High-Intensity Laser Therapy in Hemiplegic Shoulder Pain

Condition(s) studied

Investigational drug(s) / intervention(s)

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).

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.

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Shoulder Pain and Disability Index (SPADI) — Baseline and Week 4
  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.
• Functional Independence Measure (FIM) — Baseline and Week 4
  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.
• Ultrasonographic Assessment — Baseline and Week 4
  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

Trial sites (1)

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