NCT07501416

High-Intensity Laser Therapy in Hemiplegic Shoulder Pain

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Kutahya Health Sciences University · Academic / Other
• Sex: All
• Age: 30 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Hemiplegia and/or Hemiparesis Following Stroke

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-04-01
• Primary completion: 2026-12-30
• Completion: 2027-01-30
• First posted: 2026-03-30
• Last updated: 2026-03-30

Locations

1 site across 1 country: Turkey (Türkiye)