Extracorporeal Shockwave Therapy for Spasticity in People With Spinal Cord Injury

NCT ID: NCT05432999

Last Updated: 2025-05-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2026-02-01

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.

Conditions

Spinal Cord Injuries; Spasticity, Muscle; Spastic Paraplegia; Spastic Quadriplegia; Spastic Tetraplegia; Paraplegia; Tetraplegia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Intervention

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

Group Type: EXPERIMENTAL

Extracorporeal Shockwave Therapy

Intervention Type: DEVICE

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.

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.

Group Type: SHAM_COMPARATOR

Extracorporeal Shockwave Therapy

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Storz Medical DUOLITH SD1 Ultra modular system

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kessler Foundation

OTHER

Sponsor Role: lead

Responsible Party

Nathan Hogaboom, PhD

Research Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kessler Foundation

West Orange, New Jersey, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Nathan Hogaboom, PhD

Role: CONTACT

nhogaboom@kesslerfoundation.org

9733243584

Shalaka Paranjpe, MS

Role: CONTACT

sparanjpe@kesslerfoundation.org

9733246643

Facility Contacts

Shalaka Paranjpe, MS

Role: primary

sparanjpe@kesslerfoundation.org

9733246643

Nathan Hogaboom, PhD

Role: backup

nhogaboom@kesslerfoundation.org

9733243584

Other Identifiers

R-1178-22

Identifier Type: -

Identifier Source: org_study_id