Effect of High Intensity Laser on Hemiplegic Shoulder Dysfunction

NCT ID: NCT05595720

Last Updated: 2023-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-20
• Study Completion Date: 2023-01-20

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

treatment group

Group Type: EXPERIMENTAL

hight intenisty laser

Intervention Type: DEVICE

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

control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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)

Intervention Type: DEVICE

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Deraya University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Physical Therapy

Minya, Minya Governorate, Egypt

Countries

Egypt

Other Identifiers

Deraya U

Identifier Type: -

Identifier Source: org_study_id