High-Intensity Laser Therapy in Hemiplegic Shoulder Pain

NCT07501416 | Recruiting

• 1 other identifier: CagatayTez
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hemiplegia and/or Hemiparesis Following Stroke

Outcome Measures

Primary Outcomes (3)

• Shoulder Pain and Disability Index (SPADI)

  The Shoulder Pain and Disability Index (SPADI) was used to evaluate shoulder-related pain and functional impairment. The index consists of 13 items divided into two subscales: pain (5 items) and disability (8 items). Each item is scored on a 0-10 numerical rating scale, where 0 indicates "no pain/difficulty" and 10 indicates "worst imaginable pain/so difficult it requires help." The total score is calculated by averaging the subscale scores and converting them to a percentage, ranging from 0 to 100. Higher scores represent greater levels of pain and disability. The SPADI is a widely recognized tool with high internal consistency and responsiveness to clinical changes in shoulder conditions.

  Baseline and Week 4

• Functional Independence Measure (FIM)

  Assesses functional independence in activities of daily living. Includes motor and total scores. The functional status of the participants was evaluated using the Functional Independence Measure (FIM). The FIM consists of 18 items, categorized into two main domains: Motor FIM (13 items): Assessing self-care, sphincter control, transfers, and locomotion (score range: 13-91). Cognitive FIM (5 items): Assessing communication and social cognition (score range: 5-35). Each item is scored on a 7-point Likert scale, ranging from 1 (total assistance) to 7 (complete independence). Total scores range from 18 to 126, where higher scores indicate greater functional independence.

  Baseline and Week 4

• Ultrasonographic Assessment

  This description refers to the Ultrasonographic Evaluation of the shoulder. In a Method section, it is important to specify that the exam was performed by a specialist and to list the specific structures visualized. Here is the professional English text for your article: Ultrasonographic Evaluation All participants underwent a standardized musculoskeletal ultrasound (US) examination of the affected shoulder, performed by an experienced \[radiologist/physiatrist\] using a \[Insert Brand, e.g., GE Voluson\] system with a high-frequency linear transducer. The examination followed the European Society of Musculoskeletal Radiology (ESSR) guidelines. The sonographic assessment included: Tendon Pathology: Evaluation of the supraspinatus, infraspinatus, and subscapularis tendons for signs of tendinosis, calcifications, and partial or full-thickness tears. The long head of the biceps tendon was also assessed for tenosynovitis or subluxation

  Baseline and Week 4

Secondary Outcomes (6)

• Shoulder Range of Motion (ROM)

  Baseline and Week 4

• Modified Ashworth Scale

  Baseline and Week 4

• Brunnstrom Recovery Stages

  Baseline and Week 4

• Pressure Pain Threshold

  Baseline and Week 4

• Acromiohumeral Distance

  Baseline and Week 4

Study Arms (2)

High-Intensity Laser Therapy + Exercise

EXPERIMENTAL

Participants will receive high-intensity laser therapy combined with a structured exercise program.

Device: High-Intensity Laser Therapy (HILT); Other: Exercise therapy

Sham Laser Therapy + Exercise

SHAM COMPARATOR

Participants will receive sham laser therapy combined with the same exercise program.

Other: Exercise therapy; Device: Sham Laser Therapy

Interventions

High-Intensity Laser Therapy (HILT) DEVICE

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).

High-Intensity Laser Therapy + Exercise

Exercise therapy OTHER

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.

High-Intensity Laser Therapy + Exercise; Sham Laser Therapy + Exercise

Sham Laser Therapy DEVICE

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.

Sham Laser Therapy + Exercise

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Kutahya Health Sciences University: lead

Study Sites (1)

Kutahya Health Sciences University

Kütahya, 43000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

Exercise Therapy

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Fatima YAMAN, Assoc. Prof.

  Kutahya Health Sciences University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali Cagtay Dayı, MD

CONTACT

002742600043; alicagtay.dayi@ogr.ksbu.edu.tr

Fatima YAMAN, Assoc. Prof.

CONTACT

002742600043; fatima.yaman@ksbu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: March 22, 2026
• First Posted: March 30, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): January 30, 2027
• Last Updated: July 28, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)