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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

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.

Condition or disease Intervention/treatment Phase
Spasticity Device: Shock wave Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Extracorporeal Shock Wave Therapy on Spasticity
Study Start Date : August 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arm Intervention/treatment
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
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

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
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

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
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02221011


Locations
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Taiwan
Tri-Service General Hospital National Defense Medical Center
Taipei, Neihu, Taiwan, 886
Sponsors and Collaborators
Tri-Service General Hospital
Investigators
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Principal Investigator: Yung-Tsan Wu, MD Tri-Service General Hospital National Defense Medical Center
Publications:
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Responsible Party: Yung-Tsan Wu, Attending Physician, Tri-Service General Hospital
ClinicalTrials.gov Identifier: NCT02221011    
Other Study ID Numbers: TSGHIRB: 2-102-05-018
First Posted: August 20, 2014    Key Record Dates
Last Update Posted: April 14, 2016
Last Verified: April 2016
Keywords provided by Yung-Tsan Wu, Tri-Service General Hospital:
Shock wave
Spasticity
Effect
Additional relevant MeSH terms:
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Muscle Spasticity
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases