Clinical trial NCT02221011: The Effect of Extracorporeal Shock Wave Therapy on Spasticity
Official title: The Effect of Extracorporeal Shock Wave Therapy on Spasticity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spasticity
Keywords: Shock wave
Spasticity
Effect
Lead sponsor: Tri-Service General Hospital
Sponsor class: OTHER
First posted: 2014-08-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Change from baseline of spasticity on 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.
timeFrame: Pre-treatment, 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.
Secondary outcomes:
measure: Change from baseline of range of motion on 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.
timeFrame: Pre-treatment, 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.
measure: Change from baseline of pain on 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.
timeFrame: Pre-treatment, 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.
measure: Change from baseline of disability on 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.
timeFrame: Pre-treatment, 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital National Defense Medical Center
state: Neihu
Study officials:
affiliation: Tri-Service General Hospital National Defense Medical Center
name: Yung-Tsan Wu, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.