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

Chronic Pain Clinical Trial

— CRISP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02986074
• Other study ID #: SJM-CIP-10126
• Status: Completed
• Phase: N/A
• Start date: November 2016
• Est. completion date: August 19, 2019

Study information

• Verified date: April 2021
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

The primary purpose of this study is to compare the therapeutic efficacy of the conventional, paresthesia mapping-based burst spinal cord stimulation (SCS) implantation strategy to a more novel, anatomic midline-based approach that has the potential to streamline the workflow associated with the SCS treatment continuum.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 19, 2019
• Est. primary completion date: August 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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).

Related Conditions & MeSH terms

• Chronic Pain
• Paresthesia

Intervention

Device:
• Paresthesia mapping lead evaluation first
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
• Anatomical midline lead evaluation first
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

Locations

Country	Name	City	State
United Kingdom	Seacroft Hospital	Leeds	Yorkshire And The Humber
United Kingdom	St. Thomas Hospital	London

Sponsors (3)

Lead Sponsor	Collaborator
Abbott Medical Devices	Seacroft Hospital, Leeds, St Thomas

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Visual Analog Scale (VAS) for Back Pain at 3 Months	Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)	3 months after activation of permanent SCS implant
Secondary	Visual Analog Scale (VAS) for Back Pain at 6 Months	Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)	6 months after activation of permanent SCS implant
Secondary	Visual Analog Scale (VAS) for Back Pain at 12 Months	Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)	12 months after activation of permanent SCS implant
Secondary	EQ-5D at SCS Trial	Questionnaire on quality of life using european quality of life - 5 dimension questionnaire (EQ-5D) - (Scale is between 0 and 1 with 0 being worse quality of life and 1 best quality of life)	after 2 weeks of SCS trial
Secondary	EQ-5D at 3 Month	Questionnaire on quality of life using european quality of life - 5 dimension questionnaire (EQ-5D) - (Scale is between 0 and 1 with 0 being worse quality of life and 1 best quality of life)	3 months after activation of permanent SCS implant
Secondary	EQ-5D at 6 Month	Questionnaire on quality of life using european quality of life - 5 dimension questionnaire (EQ-5D) - (Scale is between 0 and 1 with 0 being worse quality of life and 1 best quality of life)	6 months after activation of permanent SCS implant
Secondary	EQ-5D at 12 Month	Questionnaire on quality of life using european quality of life - 5 dimension questionnaire (EQ-5D) - (Scale is between 0 and 1 with 0 being worse quality of life and 1 best quality of life)	12 months after activation of permanent SCS implant
Secondary	ODI at SCS Trial	questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)	first SCS trial assessment (up to two weeks after electrodes implantation)
Secondary	ODI at 3 Months	questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)	3 months after activation of permanent SCS implant
Secondary	ODI at 6 Months	questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)	6 months after activation of permanent SCS implant
Secondary	ODI at 12 Months	questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)	12 months after activation of permanent SCS implant
Secondary	Satisfaction Questionnaire	questionnaire regarding patient satisfaction with the therapy	3 month follow up
Secondary	Satisfaction Questionnaire	questionnaire regarding patient satisfaction with the therapy	6 month follow up
Secondary	Satisfaction Questionnaire	questionnaire regarding patient satisfaction with the therapy	12 month follow up