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Recruiting NCT07501416

High-Intensity Laser Therapy in Hemiplegic Shoulder Pain

No phase Interventional Hemiplegia and/or Hemiparesis Following Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: High-Intensity Laser Therapy (HILT), Exercise therapy, Sham Laser Therapy.
Who it may be relevant to
Registry conditions: Hemiplegia and/or Hemiparesis Following Stroke. Basic parameters: 30 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Effectiveness of High-Intensity Laser Therapy Combined With Exercise on Clinical and Ultrasonographic Outcomes in Patients With Hemiplegic Shoulder Pain

Overview

This randomized, sham-controlled clinical trial aims to evaluate the effectiveness of high-intensity laser therapy (HILT) combined with exercise on pain, functional status, disability, and ultrasonographic findings in patients with hemiplegic shoulder pain following stroke.

Detailed description

Hemiplegic shoulder pain (HSP) is a common complication after stroke that significantly affects functional recovery and quality of life. High-intensity laser therapy (HILT) has analgesic, anti-inflammatory, and regenerative effects.

Participants will be randomly assigned into two groups:

HILT + exercise therapy Sham HILT + exercise therapy

The treatment protocol will consist of 20 sessions over 4 weeks (5 sessions per week).

Outcome assessments will be conducted at baseline and at the end of week 4 by blinded assessors.

Interventions

  • Device High-Intensity Laser Therapy (HILT)
    High-intensity laser therapy will be applied using a 1064 nm wavelength laser device with a peak power up to 3 kW. Each session will deliver approximately 2500 Joules of over 10 minutes. The treatment will be applied to the supraspinatus, deltoid, upper trapezius, pectoralis minor, and biceps tendon regions. The treatment protocol includes fast and slow scanning phases and will be administered 5 days per week for 4 weeks (total 20 sessions).
  • Other Exercise therapy
    Participants will undergo a standardized rehabilitation program including passive, active-assisted, and active range-of-motion exercises. Exercises will be performed in 3 sets of 10 repetitions daily, 5 days per week for 4 weeks.
  • Device Sham Laser Therapy
    The same laser device will be used without active energy emission. The procedure, duration, and application areas will be identical to the active laser therapy to maintain blinding.

Primary outcome measures

  • Shoulder Pain and Disability Index (SPADI) [Time frame: Baseline and Week 4]
  • Functional Independence Measure (FIM) [Time frame: Baseline and Week 4]
  • Ultrasonographic Assessment [Time frame: Baseline and Week 4]
Secondary outcome measures (6)
  • Shoulder Range of Motion (ROM) [Time frame: Baseline and Week 4]
  • Modified Ashworth Scale [Time frame: Baseline and Week 4]
  • Brunnstrom Recovery Stages [Time frame: Baseline and Week 4]
  • Pressure Pain Threshold [Time frame: Baseline and Week 4]
  • Acromiohumeral Distance [Time frame: Baseline and Week 4]
  • Supraspinatus Tendon Thickness and occupation ratio [Time frame: Baseline and Week 4]

Eligibility criteria

Inclusion criteria

  • Age 30-75 years
  • Hemiplegic shoulder pain after stroke
  • Stroke within last 6 months
  • VAS ≥ 3 for pain
  • Medically stable

Exclusion criteria

  • Neurological disorders (MS, Parkinson, etc.)
  • Recent shoulder surgery/injection
  • Botulinum toxin (last 6 months)
  • Malignancy
  • Pregnancy
  • Epilepsy or photosensitivity
  • Cognitive impairment

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Kutahya Health Sciences University — Kütahya

Identifiers

NCT: NCT07501416 · CagatayTez

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗