The Effect of Extracorporeal Shock Wave Therapy on Spasticity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2015-06-30

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Spasticity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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shock wave (three times)

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

Group Type EXPERIMENTAL

Shock wave

Intervention Type 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.

Sham shock wave

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

Group Type SHAM_COMPARATOR

Shock wave

Intervention Type 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.

Shock wave (one time)

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

Group Type EXPERIMENTAL

Shock wave

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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E-SWT

Eligibility Criteria

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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