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

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.

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 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. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Shockwave Therapy for Spinal Cord Injury?

Research suggests that low-energy extracorporeal shock wave therapy (ESWT) can increase levels of a protein called vascular endothelial growth factor (VEGF), which may help repair nerve damage and improve movement after a spinal cord injury. Additionally, ESWT has been shown to relieve pain in various musculoskeletal conditions, indicating its potential benefits in other areas. ^{1 2 3 4 5}

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. ^{2 3 6 7 8}

Is shockwave therapy generally safe for humans?

Shockwave therapy is generally considered safe for humans, with no severe complications commonly reported. However, there is a rare case of skin irritation (irritant contact dermatitis) following high-energy treatment, which resolved without scarring. ^{2 3 6 7 8}

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. ^{1 2 3 9 10}

How is shockwave therapy different from other treatments for spinal cord injury?

Shockwave therapy is unique because it uses sound waves to stimulate the body's own healing processes, such as increasing levels of a protein called VEGF that helps repair nerve tissue and improve movement after a spinal cord injury. Unlike other treatments, it focuses on promoting natural tissue regeneration and has been used successfully in other conditions like muscle spasticity and tendon pain. ^{1 2 3 9 10}

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 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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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) 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]

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]

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]

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 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]

References

1. New Zealand 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. [2020]

2. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Shock wave therapy in oncology: in vitro, in vivo, rehabilitation]. [2022]

3. Italy pubmed.ncbi.nlm.nih.gov

Effectiveness of extracorporeal shockwave therapy in three major tendon diseases. [2018]

4. Poland 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]. [2015]

5. Korea (South) 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. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Biological mechanism of shockwave in bone. [2018]

7. United States 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. [2022]

8. China pubmed.ncbi.nlm.nih.gov

Irritant contact dermatitis following extracorporeal shockwave therapy: a case report. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Ultrasonographic Evaluation for the Effect of Extracorporeal Shock Wave Therapy on Gastrocnemius Muscle Spasticity in Patients With Chronic Stroke. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Induction of Endogenous Neural Stem Cells By Extracorporeal Shock Waves After Spinal Cord Injury. [2021]