Exoskeleton Training for Spinal Cord Injury Neuropathic Pain (ExSCIP)

Launched by UNIVERSITY COLLEGE DUBLIN · Jun 12, 2024

Keywords

ClinConnect Summary

The ExSCIP trial is studying whether using a robotic device, called an exoskeleton, can help reduce nerve pain in people who have experienced a spinal cord injury. The researchers want to find out if it's possible to offer walking practice with this device three times a week for twelve weeks, if people will want to join the program and stick with it, and if it actually helps lessen their pain. To test this, they will compare the effects of robotic walking with a relaxation program.

To be eligible for the trial, participants must be at least 18 years old and have a traumatic spinal cord injury that has lasted for over six months. They should also experience nerve pain that has persisted for more than three months, even with medication. Participants will complete questionnaires and tests about their pain before and after the trial, follow a walking or relaxation program three times a week, and share their experiences in an interview. This study is currently looking for participants, and anyone interested should discuss it with their healthcare provider to see if they qualify.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Individuals who are 18 years and over.
• • Confirmed traumatic SCI (injury resulted from an external physical impact and not an acute or chronic disease process) of \>6 months duration with complete or incomplete paraplegia or tetraplegia.
• • Individuals with above confirmed traumatic SCI who have below-level NP (≥ 3 levels below neurological level and/or extending to at-level region) starting after the SCI and persisting for \> 3 continuous months, despite pharmacotherapy.
• • NP will be confirmed based on a neurological examination, a score of ≥4 on the Douleur Neuropathique 4 (DN4) (48) and a comprehensive pain history supported by the use of the ISCIP Pain Classification. They endorse one or more of the following pain descriptors to assist in confirmation of below level NP "'hot-burning', 'tingling', 'pricking', 'pins and needles', 'sharp', 'shooting', 'squeezing', 'painful cold' and 'electric shock-like'" (45).
• • Moderate and severe NP as confirmed above will be described as pain ≥ 3 and ≥ 6 on the 0-10 Numerical Rating Scale (NRS) for NP (averaged over a week).
• • Exoskeleton naive
• • Stable medication regimen
• • Have the capacity to provide informed consent.
• Exclusion Criteria:
• • Non-traumatic SCI, cauda equina lesions or Guillain Barré diagnoses
• • NP intensities of \<3 (NRS) or nociceptive pain profiles only based on the ISCIP pain classification convention.
• • Recent lower limb fracture
• • Inadequate bone density (z score \< -2)
• • Anthropometric measurements incompatible with the exoskeleton device (i.e. height \>1.9m, weight \>100kgs, significant lower limb spasticity)
• • Unstable comorbid medical condition/psychiatric condition/medication regimen
• • Planned surgery coinciding with intervention
• • Pregnancy
• • Drug and alcohol abuse