SIRS-ESWT Trial: Shoulder Internal Rotator Spasticity Trial Treated With Extracorporeal Shock Wave Therapy Trial

Официальное название

Effects of Extracorporeal Shock Wave Therapy on Shoulder Internal Rotator Spasticity in Post-Stroke Patients: A Randomized Controlled Trial

Обзор

Extracorporeal shock wave therapy (ESWT) has shown potential in reducing post-stroke limb spasticity. This study aims to evaluate the efficacy of focused ESWT on shoulder internal rotator spasticity in post-stroke patients.

Подробное описание

This study aimed to evaluate the effects of focused extracorporeal shock wave therapy (ESWT) on shoulder internal rotator spasticity in stroke patients. Participants were randomized into two groups: an experimental group receiving targeted ESWT on specific shoulder internal rotators, and a control group receiving placebo treatments mimicking the shockwave therapy, with treatments administered twice weekly over two weeks for a total of four sessions.

The efficacy of the treatment was measured using a comprehensive set of assessment tools, including range of motion, pain levels, spasticity scales, functional assessments, as well as measures of daily living activities, and ultrasound strain elastography. The outcomes were evaluated at multiple points in time: before treatment, and 1, 4, 12, and 24 weeks after the therapy concluded, to assess both immediate and sustained effects of the treatment on shoulder function and spasticity in stroke survivors.

Вмешательства

• Устройство focused extracorporeal shock wave therapy (ESWT)
  The focused shockwaves are directed at the affected muscles in the upper limb, specifically targeting the subscapularis, pectoralis major, latissimus dorsi, and teres major muscles.
• Устройство focused extracorporeal shock wave therapy (ESWT)
  Placebo shockwave therapy directed at subscapularis, pectoralis major, latissimus dorsi, and teres major muscles.

Первичные конечные точки

• passive range of motion for the shoulder joints [Срок оценки: pre-treatment; 1, 4, 12, and 24 weeks post-treatment]
• shoulder strength [Срок оценки: pre-treatment; 1, 4, 12, and 24 weeks post-treatment]
• Visual Analogue Scale (VAS) [Срок оценки: pre-treatment; 1, 4, 12, and 24 weeks post-treatment]
• modified Ashworth scale (MAS) [Срок оценки: pre-treatment; 1, 4, 12, and 24 weeks post-treatment]

Вторичные конечные точки (5)

• Fugl-Meyer Assessment for the Upper Extremity (FMA-UE) [Срок оценки: pre-treatment; 1, 4, 12, and 24 weeks post-treatment]
• Action Research Arm Test (ARAT) [Срок оценки: pre-treatment; 1, 4, 12, and 24 weeks post-treatment]
• Barthel index [Срок оценки: pre-treatment; 1, 4, 12, and 24 weeks post-treatment]
• Wolf Motor Function Test [Срок оценки: pre-treatment; 1, 4, 12, and 24 weeks post-treatment]
• ultrasound assessment [Срок оценки: pre-treatment; 1, 4, 12, and 24 weeks post-treatment]

Критерии участия

Критерии включения

• Patients aged 18 years or older with unilateral cerebral stroke.
• Restricted passive external rotation of the spastic shoulder by more than 20 degrees.
• A Modified Ashworth Scale score of 1 or higher for shoulder internal rotator spasticity.
• Stable medical condition and vital signs.
• Clear consciousness, able to follow instructions.

Критерии исключения

• History of two or more strokes, traumatic brain injury, brain tumors, or other cerebral disorders.
• Coexisting central nervous system disorders (e.g., spinal cord injury, Parkinson's disease) or other musculoskeletal conditions affecting muscle tone assessment.
• Ineligibility for shock wave intervention due to malignancies, coagulation disorders, localized infections, or presence of a pacemaker.
• Prior shock wave intervention or botulinum toxin injection for post-stroke spasticity within the past three months.
• Inability to participate in interventions or functional assessments due to cognitive, consciousness, or language impairments.

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

Тайвань · 1 центр

• Department of Physical Medicine & Rehabilitation , National Taiwan University Hospital — Taipei

Публикации

• Haghighat S, Khosravi M, Saadatnia M, Hashemijaazi M. Effect of Extracorporeal Shockwave Therapy on Pain Management of Patients with Post-Stroke Hemiplegic Shoulder Pain: A Prospective Randomized Controlled Trial. Adv Biomed Res. 2023 Aug 31;12:216. doi: 10.4103/abr.abr_279_21. eCollection 2023. PMID 38073721
• Wu YT, Chang CN, Chen YM, Hu GC. Comparison of the effect of focused and radial extracorporeal shock waves on spastic equinus in patients with stroke: a randomized controlled trial. Eur J Phys Rehabil Med. 2018 Aug;54(4):518-525. doi: 10.23736/S1973-9087.17.04801-8. Epub 2017 Oct 25. PMID 29072044
• Yoon SH, Shin MK, Choi EJ, Kang HJ. Effective Site for the Application of Extracorporeal Shock-Wave Therapy on Spasticity in Chronic Stroke: Muscle Belly or Myotendinous Junction. Ann Rehabil Med. 2017 Aug;41(4):547-555. doi: 10.5535/arm.2017.41.4.547. Epub 2017 Aug 31. PMID 28971038
• Li G, Yuan W, Liu G, Qiao L, Zhang Y, Wang Y, Wang W, Zhao M, Wang Y, Wang J. Effects of radial extracorporeal shockwave therapy on spasticity of upper-limb agonist/antagonist muscles in patients affected by stroke: a randomized, single-blind clinical trial. Age Ageing. 2020 Feb 27;49(2):246-252. doi: 10.1093/ageing/afz159. PMID 31846499

Идентификаторы

NCT: NCT06674785 · 202409035RIND

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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