search
Back to results

The Effect of Extracorporeal Shock Wave Therapy on Spasticity

Primary Purpose

Spasticity

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Shock wave
Sponsored by
Tri-Service General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spasticity focused on measuring Shock wave, Spasticity, Effect

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tri-Service General Hospital National Defense Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

Experimental

Arm Label

shock wave (three times)

Sham shock wave

Shock wave (one time)

Arm Description

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

E-SWT, Elettronica Pagani, Italy Sham without energy, 1500 beats in FCU, FCR and 4000 beats diffuse in intrinsic muscle

E-SWT, Elettronica Pagani, Italy 3.5 bars 1500 beats in FCU, FCR 3 bars 4000 beats diffuse in intrinsic muscle Only one dose

Outcomes

Primary Outcome Measures

Change from baseline of spasticity on 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

Change from baseline of range of motion on 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.
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.
Using the Disability Assessment Scale to measure the disabilty scale before treatment and multiple time frame after treatment.

Full Information

First Posted
August 14, 2014
Last Updated
April 12, 2016
Sponsor
Tri-Service General Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT02221011
Brief Title
The Effect of Extracorporeal Shock Wave Therapy on Spasticity
Official Title
The Effect of Extracorporeal Shock Wave Therapy on Spasticity
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tri-Service General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spasticity
Keywords
Shock wave, Spasticity, Effect

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
shock wave (three times)
Arm Type
Experimental
Arm Description
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
Arm Title
Sham shock wave
Arm Type
Sham Comparator
Arm Description
E-SWT, Elettronica Pagani, Italy Sham without energy, 1500 beats in FCU, FCR and 4000 beats diffuse in intrinsic muscle
Arm Title
Shock wave (one time)
Arm Type
Experimental
Arm Description
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 Type
Device
Intervention Name(s)
Shock wave
Other Intervention Name(s)
E-SWT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline of spasticity on 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.
Description
Using the modyfied Ashworth Scale to measure the spasticity before treatment and multiple time frame after treatment.
Time Frame
Pre-treatment, 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.
Secondary Outcome Measure Information:
Title
Change from baseline of range of motion on 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.
Description
Using the digital goniometer to measure the passive range of motion before treatment and multiple time frame after treatment.
Time Frame
Pre-treatment, 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.
Title
Change from baseline of pain on 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.
Description
Using the Visual analog scale (VAS) to measure the pain from spasticity scale before treatment and multiple time frame after treatment.
Time Frame
Pre-treatment, 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.
Title
Change from baseline of disability on 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.
Description
Using the Disability Assessment Scale to measure the disabilty scale before treatment and multiple time frame after treatment.
Time Frame
Pre-treatment, 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yung-Tsan Wu, MD
Organizational Affiliation
Tri-Service General Hospital National Defense Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tri-Service General Hospital National Defense Medical Center
City
Taipei
State/Province
Neihu
ZIP/Postal Code
886
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
8666632
Citation
Rompe JD, Hope C, Kullmer K, Heine J, Burger R. Analgesic effect of extracorporeal shock-wave therapy on chronic tennis elbow. J Bone Joint Surg Br. 1996 Mar;78(2):233-7.
Results Reference
background
PubMed Identifier
10530851
Citation
Loew M, Daecke W, Kusnierczak D, Rahmanzadeh M, Ewerbeck V. Shock-wave therapy is effective for chronic calcifying tendinitis of the shoulder. J Bone Joint Surg Br. 1999 Sep;81(5):863-7. doi: 10.1302/0301-620x.81b5.9374.
Results Reference
background
PubMed Identifier
16109905
Citation
Manganotti P, Amelio E. Long-term effect of shock wave therapy on upper limb hypertonia in patients affected by stroke. Stroke. 2005 Sep;36(9):1967-71. doi: 10.1161/01.STR.0000177880.06663.5c. Epub 2005 Aug 18.
Results Reference
background
PubMed Identifier
22207070
Citation
Vidal X, Morral A, Costa L, Tur M. Radial extracorporeal shock wave therapy (rESWT) in the treatment of spasticity in cerebral palsy: a randomized, placebo-controlled clinical trial. NeuroRehabilitation. 2011;29(4):413-9. doi: 10.3233/NRE-2011-0720.
Results Reference
background
PubMed Identifier
22506181
Citation
Sohn MK, Cho KH, Kim YJ, Hwang SL. Spasticity and electrophysiologic changes after extracorporeal shock wave therapy on gastrocnemius. Ann Rehabil Med. 2011 Oct;35(5):599-604. doi: 10.5535/arm.2011.35.5.599. Epub 2011 Oct 31.
Results Reference
background

Learn more about this trial

The Effect of Extracorporeal Shock Wave Therapy on Spasticity

We'll reach out to this number within 24 hrs