Effect of High Intensity Laser on Hemiplegic Shoulder Dysfunction

NCT05595720 | Completed Phase 1 DMC

• 1 other identifier: Deraya U
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Shoulder Dislocation or Subluxation

Keywords

Stroke,; Shoulder dysfunction; High intensity laser

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

treatment group

EXPERIMENTAL

Device: hight intenisty laser

control group

NO INTERVENTION

Interventions

hight intenisty laser DEVICE

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

treatment group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• DISORDER MORE THAN 6 MONTHS
• UNILATERAL
• FIRST TIME

You may not qualify if:

• 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

Sponsors & Collaborators

• Deraya University: lead

Study Sites (1)

Physical Therapy

Minya, Minya Governorate, 05673, Egypt

Location

MeSH Terms

Conditions

Stroke; Shoulder Dislocation; Joint Dislocations

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Shoulder Injuries

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2022
• First Posted: October 27, 2022
• Study Start: October 20, 2022
• Primary Completion: January 18, 2023
• Study Completion: January 20, 2023
• Last Updated: September 26, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)