Clinical trial NCT05432999: 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
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries
Spasticity, Muscle
Spastic Paraplegia
Spastic Quadriplegia
Spastic Tetraplegia
Paraplegia
Tetraplegia
Keywords: shockwave
extracorporeal shockwave therapy
spinal cord injury
spasticity
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
First posted: 2022-06-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, controlled trial with sham control
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Modified Ashworth Scale scores
timeFrame: 4 weeks
Secondary outcomes:
measure: Change in Modified Ashworth Scale scores
timeFrame: 8 weeks
measure: Change in Modified Tardieu Scale
timeFrame: 4 weeks
measure: Change in Modified Tardieu Scale
timeFrame: 8 weeks
measure: Change in Modified Penn Spasticity Frequency Scale
timeFrame: 4 weeks
measure: Change in Modified Penn Spasticity Frequency Scale
timeFrame: 8 weeks
measure: Change in Modified Patient-Reported Impact of Spasticity Measure
timeFrame: 4 weeks
measure: Change in Modified Patient-Reported Impact of Spasticity Measure
timeFrame: 8 weeks
measure: Participant Global Impression of Change
timeFrame: 4 weeks
measure: Participant Global Impression of Change
timeFrame: 8 weeks
measure: Medial gastrocnemius muscle echogenicity
timeFrame: 4 weeks
measure: Medial gastrocnemius muscle echogenicity
timeFrame: 8 weeks
measure: Medial gastrocnemius muscle elasticity
timeFrame: 4 weeks
measure: Medial gastrocnemius muscle elasticity
timeFrame: 8 weeks
measure: Medial gastrocnemius muscle fiber length
timeFrame: 4 weeks
measure: Medial gastrocnemius muscle fiber length
timeFrame: 8 weeks
measure: Medial gastrocnemius muscle thickness
timeFrame: 4 weeks
measure: Medial gastrocnemius muscle thickness
timeFrame: 8 weeks
measure: Medial gastrocnemius muscle pennation angle
timeFrame: 4 weeks
measure: Medial gastrocnemius muscle pennation angle
timeFrame: 8 weeks
Other outcomes:
Locations:
city: West Orange
country: United States
facility: Kessler Foundation
state: New Jersey
Study officials:
References: