Shockwave Therapy for Spinal Cord Injuries

Article still in progress, please do not read it yet, it lacks Petros’ input; so far, it is only a literature review.

This article is a literature review I wrote after the publication of the following case from Cyprus by Petros Kattou – SOZO-Braincenter

Study data on the use of extracorporeal shockwave therapy (ESWT, TPS) for paraplegia/paraplegia

12 years paraplegic after stroke – starts walking within 1 week Neuromodulation

Animal Evidence

Meta-analysis of studies in animal models (rats, mice)

• Low-energy ESWT (0.1 mJ/mm²) showed significant improvements in locomotor function (SDM 1.68), axon sprouting, VEGF levels, and cell survival, as well as reduced axon cell loss (ncbi.nlm.nih.gov).
• In another study (subacute and chronic), ESWT-treated animals improved motor function significant (e.g., miR-375↑, miR-382-5p↓) (com).

Mechanisms in preclinical studies

• ESWT induces VEGF expression (neuroprotective, angiogenic), BDNF increase, less cell apoptosis, and better neuronal preservation including white matter and axon number – correlated with improvements in motor and sensory function (net).

Clinical Study in Humans

Pilot Protocol Study in the Acute Phase

• Prospective double-blind RCT with approximately 82 patients (AISA-D), treated within the first 48 hours after trauma. ESWT applied once with an EFD of 0.1–0.19 mJ/mm² at the lesion site and feet. Primary endpoint: motor-sensory function after 6 months. Secondary: spasticity, gait, urological function, quality of life (biomedcentral.com).

Narrative Reviews & Case Reports

• A few small clinical applications report improvements in spasticity, gait stability, urological function, quality of life, and daily independence without serious side effects. So far, evidence has been more narrative than controlled (ncbi.nlm.nih.gov).

Therapy parameters (according to animal and human studies)

• Energy flux density (EFD): typically 0.04–0.19 mJ/mm² (low to medium)
• Frequency: 2–5 Hz, Number of pulses: 000–3000 per session
• Therapy intervals: 1–3 sessions per week, Duration: usually 3–8 weeks (com).

Current Summary

Benefits of ESWT in SCI (based on previous studies)

• Early phase: better motor and sensory recovery (based on a human pilot study in the acute phase)
• Medium/long-term in animals: benefits in neuroregeneration, angiogenesis, and gain of function
• Clinically reported improvements in spasticity, mobility, quality of life, and urological function

Limitations & Open points

• No large-scale human studies – only pilot and narrative studies
• Standardized treatment protocols are lacking (dose, frequency, duration, location)
• Long-term efficacy and safety still unclear
• Little data on effects on bladder/bowel function

Evidence Level for this Therapy

Currently, the following evidence level can be classified according to EBM criteria for TPS (Transcranial Pulse Stimulation / Focused Shock Wave Therapy) on the spine for spinal cord injury (paraplegia):

Evidence Level: Level 4–5 (current)

Justification:

• Level 5: Animal studies withpositive effects on regeneration, VEGF/BDNF, motor function
  → e.g. B. Mouse/rat models with significant motor recovery through focused ESWTLevel 4: Clinical case reports / expert opinions without a control group, pilot studies in planning
  → Initial protocol studies in humans exist (e.g., study protocol PMID: 36257581), but no published results from RCTs yet

Potential for Level 2b–1b in the near future:

A large randomized study (82 patients, prospective, multicenter, double-blind) on the use of focused shock wave therapy for acute spinal cord injuries has been registered and is being conducted, but is still ongoing Without published final results.

→ After publication of these results, depending on the data quality, an evidence level of 2b (RCT without systematic review) or even 1b (high-quality RCT with follow-up) could be achieved.

Summary for Clinical Practice

• Currently no established clinical evidence (still experimental)
• Use only justifiable in a study context or as an individual therapeutic trial
• Animal studies show robust evidence, but clinical validation is still lacking
• Waiting for results from the aforementioned RCTs

If you’d like, I can also write you a formatted patient information sheet with this evidence classification.

What is ESWT?

Extracorporeal shock wave therapy is an external, non-invasive mechanical stimulation of the spinal cord area – so far established, for example, for muscle/tendon pain.

What do the studies show?

Preclinical studies: significant improvements in motor function, neuronal regeneration, and angiogenic markers such as VEGF and BDNF

Initial human pilot studies (within 48 hours of spinal cord injury) indicate functional improvements after 6 months, without serious side effects.

What effects are possible?

• Recovery of movement and sensation
• Reduction of spasticity
• Improved control, mobility, and quality of life
• Potential: improved urological functions

What are the limitations?

• No standardized protocols
• Lack of large-scale, randomized trials
• Effect on bladder/bowel function still unclear
• Uncertain efficacy in chronic spinal cord injuries

Current Outlook

A pilot RCT with approximately 82 patients is active. Until reliable data are published, ESWT should be considered an experimental therapy – possibly within the framework of a study protocol or individual therapeutic trials under strict medical supervision.

Conclusion for patient information

• ESWT for spinal cord injury is experimental, based on animal studies and early clinical data.
• Mechanistically sound: Angiogenesis, neuroprotection, functional improvements.
• No established recommendation for use – only in studies or under close medical supervision.
• Further research urgently needed, especially standardized treatment protocols and large RCTs.

Currently, the following level of evidence can be classified according to EBM criteria for TPS (transcranial pulse stimulation / focused shock wave therapy) on the spine in cases of paraplegia:

Level of evidence: Level 4–5 (current)

Justification:

• Level 5: Animal studies with positive effects on regeneration, VEGF/BDNF, and motor function
  → e.g. B. Mouse/rat models with significant motor recovery through focused ESWTLevel 4: Clinical case reports / expert opinions without a control group, pilot studies in planning
  → Initial protocol studies in humans exist (e.g., study protocol PMID: 36257581), but no published results from RCTs yet

Potential for Level 2b–1b in the near future:

A large randomized study (82 patients, prospective, multicenter, double-blind) on the use of focused shock wave therapy for acute spinal cord injuries has been registered and is being conducted, but is still ongoing without published final results.

→ After publication Depending on the data quality, these results could achieve an evidence level of 2b (RCT without systematic review) or even 1b (high-quality RCT with follow-up).

Summary for clinical practice

• Currently no established clinical evidence (still experimental)
• Use only justifiable in a study context or as an individual therapeutic trial
• Animal studies show robust evidence, but clinical validation is still lacking
• Awaiting results from the aforementioned RCTs