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Trial record 2 of 654 for:    Paresthesia

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

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ClinicalTrials.gov Identifier: NCT02986074
Recruitment Status : Active, not recruiting
First Posted : December 8, 2016
Last Update Posted : June 20, 2018
Sponsor:
Collaborators:
St Thomas
Seacroft Hospital, Leeds
Information provided by (Responsible Party):
St. Jude Medical

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.

Condition or disease Intervention/treatment Phase
Chronic Pain Device: Paresthesia mapping lead evaluation first Device: Anatomical midline lead evaluation first Not Applicable

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  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: CompaRison of Paresthesia Mapping to anatomIc Midline-based burSt Programming Strategies
Actual Study Start Date : November 2016
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

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
Device: 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

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
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




Primary Outcome Measures :
  1. Change in relief of pain as measured using Visual Analog Scale (VAS) for pain between the first and second SCS trial assessments [ Time Frame: first SCS trial assessment (up to two weeks after electrodes implantation) and second SCS trial assessment (up to two weeks after the first trial assessment) ]
    Subjective evaluation of pain levels routinely used in clinical practice


Secondary Outcome Measures :
  1. Change from baseline in Visual Analog Scale (VAS) for pain at 3 months [ Time Frame: 3 months after activation of permanent SCS implant ]
    Subjective evaluation of pain levels routinely used in clinical practice

  2. Change from baseline in Visual Analog Scale (VAS) for pain at 6 months [ Time Frame: 6 months after activation of permanent SCS implant ]
    Subjective evaluation of pain levels routinely used in clinical practice

  3. Change from baseline in Visual Analog Scale (VAS) for pain at 12 months [ Time Frame: 12 months after activation of permanent SCS implant ]
    Subjective evaluation of pain levels routinely used in clinical practice

  4. Change from baseline in EQ-5D at SCS trial assessment 1 [ Time Frame: first SCS trial assessment (up to two weeks after electrodes implantation) ]
    questionnaire regarding quality of life

  5. Change from baseline in EQ-5D at SCS trial assessment 2 [ Time Frame: second SCS trial assessment (up to two weeks after first SCS trial assessment) ]
    questionnaire regarding quality of life

  6. Change from baseline in EQ-5D at 3 month [ Time Frame: 3 months after activation of permanent SCS implant ]
    questionnaire regarding quality of life

  7. Change from baseline in EQ-5D at 6 month [ Time Frame: 6 months after activation of permanent SCS implant ]
    questionnaire regarding quality of life

  8. Change from baseline in EQ-5D at 12 month [ Time Frame: 12 months after activation of permanent SCS implant ]
    questionnaire regarding quality of life

  9. Change from baseline in ODI at SCS trial assessment 1 [ Time Frame: first SCS trial assessment (up to two weeks after electrodes implantation) ]
    questionnaire regarding disability level

  10. Change from baseline in ODI at SCS trial assessment 2 [ Time Frame: second SCS trial assessment (up to two weeks after first SCS trial assessment) ]
    questionnaire regarding disability level

  11. Change from baseline in ODI at SCS 3 months [ Time Frame: 3 months after activation of permanent SCS implant ]
    questionnaire regarding disability level

  12. Change from baseline in ODI at SCS 6 months [ Time Frame: 6 months after activation of permanent SCS implant ]
    questionnaire regarding disability level

  13. Change from baseline in ODI at SCS 12 months [ Time Frame: 12 months after activation of permanent SCS implant ]
    questionnaire regarding disability level

  14. Satisfaction [ Time Frame: 3 month follow up ]
    questionnaire regarding patient satisfaction with the therapy

  15. Satisfaction [ Time Frame: 6 month follow up ]
    questionnaire regarding patient satisfaction with the therapy

  16. Satisfaction [ Time Frame: 12 month follow up ]
    questionnaire regarding patient satisfaction with the therapy



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02986074


Locations
United Kingdom
Seacroft Hospital
Leeds, Yorkshire And The Humber, United Kingdom, LS14 6UH
St. Thomas Hospital
London, United Kingdom, SE1 7EH
Sponsors and Collaborators
St. Jude Medical
St Thomas
Seacroft Hospital, Leeds
Investigators
Study Director: Lalit Venkatesan, Ph.D. St. Jude Medical

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT02986074     History of Changes
Other Study ID Numbers: SJM-CIP-10126
First Posted: December 8, 2016    Key Record Dates
Last Update Posted: June 20, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Additional relevant MeSH terms:
Chronic Pain
Paresthesia
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Somatosensory Disorders
Sensation Disorders