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

• Sponsor: Abbott Medical Devices (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02986074
• Collaborator: St Thomas (Other), Seacroft Hospital, Leeds (Other)
• Enrollment: 60
• Locations: 2
• Arms: 2
• Actual Duration (Months): 33.5
• Patients Per Site: 30
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• 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: Nov 1, 2016
• Actual Primary Completion Date: Aug 19, 2019
• Actual Study Completion Date: Aug 19, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Visual Analog Scale (VAS) for Back Pain at SCS Trial [after 2 weeks of SCS trial]

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

Secondary Outcome Measures

1. Visual Analog Scale (VAS) for Back Pain at 3 Months [3 months after activation of permanent SCS implant]

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

2. Visual Analog Scale (VAS) for Back Pain at 6 Months [6 months after activation of permanent SCS implant]

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

3. Visual Analog Scale (VAS) for Back Pain at 12 Months [12 months after activation of permanent SCS implant]

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

4. EQ-5D at SCS Trial [after 2 weeks of 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)

5. EQ-5D at 3 Month [3 months after activation of permanent SCS implant]

   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. EQ-5D at 6 Month [6 months after activation of permanent SCS implant]

   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)

7. EQ-5D at 12 Month [12 months after activation of permanent SCS implant]

   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)

8. ODI at SCS Trial [first SCS trial assessment (up to two weeks after electrodes implantation)]

   questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)

9. ODI at 3 Months [3 months after activation of permanent SCS implant]

   questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)

10. ODI at 6 Months [6 months after activation of permanent SCS implant]

    questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)

11. ODI at 12 Months [12 months after activation of permanent SCS implant]

    questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)

12. Satisfaction Questionnaire [3 month follow up]

    questionnaire regarding patient satisfaction with the therapy

13. Satisfaction Questionnaire [6 month follow up]

    questionnaire regarding patient satisfaction with the therapy

14. Satisfaction Questionnaire [12 month follow up]

    questionnaire regarding patient satisfaction with the therapy

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seacroft Hospital	Leeds	Yorkshire And The Humber	United Kingdom	LS14 6UH
2	St. Thomas Hospital	London		United Kingdom	SE1 7EH

Sponsors and Collaborators

• Abbott Medical Devices
• St Thomas
• Seacroft Hospital, Leeds

Investigators

• Study Director: Lalit Venkatesan, Ph.D., Abbott Medical Devices

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 5, 2016

More Information

Publications

None provided.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT02986074
• Other Study ID Numbers: SJM-CIP-10126
• First Posted: Dec 8, 2016
• Last Update Posted: May 3, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Additional relevant MeSH terms: Paresthesia; Chronic Pain

Study Results

Participant Flow

Recruitment Details	60 patients were enrolled and screened for eligibility between October 2016 and June 2018 in hospitals in London and Leeds U.K.
Pre-assignment Detail	55 of 60 subjects were randomized. Of those not randomized 3 did not meet inclusion criteria, 1 withdrew consent and 1 was withdrawn by the investigator because his diabetes become uncontrolled increasing the risk associated with SCS implant

Arm/Group Title	Anatomical Positioning Lead First	Paresthesia Mapping Lead First	Follow up Using Paresthesia Mapping Lead Stimulation	Follow up Using Anatomical Placement Lead Stimulation
Arm/Group Description	subjects in this group will receive stimulation first using an anatomical midline placed lead and subsequently using a paresthesia mapping placed lead 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	subjects in this group will receive stimulation first using a paresthesia mapping placed lead and subsequently using an anatomical midline placed lead 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	Subjects that were successful at SCS trial, expressed preference for stimulation delivered using the lead implanted with the paresthesia mapping approach and received permanent implant, were followed up for 12 months while receiving stimulation delivered using the lead implanted with the paresthesia mapping approach	Subjects that were successful at SCS trial, expressed preference for stimulation delivered using the lead implanted with the anatomical positioning approach and received permanent implant, were followed up for 12 months while receiving stimulation delivered using the lead implanted with the anatomical positioning approach
Period Title: First Trial Period
STARTED	26	29	0	0
COMPLETED	25	29	0	0
NOT COMPLETED	1	0	0	0
Period Title: First Trial Period
STARTED	25	29	0	0
COMPLETED	25	29	0	0
NOT COMPLETED	0	0	0	0
Period Title: First Trial Period
STARTED	0	0	21	22
3 Month Follow up	0	0	21	21
6 Month Follow up	0	0	21	20
COMPLETED	0	0	20	19
NOT COMPLETED	0	0	1	3

Baseline Characteristics

Arm/Group Title	All Subjects
Arm/Group Description	All subjects who were enrolled in the study
Overall Participants	55
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	51 (12.1)
Sex: Female, Male (Count of Participants)
Female	28 50.9%
Male	25 45.5%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
United Kingdom	55 100%

Outcome Measures

1. Primary Outcome

Title	Visual Analog Scale (VAS) for Back Pain at SCS Trial
Description	Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)
Time Frame	after 2 weeks of SCS trial

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Anatomically Positioned Lead	Paresthesia Mapping Lead
Arm/Group Description	Stimulation delivered using the anatomical lead	Stimulation delivered using the paresthesia mapping lead
Measure Participants	54	54
Mean (Standard Deviation) [units on a scale]	32 (25.9)	30.5 (25.4)

2. Secondary Outcome

Title	Visual Analog Scale (VAS) for Back Pain at 3 Months
Description	Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)
Time Frame	3 months after activation of permanent SCS implant

Outcome Measure Data

Analysis Population Description

one in the paresthesia mapping lead group had missing data

Arm/Group Title	Anatomically Positioned Lead	Paresthesia Mapping Lead
Arm/Group Description	Stimulation delivered using the anatomical lead	Stimulation delivered using the paresthesia mapping lead
Measure Participants	21	20
Mean (Standard Deviation) [units on a scale]	28.5 (28.1)	24.6 (19)

3. Secondary Outcome

Title	Visual Analog Scale (VAS) for Back Pain at 6 Months
Description	Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)
Time Frame	6 months after activation of permanent SCS implant

Outcome Measure Data

Analysis Population Description

Two subjects had missing data in the paresthesia mapping lead group, one patient had missing data in the anatomically positioned lead group

Arm/Group Title	Anatomically Positioned Lead	Paresthesia Mapping Lead
Arm/Group Description	Stimulation delivered using the anatomical lead	Stimulation delivered using the paresthesia mapping lead
Measure Participants	19	19
Mean (Standard Deviation) [units on a scale]	24 (24.5)	35.2 (23.7)

4. Secondary Outcome

Title	Visual Analog Scale (VAS) for Back Pain at 12 Months
Description	Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)
Time Frame	12 months after activation of permanent SCS implant

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Anatomically Positioned Lead	Paresthesia Mapping Lead
Arm/Group Description	Stimulation delivered using the anatomical lead	Stimulation delivered using the paresthesia mapping lead
Measure Participants	19	20
Mean (Standard Deviation) [units on a scale]	24 (24.5)	31.8 (26.4)

5. Secondary Outcome

Title	EQ-5D at SCS Trial
Description	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)
Time Frame	after 2 weeks of SCS trial

Outcome Measure Data

Analysis Population Description

Data missing for one patient in the anatomically positioned lead group and one patient for the paresthesia mapping lead group

Arm/Group Title	Anatomically Positioned Lead	Paresthesia Mapping Lead
Arm/Group Description	Stimulation delivered using the anatomical lead	Stimulation delivered using the paresthesia mapping lead
Measure Participants	53	53
Mean (Standard Deviation) [score on a scale]	0.68 (0.17)	0.65 (0.16)

6. Secondary Outcome

Title	EQ-5D at 3 Month
Description	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)
Time Frame	3 months after activation of permanent SCS implant

Outcome Measure Data

Analysis Population Description

Two subjects had missing data in the paresthesia mapping lead group, one patient had missing data in the anatomically positioned lead group

Arm/Group Title	Anatomically Positioned Lead	Paresthesia Mapping Lead
Arm/Group Description	Stimulation delivered using the anatomical lead	Stimulation delivered using the paresthesia mapping lead
Measure Participants	20	19
Mean (Standard Deviation) [score on a scale]	0.73 (0.2)	0.63 (0.22)

7. Secondary Outcome

Title	EQ-5D at 6 Month
Description	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)
Time Frame	6 months after activation of permanent SCS implant

Outcome Measure Data

Analysis Population Description

One patient had missing data in the anatomically positioned lead group

Arm/Group Title	Anatomically Positioned Lead	Paresthesia Mapping Lead
Arm/Group Description	Stimulation delivered using the anatomical lead	Stimulation delivered using the paresthesia mapping lead
Measure Participants	19	21
Mean (Standard Deviation) [score on a scale]	0.62 (0.27)	0.64 (0.22)

8. Secondary Outcome

Title	EQ-5D at 12 Month
Description	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)
Time Frame	12 months after activation of permanent SCS implant

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Anatomically Positioned Lead	Paresthesia Mapping Lead
Arm/Group Description	Stimulation delivered using the anatomical lead	Stimulation delivered using the paresthesia mapping lead
Measure Participants	19	20
Mean (Standard Deviation) [score on a scale]	0.69 (0.22)	0.67 (0.21)

9. Secondary Outcome

Title	ODI at SCS Trial
Description	questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)
Time Frame	first SCS trial assessment (up to two weeks after electrodes implantation)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Anatomically Positioned Lead	Paresthesia Mapping Lead
Arm/Group Description	Stimulation delivered using the anatomical lead	Stimulation delivered using the paresthesia mapping lead
Measure Participants	54	54
Mean (Standard Deviation) [score on a scale]	40.2 (17.1)	41.8 (16.5)

10. Secondary Outcome

Title	ODI at 3 Months
Description	questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)
Time Frame	3 months after activation of permanent SCS implant

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Anatomically Positioned Lead	Paresthesia Mapping Lead
Arm/Group Description	Stimulation delivered using the anatomical lead	Stimulation delivered using the paresthesia mapping lead
Measure Participants	21	21
Mean (Standard Deviation) [score on a scale]	33.8 (22.6)	37.3 (20.5)

11. Secondary Outcome

Title	ODI at 6 Months
Description	questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)
Time Frame	6 months after activation of permanent SCS implant

Outcome Measure Data

Analysis Population Description

One patient had missing data in the anatomically positioned lead group

Arm/Group Title	Anatomically Positioned Lead	Paresthesia Mapping Lead
Arm/Group Description	Stimulation delivered using the anatomical lead	Stimulation delivered using the paresthesia mapping lead
Measure Participants	19	21
Mean (Standard Deviation) [score on a scale]	41.5 (23.5)	36.9 (20.2)

12. Secondary Outcome

Title	ODI at 12 Months
Description	questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)
Time Frame	12 months after activation of permanent SCS implant

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Anatomically Positioned Lead	Paresthesia Mapping Lead
Arm/Group Description	Stimulation delivered using the anatomical lead	Stimulation delivered using the paresthesia mapping lead
Measure Participants	19	20
Mean (Standard Deviation) [score on a scale]	33.9 (21.5)	39.4 (20.8)

13. Secondary Outcome

Title	Satisfaction Questionnaire
Description	questionnaire regarding patient satisfaction with the therapy
Time Frame	3 month follow up

Outcome Measure Data

Analysis Population Description

One patient had missing data in the paresthesia mapping lead group

Arm/Group Title	Anatomically Positioned Lead	Paresthesia Mapping Lead
Arm/Group Description	Stimulation delivered using the anatomical lead	Stimulation delivered using the paresthesia mapping lead
Measure Participants	21	20
very dissatisfied	0 0%	0 NaN
dissatisfied	0 0%	0 NaN
neither satisfied or dissatisfied	4 7.3%	1 NaN
satisfied	8 14.5%	7 NaN
very satisfied	9 16.4%	12 NaN

14. Secondary Outcome

Title	Satisfaction Questionnaire
Description	questionnaire regarding patient satisfaction with the therapy
Time Frame	6 month follow up

Outcome Measure Data

Analysis Population Description

four patients had missing data in the anatomically positioned lead group

Arm/Group Title	Anatomically Positioned Lead	Paresthesia Mapping Lead
Arm/Group Description	Stimulation delivered using the anatomical lead	Stimulation delivered using the paresthesia mapping lead
Measure Participants	17	21
very dissatisfied	1 1.8%	0 NaN
dissatisfied	1 1.8%	2 NaN
neither satisfied nor dissatisfied	4 7.3%	3 NaN
satisfied	4 7.3%	5 NaN
very satisfied	7 12.7%	11 NaN

15. Secondary Outcome

Title	Satisfaction Questionnaire
Description	questionnaire regarding patient satisfaction with the therapy
Time Frame	12 month follow up

Outcome Measure Data

Analysis Population Description

One patient had missing data in the anatomically positioned lead group

Arm/Group Title	Anatomically Positioned Lead	Paresthesia Mapping Lead
Arm/Group Description	Stimulation delivered using the anatomical lead	Stimulation delivered using the paresthesia mapping lead
Measure Participants	18	20
very dissatisfied	0 0%	0 NaN
dissatisfied	1 1.8%	1 NaN
neither satisfied nor dissatisfied	0 0%	2 NaN
satisfied	9 16.4%	4 NaN
very satisfied	8 14.5%	13 NaN

Adverse Events

Time Frame	Through completion of the study, on average about 1 year
Adverse Event Reporting Description	Adverse events in this study were not collected per intervention as there were no primary safety endpoints and no investigational devices used in this study.
Arm/Group Title	Anatomically Positioned Leads and Parasthesia Mapped Leads
Arm/Group Description	All subjects enrolled in the study
All Cause Mortality
	Anatomically Positioned Leads and Parasthesia Mapped Leads
	Affected / at Risk (%)	# Events
Total	0/55 (0%)
Serious Adverse Events
	Anatomically Positioned Leads and Parasthesia Mapped Leads
	Affected / at Risk (%)	# Events
Total	6/55 (10.9%)
Gastrointestinal disorders
abdominal pain due to gall stones	1/55 (1.8%)	1
General disorders
difficulty urination and inability to weight bear on right leg	1/55 (1.8%)	1
right leg numbness	1/55 (1.8%)	1
worsening of pain	1/55 (1.8%)	1
photophobia	1/55 (1.8%)	1
Infections and infestations
system explant due to suspicion of infection	1/55 (1.8%)	1
Surgical and medical procedures
wound exploration	1/55 (1.8%)	1
Other (Not Including Serious) Adverse Events
	Anatomically Positioned Leads and Parasthesia Mapped Leads
	Affected / at Risk (%)	# Events
Total	5/55 (9.1%)
General disorders
IPG pain	3/55 (5.5%)	4
headache	3/55 (5.5%)	3

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.