CompaRison of Paresthesia Mapping to anatomIc Midline-based burSt Programming Strategies

NCT02986074 | Completed Results

• 1 other identifier: SJM-CIP-10126
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

The study will compare therapeutic efficacy of a novel spinal cord stimulation leads implant based on anatomical landmarks with standard surgical implantation technique.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale (VAS) for Back Pain at SCS Trial

  Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)

  after 2 weeks of SCS trial

Secondary Outcomes (14)

• Visual Analog Scale (VAS) for Back Pain at 3 Months

  3 months after activation of permanent SCS implant

• Visual Analog Scale (VAS) for Back Pain at 6 Months

  6 months after activation of permanent SCS implant

• Visual Analog Scale (VAS) for Back Pain at 12 Months

  12 months after activation of permanent SCS implant

• EQ-5D at SCS Trial

  after 2 weeks of SCS trial

• EQ-5D at 3 Month

  3 months after activation of permanent SCS implant

Study Arms (2)

Anatomical midline lead first

EXPERIMENTAL

subjects in this group will receive stimulation first using an anatomical midline placed lead and subsequently using a paresthesia mapping placed lead

Device: Anatomical midline lead evaluation first

Paresthesia mapping lead first

EXPERIMENTAL

subjects in this group will receive stimulation first using a paresthesia mapping placed lead and subsequently using an anatomical midline placed lead

Device: Paresthesia mapping lead evaluation first

Interventions

Paresthesia mapping lead evaluation first DEVICE

Subjects will evaluate the clinical efficacy of stimulation delivered using the lead implanted using paresthesia mapping in the first part of the SCS trial and using the lead implanted using anatomical midline placement in the second part of the SCS trial

Paresthesia mapping lead first

Anatomical midline lead evaluation first DEVICE

Subjects will evaluate the clinical efficacy of stimulation delivered using the lead implanted using anatomical midline in the first part of the SCS trial and using the lead implanted using paresthesia mapping placement in the second part of the SCS trial

Anatomical midline lead first

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is able to provide informed consent to participate in the study;
• Subject is 18 years of age or older;
• Subject has failed to respond to at least 6 months of conventional treatment including pharmacological treatment, physical therapy, epidural injections and/or radiofrequency therapy as per NICE Tag 0159;
• FBSS subjects with predominant low back pain;
• Subject has a lower back pain intensity of at least 6.0 out of 10.0 on the VAS at baseline;
• Subject is on stable pain medications with a total opioid equivalent of 120 mgs a day or less for at least 28 days prior to enrolling in this study, and is willing to stay on those medications with no dose adjustments until activation of the permanently implanted SCS device;
• Subject's medical record has been evaluated by the Investigator to ensure that the subject is a good candidate for a neurostimulation system;
• Subject is willing to cooperate with the study requirements including compliance with the regimen and completion of all office visits;
• Female candidates of child-bearing potential agree to commit to the use of an effective method of contraception (including but not limited to sterilization, barrier devices, oral contraceptives, intrauterine devices (IUDs), condoms, rhythm method, or abstinence) for the duration of the study

You may not qualify if:

• Subjects with significant scoliosis even if surgically corrected
• Subject is currently participating in a clinical investigation that includes an active treatment arm;
• Subject has been implanted with or participated in a trial period for a neurostimulation system;
• Subject has an infusion pump;
• Subject has evidence of an active disruptive psychological or psychiatric disorder as determined as per standard of care;
• Subject has a current diagnosis of a coagulation disorder, bleeding diathesis, progressive peripheral vascular disease or uncontrolled diabetes mellitus;
• Subject has a current diagnosis of a progressive neurological disease as determined by the Investigator;
• Subject is immunocompromised;
• Subject has an existing medical condition that is likely to require repetitive MRI evaluation in the future (i.e. epilepsy, stroke, multiple sclerosis, acoustic neuroma, tumor);
• Subject has history of cancer requiring active treatment in the last 12 months;
• Subject has an existing medical condition that is likely to require the use of diathermy in the future;
• Subject has documented history of allergic response to titanium or silicone;
• Subject has a documented history of substance abuse (narcotics, alcohol, etc.) or substance dependency in the 6 months prior to baseline data collection;
• Female candidates of child bearing potential that are pregnant (confirmed by positive urine/blood pregnancy test).

Sponsors & Collaborators

• Abbott Medical Devices: lead
• St Thomas: collaborator
• Seacroft Hospital: collaborator

Study Sites (2)

Seacroft Hospital

Leeds, Yorkshire and the Humber, LS14 6UH, United Kingdom

Location

St. Thomas Hospital

London, SE1 7EH, United Kingdom

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Yagna Pathak
• Organization: Abbott

yagna.pathak@abbott.com

+1-469-243-0088

Study Officials

• Lalit Venkatesan, Ph.D.

  Abbott Medical Devices

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2016
• First Posted: December 8, 2016
• Study Start: November 1, 2016
• Primary Completion: August 19, 2019
• Study Completion: August 19, 2019
• Last Updated: May 3, 2021
• Results First Posted: May 3, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share

Locations

GB (2)