Clinical trial NCT06674785: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Muscle Spasticity
Keywords: stroke
spasticity
shock wave
shoulder
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2024-11-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Primary outcomes:
measure: passive range of motion for the shoulder joints
timeFrame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
measure: shoulder strength
timeFrame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
measure: Visual Analogue Scale (VAS)
timeFrame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
measure: modified Ashworth scale (MAS)
timeFrame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
Secondary outcomes:
measure: Fugl-Meyer Assessment for the Upper Extremity (FMA-UE)
timeFrame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
measure: Action Research Arm Test (ARAT)
timeFrame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
measure: Barthel index
timeFrame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
measure: Wolf Motor Function Test
timeFrame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
measure: ultrasound assessment
timeFrame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Physical Medicine & Rehabilitation , National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Shu-mei Yang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.