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

WithdrawnNCT04943770
View the official record on ClinicalTrials.gov

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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
Prospective Single-centre, Double-blind, Randomised Study to Evaluate the Effect of Spinal Cord Stimulation Frequency on wash-in/Wash-out Time and Clinical Outcomes in Subjects Using Fast-Acting Sub-perception Therapy (FAST) for Chronic Pain
Conditions
  • Neuropathic Low Back Pain
Interventions
  • Procedure: Spinal cord stimulator implant
  • Diagnostic test: Healing period
  • Device: WaveWriter™ Alpha Spinal Cord Stimulator (SCS) system
Sponsor
Barts & The London NHS Trust
Collaborators
Boston Scientific Corporation
Start date
2022-10-01
Primary completion
2023-07-31
Sex
All
Age range
from 18 Years to 75 Years
Results posted
No results posted in this snapshot
Countries
United Kingdom
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * The subject is between 18 and 75 years of age when written informed consent is obtained. * Complaint of persistent or recurrent low back pain, with or without equal or lesser leg pain, for at least 90 days prior to Screen. * Received at least 90 days of documented pain management care to address the primary pain complaint, prior to Screening (e.g. medication, physical therapy.) * Diagnosed with chronic neuropathic pain of the low back and legs (of neuropathic origin only). * Eligible candidate for SCS from a psychological and psychiatric standpoint as determined prior to Baseline Visit, per site's routine screening process No back surgery within 6 months prior to Screening. * Average low back pain intensity, during the position/activity, which routinely causes worst pain, of 5 or greater on a 0-10 numerical rating scale during Baseline period based on eDiary. * If taking prescription opioids for primary chronic pain complaint (low back and/or leg pain), must have been on a stable prescription (same drug(s) and dose(s)) 30 days prior to Screening to a total of less than 180 mg Oral Morphine equivalent. * Willing and able to comply with all protocol-required procedures and assessments/evaluations (e.g. willing to comply with opioid prescription lock from the Baseline visit through End of Rate Randomization and protocol required stimulation parameter locks, complete daily eDiary). * If female of childbearing potential: not pregnant, as evidenced by a negative pregnancy test at Screening. * Subject signed a valid, IRB-approved informed consent form (ICF) provided in English. Exclusion Criteria: * Significant cognitive impairment at Screening that, in the opinion of the Investigator, would reasonably be expected to impair the study candidates to participate in the study * Have untreated major psychiatric comorbidity, serious drug related behaviour issues. * Previous spinal cord stimulation trial or is already implanted with an active implantable device(s) (e.g. pacemaker, drug pump, implantable pulse generator). * Participating (or intends to participate) in another drug or device clinical trial that may influence the data that will be collected for this study * Currently on any anticoagulant medications that cannot be discontinued during perioperative period * Current condition associated with risk of immunocompromised that might increase risk of infection during study duration. * A female who is pregnant, is breastfeeding, or is of child…

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04943770