Spinal Cord InjuryESWTNCT02203994
Extracorporeal Shock Wave Therapy (ESWT) for the Treatment of Spasticity in Persons With Spinal Cord Injury
A study testing Duolith® SD 1 "T-Top" (Storz Medical AG, Switzerland) in people with Spinal Cord Injury and Spasticity, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
Trial summary
Spasticity is the most problematic self-reported secondary medical problem in patients with spinal cord injury. It has the potential to negatively influence quality of life through restricting activities of daily living. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Spinal Cord Injury, Spasticity
- What is being tested?
- Duolith® SD 1 "T-Top" (Storz Medical AG, Switzerland)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2014to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Traumatic or non traumatic spinal cord injury
- Minimum age: 18 years
- Minimum time since spinal cord injury: two years
- Lesion: C3-Th10
- American Association of Spinal Cord Injury Impairment Score C and D
- Focal spasticity in the adductor muscles and/ or triceps surae
- Ability to walk 14 meters
- Spasticity/clonus/spasms disturbing the activities of daily living or participation
Who cannot join
- Changes in spasticity medication during the last 3 months
- Treatment with botulinum toxin during the last 6 months
- Anticoagulant medication
- Thrombosis
- Malignant tumors
- Pregnancy
Show all 9Show fewer
- Inflammations or skin lesions in the treated area
- Acute urinary tract infection
- Intended change in spasticity medication within 5 days after intervention
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Swiss Paraplegic Centre
Nottwil, Canton of Lucerne, 6207
About this study
Official title: The Effect of Extracorporeal Shock Wave Therapy (ESWT) on Lower Limb Spasticity in Persons With an Incomplete Spinal Cord Injury
Spasticity is the most problematic self-reported secondary medical problem in patients with spinal cord injury. It has the potential to negatively influence quality of life through restricting activities of daily living. Problematic spasticity can cause pain and fatigue, disturb sleep, contribute to the developement of contractures and pressure ulcers, and has a negative effect on patients morbidity. For this reason there is enormous interest in therapeutic interventions addressing to decrease spasticity in persons with spinal cord injury. Recently, studies reported positive effects of extracorporeal shock wave therapy on spasticity in patients with stroke, focal limb dystonia and cerebral palsy. To date, no studies are published, assessing the effect of extracorporeal shock wave therapy on focal spasticity in patients with spinal cord injury.
The purpose of this study is to investigate the effect of a one-time ESWT on lower limb spasticity in patients with an incomplete spinal cord injury.
- Conditions
- Spinal Cord Injury, Spasticity
- Being tested
- Duolith® SD 1 "T-Top" (Storz Medical AG, Switzerland)
- Keywords
- extracorporal shock wave therapy (ESWT), spasticity, spinal cord injury
- Medical subject headings
- Spinal Cord Injuries, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Duolith® SD 1 "T-Top" (Storz Medical AG, Switzerland)Device
2000 pulses per muscle, energy level: 0.030 mJ/mm2, frequency: 4 Hz
| Study group | Role | What they receive |
|---|---|---|
| extracorporeal shock wave therapy (ESWT) | Experimental | one-time treatment of the spastic muscle/ spastic muscles (adductor muscles and/ or M. triceps surae) with extracorporeal shock wave therapy (device: Duolith® SD 1 "T-Top" (Storz Medical AG, Tägerwilen, Switzerland)) Receives: Device: Duolith® SD 1 "T-Top" (Storz Medical AG, Switzerland) |
What is being measured
The primary outcome is the main question the study is designed to answer.
severity of spasticity
Ashworth Scale
Measured: time 0, time 2h
Secondary outcomes (7)
personal goal attainment
Goal Attainment Scale
Measured: at day 0, 1, 3 and 5
walking speed
10 Meters Walking Test
Measured: difference between pre- and post-intervention
walking distance
6 Minutes Walking Test
Measured: difference between pre- and post-intervention
thickness of the treated muscle
thickness measurement of the treated muscle using ultrasound
Measured: difference between pre- and post-intervention
severity of spasticity
Adductor Tone Rating Scale
Measured: time 0, time 2h
severity of spasticity
Penn Spasm Frequency Scale
Measured: time 0, time 2h
severity of spasticity
Clonus Scale
Measured: time 0, time 2h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionOct 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Paraplegic Research, Nottwil
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Michael Baumberger, Dr. med., Principal investigator, Swiss Paraplegic Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02203994
- Sponsor's protocol ID
- 2014-07
- Acronym
- ESWT
- Status last verified
- Jan 2017
- First submitted
- 28 Jul 2014
- Last updated
- 26 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Extracorporeal Shock Wave Therapy (ESWT) on Lower Limb Spasticity in Persons With an Incomplete Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT02203994
- Acronym / sponsor ID
- ESWT / 2014-07
- Conditions
- Spinal Cord Injury, Spasticity
- Keywords
- extracorporal shock wave therapy (ESWT), spasticity, spinal cord injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Swiss Paraplegic Research, NottwilResearch network
- Study start
- Jul 2014 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 30 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Spasticity is the most problematic self-reported secondary medical problem in patients with spinal cord injury. It has the potential to negatively influence quality of life through restricting activities of daily living. Problematic spasticity can cause pain and fatigue, disturb sleep, contribute to the developement of contractures and pressure ulcers, and has a negative effect on patients morbidity. For this reason there is enormous interest in therapeutic interventions addressing to decrease spasticity in persons with spinal cord injury. Recently, studies reported positive effects of extracorporeal shock wave therapy on spasticity in patients with stroke, focal limb dystonia and cerebral palsy. To date, no studies are published, assessing the effect of extracorporeal shock wave therapy on focal spasticity in patients with spinal cord injury.
The purpose of this study is to investigate the effect of a one-time ESWT on lower limb spasticity in patients with an incomplete spinal cord injury.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| extracorporeal shock wave therapy (ESWT) | Experimental | Device: Duolith® SD 1 "T-Top" (Storz Medical AG, Switzerland)one-time treatment of the spastic muscle/ spastic muscles (adductor muscles and/ or M. triceps surae) with extracorporeal shock wave therapy (device: Duolith® SD 1 "T-Top" (Storz Medical AG, Tägerwilen, Switzerland)) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Traumatic or non traumatic spinal cord injury
- Minimum age: 18 years
- Minimum time since spinal cord injury: two years
- Lesion: C3-Th10
- American Association of Spinal Cord Injury Impairment Score C and D
Key exclusion criteria (9 listed)
- Changes in spasticity medication during the last 3 months
- Treatment with botulinum toxin during the last 6 months
- Anticoagulant medication
- Thrombosis
- Malignant tumors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Duolith® SD 1 "T-Top" (Storz Medical AG, Switzerland)2000 pulses per muscle, energy level: 0.030 mJ/mm2, frequency: 4 Hz | Device | extracorporeal shock wave therapy (ESWT) |
Primary outcome
severity of spasticity
Time frame: time 0, time 2h
Ashworth Scale
7 secondary outcomes
personal goal attainment
Time frame: at day 0, 1, 3 and 5
walking speed
Time frame: difference between pre- and post-intervention
walking distance
Time frame: difference between pre- and post-intervention
thickness of the treated muscle
Time frame: difference between pre- and post-intervention
severity of spasticity
Time frame: time 0, time 2h
severity of spasticity
Time frame: time 0, time 2h
severity of spasticity
Time frame: time 0, time 2h
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Baumberger, Dr. med. principal investigator
Swiss Paraplegic Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Duolith® SD 1 "T-Top" (Storz Medical AG, Switzerland) in people with Spinal Cord Injury and Spasticity, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
severity of spasticity (time frame: time 0, time 2h). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2017.