15, 2025 (Anticipated)

Study Completion Date

March 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Chang Gung Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Post Stroke Shoulder Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

58 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intervention group (verum laser acupuncture group )

Arm Type

Experimental

Arm Description

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

Arm Title

Control group (sham laser acupuncture group)

Arm Type

Sham Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Verum laser acupuncture

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Sham laser acupuncture

Intervention Description

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

Primary Outcome Measure Information:

Title

Passive range of motion of shoulder

Description

Time Frame

3 weeks

Title

Numerical rating scale

Description

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.

Time Frame

3 weeks

Secondary Outcome Measure Information:

Title

Brief Pain Inventory - Short Form (BPI-sf)

Description

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.

Time Frame

3 weeks

Title

Visual graphic rating scale (VGRS) of ShoulderQ

Description

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.

Time Frame

3 weeks

Title

Meridian energy by Meridian Energy Analysis Devices

Description

Time Frame

3 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yu Wei Chang

Phone

+886 975360678

yahwehmax@cgmh.org.tw

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yu Wei Chang

Organizational Affiliation

Chang Gung Medical Foundation

Official's Role

Study Director

Facility Information:

Facility Name

Chang Gung Memorial Hospital, Keelung Medical Center

City

Keelung

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yu Wei Chang

Phone

+886 975360678

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

We do not share the data of this study.

Learn more about this trial

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

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