Comparison of Effectiveness of Low Dose Laser and Transcutaneous Electrical Stimulation in Hemiplegic Shoulder

Официальное название

Comparison of the Efficacy of Low-Dose Laser and Transcutaneous Electrical Nerve Stimulation in Subacute Hemiplegic Shoulder Pain, and the Effect of Treatments on Upper Extremity Function and Quality of Life

Обзор

The primary aim of this study is to compare the efficacy of Transcutaneous Electrical Nerve Stimulation (TENS) and Low Level Laser Therapy (LLLT), which are analgesic modalities that play an important role in the treatment of this frequently encountered complication. The secondary aim of the study is to evaluate its effectiveness on upper extremity function, quality of life, sleep, and fatigue.

Подробное описание

Stroke is a leading cause of morbidity and mortality worldwide. (1) Hemiplegic shoulder pain (HSP) is one of the common complications seen in up to 40% of stroke patients and negatively affects the rehabilitation process. (2) It is also a significant complication that prolongs hospital stay. Therefore, developing effective treatment strategies is extremely important.

The primary aim of our study is to compare the efficacy of Transcutaneous Electrical Nerve Stimulation (TENS) and Low Level Laser Therapy (LLLT), which are analgesic modalities that play an important role in the treatment of this frequently encountered complication.

Treatment methods used for hemiplegic shoulder pain: Exercises (joint range of motion, stretching and strengthening exercises), physical therapy agents, kinesiology taping, transcutaneous electrical nerve stimulation (TENS), suprascapular nerve block (SSNB), suprascapular nerve pulsed radiofrequency (PRF), botulinum toxin type A (BoNT-A) intramuscular injections, corticosteroid injections, segmental neuromyotherapy (SNMT), trigger point dry needling (TrPs-DN), robot-assisted shoulder rehabilitation therapy (RSRT), platelet-rich plasma (PrP) injection, repetitive transcranial magnetic stimulation ( rTMS), peripheral nerve stimulation (PNS), neuromuscular electrical stimulation (NMES), functional electrical stimulation (FES), and interferential current stimulation (IFC) play a role in the management of the hemiplegic shoulder pain clinic. (3)

Вмешательства

• Устройство Low Dose Laser
  Patients with subacromial-subdeltoid bursa, m. deltoideus, m. biceps longus, m. infraspinatus, and m. supraspinatus muscles (at the most painful point of the muscles) with a 13-diode Gallium-Aluminium-Arsenide laser device (Intelect Mobile Laser) with a wavelength of 850 nm and 50 mW, 4 Joules per day, 20 seconds, for a total of 15 laser sessions.
• Устройство TENS
  TENS therapy will be administered using the TENS device (Intelect Advanced Therapy System) for a total of 15 sessions, 5 days a week, 20 minutes per day, at a dose of 20-40 mA.
• Другое Conventional physical therapy
  Only conventional physiotherapy is planned to be administered to patients.

Первичные конечные точки

• Visual Analogue Scale (VAS) [Срок оценки: patients will be checked on first day of hospitalization, after treatment at 4 weeks and after treatment 3 months]

Вторичные конечные точки (7)

• Fugl Meyer Upper Extremity Motor Function Scale [Срок оценки: patients will be checked on first day of hospitalization, after treatment at 4 weeks and after treatment 3 months]
• Joint Range of Motion (ROM) Measurement [Срок оценки: patients will be checked on first day of hospitalization, after treatment at 4 weeks and after treatment 3 months]
• Stroke-Specific Quality of Life Scale [Срок оценки: patients will be checked on first day of hospitalization, after treatment at 4 weeks and after treatment 3 months]
• Barthel Index [Срок оценки: patients will be checked on first day of hospitalization, after treatment at 4 weeks and after treatment 3 months]
• Beck Depression Scale [Срок оценки: patients will be checked on first day of hospitalization, after treatment at 4 weeks and after treatment 3 months]
• Pittsburgh Sleep Quality Index [Срок оценки: patients will be checked on first day of hospitalization, after treatment at 4 weeks and after treatment 3 months]
• Ultrasonographic findings [Срок оценки: patients will be checked on first day of hospitalization, after treatment at 4 weeks and after treatment 3 months]

Критерии участия

Критерии включения

• Patients aged 18-75 years
• Patients with shoulder pain on the hemiplegic side \*Mini mental state examination ≥ 25
• History of stroke within the last 2 weeks to 6 months
• Patients with shoulder pain scoring 40-100 points on the visual analogue scale (moderate to severe) will be included.

Критерии исключения

• Patients who refuse to provide written consent or attend follow-up visits
• Being under 18 years of age
• Patients with motor aphasia
• Patients who have had a shoulder injection within the last 3 months
• Patients who have undergone upper extremity botulinum toxin application within the last 6 months

\*Pregnant women or those planning to become pregnant

• Inflammatory rheumatic disease
• Patients who have undergone shoulder injury and surgery prior to stroke
• Patients with other conditions that could explain shoulder pain
• Patients with complex regional pain syndrome
• Patients with a history of epilepsy, pacemaker, or arrhythmia diagnosis
• Malignancy
• Diseases such as Alzheimer's or dementia that cause cognitive impairment -History of psychiatric disorders such as major depression or personality disorders
• Alcohol and drug addiction

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Ankara Etlik City Hospital — Ankara

Идентификаторы

NCT: NCT07203222 · AEŞH-EK-2025-066

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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