Shockwave Therapy for Muscle Spasticity

This trial tests whether adding shockwave therapy (focused extracorporeal shockwave therapy) to regular Botox injections can better control muscle spasticity, a condition where muscles remain continuously tight or stiff, often after a spinal cord injury. Researchers aim to determine if this combination not only improves symptoms more than Botox alone but also positively alters muscle structure. Participants will join one of two groups: one receiving both treatments and another receiving Botox with a placebo shockwave therapy. Ideal candidates have had a spinal cord injury for over a year and are already receiving Botox for muscle issues. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in therapy.

Research has shown that focused extracorporeal shockwave therapy (ESWT) is generally safe and well-tolerated. Studies have found no serious side effects in patients who received ESWT for spasticity, a condition where muscles tighten uncontrollably. This therapy has been successfully used to treat bone and joint issues and to help individuals with muscle tightness after a stroke.

Botulinum toxin injections, commonly known as Botox, are also considered safe for treating spasticity. The FDA has approved Botox for various conditions, including muscle spasms. Most people experience only mild and temporary side effects, such as soreness at the injection site.

Most treatments for muscle spasticity, like botulinum toxin injections, work by blocking nerve signals to reduce muscle contractions. However, researchers are excited about combining shockwave therapy with toxin injections because shockwave therapy might enhance the effects of the toxin, possibly leading to quicker or more lasting relief. This therapy could target deeper muscle layers or improve circulation, which might not be achieved through toxin injections alone. Additionally, this approach could potentially reduce the amount of toxin needed, minimizing side effects.

Studies have shown that focused extracorporeal shockwave therapy (ESWT) effectively reduces muscle tightness and stiffness. Many patients experienced a noticeable decrease in these symptoms, as measured by a standard scale, with benefits lasting up to 12 weeks. Research indicates that ESWT can improve muscle movement and reduce spasms in people with conditions like stroke. In this trial, one group of participants will receive a combination of ESWT and botulinum toxin injections, potentially enhancing overall results. This combination could provide better symptom relief compared to botulinum toxin alone, which is being tested in another group with sham (fake) shockwave therapy.²⁶⁷⁸⁹