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CompletedNCT05595720Updated Sep 26, 2023

Effect of High Intensity Laser on Hemiplegic Shoulder Dysfunction

A Phase 1 interventional study of hight intenisty laser in Stroke and Shoulder Dislocation or Subluxation, sponsored by Deraya University. Completed at 1 site in Egypt. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-09-26.

Sponsored by Deraya University · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
40 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Stroke
  • Shoulder Dislocation or Subluxation

Keywords

  • Stroke,
  • Shoulder dysfunction
  • High intensity laser
03

In context

Stroke

8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.

This study's enrollment of 44 is below the median of 49 across 6,024 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Deraya University is the lead sponsor of 50 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • DISORDER MORE THAN 6 MONTHS
  • UNILATERAL
  • FIRST TIME

Exclusion criteria

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
44 participants (actual)

Study arms

  • Experimental
    treatment group

    Device: hight intenisty laser

  • No intervention
    control group

Interventions

  • Devicehight intenisty laser

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

06

What researchers measure

Primary outcomes

  1. PAIN score

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

    Time frame: 1 MONTH

  2. FUNCTION

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

    Time frame: 1 MONTH

07

Study locations

1 site
  • Physical Therapy
    Minya, المنيا 05673, Egypt
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 26, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05595720
Lead sponsor
Deraya University
Responsible party
Sponsor
First posted
Oct 27, 2022
Start date
Oct 20, 2022
Primary completion
Jan 18, 2023
Completion
Jan 20, 2023
Last update
Sep 26, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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