NCT05595720

Effect of High Intensity Laser on Hemiplegic Shoulder Dysfunction

Completed Phase 1 Last updated 26 September 2023

What this trial tests

Phase 1 trial testing hight intenisty laser in Stroke in 44 participants. Completed in 20 January 2023.

Timeline

20 October 2022

Primary endpoint
18 January 2023

20 January 2023

Quick facts

Lead sponsor	Deraya University
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	44
Start date	20 October 2022
Primary completion	18 January 2023
Estimated completion	20 January 2023
Sites	1 location across Egypt

Drugs / interventions tested

• hight intenisty laser

Conditions studied

• Stroke — all drugs for Stroke →
• Shoulder Dislocation or Subluxation — all drugs for Shoulder Dislocation or Subluxation →

Sponsor

Deraya University

Who can join

Adults 40 to 75, any sex, with Stroke or Shoulder Dislocation or Subluxation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effectiveness of a high-intensity laser for improving hemiplegic shoulder dysfunction: a randomized controlled trial.
   Abdelhakiem NM, Mustafa Saleh MS, Shabana MMA, Abd El Wahaab HA, et al · · 2024 · cited 7× · PMID 38538637 · DOI 10.1038/s41598-024-57453-9