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The Effect of Extracorporeal Shock Wave Therapy on Spasticity

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ClinicalTrials.gov Identifier: NCT02221011
Recruitment Status : Completed
First Posted : August 20, 2014
Last Update Posted : April 14, 2016
Sponsor:
Information provided by (Responsible Party):
Yung-Tsan Wu, Tri-Service General Hospital

Tracking Information
First Submitted Date  ICMJE August 14, 2014
First Posted Date  ICMJE August 20, 2014
Last Update Posted Date April 14, 2016
Study Start Date  ICMJE August 2014
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 19, 2014)
Change from baseline of spasticity on 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment. [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 19, 2014)
  • Change from baseline of range of motion on 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment. [ Time Frame: 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. [ Time Frame: 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.
  • Change from baseline of disability on 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment. [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Extracorporeal Shock Wave Therapy on Spasticity
Official Title  ICMJE The Effect of Extracorporeal Shock Wave Therapy on Spasticity
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Spasticity
Intervention  ICMJE Device: Shock wave

Shock waves are defined a sequence of acoustic pulse characterized by a high peak pressure (100 MPa), fast pressure rise (< 10 ns) and short duration (10 μs) is conveyed by an appropriate generator to a specific target area with an energy density in the range of 0.003-0.890 mJ/mm2.

Different studies and clinical experiments have demonstrated the efficacy of shock waves in the treatment of musculoskeletal system such as chronic tendinopathies, calcific tendinitis of the shoulder, lateral epicondylitis, plantar fasciitis, and several tendon diseases.

Other Name: E-SWT
Study Arms  ICMJE
  • Experimental: shock wave (three times)
    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
    Intervention: Device: Shock wave
  • Sham Comparator: Sham shock wave
    E-SWT, Elettronica Pagani, Italy Sham without energy, 1500 beats in FCU, FCR and 4000 beats diffuse in intrinsic muscle
    Intervention: Device: Shock wave
  • Experimental: Shock wave (one time)
    E-SWT, Elettronica Pagani, Italy 3.5 bars 1500 beats in FCU, FCR 3 bars 4000 beats diffuse in intrinsic muscle Only one dose
    Intervention: Device: Shock wave
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 19, 2014)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02221011
Other Study ID Numbers  ICMJE TSGHIRB: 2-102-05-018
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yung-Tsan Wu, Tri-Service General Hospital
Study Sponsor  ICMJE Tri-Service General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yung-Tsan Wu, MD Tri-Service General Hospital National Defense Medical Center
PRS Account Tri-Service General Hospital
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP