- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02986074
CompaRison of Paresthesia Mapping to anatomIc Midline-based burSt Programming Strategies (CRISP)
April 6, 2021 updated by: Abbott Medical Devices
The study will compare therapeutic efficacy of a novel spinal cord stimulation leads implant based on anatomical landmarks with standard surgical implantation technique.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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London, United Kingdom, SE1 7EH
- St. Thomas Hospital
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Yorkshire And The Humber
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Leeds, Yorkshire And The Humber, United Kingdom, LS14 6UH
- Seacroft Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Anatomical midline lead first
subjects in this group will receive stimulation first using an anatomical midline placed lead and subsequently using a paresthesia mapping placed lead
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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
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EXPERIMENTAL: Paresthesia mapping lead first
subjects in this group will receive stimulation first using a paresthesia mapping placed lead and subsequently using an anatomical midline placed lead
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analog Scale (VAS) for Back Pain at SCS Trial
Time Frame: after 2 weeks of SCS trial
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Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)
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after 2 weeks of SCS trial
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analog Scale (VAS) for Back Pain at 3 Months
Time Frame: 3 months after activation of permanent SCS implant
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Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)
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3 months after activation of permanent SCS implant
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Visual Analog Scale (VAS) for Back Pain at 6 Months
Time Frame: 6 months after activation of permanent SCS implant
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Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)
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6 months after activation of permanent SCS implant
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Visual Analog Scale (VAS) for Back Pain at 12 Months
Time Frame: 12 months after activation of permanent SCS implant
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Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)
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12 months after activation of permanent SCS implant
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EQ-5D at SCS Trial
Time Frame: after 2 weeks of SCS trial
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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)
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after 2 weeks of SCS trial
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EQ-5D at 3 Month
Time Frame: 3 months after activation of permanent SCS implant
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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)
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3 months after activation of permanent SCS implant
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EQ-5D at 6 Month
Time Frame: 6 months after activation of permanent SCS implant
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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)
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6 months after activation of permanent SCS implant
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EQ-5D at 12 Month
Time Frame: 12 months after activation of permanent SCS implant
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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)
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12 months after activation of permanent SCS implant
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ODI at SCS Trial
Time Frame: first SCS trial assessment (up to two weeks after electrodes implantation)
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questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)
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first SCS trial assessment (up to two weeks after electrodes implantation)
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ODI at 3 Months
Time Frame: 3 months after activation of permanent SCS implant
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questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)
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3 months after activation of permanent SCS implant
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ODI at 6 Months
Time Frame: 6 months after activation of permanent SCS implant
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questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)
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6 months after activation of permanent SCS implant
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ODI at 12 Months
Time Frame: 12 months after activation of permanent SCS implant
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questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)
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12 months after activation of permanent SCS implant
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Satisfaction Questionnaire
Time Frame: 3 month follow up
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questionnaire regarding patient satisfaction with the therapy
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3 month follow up
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Satisfaction Questionnaire
Time Frame: 6 month follow up
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questionnaire regarding patient satisfaction with the therapy
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6 month follow up
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Satisfaction Questionnaire
Time Frame: 12 month follow up
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questionnaire regarding patient satisfaction with the therapy
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12 month follow up
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
November 1, 2016
Primary Completion (ACTUAL)
August 19, 2019
Study Completion (ACTUAL)
August 19, 2019
Study Registration Dates
First Submitted
December 2, 2016
First Submitted That Met QC Criteria
December 5, 2016
First Posted (ESTIMATE)
December 8, 2016
Study Record Updates
Last Update Posted (ACTUAL)
May 3, 2021
Last Update Submitted That Met QC Criteria
April 6, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SJM-CIP-10126
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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