Neck PainNU-BURSTNCT03159169
Treatment of Neck and Upper Limb Pain Using BurstDR (De Ridder) Stimulation
A study testing Spinal Cord Stimulation (SCS) in people with Neck Pain and Upper Limb Pain, run by Abbott Medical Devices at 3 sites in United Kingdom.
Trial summary
This is a prospective, open label, multicenter feasibility study to evaluate the safety and therapeutic efficacy of BurstDRTM SCS in treating chronic neck pain with or without radiation down to arm/shoulder/upper back Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neck Pain, Upper Limb Pain
- What is being tested?
- Spinal Cord Stimulation (SCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 15 May 2018to 31 Aug 2022
- 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 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 which may include pharmacological treatment, physical therapy, and injections;
- Subject has failed to respond to medial branch blocks;
- Subject diagnosed with chronic predominant intractable neck pain with or without radiation down to arm/shoulder/upper back;
- Subject has neck pain intensity of at least 6.0 cm out of 10.0 cm on the average neck pain VAS at baseline (according to the last 3 days of the baseline pain diary);
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- Subject is on stable pain medications with a total opioid equivalent of120 mg or less for at least 28 days prior to enrolling in this study, and is willing to stay on those medications with no dose increase 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
Who cannot join
- Subject has a current diagnosis of a coagulation disorder, bleeding diathesis, progressive peripheral vascular disease, moderate or severe cervical stenosis determined by existing or new MRI scan performed as part of standard of care, mechanical neck pain originating from cervical facet joint syndrome, post-herpetic neuralgia, spondylolisthesis, retrolisthesis, CRPS (Chronic Regional Pain Syndrome) or uncontrolled diabetes mellitus;
- Subject 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;
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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;
- Subject is a female candidates of child bearing potential that are pregnant (confirmed by positive urine/blood pregnancy test);
- Subject has life expectancy of less than 1 year;
- Subject is involved in an injury claim under current litigation
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Southmead hospital
Bristol
Guy's St. Thomas Hospital
London
University Hospital Southampton NHS Foundation Trust
Southampton
About this study
Official title: Treatment of Neck and Upper (NU) Limb Pain Using BurstDR Stimulation
This is a prospective, open label, multicenter feasibility study to evaluate the safety and therapeutic efficacy of BurstDRTM SCS in treating chronic neck pain with or without radiation down to arm/shoulder/upper back
Read the detailed description
Subjects diagnosed with chronic intractable neck pain with or without radiation down to arm/shoulder/upper back will be considered for inclusion in this study. After baseline evaluation, subjects will undergo a SCS trial using the Abbott Invisible Trial system. At the end of the SCS trial, subjects experiencing at least 50% pain relief, according to average neck VAS (calculated by the average of last 3 days on the pain diary), will be considered for permanent implant and further participation in the study. Pain intensity, quality of life, disability, headache severity, sleep quality, patient satisfaction, anxiety, depression, stimulation sensation and medication usage assessments will be performed at baseline, after SCS trial and at the 3, 6 and 12 month follow up visits.
- Conditions
- Neck Pain, Upper Limb Pain
- Being tested
- Spinal Cord Stimulation (SCS)
- Keywords
- Neck Pain, Upper Limb Pain
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal Cord Stimulation (SCS)Device
Implantation of SCS electrodes and stimulator according to clinical standards
| Study group | Role | What they receive |
|---|---|---|
| study patients | Experimental | Single arm study. Patients will receive Spinal Cord Stimulation (SCS) according to standard clinical procedures. Receives: Device: Spinal Cord Stimulation (SCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the change in pain intensity between baseline, trial and long-term follow up evaluations using Visual Analog Scale (VAS) assessments.
Golden standard self-evaluation of pain intensity
Measured: 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2017
- Study start15 May 2018
- Primary completion30 Apr 2022
- Study completion31 Aug 2022
Why it stopped: The study was discontinued early due to poor recruitment (low enrollment rate)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neck 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Adnan Al-Kaisy, MD, Principal investigator, Guy's St. Thomas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03159169
- Sponsor's protocol ID
- SJM-CIP-10194
- Acronym
- NU-BURST
- Status last verified
- Sep 2024
- First submitted
- 11 May 2017
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Al-Kaisy A, Vajramani G, Love-Jones S, Patel NK, Royds J, Palmisani S, Pang D, Wesley S, Park HJ, Raza A, Agnesi F. Multicentre, clinical trial of burst spinal cord stimulation for neck and upper limb pain NU-BURST: a trial protocol. Neurol Sci. 2021 Aug;42(8):3285-3296. doi: 10.1007/s10072-020-04907-3. Epub 2021 Jan 2.
PubMed 33387056
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Neck and Upper (NU) Limb Pain Using BurstDR Stimulation
- ClinicalTrials.gov ID
- NCT03159169
- Acronym / sponsor ID
- NU-BURST / SJM-CIP-10194
- Conditions
- Neck Pain, Upper Limb Pain
- Keywords
- Neck Pain, Upper Limb Pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was discontinued early due to poor recruitment (low enrollment rate)
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 15 May 2018 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 18 May 2017 (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 is a prospective, open label, multicenter feasibility study to evaluate the safety and therapeutic efficacy of BurstDRTM SCS in treating chronic neck pain with or without radiation down to arm/shoulder/upper back
Detailed description
Subjects diagnosed with chronic intractable neck pain with or without radiation down to arm/shoulder/upper back will be considered for inclusion in this study. After baseline evaluation, subjects will undergo a SCS trial using the Abbott Invisible Trial system. At the end of the SCS trial, subjects experiencing at least 50% pain relief, according to average neck VAS (calculated by the average of last 3 days on the pain diary), will be considered for permanent implant and further participation in the study. Pain intensity, quality of life, disability, headache severity, sleep quality, patient satisfaction, anxiety, depression, stimulation sensation and medication usage assessments will be performed at baseline, after SCS trial and at the 3, 6 and 12 month follow up visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study patients | Experimental | Device: Spinal Cord Stimulation (SCS)Single arm study. Patients will receive Spinal Cord Stimulation (SCS) according to standard clinical procedures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 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 which may include pharmacological treatment, physical therapy, and injections;
- Subject has failed to respond to medial branch blocks;
- Subject diagnosed with chronic predominant intractable neck pain with or without radiation down to arm/shoulder/upper back;
Key exclusion criteria (16 listed)
- Subject has a current diagnosis of a coagulation disorder, bleeding diathesis, progressive peripheral vascular disease, moderate or severe cervical stenosis determined by existing or new MRI scan performed as part of standard of care, mechanical neck pain originating from cervical facet joint syndrome, post-herpetic neuralgia, spondylolisthesis, retrolisthesis, CRPS (Chronic Regional Pain Syndrome) or uncontrolled diabetes mellitus;
- Subject 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;
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 |
|---|---|---|
| Spinal Cord Stimulation (SCS)Implantation of SCS electrodes and stimulator according to clinical standards | Device | study patients |
Primary outcome
Evaluate the change in pain intensity between baseline, trial and long-term follow up evaluations using Visual Analog Scale (VAS) assessments.
Time frame: 3, 6 and 12 months
Golden standard self-evaluation of pain intensity
Results and safety
The study was stopped early (reason given: The study was discontinued early due to poor recruitment (low enrollment rate)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
- Derived from this study: PubMed 33387056Al-Kaisy A, Vajramani G, Love-Jones S, Patel NK, Royds J, Palmisani S, Pang D, Wesley S, Park HJ, Raza A, Agnesi F. Multicentre, clinical trial of burst spinal cord stimulation for neck and upper limb pain NU-BURST: a trial protocol. Neurol Sci. 2021 Aug;42(8):3285-3296. doi: 10.1007/s10072-020-04907-3. Epub 2021 Jan 2.
- 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.
Adnan Al-Kaisy, MD principal investigator
Guy's St. Thomas
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal Cord Stimulation (SCS) in people with Neck Pain and Upper Limb Pain, run by Abbott Medical Devices at 3 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 10 inclusion and 16 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: stopped early, as of the sponsor's last update on 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
The study was stopped early (reason given: The study was discontinued early due to poor recruitment (low enrollment rate)). Results are not available in the source record.
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?
Evaluate the change in pain intensity between baseline, trial and long-term follow up evaluations using Visual Analog Scale (VAS) assessments. (time frame: 3, 6 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03159169, which also lists 1 linked publication.
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 23 Sep 2024.