RECRUITING

Transcutaneous Spinal Cord Stimulation for Chronic Low Back Pain

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

As a leading cause of disability worldwide, chronic low back pain (cLBP) represents a significant medical and socioeconomic problem with estimated health care spending of $87 billion/annually. The efficacy of dorsal column electrical stimulation to inhibit pain was first described over 50 years ago. Since then, several large clinical trials have investigated the therapeutic potential of electrical spinal cord stimulation (SCS) and found that over 70% of patients with intractable pain had over 50% pain relief after 1 year of treatment. Thus, SCS is a promising therapeutic intervention that has superior patient outcomes when compared to traditional modalities for the treatment of cLBP. To date, SCS for treatment of cLBP has been delivered via epidural electrodes, requiring neurosurgical implantation. Although, the implantable stimulators have a low rate of adverse events, secondary complications associated with surgical intervention still occur.Transcutaneous spinal cord stimulation (tSCS) is a rapidly developing non invasive neuromodulation technique in the field of spinal cord injury. Its application potentiates lumbosacral spinal cord excitability enabling motor functions, (e.g. independent standing, postural control) in patients with chronic complete motor paralysis. Given that epidural and transcutaneous SCS activate similar neuronal networks, tSCS for cLBP treatment may be advantageous due to its non-invasive nature which may also allow for a mass market production and rapid patient availability if tSCS is proven efficacious. In this pilot study we will establish the feasibility of tSCS to acutely improve patient reported outcomes (pain scores) and several objective measures, including sit-to-stand biomechanics, neurophysiological and neuroimaging outcomes.

Official Title

Transcutaneous Spinal Cord Stimulation for Chronic Low Back Pain

Quick Facts

Study Start:2022-08-01
Study Completion:2024-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05265000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Low back pain
  2. * Able to get in and out of chair unassisted
  3. * No changes in medication within 2 weeks of study enrollment
  4. * Stable dose of their medications within 2 weeks of study enrollment
  1. * Body Mass Index (BMI) \> 28
  2. * Hardware in the spine from prior surgeries
  3. * Presence of epidural stimulation leads
  4. * Presence of any additional neuromuscular pain unrelated to spinal condition
  5. * Intolerance to any form of electrical stimulation, such as neuromuscular stimulation in the past
  6. * Lack of perceived endurance to go through multiple experimental assessments in one day/complete the study which may take up to 3 hours
  7. * Changes in medications within 2 weeks of study enrollment
  8. * Moderate/severe depression (Beck Depression Inventory score \> 20)

Contacts and Locations

Study Contact

Anastasia Keller
CONTACT
628-206-3734
anastasia.keller@ucsf.edu

Principal Investigator

Anastasia Keller, PhD
PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Jeannie Bailey, PhD
PRINCIPAL_INVESTIGATOR
University of California, San Francisco

Study Locations (Sites)

San Francisco VA Medical Center
San Francisco, California, 94121
United States

Collaborators and Investigators

Sponsor: University of California, San Francisco

  • Anastasia Keller, PhD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco
  • Jeannie Bailey, PhD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-08-01
Study Completion Date2024-12-01

Study Record Updates

Study Start Date2022-08-01
Study Completion Date2024-12-01

Terms related to this study

Keywords Provided by Researchers

  • non-invasive, spinal cord stimulation, neuromodulation

Additional Relevant MeSH Terms

  • Chronic Low-back Pain