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

Official title

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

Overview

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.

Detailed description

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.

Interventions

• Device 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.
• Device focused extracorporeal shock wave therapy (ESWT)
  Placebo shockwave therapy directed at subscapularis, pectoralis major, latissimus dorsi, and teres major muscles.

Primary outcome measures

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

Secondary outcome measures (5)

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

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Taiwan · 1 center

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

Publications

• 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

Identifiers

NCT: NCT06674785 · 202409035RIND

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗