Shockwave Therapy for Spinal Cord Injury

Overseen By Shalaka Paranjpe, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kessler Foundation

Must not be taking: Anticoagulants, Botulinum toxin

Disqualifiers: Surgical history, Ankle contracture, Arthritis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 3 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to assist people with spinal cord injuries who experience spasticity, a condition causing frequent muscle spasms and stiffness. The focus is on extracorporeal shockwave therapy, a non-invasive treatment that has shown promise in reducing these symptoms without long-term side effects. Participants will receive either this therapy or a placebo treatment to compare results. Suitable candidates have had a spinal cord injury for over a year, experience muscle stiffness, and have not recently changed their spasticity medications.

As an unphased trial, this study offers participants the chance to contribute to innovative research that could lead to new treatment options.

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.

Will I have to stop taking my current medications?

The trial requires that you do not change your antispasmodic medications during the study. If you are on anticoagulant medications, you may not be eligible to participate.

What prior data suggests that shockwave therapy is safe for treating spasticity in people with spinal cord injury?

Research has shown that extracorporeal shockwave therapy (ESWT) is safe for people with spinal cord injuries. Past studies reported no harmful effects, indicating participants did not experience negative side effects. ESWT has also been used in individuals with muscle stiffness and spasms after a stroke, without causing long-term side effects.

These findings suggest that ESWT is generally well-tolerated. It may help improve muscle stiffness, spasms, and overall quality of life for people with spinal cord injuries. Although more research is needed to confirm these results, current evidence indicates a low risk of side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for spinal cord injury, such as physical therapy or medication to manage symptoms, extracorporeal shockwave therapy offers a non-invasive approach that directly targets spasticity. This therapy uses focused shockwaves to stimulate healing and reduce muscle stiffness, which could potentially lead to improved mobility and quality of life. Researchers are excited because it provides a novel mechanism to address the underlying issues of muscle spasticity rather than just alleviating symptoms. Plus, with just a few sessions over a short period, it could offer faster results compared to other long-term therapies.

What evidence suggests that extracorporeal shockwave therapy is effective for spasticity in spinal cord injury?

Research has shown that extracorporeal shockwave therapy (ESWT) can reduce muscle stiffness in people with spinal cord injuries. Some studies found that it improves walking, bladder control, and overall quality of life. In this trial, one group will receive focused ESWT treatment to assess its effectiveness. ESWT has also proven effective for muscle stiffness after a stroke, with no long-term side effects reported. Additionally, ESWT has helped many people with spinal cord injuries perform daily activities better. Evidence even suggests it supports nerve healing, which might aid in recovery. These findings indicate that ESWT could be a promising option for reducing issues related to muscle stiffness. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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 have had a spinal cord injury for over a year without getting worse.

I haven't changed my muscle relaxer meds in the last 3 months.

Participant is able and willing to comply with the protocol

Exclusion Criteria

I have a severe, inflammatory arthritis condition.

I haven't had botulinum toxin injections in the last 6 months or phenol/alcohol injections in the last 12 months.

I have had a blood clot.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive extracorporeal shockwave therapy or sham treatment over three weeks

3 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Extracorporeal Shockwave Therapy

Trial Overview 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.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

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

Group II: Control Placebo Group 1 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

Who Is Running the Clinical Trial?

Kessler Foundation

Lead Sponsor

Trials

190

Recruited

11,300+

Published Research Related to This Trial

A single session of extracorporeal shock wave therapy (ESWT) significantly improved spasticity in patients with chronic stroke, as measured by the Modified Ashworth Scale and various ultrasonographic measures, with the most notable improvements observed at the 4-week follow-up.

The study involved 18 participants and demonstrated that ESWT led to measurable changes in muscle characteristics, such as muscle fascicle length and pennation angle, indicating its potential efficacy in managing spasticity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasonographic Evaluation for the Effect of Extracorporeal Shock Wave Therapy on Gastrocnemius Muscle Spasticity in Patients With Chronic Stroke. Lee, CH., Lee, SH., Yoo, JI., et al.[2020]

Extracorporeal shock wave therapy (ESWT) shows promise in oncology by significantly reducing the viability of various cancer cell lines and enhancing the effectiveness of chemotherapy, indicating its potential as a treatment adjunct.

ESWT also demonstrates clinical efficacy in rehabilitating cancer patients suffering from conditions like erectile dysfunction post-prostatectomy and lymphedema, but more long-term studies are needed to establish clear guidelines for its use in cancer rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Shock wave therapy in oncology: in vitro, in vivo, rehabilitation]. Grushina, TI., Orlov, II.[2022]

Extracorporeal shock waves (ESWs) applied four weeks after spinal cord injury in rats significantly increased the proliferation of endogenous neural stem cells (NSCs) and promoted axonal regeneration, indicating a potential therapeutic effect for spinal cord injuries.

The study observed functional improvement in hindlimb movement without any clinical deterioration, suggesting that ESWs could be a safe and effective treatment to enhance recovery in the chronic phase of spinal cord injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Induction of Endogenous Neural Stem Cells By Extracorporeal Shock Waves After Spinal Cord Injury. Shin, DC., Ha, KY., Kim, YH., et al.[2021]

This systematic review aims to evaluate the effectiveness and safety of extracorporeal shock-wave therapy (ESWT) for chronic musculoskeletal pain, focusing on randomized controlled trials to ensure high-quality evidence.

The review will assess primary outcomes like pain levels and secondary outcomes such as functional limitations and adverse events, providing crucial insights for patients and healthcare providers regarding ESWT's role in managing chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of extracorporeal shock wave for chronic musculoskeletal pain conditions: A protocol of systematic review and meta-analysis of randomized controlled trials. Qin, J., Jin, T., He, Z., et al.[2022]

Extracorporeal shockwave therapy (ESWT) is generally effective for treating musculoskeletal disorders, with no severe complications reported until this case of irritant contact dermatitis following high-energy treatment.

A 42-year-old male developed significant skin damage after a high-energy ESWT session, highlighting the need for patient awareness regarding this rare but serious side effect, despite the overall safety of the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Irritant contact dermatitis following extracorporeal shockwave therapy: a case report. Shi, L., Li, Z., Wang, P., et al.[2021]

Extracorporeal shockwave therapy significantly reduced pain in patients with chronic musculoskeletal disorders, with the numeric rating scale (NRS) score improving from 6.25 to 0.2 one year after treatment across various conditions.

The therapy demonstrated effective functional improvements, as shown by significant increases in specific scores for shoulder, elbow, and ankle function, indicating it is a safe and effective treatment option for conditions like calcific tendonitis, chronic Achilles tendinopathy, and lateral epicondylitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of extracorporeal shockwave therapy in three major tendon diseases. Carulli, C., Tonelli, F., Innocenti, M., et al.[2018]

Extracorporeal shockwave therapy (ESWT) has gained popularity in Poland for treating musculoskeletal disorders, with a review of 15 studies involving 1326 patients showing beneficial therapeutic effects.

Despite the positive outcomes reported, there is a need for further research to better understand the long-term effectiveness and safety of ESWT in treating inflammatory musculoskeletal conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Evaluation of the effectiveness of extracorporeal shock wave therapy in selected musculoskeletal system disorders of the inflammatory etiology--a critical review of the literature]. Dymarek, R., Bidzińska, G., Zwierzchowski, K., et al.[2015]

Extracorporeal shockwave therapy (ESWT) uses rapid acoustic waves to stimulate biological healing processes in tissues, promoting effects like tissue regeneration, wound healing, and bone remodeling.

The article reviews the current understanding of the molecular mechanisms behind ESWT, highlighting its potential applications in treating bone disorders, although detailed mechanisms remain largely unexplored.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biological mechanism of shockwave in bone. Cheng, JH., Wang, CJ.[2018]

Low-energy extracorporeal shock wave therapy (ESWT) significantly increases levels of vascular endothelial growth factor (VEGF), which helps protect nervous tissue after spinal cord injury (SCI) and improves motor function recovery in rats.

In a study involving 90 adult female rats, those receiving low-energy ESWT after SCI showed better motor function recovery and increased neuron survival compared to those who did not receive the treatment, indicating its potential as an effective adjunctive therapy for spinal injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of low-energy extracorporeal shock wave on vascular regeneration after spinal cord injury and the recovery of motor function. Wang, L., Jiang, Y., Jiang, Z., et al.[2020]

Extracorporeal shockwave therapy (ESWT) significantly reduces spasticity levels in patients with conditions like stroke, multiple sclerosis, and cerebral palsy, with effects lasting up to 12 weeks after treatment, as measured by the Modified Ashworth Scale (MAS).

The number of shocks and the site of application did not significantly affect the therapeutic outcomes, suggesting that ESWT is effective across different patient groups and treatment parameters.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Duration of Treatment Effect of Extracorporeal Shock Wave on Spasticity and Subgroup-Analysis According to Number of Shocks and Application Site: A Meta-Analysis. Oh, JH., Park, HD., Han, SH., et al.[2020]

Citations

1. tandfonline.com tandfonline.com/doi/full/10.1080/10790268.2024.2379067?src=

Shockwave therapy in persons with a spinal cord injury ... In this study, ESWT resulted in improved performance of specific ADL items in most persons with SCI. More research is needed to confirm these ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8649182/

Extracorporeal shockwave therapy in spinal cord injury, early ... The results of the current study indicate that ESWT significantly improves locomotor recovery following SCI through regeneration of the neural tissue.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11396197/

Extracorporeal Shock Wave Therapy (eSWT) in Spinal Cord ... Some reports have shown that eSWT can improve spasticity, walking ability, urological function, quality of life, and independence in daily life.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05432999?cond=Chronic%20Wounds&term=focused%20ultrasound&aggFilters=status:not%20rec&rank=3

Extracorporeal Shockwave Therapy for Spasticity in People ... ESWT has shown some benefits in people with post-stroke spasticity with no long term side effects.

5. mayoclinic.org mayoclinic.org/medical-professionals/physical-medicine-rehabilitation/news/the-evolving-use-of-extracorporeal-shock-wave-therapy-in-managing-musculoskeletal-and-neurological-diagnoses/mac-20527246

The evolving use of extracorporeal shock wave therapy ... Researchers demonstrated the use of ESWT to reduce pain and promote healing in bone, tendon, ligament and fascia in patients with musculoskeletal disorders.

6. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-022-06161-8

The effect of extracorporeal shock wave therapy in acute ... The aim of this clinical study is to investigate the effect of ESWT in humans within the first 48 h after an acute traumatic SCI.