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Extracorporeal Shockwave Therapy for Spasticity in People With Spinal Cord Injury

Primary Purpose

Spinal Cord Injuries, Spasticity, Muscle, Spastic Paraplegia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Extracorporeal Shockwave Therapy
Sponsored by
Kessler Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries focused on measuring shockwave, extracorporeal shockwave therapy, spinal cord injury, spasticity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 18 years of age or older.
  2. Have a non-progressive traumatic SCI (complete or incomplete) with residual neurological deficits that occurred greater than 1 year prior to their enrollment.
  3. MAS score of 2 or greater in the gastrocnemius of the treated limb.
  4. Can be treated with shockwaves. Contraindications include current or recent (within the past 3 months) infection at the site of treatment and severe coagulopathies (e.g. hemophilia).164
  5. No change in antispasmodic medications within the past three months or intended changes over the course of the trial.
  6. Participant is able and willing to comply with the protocol.

Exclusion Criteria:

  1. History of surgical procedures of the lower extremity.
  2. Ankle contracture.
  3. Sever, inflammatory arthritic diseases.
  4. Thrombosis.
  5. Anticoagulant medications.
  6. Pregnancy.
  7. Cancer.
  8. Recent history of local injection of botulinum toxin within 6 months, or phenol/alcohol with 12 months.

Sites / Locations

  • Kessler FoundationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Intervention

Control

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Change in Modified Ashworth Scale scores
The Modified Ashworth Scale (MAS) is a physical exam maneuver used frequently both clinically and for research purposes to assess the increase in velocity-dependent muscle tone after neurologic disorders. We will be focusing on the MAS score of the ankle plantar flexors. This measure is included in the NINDS list of CDE recommendations for SCI. Specifically, it evaluates the resistance to passive stretch of the ankle joint through full range of motion.

Secondary Outcome Measures

Change in Modified Ashworth Scale scores
The Modified Ashworth Scale (MAS) is a physical exam maneuver used frequently both clinically and for research purposes to assess the increase in velocity-dependent muscle tone after neurologic disorders. We will be focusing on the MAS score of the ankle plantar flexors. This measure is included in the NINDS list of CDE recommendations for SCI. Specifically, it evaluates the resistance to passive stretch of the ankle joint through full range of motion.
Change in Modified Tardieu Scale
The Modified Tardieu Scale (MTS) was developed as a more accurate method to measure spasticity by assessing muscle tone at different velocities. Since its development, it has gone through multiple modifications. The MTS is also included in the NINDS CDE recommendations as a measure of spasticity in people with SCI. The MTS includes two measurements, quality and angle of muscle reaction.
Change in Modified Tardieu Scale
The Modified Tardieu Scale (MTS) was developed as a more accurate method to measure spasticity by assessing muscle tone at different velocities. Since its development, it has gone through multiple modifications. The MTS is also included in the NINDS CDE recommendations as a measure of spasticity in people with SCI. The MTS includes two measurements, quality and angle of muscle reaction.
Change in Modified Penn Spasticity Frequency Scale
The Modified Penn Spasticity Frequency Scale (mPSFS) is a self-report scale with two components, which is meant to provide a more complete understanding of an individual's spasticity status. The first component is comprised of a five-point scale, which assesses spasm frequency between 0 ("no spasms") and 4 ("spontaneous spasms occurring more than 10 times per hour"). The second component includes a three-point scale, which assesses spasm severity between 1 ("mild") and 3 ("severe"); this component is not answered if the individual reports no spasms in part one.
Change in Modified Penn Spasticity Frequency Scale
The Modified Penn Spasticity Frequency Scale (mPSFS) is a self-report scale with two components, which is meant to provide a more complete understanding of an individual's spasticity status. The first component is comprised of a five-point scale, which assesses spasm frequency between 0 ("no spasms") and 4 ("spontaneous spasms occurring more than 10 times per hour"). The second component includes a three-point scale, which assesses spasm severity between 1 ("mild") and 3 ("severe"); this component is not answered if the individual reports no spasms in part one.
Change in Modified Patient-Reported Impact of Spasticity Measure
The Modified Patient-Reported Impact of Spasticity Measure (mPRISM) is a self-reported instrument with 37 items that assesses the impact of spasticity on health-related quality of life. It is separated into physical, psychological, and social subdomains, making is possible to investigate how spasticity impacts different aspects of quality of life. Each item is rated using a scale of 0 ("never") to 3 ("often to very often").
Change in Modified Patient-Reported Impact of Spasticity Measure
The Modified Patient-Reported Impact of Spasticity Measure (mPRISM) is a self-reported instrument with 37 items that assesses the impact of spasticity on health-related quality of life. It is separated into physical, psychological, and social subdomains, making is possible to investigate how spasticity impacts different aspects of quality of life. Each item is rated using a scale of 0 ("never") to 3 ("often to very often").
Participant Global Impression of Change
The Participant Global Impression of Change (PGIC, also referred to as the original Guy-Farrar/PGIC scale) is used to measure global treatment effect. It asks the participant to rate, using a 7-point scale (anchored by "very much worse" and "very much improved"), his or her overall impression following treatment as compared to before the treatment. This scale is particularly useful as it provides an indication of clinically important improvement. Although it was designed for and has commonly been used in pain trials, it has been used to assess efficacy of spasticity treatments in people with SCI.
Participant Global Impression of Change
The Participant Global Impression of Change (PGIC, also referred to as the original Guy-Farrar/PGIC scale) is used to measure global treatment effect. It asks the participant to rate, using a 7-point scale (anchored by "very much worse" and "very much improved"), his or her overall impression following treatment as compared to before the treatment. This scale is particularly useful as it provides an indication of clinically important improvement. Although it was designed for and has commonly been used in pain trials, it has been used to assess efficacy of spasticity treatments in people with SCI.
Medial gastrocnemius muscle echogenicity
Average "brightness" of the medial gastrocnemius muscle, measured using quantitative ultrasound techniques.
Medial gastrocnemius muscle echogenicity
Average "brightness" of the medial gastrocnemius muscle, measured using quantitative ultrasound techniques.
Medial gastrocnemius muscle elasticity
Average elasticity of the medial gastrocnemius muscle, measured using shear wave elastography.
Medial gastrocnemius muscle elasticity
Average elasticity of the medial gastrocnemius muscle, measured using shear wave elastography.
Medial gastrocnemius muscle fiber length
Fiber length of the medial gastrocnemius muscle, measured quantitatively using ultrasound.
Medial gastrocnemius muscle fiber length
Fiber length of the medial gastrocnemius muscle, measured quantitatively using ultrasound.
Medial gastrocnemius muscle thickness
Thickness of the medial gastrocnemius muscle, measured quantitatively using ultrasound.
Medial gastrocnemius muscle thickness
Thickness of the medial gastrocnemius muscle, measured quantitatively using ultrasound.
Medial gastrocnemius muscle pennation angle
Pennation angle of the medial gastrocnemius muscle, measured quantitatively using ultrasound.
Medial gastrocnemius muscle pennation angle
Pennation angle of the medial gastrocnemius muscle, measured quantitatively using ultrasound.

Full Information

First Posted
June 23, 2022
Last Updated
September 13, 2022
Sponsor
Kessler Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05432999
Brief Title
Extracorporeal Shockwave Therapy for Spasticity in People With Spinal Cord Injury
Official Title
Effect of Extracorporeal Shockwave Therapy on Spasticity in Chronic SCI: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
February 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kessler Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
People with spinal cord injury (SCI) experience a host of secondary complications that can impact their quality of life and functional independence. One of the more prevalent complications is spasticity, which occurs in response to spinal cord damage and the resulting disruption of motor pathways. Common symptoms include spasms and stiffness, and can occur more than once per hour in many people with SCI. Spasticity can have a negative impact over many quality of life domains, including loss of functional independence, activity limitations, and even employment. Its impact on health domains is also pronounced, with many people who have spasticity reporting mood disorders, depression, pain, sleep disturbances, and contractures. Spasticity can interfere with post-injury rehabilitation and lead to hospitalization. There are many treatments for spasticity in this population. However, many do not have long-term efficacy, and, if they do, they are often pharmacological in nature and carry side effects that could limit function or affect health. The goal of this pilot, randomized-controlled study is to investigate the potential efficacy and safety of a non-invasive treatment with a low side effect profile, extracorporeal shockwave therapy (ESWT). ESWT has shown some benefits in people with post-stroke spasticity with no long term side effects. Thirty individuals with chronic, traumatic SCI will be recruited. Fifteen will be provided with ESWT while the other fifteen will be given a sham treatment. Clinical and self-report measures of spasticity and its impact on quality of life will be collected, as well as quantitative ultrasound measures of muscle architecture and stiffness. The ultimate goal of this pilot project is to collect the data necessary to apply for a larger randomized-controlled trial. Conducting a larger trial will allow for a more powerful estimation of safety and efficacy of ESWT as a treatment for spasticity in people with SCI.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries, Spasticity, Muscle, Spastic Paraplegia, Spastic Quadriplegia, Spastic Tetraplegia, Paraplegia, Tetraplegia
Keywords
shockwave, extracorporeal shockwave therapy, spinal cord injury, spasticity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, controlled trial with sham control
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
This group will receive a focused extracorporeal shockwave therapy treatment (three applications over three weeks), applied to the spastic medial gastrocnemius.
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Extracorporeal Shockwave Therapy
Other Intervention Name(s)
Storz Medical DUOLITH SD1 Ultra modular system
Intervention Description
Shockwaves are high pressure sound waves that interact with tissues to elicit a biological response. The shockwave probe will be placed on the skin with ultrasound gel and the muscle will be stimulated for a few minutes.
Primary Outcome Measure Information:
Title
Change in Modified Ashworth Scale scores
Description
The Modified Ashworth Scale (MAS) is a physical exam maneuver used frequently both clinically and for research purposes to assess the increase in velocity-dependent muscle tone after neurologic disorders. We will be focusing on the MAS score of the ankle plantar flexors. This measure is included in the NINDS list of CDE recommendations for SCI. Specifically, it evaluates the resistance to passive stretch of the ankle joint through full range of motion.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Change in Modified Ashworth Scale scores
Description
The Modified Ashworth Scale (MAS) is a physical exam maneuver used frequently both clinically and for research purposes to assess the increase in velocity-dependent muscle tone after neurologic disorders. We will be focusing on the MAS score of the ankle plantar flexors. This measure is included in the NINDS list of CDE recommendations for SCI. Specifically, it evaluates the resistance to passive stretch of the ankle joint through full range of motion.
Time Frame
8 weeks
Title
Change in Modified Tardieu Scale
Description
The Modified Tardieu Scale (MTS) was developed as a more accurate method to measure spasticity by assessing muscle tone at different velocities. Since its development, it has gone through multiple modifications. The MTS is also included in the NINDS CDE recommendations as a measure of spasticity in people with SCI. The MTS includes two measurements, quality and angle of muscle reaction.
Time Frame
4 weeks
Title
Change in Modified Tardieu Scale
Description
The Modified Tardieu Scale (MTS) was developed as a more accurate method to measure spasticity by assessing muscle tone at different velocities. Since its development, it has gone through multiple modifications. The MTS is also included in the NINDS CDE recommendations as a measure of spasticity in people with SCI. The MTS includes two measurements, quality and angle of muscle reaction.
Time Frame
8 weeks
Title
Change in Modified Penn Spasticity Frequency Scale
Description
The Modified Penn Spasticity Frequency Scale (mPSFS) is a self-report scale with two components, which is meant to provide a more complete understanding of an individual's spasticity status. The first component is comprised of a five-point scale, which assesses spasm frequency between 0 ("no spasms") and 4 ("spontaneous spasms occurring more than 10 times per hour"). The second component includes a three-point scale, which assesses spasm severity between 1 ("mild") and 3 ("severe"); this component is not answered if the individual reports no spasms in part one.
Time Frame
4 weeks
Title
Change in Modified Penn Spasticity Frequency Scale
Description
The Modified Penn Spasticity Frequency Scale (mPSFS) is a self-report scale with two components, which is meant to provide a more complete understanding of an individual's spasticity status. The first component is comprised of a five-point scale, which assesses spasm frequency between 0 ("no spasms") and 4 ("spontaneous spasms occurring more than 10 times per hour"). The second component includes a three-point scale, which assesses spasm severity between 1 ("mild") and 3 ("severe"); this component is not answered if the individual reports no spasms in part one.
Time Frame
8 weeks
Title
Change in Modified Patient-Reported Impact of Spasticity Measure
Description
The Modified Patient-Reported Impact of Spasticity Measure (mPRISM) is a self-reported instrument with 37 items that assesses the impact of spasticity on health-related quality of life. It is separated into physical, psychological, and social subdomains, making is possible to investigate how spasticity impacts different aspects of quality of life. Each item is rated using a scale of 0 ("never") to 3 ("often to very often").
Time Frame
4 weeks
Title
Change in Modified Patient-Reported Impact of Spasticity Measure
Description
The Modified Patient-Reported Impact of Spasticity Measure (mPRISM) is a self-reported instrument with 37 items that assesses the impact of spasticity on health-related quality of life. It is separated into physical, psychological, and social subdomains, making is possible to investigate how spasticity impacts different aspects of quality of life. Each item is rated using a scale of 0 ("never") to 3 ("often to very often").
Time Frame
8 weeks
Title
Participant Global Impression of Change
Description
The Participant Global Impression of Change (PGIC, also referred to as the original Guy-Farrar/PGIC scale) is used to measure global treatment effect. It asks the participant to rate, using a 7-point scale (anchored by "very much worse" and "very much improved"), his or her overall impression following treatment as compared to before the treatment. This scale is particularly useful as it provides an indication of clinically important improvement. Although it was designed for and has commonly been used in pain trials, it has been used to assess efficacy of spasticity treatments in people with SCI.
Time Frame
4 weeks
Title
Participant Global Impression of Change
Description
The Participant Global Impression of Change (PGIC, also referred to as the original Guy-Farrar/PGIC scale) is used to measure global treatment effect. It asks the participant to rate, using a 7-point scale (anchored by "very much worse" and "very much improved"), his or her overall impression following treatment as compared to before the treatment. This scale is particularly useful as it provides an indication of clinically important improvement. Although it was designed for and has commonly been used in pain trials, it has been used to assess efficacy of spasticity treatments in people with SCI.
Time Frame
8 weeks
Title
Medial gastrocnemius muscle echogenicity
Description
Average "brightness" of the medial gastrocnemius muscle, measured using quantitative ultrasound techniques.
Time Frame
4 weeks
Title
Medial gastrocnemius muscle echogenicity
Description
Average "brightness" of the medial gastrocnemius muscle, measured using quantitative ultrasound techniques.
Time Frame
8 weeks
Title
Medial gastrocnemius muscle elasticity
Description
Average elasticity of the medial gastrocnemius muscle, measured using shear wave elastography.
Time Frame
4 weeks
Title
Medial gastrocnemius muscle elasticity
Description
Average elasticity of the medial gastrocnemius muscle, measured using shear wave elastography.
Time Frame
8 weeks
Title
Medial gastrocnemius muscle fiber length
Description
Fiber length of the medial gastrocnemius muscle, measured quantitatively using ultrasound.
Time Frame
4 weeks
Title
Medial gastrocnemius muscle fiber length
Description
Fiber length of the medial gastrocnemius muscle, measured quantitatively using ultrasound.
Time Frame
8 weeks
Title
Medial gastrocnemius muscle thickness
Description
Thickness of the medial gastrocnemius muscle, measured quantitatively using ultrasound.
Time Frame
4 weeks
Title
Medial gastrocnemius muscle thickness
Description
Thickness of the medial gastrocnemius muscle, measured quantitatively using ultrasound.
Time Frame
8 weeks
Title
Medial gastrocnemius muscle pennation angle
Description
Pennation angle of the medial gastrocnemius muscle, measured quantitatively using ultrasound.
Time Frame
4 weeks
Title
Medial gastrocnemius muscle pennation angle
Description
Pennation angle of the medial gastrocnemius muscle, measured quantitatively using ultrasound.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years of age or older. Have a non-progressive traumatic SCI (complete or incomplete) with residual neurological deficits that occurred greater than 1 year prior to their enrollment. MAS score of 2 or greater in the gastrocnemius of the treated limb. Can be treated with shockwaves. Contraindications include current or recent (within the past 3 months) infection at the site of treatment and severe coagulopathies (e.g. hemophilia).164 No change in antispasmodic medications within the past three months or intended changes over the course of the trial. Participant is able and willing to comply with the protocol. Exclusion Criteria: History of surgical procedures of the lower extremity. Ankle contracture. Sever, inflammatory arthritic diseases. Thrombosis. Anticoagulant medications. Pregnancy. Cancer. Recent history of local injection of botulinum toxin within 6 months, or phenol/alcohol with 12 months.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nathan Hogaboom, PhD
Phone
9733243584
Email
nhogaboom@kesslerfoundation.org
First Name & Middle Initial & Last Name or Official Title & Degree
Shalaka Paranjpe, MS
Phone
9733246643
Email
sparanjpe@kesslerfoundation.org
Facility Information:
Facility Name
Kessler Foundation
City
West Orange
State/Province
New Jersey
ZIP/Postal Code
07052
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shalaka Paranjpe, MS
Phone
973-324-6643
Email
sparanjpe@kesslerfoundation.org
First Name & Middle Initial & Last Name & Degree
Nathan Hogaboom, PhD
Phone
9733243584
Email
nhogaboom@kesslerfoundation.org
First Name & Middle Initial & Last Name & Degree
Nathan Hogaboom, PhD
First Name & Middle Initial & Last Name & Degree
Trevor Dyson-Hudson, MD
First Name & Middle Initial & Last Name & Degree
Steven Kirshblum, MD
First Name & Middle Initial & Last Name & Degree
Brittany Snider, MD
First Name & Middle Initial & Last Name & Degree
Fatma Eren, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Extracorporeal Shockwave Therapy for Spasticity in People With Spinal Cord Injury

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