Neuropathic PainNCT03716973
A Study to Investigate High-density Spinal Cord Stimulation in Virgin-back Patients
A study testing High Density Programming in people with Neuropathic Pain, run by Barts & The London NHS Trust at 1 site in United Kingdom.
Trial summary
This study will look into the effectiveness of spinal cord stimulation (SCS) in reducing chronic neuropathic pain in patients who have not had previous spinal surgery. This will be assessed by comparing the Numerical Rating Scale (NRS) questionnaire responses before and after the SCS intervention. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Neuropathic Pain
- What is being tested?
- High Density Programming
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 May 2017to 9 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Patients with diabetes or any underlying neurological condition.
- Patients known to have a condition that in the investigator's judgement precludes participation in the study.
- Patients who have received an investigational drug or have used an investigational device in the 30 days preceding study entry.
- Patients unable to comply with the study assessments and to complete the questionnaires.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label Pilot Study to Investigate the Response to High Density Stimulation With Medtronic Restore Sensor Technology in Patients With Intractable Neuropathic Pain Who Have Not Had Spinal Surgery
This study will look into the effectiveness of spinal cord stimulation (SCS) in reducing chronic neuropathic pain in patients who have not had previous spinal surgery. This will be assessed by comparing the Numerical Rating Scale (NRS) questionnaire responses before and after the SCS intervention.
We will also investigate the effect of HD frequency parameters on the improvement of quality of life, sleep and any adverse events following the spinal cord stimulation.
Read the detailed description
Traditionally, spinal cord stimulation (SCS) has been used for patients with chronic neuropathic pain following back surgery (a condition known as Failed Back Surgery Syndrome (FBSS)). Although the National Institute for Health and Care Excellence (NICE) also recommends SCS for chronic neuropathic pain without previous back surgery, clinical outcome data is much needed in this patient group. Conventionally, patients receiving SCS are provided with tonic stimulation settings (where they feel tingling and paraesthesia); however newer methods include high-density stimulation (HD) that provides higher energy allowing the voltage to be reduced to subthreshold parameters, hence minimizing the tingling and paraesthesia. HD stimulation is widely offered to patients with SCS as part of routine clinical practice, although no known studies have yet investigated HD settings in patients with neuropathic pain without previous spinal surgery. Therefore, the purpose of this study is to determine the effectiveness of HD settings in patients without previous spinal surgery undergoing SCS. 20 patients without previous spinal surgery who are deemed suitable for SCS as part of NICE guidelines 159 pathway will be recruited for the study.
All patients have a trial of SCS where they will be offered HD settings. If successful (>50% improvement in pain scores) they will be offered permanent implant. Those patients whose pain does not improve with HD settings will be further offered conventional tonic stimulation for one more week. Those patients who do not respond to both tonic and HD settings will be excluded and will not have permanent implant. This will also allow us to investigate the patient's preference between the HD neurostimulator settings and conventional tonic settings. We will also investigate the response to these stimulator settings on health related quality of life. Patients will complete quality of life questionnaires at Baseline, 1-month, 3-months and 12-months post-implant.
- Conditions
- Neuropathic Pain
- Being tested
- High Density Programming
- Keywords
- spinal cord stimulation, paraesthesia-free
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Density ProgrammingDevice
Patients implanted with Medtronic spinal cord stimulator will have high density programming.
| Study group | Role | What they receive |
|---|---|---|
| High density programming | Experimental | High density programming of spinal cord stimulator for paraesthesia-free therapy. Receives: Device: High Density Programming |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Rating Scale (NRS)
Investigate the change in reported pain scores (NRS) following percutaneous spinal cord stimulation (SCS) with Restore Sensor in patients with lumbar radiculopathy who have not undergone any spinal surgery ("virgin back").
Measured: Baseline, 1-month, 3-months, 12months
Secondary outcomes (3)
Oswestry Disability Index (ODI)
low back functional outcome tool
Measured: Baseline, 1-month, 3-months, 12months
Patient's Global Impression of change (PGIC)
A standard seven point scale would be used to assess the SCS outcome.
Measured: Baseline, 1-month, 3-months, 12months
Pain and Sleep Questionnaire _3 (PSQ_3)
A three-item index for the assessment of the impact of pain on sleep.
Measured: Baseline, 1-month, 3-months, 12months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2018
- Study start9 May 2017
- Primary completion9 Sep 2020
- Study completion9 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Open label pilot study
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barts & The London NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- Vivek Mehta, MD, Principal investigator, Barts & The London NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03716973
- Sponsor's protocol ID
- 011454
- Status last verified
- Nov 2024
- First submitted
- 18 Oct 2018
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Pilot Study to Investigate the Response to High Density Stimulation With Medtronic Restore Sensor Technology in Patients With Intractable Neuropathic Pain Who Have Not Had Spinal Surgery
- ClinicalTrials.gov ID
- NCT03716973
- Acronym / sponsor ID
- 011454
- Conditions
- Neuropathic Pain
- Keywords
- spinal cord stimulation, paraesthesia-free
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Barts & The London NHS TrustUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 9 May 2017 (actual)
- Primary completion
- 9 Sep 2020 (actual)
- Study completion
- 9 Sep 2020 (actual)
- First posted
- 23 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will look into the effectiveness of spinal cord stimulation (SCS) in reducing chronic neuropathic pain in patients who have not had previous spinal surgery. This will be assessed by comparing the Numerical Rating Scale (NRS) questionnaire responses before and after the SCS intervention.
We will also investigate the effect of HD frequency parameters on the improvement of quality of life, sleep and any adverse events following the spinal cord stimulation.
Detailed description
Traditionally, spinal cord stimulation (SCS) has been used for patients with chronic neuropathic pain following back surgery (a condition known as Failed Back Surgery Syndrome (FBSS)). Although the National Institute for Health and Care Excellence (NICE) also recommends SCS for chronic neuropathic pain without previous back surgery, clinical outcome data is much needed in this patient group. Conventionally, patients receiving SCS are provided with tonic stimulation settings (where they feel tingling and paraesthesia); however newer methods include high-density stimulation (HD) that provides higher energy allowing the voltage to be reduced to subthreshold parameters, hence minimizing the tingling and paraesthesia. HD stimulation is widely offered to patients with SCS as part of routine clinical practice, although no known studies have yet investigated HD settings in patients with neuropathic pain without previous spinal surgery. Therefore, the purpose of this study is to determine the effectiveness of HD settings in patients without previous spinal surgery undergoing SCS. 20 patients without previous spinal surgery who are deemed suitable for SCS as part of NICE guidelines 159 pathway will be recruited for the study.
All patients have a trial of SCS where they will be offered HD settings. If successful (>50% improvement in pain scores) they will be offered permanent implant. Those patients whose pain does not improve with HD settings will be further offered conventional tonic stimulation for one more week. Those patients who do not respond to both tonic and HD settings will be excluded and will not have permanent implant. This will also allow us to investigate the patient's preference between the HD neurostimulator settings and conventional tonic settings. We will also investigate the response to these stimulator settings on health related quality of life. Patients will complete quality of life questionnaires at Baseline, 1-month, 3-months and 12-months post-implant.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label pilot study
| Arm | Type | Receives |
|---|---|---|
| High density programming | Experimental | Device: High Density ProgrammingHigh density programming of spinal cord stimulator for paraesthesia-free therapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- Patients with diabetes or any underlying neurological condition.
- Patients known to have a condition that in the investigator's judgement precludes participation in the study.
- Patients who have received an investigational drug or have used an investigational device in the 30 days preceding study entry.
- Patients unable to comply with the study assessments and to complete the questionnaires.
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 |
|---|---|---|
| High Density ProgrammingPatients implanted with Medtronic spinal cord stimulator will have high density programming. | Device | High density programming |
Primary outcome
Numerical Rating Scale (NRS)
Time frame: Baseline, 1-month, 3-months, 12months
Investigate the change in reported pain scores (NRS) following percutaneous spinal cord stimulation (SCS) with Restore Sensor in patients with lumbar radiculopathy who have not undergone any spinal surgery ("virgin back").
3 secondary outcomes
Oswestry Disability Index (ODI)
Time frame: Baseline, 1-month, 3-months, 12months
Patient's Global Impression of change (PGIC)
Time frame: Baseline, 1-month, 3-months, 12months
Pain and Sleep Questionnaire _3 (PSQ_3)
Time frame: Baseline, 1-month, 3-months, 12months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
- Individual participant dataSharing planned: No
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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.
Vivek Mehta, MD principal investigator
Barts & The London NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Density Programming in people with Neuropathic Pain, run by Barts & The London NHS Trust at 1 site 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 0 inclusion and 4 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 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Numerical Rating Scale (NRS) (time frame: Baseline, 1-month, 3-months, 12months). 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 5 Nov 2024.