Effect of High Intensity Laser on Hemiplegic Shoulder Dysfunction

Sponsor
Deraya University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05595720
Collaborator
(none)
44
1
2
3
14.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: hight intenisty laser
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
44 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effect of High Intensity Laser on Hemiplegic Shoulder Dysfunction Double Blinded, Placebo-controlled Trial
Anticipated Study Start Date :
Oct 20, 2022
Anticipated Primary Completion Date :
Jan 18, 2023
Anticipated Study Completion Date :
Jan 20, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: treatment group

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

No Intervention: control group

Outcome Measures

Primary Outcome Measures

  1. PAIN score [1 MONTH]

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

  2. FUNCTION [1 MONTH]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Physical Therapy Minya المنيا Egypt 05673

Sponsors and Collaborators

  • Deraya University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Deraya University
ClinicalTrials.gov Identifier:
NCT05595720
Other Study ID Numbers:
  • Deraya U
First Posted:
Oct 27, 2022
Last Update Posted:
Oct 27, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Deraya University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 27, 2022