Evaluating the Effect of Spinal Cord Stimulation Frequency on Fast-Acting Sub-perception Therapy (FAST) for Chronic Pain

WithdrawnOBSERVATIONAL
0
Timeline

Start Date

October 1, 2022

Primary Completion Date

July 31, 2023

Study Completion Date

July 31, 2023

Conditions
Neuropathic Low Back Pain
Interventions
PROCEDURE

Spinal cord stimulator implant

"Patients will undergo spinal cord implant procedures as per standard of care and be implanted with the WaveWriter™ Alpha Spinal Cord Stimulator (SCS) system.~Implant Procedures will be followed by a healing period (4-6 weeks) during which patients will be offered therapy (up to one 1Khz). Patients will then be randomised to receive therapy at four different rates (A, B, C, D) in no particular order for 3-6 weeks each. Patients will then be followed up at 3 and 6 months after the last randomization visit."

DIAGNOSTIC_TEST

Healing period

Acute opioid pain medications may be continued. No additional scheduled assessments will be completed during this period.

DEVICE

WaveWriter™ Alpha Spinal Cord Stimulator (SCS) system

Patients will then be randomised to receive therapy (up to 1KHz) at four different rates in no particular order for 3-6 weeks each. Patients will then be followed up at 3 and 6 months after the last randomization visit.

Trial Locations (1)

EC1A 4NP

Barts Health NHS Trust, London

Sponsors
All Listed Sponsors
collaborator

Boston Scientific Corporation

INDUSTRY

lead

Barts & The London NHS Trust

OTHER