The Effect of Extracorporeal Shock Wave Therapy on Spasticity

NCT02221011 | Completed DMC

• 1 other identifier: TSGHIRB: 2-102-05-018
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Spasticity

Keywords

Shock wave; Spasticity; Effect

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (3)

• Change from baseline of range of motion on 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.

  Pre-treatment, 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.

• Change from baseline of pain on 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.

  Pre-treatment, 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.

• Change from baseline of disability on 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.

  Pre-treatment, 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.

Study Arms (3)

shock wave (three times)

EXPERIMENTAL

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

Sham shock wave

SHAM COMPARATOR

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

Device: Shock wave

Shock wave (one time)

EXPERIMENTAL

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

Interventions

Shock wave DEVICE

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.

Also known as: E-SWT

Sham shock wave; Shock wave (one time); shock wave (three times)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Cancer Joint contracture Coagulopathy Pregnancy Pacemaker Inflammation status

Sponsors & Collaborators

• Tri-Service General Hospital: lead

Study Sites (1)

Tri-Service General Hospital National Defense Medical Center

Taipei, Neihu, 886, Taiwan

Location

Related Publications (5)

• 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.

  PMID: 8666632 BACKGROUND

• 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.

  PMID: 10530851 BACKGROUND

• 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.

  PMID: 16109905 BACKGROUND

• 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.

  PMID: 22207070 BACKGROUND

• 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.

  PMID: 22506181 BACKGROUND

MeSH Terms

Conditions

Muscle Spasticity

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Yung-Tsan Wu, MD

  Tri-Service General Hospital National Defense Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: August 14, 2014
• First Posted: August 20, 2014
• Study Start: August 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: April 14, 2016

Record last verified: 2016-04

Locations

TW (1)