Chronic PainCRISPNCT02986074
CompaRison of Paresthesia Mapping to anatomIc Midline-based burSt Programming Strategies
A study testing Paresthesia mapping lead evaluation first and Anatomical midline lead evaluation first in people with Chronic Pain, run by Abbott Medical Devices at 2 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Paresthesia mapping lead evaluation first and Anatomical midline lead evaluation first
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Nov 2016to 19 Aug 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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
Who cannot join
- 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;
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- 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).
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Seacroft Hospital
Leeds, Yorkshire and the Humber, LS14 6UH
St. Thomas Hospital
London, SE1 7EH
About this study
The study will compare therapeutic efficacy of a novel spinal cord stimulation leads implant based on anatomical landmarks with standard surgical implantation technique.
Read the 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.
- Conditions
- Chronic Pain
- Being tested
- Paresthesia mapping lead evaluation first, Anatomical midline lead evaluation first
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paresthesia mapping lead evaluation firstDevice
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 firstDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: Paresthesia mapping lead evaluation first |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: after 2 weeks of SCS trial
Secondary outcomes (14)
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)
Measured: 3 months after activation of permanent SCS implant
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)
Measured: 6 months after activation of permanent SCS implant
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)
Measured: 12 months after activation of permanent SCS implant
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)
Measured: after 2 weeks of SCS trial
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)
Measured: 3 months after activation of permanent SCS implant
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)
Measured: 6 months after activation of permanent SCS implant
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)
Measured: 12 months after activation of permanent SCS implant
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)
Measured: first SCS trial assessment (up to two weeks after electrodes implantation)
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)
Measured: 3 months after activation of permanent SCS implant
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)
Measured: 6 months after activation of permanent SCS implant
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)
Measured: 12 months after activation of permanent SCS implant
Satisfaction Questionnaire
questionnaire regarding patient satisfaction with the therapy
Measured: 3 month follow up
Satisfaction Questionnaire
questionnaire regarding patient satisfaction with the therapy
Measured: 6 month follow up
Satisfaction Questionnaire
questionnaire regarding patient satisfaction with the therapy
Measured: 12 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2016 (estimated)
- Study startNov 2016
- Primary completion19 Aug 2019
- Study completion19 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust, Seacroft Hospital
- Responsible party
- Sponsor
- Investigators
- Lalit Venkatesan, Ph.D., Study director, Abbott Medical Devices
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02986074
- Sponsor's protocol ID
- SJM-CIP-10126
- Acronym
- CRISP
- Status last verified
- May 2026
- First submitted
- 2 Dec 2016
- Last updated
- 22 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CompaRison of Paresthesia Mapping to anatomIc Midline-based burSt Programming Strategies
- ClinicalTrials.gov ID
- NCT02986074
- Acronym / sponsor ID
- CRISP / SJM-CIP-10126
- Conditions
- Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust, Seacroft Hospital
- Study start
- Nov 2016 (actual)
- Primary completion
- 19 Aug 2019 (actual)
- Study completion
- 19 Aug 2019 (actual)
- First posted
- 8 Dec 2016 (estimated)
- Results
- Posted 3 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will compare therapeutic efficacy of a novel spinal cord stimulation leads implant based on anatomical landmarks with standard surgical implantation technique.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anatomical midline lead first | Experimental | Device: Anatomical midline lead evaluation firstsubjects in this group will receive stimulation first using an anatomical midline placed lead and subsequently using a paresthesia mapping placed lead |
| Paresthesia mapping lead first | Experimental | Device: Paresthesia mapping lead evaluation firstsubjects in this group will receive stimulation first using a paresthesia mapping placed lead and subsequently using an anatomical midline placed lead |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paresthesia mapping lead evaluation firstSubjects 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 | Device | Paresthesia mapping lead first |
| Anatomical midline lead evaluation firstSubjects 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 | Device | Anatomical midline lead first |
Primary outcome
Visual Analog Scale (VAS) for Back Pain at SCS Trial
Time frame: after 2 weeks of SCS trial
Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)
14 secondary outcomes
Visual Analog Scale (VAS) for Back Pain at 3 Months
Time frame: 3 months after activation of permanent SCS implant
Visual Analog Scale (VAS) for Back Pain at 6 Months
Time frame: 6 months after activation of permanent SCS implant
Visual Analog Scale (VAS) for Back Pain at 12 Months
Time frame: 12 months after activation of permanent SCS implant
EQ-5D at SCS Trial
Time frame: after 2 weeks of SCS trial
EQ-5D at 3 Month
Time frame: 3 months after activation of permanent SCS implant
EQ-5D at 6 Month
Time frame: 6 months after activation of permanent SCS implant
EQ-5D at 12 Month
Time frame: 12 months after activation of permanent SCS implant
ODI at SCS Trial
Time frame: first SCS trial assessment (up to two weeks after electrodes implantation)
ODI at 3 Months
Time frame: 3 months after activation of permanent SCS implant
ODI at 6 Months
Time frame: 6 months after activation of permanent SCS implant
ODI at 12 Months
Time frame: 12 months after activation of permanent SCS implant
Satisfaction Questionnaire
Time frame: 3 month follow up
Satisfaction Questionnaire
Time frame: 6 month follow up
Satisfaction Questionnaire
Time frame: 12 month follow up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lalit Venkatesan, Ph.D. study director
Abbott Medical Devices
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paresthesia mapping lead evaluation first and Anatomical midline lead evaluation first in people with Chronic Pain, run by Abbott Medical Devices at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) for Back Pain at SCS Trial (time frame: after 2 weeks of SCS trial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.