MedTrace Logo

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

NCT04943770 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2024-11-05

No results posted yet for this study

Summary

The study design is prospective, post-market, exploratory, single-centre, rate randomised, double-blinded (subject, evaluator blinded; programmer un-blinded). The study is designed to evaluate the wash-in and wash-out time of FAST (Fast Acting Sub-perception Therapy) at 90 Hz and various frequencies above and below 90 Hz.

A prospective study design will eliminate the bias associated with case selection in a retrospective review and will ensure that identical procedures are followed for data capture and review.

Randomization of rates will be used to minimise the sequence effects and the impact of carryover effects, as well as addressing issues that may be related to order effect.

The electronic diary will be used to log the subjects' pain intensity and medication usage. Additionally, the numerical rating scale for measuring pain intensity is a validated measure and has been used in other randomized controlled trials to measure the outcomes of spinal cord stimulation (SCS).

The electronic real-time NRS (Numerical rating score) recording will be used to log the subjects' pain intensity and time during wash-in evaluation session.

This study aims to evaluate pain relief and wash-in/wash-out frequency sensitivity using FAST at different stimulation rates. The different randomization period included in the study design allows for comparing these treatments using one of the stimulation rates as an active control.

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.

Sponsors & Collaborators

  • Boston Scientific Corporation

    collaborator INDUSTRY

  • Barts & The London NHS Trust

    lead OTHER

Principal Investigators

  • Vivek Mehta · Barts & The London NHS Trust

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-01
Primary Completion
2023-07-31
Completion
2023-07-31
FDA Device
Yes

Countries

  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04943770 on ClinicalTrials.gov