Shockwave Therapy, Spasticity, Spinal Cord Injury
Conditions
Brief summary
Approximately 305,000 people live with a spinal cord injury (SCI) in the United States. Sixty percent of these individuals have tetraplegia, which can cause significant dysfunction of the arms and hands. One of the consequences of SCI is spasticity - involuntary activation of muscles that can hinder bodily functions and negatively affect participation in various aspects of life. Spasticity can lead to loss of functional independence and activity limitations, cause pain, and lead to mood disorders like depression. It can even interfere with rehabilitation and lead to hospitalization. In people with tetraplegia, spasticity of the arms and hands can have a tremendous impact on independence and quality of life, and thus regaining function in these areas remains a top priority. Unfortunately, spasticity is difficult to treat. Common treatments include physical therapy, including exercise or stretching; medications such as Baclofen; and injections with agents like botulinum toxin (also known as Botox). Botox injections are often implemented alongside other modalities like therapy, yet they are invasive, tend to last for only a few months, and carry potential side effects. One potential non-invasive treatment for upper limb spasticity is focused extracorporeal shockwave therapy (f-ESWT), which involves an external application of high-pressure sound waves, similar to ultrasound. An applicator/handpiece is placed on the skin over the spastic muscle and the focused sound waves are applied. f-ESWT carries no long-term side effects with minimal discomfort during application. However, there has been limited research on this treatment option in people with SCI who have arm and hand dysfunction caused by spasticity. The purpose of this study is to fill in that knowledge gap. This will be accomplished by measuring different aspects of spasticity from the perspective of both the clinician and the person with SCI. These will include clinical measures, such as elbow and wrist range of motion, as well as how the treatment impacts the person's functional independence and quality of life. Ultrasound methods will be used to look at the person's muscles to see if any beneficial changes occur in their structure and stiffness. People with SCI who meet eligibility criteria will be invited to the laboratory to receive f-ESWT, which will occur once per week for three consecutive weeks. Treatment will entail application of f-ESWT to the elbow and wrist flexor muscles. Participants will be invited back to the laboratory to have their spasticity measured by a clinician, be asked questions about how their spasticity has impacted their lives, and have their muscles imaged with ultrasound. Findings from this study are expected to generate insight on whether f-ESWT could be a viable treatment option for spasticity of the arms and hands in people with SCI, and if a larger clinical trial is warranted.
Interventions
Three sessions of focused extracorporeal shockwave therapy, applied to forearm and elbow flexor muscles.
Sponsors
Kessler Foundation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 18 years of age or older. 2. Have chronic, non-progressive SCI of all levels and severities that occurred greater than 1 year prior to their enrollment. 3. MAS score of between 1+ and 3 in elbow and wrist flexors of the treated upper 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).129 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 in the upper extremity 2. Severe, inflammatory arthritic diseases 3. Thrombosis 4. Anticoagulant medication; 5. Pregnancy 6. Cancer 7. Recent history of local injection of botulinum toxin within 6 months, or phenol/alcohol within the 12 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. Scores range from 0 (no spasticity) to 4 (severe spasticity). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. Scores range from 0 (no spasticity) to 4 (severe spasticity). |
| 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 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 to quantify the impact of spasticity on physical, psychological, and social health-related QOL domains. Each item is rated using a scale of 0 ("never") to 3 ("often/very often"). The scale's psychometric properties have been well-established, including floor and ceiling effects for the various subscales, and it has been shown to be both valid and reliable. |
| Participant Global Impression of Change | 4 weeks | The Participant Global Impression of Change (PGIC) measures global treatment effect by asking the participant to rate with a 7-point scale (anchored by 1 \["very much worse"\] and 7 \["very much improved"\]) their overall impression following treatment as compared to prior. This scale provides an indication of clinically important improvement and has been used to assess efficacy of spasticity treatments in SCI. 11-week scores will be considered a primary outcome. |
| Biceps brachii muscle echogenicity | 4 weeks | Echogenicity is a measure of a tissue's "brightness." In muscle, this reflects the concentration of connective tissue and thus is a marker of muscle health. We will apply quantitative ultrasound image collection and analysis techniques to quantify the average echogenicity of biceps muscle in longitudinal view. |
| Biceps brachii muscle elasticity | 4 weeks | Elasticity is a measure of a tissue's stiffness. Muscles that are more spastic and have a greater concentration of connective tissue appear stiffer than those in better health. We will apply quantitative ultrasound image collection and analysis techniques to quantify the average elasticity of biceps muscle in longitudinal view. |
Countries
United States
Contacts
CONTACTShalaka Paranjpe, MS
CONTACTNathan Hogaboom, PhD
Outcome results
None listed