Extracorporeal Shockwave Therapy for Spasticity in People With Spinal Cord Injury

Sponsor

Kessler Foundation (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05432999

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Spinal Cord Injuries Spasticity, Muscle Spastic Paraplegia Spastic Quadriplegia Spastic Tetraplegia Paraplegia Tetraplegia	Device: Extracorporeal Shockwave Therapy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized, controlled trial with sham controlRandomized, controlled trial with sham control

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Effect of Extracorporeal Shockwave Therapy on Spasticity in Chronic SCI: A Pilot Study

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Feb 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention This group will receive a focused extracorporeal shockwave therapy treatment (three applications over three weeks), applied to the spastic medial gastrocnemius.	Device: Extracorporeal Shockwave Therapy 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. Other Names: Storz Medical DUOLITH SD1 Ultra modular system
Sham Comparator: Control 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.	Device: Extracorporeal Shockwave Therapy 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. Other Names: Storz Medical DUOLITH SD1 Ultra modular system

Arm

Intervention/Treatment

Experimental: Intervention

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

Device: Extracorporeal Shockwave Therapy

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.

Other Names:

Storz Medical DUOLITH SD1 Ultra modular system

Sham Comparator: Control

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.

Device: Extracorporeal Shockwave Therapy

Other Names:

Storz Medical DUOLITH SD1 Ultra modular system

Outcome Measures

Primary Outcome Measures

Change in Modified Ashworth Scale scores [4 weeks]
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 [8 weeks]
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 [4 weeks]
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 [8 weeks]
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 [4 weeks]
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 [8 weeks]
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 [4 weeks]
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 [8 weeks]
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 [4 weeks]
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 [8 weeks]
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 [4 weeks]
Average "brightness" of the medial gastrocnemius muscle, measured using quantitative ultrasound techniques.
Medial gastrocnemius muscle echogenicity [8 weeks]
Average "brightness" of the medial gastrocnemius muscle, measured using quantitative ultrasound techniques.
Medial gastrocnemius muscle elasticity [4 weeks]
Average elasticity of the medial gastrocnemius muscle, measured using shear wave elastography.
Medial gastrocnemius muscle elasticity [8 weeks]
Average elasticity of the medial gastrocnemius muscle, measured using shear wave elastography.
Medial gastrocnemius muscle fiber length [4 weeks]
Fiber length of the medial gastrocnemius muscle, measured quantitatively using ultrasound.
Medial gastrocnemius muscle fiber length [8 weeks]
Fiber length of the medial gastrocnemius muscle, measured quantitatively using ultrasound.
Medial gastrocnemius muscle thickness [4 weeks]
Thickness of the medial gastrocnemius muscle, measured quantitatively using ultrasound.
Medial gastrocnemius muscle thickness [8 weeks]
Thickness of the medial gastrocnemius muscle, measured quantitatively using ultrasound.
Medial gastrocnemius muscle pennation angle [4 weeks]
Pennation angle of the medial gastrocnemius muscle, measured quantitatively using ultrasound.
Medial gastrocnemius muscle pennation angle [8 weeks]
Pennation angle of the medial gastrocnemius muscle, measured quantitatively using ultrasound.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.