Skip to main content
OpenTrials
Completed

NCT Number: NCT02221011

The Effect of Extracorporeal Shock Wave Therapy on Spasticity

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tri-Service General Hospital National Defense Medical Center

Taipei, Neihu, 886, Taiwan

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: E-SWT

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Tri-Service General Hospital (TSGH)

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 20, 2014
Registry last updated
Apr 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.