Effect of High Intensity Laser on Hemiplegic Shoulder Dysfunction

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

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Shoulder Dislocation or Subluxation
• Intervention / Treatment: Device: hight intenisty laser

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Phase 1

Contacts and Locations

Study Locations

• Egypt
  • المنيا
    • Minya, المنيا, Egypt, 05673
      • Physical Therapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control group
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PAIN score	McGill pain questioner scale, scoring from zero to 78 zero is the best score seventy eight is the worst score	1 MONTH
FUNCTION	UCLA shoulder score from zero to 35 zero is the worst 35 is the best	1 MONTH

Collaborators and Investigators

• Sponsor: Deraya University

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2022
• Primary Completion (Actual): January 18, 2023
• Study Completion (Actual): January 20, 2023

Study Registration Dates

• First Submitted: October 17, 2022
• First Submitted That Met QC Criteria: October 23, 2022
• First Posted (Actual): October 27, 2022

Study Record Updates

• Last Update Posted (Actual): September 26, 2023
• Last Update Submitted That Met QC Criteria: September 24, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Stroke,; Shoulder dysfunction; High intensity laser
• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Joint Dislocations; Shoulder Dislocation
• Other Study ID Numbers: Deraya U

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No