The Effect of Extracorporeal Shock Wave Therapy on Spasticity

Not Applicable

Completed

• Conditions: Spasticity
• Interventions: Device: Shock wave

• Registration Number: NCT02221011
• Lead Sponsor: Tri-Service General Hospital

Brief Summary

The effect of traditional treatment for spasticity is barely satisfactory. The shock wave has been used to treat the spasticity with expressively response and the effect could persist for 1-3 months in different studies. However most sutdies lack the sham or control group. The purpose of this study was to assess the effect of shock wave for spasticity in wrist and hand.

Detailed Description

The patients with spasticity for at least 6 months were randomized for 3 groups. Group I: patients receive one session of shock wave per week for 3 weeks; Group II: patients receive only one session of shock wave; Group III: patients receive the sham shock wave per week for 3 weeks. The outcome measurements include Modified Asthow scale, passive range of motion, Disability Assessment Scale and Fugl-Meyer Assessment Scale (hand function and wrist control).

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-08-14
• Study First Submitted QC: 2014-08-19
• Study First Posted: 2014-08-20
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-12
• Last Update Posted: 2016-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Age between 20-80 year-old Spasticity measured as Modified Asthow Scale more than 1+ point and persist at least 6 months Clear consciousness No receive Phenol injection or Botulinum toxin in past 6 months

Exclusion Criteria

Cancer Joint contracture Coagulopathy Pregnancy Pacemaker Inflammation status

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Shock wave (one time)	Shock wave	E-SWT, Elettronica Pagani, Italy 3.5 bars 1500 beats in FCU, FCR 3 bars 4000 beats diffuse in intrinsic muscle Only one dose
Sham shock wave	Shock wave	E-SWT, Elettronica Pagani, Italy Sham without energy, 1500 beats in FCU, FCR and 4000 beats diffuse in intrinsic muscle
shock wave (three times)	Shock wave	E-SWT, Elettronica Pagani, Italy 3.5 bars 1500 beats in FCU, FCR 3 bars 4000 beats diffuse in intrinsic muscle Once a week for 3 weeks

Primary Outcome Measures

Name	Time	Method
Change from baseline of spasticity on 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.	Pre-treatment, 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.	Using the modyfied Ashworth Scale to measure the spasticity before treatment and multiple time frame after treatment.

Secondary Outcome Measures

Name	Time	Method
Change from baseline of disability on 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.	Pre-treatment, 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.	Using the Disability Assessment Scale to measure the disabilty scale before treatment and multiple time frame after treatment.
Change from baseline of range of motion on 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.	Pre-treatment, 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.	Using the digital goniometer to measure the passive range of motion before treatment and multiple time frame after treatment.
Change from baseline of pain on 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.	Pre-treatment, 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.	Using the Visual analog scale (VAS) to measure the pain from spasticity scale before treatment and multiple time frame after treatment.

Trial Locations

Locations (1)

Tri-Service General Hospital National Defense Medical Center; 🇨🇳 Taipei, Neihu, Taiwan