The Effect of Extracorporeal Shock Wave Therapy on Spasticity

Spasticity Clinical Trial

Official title:

The Effect of Extracorporeal Shock Wave Therapy on Spasticity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02221011
• Other study ID #: TSGHIRB: 2-102-05-018
• Status: Completed
• Phase: N/A
• First received: August 14, 2014
• Last updated: April 12, 2016
• Start date: August 2014
• Est. completion date: June 2015

Study information

• Verified date: April 2016
• Source: Tri-Service General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Ministry of Health and Welfare
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Muscle Spasticity
• Spasticity

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Tri-Service General Hospital National Defense Medical Center	Taipei	Neihu

Sponsors (1)

Lead Sponsor	Collaborator
Tri-Service General Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (5)

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. — View 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. Epub 2005 Aug 18. — View Citation

Rompe JD, Hope C, Küllmer K, Heine J, Bürger R. Analgesic effect of extracorporeal shock-wave therapy on chronic tennis elbow. J Bone Joint Surg Br. 1996 Mar;78(2):233-7. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Pre-treatment, 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.	No
Secondary	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.	Pre-treatment, 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.	No
Secondary	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.	Pre-treatment, 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.	No
Secondary	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.	Pre-treatment, 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.	No