Shockwave Therapy for Spinal Cord Injury
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Kessler Foundation
No Placebo Group
Approved in 1 jurisdiction
Trial Summary
What is the purpose of this trial?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.
Is Shockwave Therapy a promising treatment for Spinal Cord Injury?Yes, Shockwave Therapy is promising for Spinal Cord Injury. It can help improve blood flow and protect nerve tissues, which may aid in motor function recovery. It also encourages the growth of neural stem cells, which are important for healing.245610
What data supports the idea that Shockwave Therapy for Spinal Cord Injury is an effective treatment?The available research shows that Shockwave Therapy can help improve recovery after a spinal cord injury by increasing levels of a substance that helps repair nerve damage. This can lead to better movement abilities. While there is evidence of its effectiveness in treating other conditions like tendon issues and muscle stiffness, more research is needed to fully understand its benefits and safety for spinal cord injuries.234710
Do I have to stop taking my current medications for the trial?The trial requires that you do not change your antispasmodic medications during the trial. If you are on anticoagulant medications, you cannot participate.
What safety data exists for shockwave therapy?The safety data for shockwave therapy, also known as extracorporeal shockwave therapy (ESWT), indicates that it is widely used for musculoskeletal disorders with remarkable efficacy and no severe complications reported. However, a rare case of irritant contact dermatitis was documented following high-energy ESWT, suggesting that while generally safe, there can be rare skin-related side effects.128910
Eligibility Criteria
This trial is for adults over 18 with non-progressive traumatic spinal cord injury that happened more than a year ago, causing spasticity. They must have stable medication use for the past three months and not plan changes during the trial. Excluded are those with recent lower extremity surgery, ankle contracture, pregnancy, severe arthritis, thrombosis, cancer or recent injections for spasticity.Inclusion Criteria
I haven't changed my muscle relaxer meds in the last 3 months.
I haven't changed my muscle relaxer meds in the last 3 months and don't plan to during the trial.
I am 18 years old or older.
I am 18 years old or older.
Exclusion Criteria
I have a severe, inflammatory arthritis condition.
I have had a blood clot.
I am taking blood thinners.
I have had surgery on my leg or foot.
I have stiffness in my ankle that limits its movement.
Participant Groups
The study tests Extracorporeal Shockwave Therapy (ESWT) to treat spasticity in people with spinal cord injuries. It's a pilot randomized-controlled trial where half of the participants receive ESWT and half get sham treatment to compare effects on muscle stiffness and quality of life.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: InterventionExperimental Treatment1 Intervention
This group will receive a focused extracorporeal shockwave therapy treatment (three applications over three weeks), applied to the spastic medial gastrocnemius.
Group II: ControlPlacebo Group1 Intervention
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.
Extracorporeal Shockwave Therapy is already approved in United States for the following indications:
🇺🇸 Approved in United States as ESWT for:
- Chronic plantar fasciitis
- Lateral epicondylitis of the elbow
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Kessler FoundationWest Orange, NJ
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Who is running the clinical trial?
Kessler FoundationLead Sponsor
References
Biological mechanism of shockwave in bone. [2018]Shockwave is a rapid, short duration acoustic wave that carries energy and can propagate through tissue medium. This kind of physical force can be a mechanical stimulus that induces biological effects in living tissue. Extracorporeal shockwave therapy (ESWT) acts as a mechanical stimulus which promotes biological healing processes through a mechanotransduction. The biological effects of ESWT are reported such as tissue regeneration, wound healing, angiogenesis, bone remodeling, and anti-inflammation. Until now, however, little is known about the basic mechanism of action of this type of therapy. This article describes the molecular mechanism on the current status of ESWT with pre-clinical and clinical applications for treating disorders in bone.
Effectiveness of extracorporeal shockwave therapy in three major tendon diseases. [2018]Extracorporeal shockwave therapy is a conservative treatment for several painful musculoskeletal disorders. The aim of the study was the assessment of the relief from pain by the shockwave therapy in a population of consecutive patients affected by specific pathologies.
[Evaluation of the effectiveness of extracorporeal shock wave therapy in selected musculoskeletal system disorders of the inflammatory etiology--a critical review of the literature]. [2015]Extracorporeal shockwave therapy (ESWT) is a modern method from the scope of physical medicine. In Poland, atthe end of the last decade, ESWT has become an extremely popular form of treatment for many diseases, especially musculoskeletal. The aim of this study is to provide an overview of the most up to date scientific reports assessing the effectiveness of ESWT in the most common musculoskeletal system disorders of the inflammatory etiology. To review, there were qualified 15 subjects of research works in English language only, which were published between 2002-2013. The following summary includes a total amount of 1326 patients. Review of the scientific reports ware made based on international medical databases review. All qualified articles were characterized in detail in terms of material and research methods with a precise determination of treatment parameters, as well as the results achieved separated fora specific diagnosis. Despite the beneficial therapeutic effects as a result of ESWT treatment, which are described in numerous publications, there is a justified need for further observation the progress of scientific research, in particular with regard to the effectiveness and safety of ESWT.
Effect of low-energy extracorporeal shock wave on vascular regeneration after spinal cord injury and the recovery of motor function. [2020]Latest studies show that low-energy extracorporeal shock wave therapy (ESWT) can upregulate levels of vascular endothelial growth factor (VEGF). VEGF can ease nervous tissue harm after spinal cord injury (SCI). This study aims to explore whether low-energy ESWT can promote expression of VEGF, protect nervous tissue after SCI, and improve motor function.
Induction of Endogenous Neural Stem Cells By Extracorporeal Shock Waves After Spinal Cord Injury. [2021]Animal experimental study OBJECTIVES.: The purpose of this study is to investigate the effects of extracorporeal shock waves (ESWs) on endogenous neural stem cells (NSCs) proliferation after spinal cord injury (SCI).
Ultrasonographic Evaluation for the Effect of Extracorporeal Shock Wave Therapy on Gastrocnemius Muscle Spasticity in Patients With Chronic Stroke. [2020]Extracorporeal shock wave therapy (ESWT) has been suggested as a useful treatment for spasticity in patients with stroke. To date, most studies have used clinical or biomechanical assessments to determine the effects of treatment.
Duration of Treatment Effect of Extracorporeal Shock Wave on Spasticity and Subgroup-Analysis According to Number of Shocks and Application Site: A Meta-Analysis. [2020]To investigate duration of the treatment effect of extracorporeal shockwave therapy (ESWT) on spasticity levels measured with Modified Ashworth Scale (MAS) regardless of the patient group (stroke, multiple sclerosis, and cerebral palsy) and evaluate its spasticity-reducing effect depending on the number of shocks and site of application.
The efficacy of extracorporeal shock wave for chronic musculoskeletal pain conditions: A protocol of systematic review and meta-analysis of randomized controlled trials. [2022]This systematic review is the first one to assess the effectiveness and safety of extracorporeal shock-wave therapy (ESWT) for patients with chronic musculoskeletal pain conditions (CMPC).
Irritant contact dermatitis following extracorporeal shockwave therapy: a case report. [2021]Extracorporeal shockwave therapy (ESWT) has been widely used in the treatment of various musculoskeletal disorders with remarkable efficacy, with no relevant severe complications being reported. In this study, we report a rare case of acute irritant contact dermatitis following ESWT with serious skin damage, which has never been previously reported. A 42-year-old male patient with osteonecrosis of the femoral head (ONFH) was subjected to two sessions of ESWT. In the first session of low-energy ESWT (0.15 mJ/mm2, 3 Hz, and a total of 2,000 impulses), no local or systematic adverse reactions occurred. Three months later, he was subjected to a second session of high-energy ESWT (0.28 mJ/mm2, 4 Hz, and a total of 2,000 impulses). However, on the second day, the patient presented with itching and painful erythema and blisters on the local skin of the hip. Based on these manifestations and the results of patch testing, the patient was diagnosed with irritant contact dermatitis and treated by an oral antihistamine combined with external calamine lotions. The skin lesions began to develop exudate from erosion and scabs had gradually formed with treatment, and finally dry scabs fell off with no scar left. This is the first reported irritant contact dermatitis after ESWT. Although bone pathologies should be treated with high energy, patients should be informed of this potential rare complication.
[Shock wave therapy in oncology: in vitro, in vivo, rehabilitation]. [2022]Extracorporeal shock wave therapy (ESWT) is a relatively new branch of physiotherapy.