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Effect of High Intensity Laser on Hemiplegic Shoulder Dysfunction

Primary Purpose

Stroke, Shoulder Dislocation or Subluxation

Status

Completed

Phase

Phase 1

Locations

Egypt

Study Type

Interventional

Intervention

hight intenisty laser

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke,, Shoulder dysfunction, High intensity laser

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

DISORDER MORE THAN 6 MONTHS
UNILATERAL
FIRST TIME

Exclusion Criteria:

Iinflammatory rheumatic disease,
cervical radiculopathy,
diabetes mellitus,
thyroid disease,
coronary heart disease,
cardiac pacemaker,
neurological disease,
shoulder surgery, and
shoulder injection in the last 3 months

Sites / Locations

Physical Therapy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

treatment group

control group

Arm Description

Outcomes

Primary Outcome Measures

PAIN score

McGill pain questioner scale, scoring from zero to 78 zero is the best score seventy eight is the worst score

FUNCTION

UCLA shoulder score from zero to 35 zero is the worst 35 is the best

Secondary Outcome Measures

Full Information

NCT ID

NCT05595720

First Posted

October 17, 2022

Last Updated

September 24, 2023

Sponsor

Deraya University

1. Study Identification

Unique Protocol Identification Number

NCT05595720

Brief Title

Effect of High Intensity Laser on Hemiplegic Shoulder Dysfunction

Official Title

Effect of High Intensity Laser on Hemiplegic Shoulder Dysfunction Double Blinded, Placebo-controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Completed

Study Start Date

October 20, 2022 (Actual)

Primary Completion Date

January 18, 2023 (Actual)

Study Completion Date

January 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Deraya University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Hemiplegic shoulder pain (HSP) is a common and disabling complication following a stroke, and it may affect the quality of life. It often occurs following two to three months of stroke. Upper limb impairment is seen in 90% of patients affected by stroke. Numerous causes have been implicated in developing HSP in stroke. This includes muscle flaccidity around the shoulder joint, shoulder subluxation, shoulder-hand syndrome, increased muscle tone, impingement syndrome, frozen shoulder, brachial plexus injury, and the thalamic syndrome. Muscle paresis, abnormal muscle tone and loss of proprioception following stroke may render the shoulder complex unstable and therefore prone to misalignment. In recent years, high-intensity laser therapy (HILT) has been considered as a treatment option for shoulder pain. HILT increases microcirculation and tissue regeneration and lowers edema, inflammation, and pain with its photomechanical, thermal, electrical, and bio stimulating effects in deep tissues that cannot be reached with LILT. It has some advantages over LILT, i.e., having higher power, greater tissue penetration capacity to deep tissues, the short emission time, and long rest periods preventing heat accumulation. In recent studies, effectiveness of HILT has been shown in the treatment of subacromial impingement syndrome, rotator cuff tendinopathy, and frozen shoulder.

6. Conditions and Keywords

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

Stroke, Shoulder Dislocation or Subluxation

Keywords

Stroke,, Shoulder dysfunction, High intensity laser

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

44 (Actual)

8. Arms, Groups, and Interventions

Arm Title

treatment group

Arm Type

Experimental

Arm Title

control group

Arm Type

No Intervention

Intervention Type

Device

Intervention Name(s)

hight intenisty laser

Intervention Description

7W(LAZR-207)/15W(LAZR-215&115)HIGH POWER LASER THERAPYUNIT WITH 2 WAVELENGTHMODES,COMBINATION(810+980 NM) AND SINGLE(1064 NM)

Primary Outcome Measure Information:

Title

PAIN score

Description

McGill pain questioner scale, scoring from zero to 78 zero is the best score seventy eight is the worst score

Time Frame

1 MONTH

Title

FUNCTION

Description

UCLA shoulder score from zero to 35 zero is the worst 35 is the best

Time Frame

1 MONTH

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: DISORDER MORE THAN 6 MONTHS UNILATERAL FIRST TIME Exclusion Criteria: Iinflammatory rheumatic disease, cervical radiculopathy, diabetes mellitus, thyroid disease, coronary heart disease, cardiac pacemaker, neurological disease, shoulder surgery, and shoulder injection in the last 3 months

Facility Information:

Facility Name

Physical Therapy

City

Minya

State/Province

المنيا

ZIP/Postal Code

05673

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Yes

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Effect of High Intensity Laser on Hemiplegic Shoulder Dysfunction

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