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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
Awards & highlights
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 belowSelect...
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:Select...
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
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 moreTrial 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
Find a Location
Who is running the clinical trial?
Kessler FoundationLead Sponsor
178 Previous Clinical Trials
10,958 Total Patients Enrolled
3 Trials studying Spasticity
100 Patients Enrolled for Spasticity
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a spinal cord injury for over a year without getting worse.I have a severe, inflammatory arthritis condition.I haven't changed my muscle relaxer meds in the last 3 months.I haven't changed my muscle relaxer meds in the last 3 months and don't plan to during the trial.I haven't had botulinum toxin injections in the last 6 months or phenol/alcohol injections in the last 12 months.I have had a blood clot.I have had a spinal cord injury for over a year without getting worse.You have a muscle stiffness score of 2 or higher in the calf muscle of the treated leg.I am taking blood thinners.I have had surgery on my leg or foot.I have stiffness in my ankle that limits its movement.I can receive shockwave treatment and don't have recent infections or severe bleeding disorders.I am 18 years old or older.I have cancer.I am 18 years old or older.The muscle in your treated leg has a score of 2 or higher on the MAS scale.I can receive shockwave treatment and don't have recent infections or severe bleeding disorders.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention
- Group 2: Control
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Spasticity Patient Testimony for trial: Trial Name: NCT05432999 — N/A
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