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Shockwave Therapy for Spinal Cord Injury

N/A

Recruiting

Research Sponsored by Kessler Foundation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No change in antispasmodic medications within the past three months or intended changes over the course of the trial

No change in antispasmodic medications within the past three months or intended changes over the course of the trial.

Must not have

Sever, inflammatory arthritic diseases

Thrombosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks

Summary

This trial is investigating whether a non-invasive treatment, extracorporeal shockwave therapy (ESWT), is effective and safe for treating spasticity in people with spinal cord injury (SCI).

Who is the study for?

This trial is for adults over 18 with non-progressive traumatic spinal cord injury that happened more than a year ago, causing spasticity. They must have stable medication use for the past three months and not plan changes during the trial. Excluded are those with recent lower extremity surgery, ankle contracture, pregnancy, severe arthritis, thrombosis, cancer or recent injections for spasticity.

What is being tested?

The study tests Extracorporeal Shockwave Therapy (ESWT) to treat spasticity in people with spinal cord injuries. It's a pilot randomized-controlled trial where half of the participants receive ESWT and half get sham treatment to compare effects on muscle stiffness and quality of life.

What are the potential side effects?

ESWT is considered low-risk with no long-term side effects reported in similar conditions like post-stroke spasticity. However, potential short-term side effects may include mild pain or discomfort at the treatment site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I haven't changed my muscle relaxer meds in the last 3 months.

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I haven't changed my muscle relaxer meds in the last 3 months and don't plan to during the trial.

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I am 18 years old or older.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a severe, inflammatory arthritis condition.

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I have had a blood clot.

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I am taking blood thinners.

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I have had surgery on my leg or foot.

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I have stiffness in my ankle that limits its movement.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Change in Modified Ashworth Scale scores

Change in Modified Patient-Reported Impact of Spasticity Measure

Change in Modified Penn Spasticity Frequency Scale

+7 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: InterventionExperimental Treatment1 Intervention

This group will receive a focused extracorporeal shockwave therapy treatment (three applications over three weeks), applied to the spastic medial gastrocnemius.

Group II: ControlPlacebo Group1 Intervention

This group will go through the same procedures as the intervention group, but the shockwave device will not touch their skin and thus they will receive no therapeutic effect.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Extracorporeal Shockwave Therapy

2008

Completed Phase 2

~150

0 / 9Eligibility criteria met