Peripheral Neuropathic PainNCT03733886
Burst Spinal Cord Stimulation for Neuropathic Pain.
A study testing Burst SCS (Abbott Proclaim IPG and single lead Abbott Octrode at level Th9/10) in people with Peripheral Neuropathic Pain and Radiculopathy, run by Oslo University Hospital at 2 sites in 2 countries.
Trial summary
This study will evaluate the effect of Burst spinal cord stimulation (SCS) in the treatment of painful radiculopathy in lower extremity(ies) with or without lower back pain. It is a multicenter double-blinded "n-of-1" RCT with repeated two-week periods of Burst SCS or sham in randomised order. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Peripheral Neuropathic Pain, Radiculopathy, Lower Back Pain
- What is being tested?
- Burst SCS (Abbott Proclaim IPG and single lead Abbott Octrode at level Th9/10)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 9 Sep 2019to 22 Jun 2023
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History, symptoms and clinical findings consistent with painful radiculopathy in lower extremity(ies) ("probable" or "definite") for at least 3 months, with or without lower back pain. The pain in the extremity(ies) must dominate.
- Understand Norwegian or Swedish language (written and spoken).
- Usual pain intensity ≥ 3.5 / 10 (NRS 0-10)
Who cannot join
- Absolute
- Opioid dose > 100 mg morphine equivalents / day
- Ongoing litigation
- Mental / psychiatric disorder that may affect treatment
- Chronic generalized pain
- Pregnancy
Show all 12Show fewer
- Hypersensitivity to local anesthetics
- Serious or unclear medical condition such as angina pectoris, severe vascular disorder, infection, malignancy disease, bleeding disorders
- Laminectomy in or above level for planned epidural access
- Spine surgery the last 3 months
- Relative
- Ongoing medication that affects coagulation or platelet function
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Norway1 site
Oslo University Hospital, Department of Pain Management and Research
Oslo
Sweden1 site
Uppsala University Hospital, Multidisciplinary Pain Center
Uppsala
About this study
Official title: A Randomised Sham-controlled Double-blinded Study of Burst Spinal Cord Stimulation for Chronic Peripheral Neuropathic Pain.
This study will evaluate the effect of Burst spinal cord stimulation (SCS) in the treatment of painful radiculopathy in lower extremity(ies) with or without lower back pain. It is a multicenter double-blinded "n-of-1" RCT with repeated two-week periods of Burst SCS or sham in randomised order.
Read the detailed description
SCS is a treatment offered to patients with peripheral neuropathic pain, and involves electrical stimulation of the spinal cord. The analgesic effect is possibly mediated via both spinal and supra-spinal mechanisms.
Traditional "tonic" SCS causes paresthesia during treatment, but the newer burst technique (five electrical pulses at 500Hz delivered in intermittent packets of 40 Hz) can be performed below detection level. Thus, it is possible to do double-blinded sham-controlled studies.
In this study, we will study the effect of burst SCS compared with sham on pain intensity and function (Patient-Specific Functional Scale). In addition, we will use several questionnaires (psychometric data, health-related quality of life, sleep, global impression of change, use of analgesics, blinding).
- Conditions
- Peripheral Neuropathic Pain, Radiculopathy, Lower Back Pain
- Being tested
- Burst SCS (Abbott Proclaim IPG and single lead Abbott Octrode at level Th9/10)
- Medical subject headings
- Radiculopathy, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Burst SCS (Abbott Proclaim IPG and single lead Abbott Octrode at level Th9/10)Device
Burst SCS implies high frequency SCS treatment in intermittent packets with stimulation below detection level. Abbott BurstDR at default setting: Pulse width 1000 microseconds, frequency 500 Hz/40 Hz, continuous stimulation (no cycling). Pulse amplitude at maximum 60% of sensory threshold
| Study group | Role | What they receive |
|---|---|---|
| Burst SCS | Active comparator | In the active comparator the burst SCS system will be turned on according to randomisation.
A treatment period is a 2-week period where the patient receives either active treatment or sham. Each patient will go through 6 treatment periods (in total 12 weeks). A treatment cycle is a 4-week period with two treatment periods, one of active treatment and one of sham. Each patient will go through three treatment cycles. Receives: Device: Burst SCS (Abbott Proclaim IPG and single lead Abbott Octrode at level Th9/10) |
| Sham | Sham comparator | In the sham comparator the burst SCS system will be turned off according to randomisation. Receives: Device: Burst SCS (Abbott Proclaim IPG and single lead Abbott Octrode at level Th9/10) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usual pain intensity in lower extremity(ies)
Numeric rating scale (0-10); usual pain intensity over the last 24 h (day 7-13) with anchor points 0 = No pain and 10 = Worst imaginable pain.
Measured: Will be measured at day 7 to day 13 in each period (to avoid carry-over effects from previous treatment period)
Secondary outcomes (12)
Highest pain intensity in lower extremity(ies)
Numeric rating scale (0-10); highest pain intensity over the last 24 h (day 7-13) with anchor points 0 = No pain and 10 = Worst imaginable pain
Measured: Will be measured at day 7 to day 13 in each period (to avoid carry-over effects from previous treatment period)
Lowest pain intensity in lower extremity(ies)
Numeric rating scale (0-10); lowest pain intensity over the last 24 h (day 7-13) with anchor points 0 = No pain and 10 = Worst imaginable pain
Measured: Time Frame: Will be measured at day 7 to day 13 in each period (to avoid carry-over effects from previous treatment period)
Pain intensity in lower extremity(ies)"now"
Numeric rating scale (0-10); evening pain intensity (day 7-13), with anchor points 0 = No pain and 10 = Worst imaginable pain
Measured: Time Frame: Will be measured at day 7 to day 13 in each period (to avoid carry-over effects from previous treatment period)
Pain unpleasantness
Numeric rating scale (0-10) of pain unpleasantness the last 24 hours, with anchor points 0 = no unpleasantness to 10 = worst imaginable unpleasantness.
Measured: Time Frame: Will be measured at day 7 to day 13 in each period (to avoid carry-over effects from previous treatment period)
Three individually chosen functions that are inhibited by the pain
The Patient-Specific Functional Scale (Numeric Rating Scale (0-10)) (day 7-13). Anchor points 0 = Unable to perform activity to 10 = Able to perform activity.
Measured: Time Frame: Will be measured at day 7 to day 13 in each 14-day treatment period (to avoid carry-over effects from previous treatment period)
Insomnia
Insomnia Severity Index questionnaire. (Likert scale: 0= no problem, 4 = very severe problem, total score up to 28. Total score (continuous variable)
Measured: Time Frame: Will be measured at the end of each 14-day treatment period
EQ-5D index values
EQ5D index values according to the EQ-5D UK Time Trade-off (TTO) value set.
Measured: Time Frame: Will be measured at the end of each 14-day treatment period
EQ-5D self-rated health
VAS 0-100 scale.
Measured: Time Frame: Will be measured at the end of each 14-day treatment period
Patient impression of change
Patient Global Impression of Change questionnaire. Patient's global impression of change (function, symptoms and quality of life) since last control (about 14 days prior): Very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse.
Measured: Time Frame: Will be measured at the end of each 14-day treatment period
Patient blinding questionnaire
Does the patient think that the system has been turned on or off
Measured: Time Frame: Will be measured at the end of each 14-day treatment period
Synptoms of anxiety and depression
Hopkins Symptom Checklist-25. Likert scale, from 1(Not at all) to 4 (Extremely), mean of sumscore, 25 in total. Change in totalscore (Continious variable).
Measured: Time Frame: Will be measured at the end of each 14-day treatment period
Usual pain intensity in lower back
Numeric rating scale (0-10); usual pain intensity over the last 24 h (day 7-13) with anchor points 0 = No pain and 10 = Worst imaginable pain.
Measured: Will be measured at day 7 to day 13 in each period (to avoid carry-over effects from previous treatment period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2018
- Study start9 Sep 2019
- Primary completion22 Jun 2023
- Study completion22 Jun 2023
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 Peripheral Neuropathic PainStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe 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
- Model description
- N-of-1-study. Each patient will go through three treatment cycles each consisting of two weeks of active treatment and two weeks of sham in randomised order. In total the study period will be 12 weeks.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Uppsala University Hospital
- Responsible party
- Principal investigator, Bård Lundeland, Oslo University Hospital
- Investigators
- Bård Lundeland, PhD, Principal investigator, Department of Pain Management and Research, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03733886
- Sponsor's protocol ID
- 2017/402/REK nord
- Status last verified
- Aug 2023
- First submitted
- 6 Nov 2018
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data collected during the trial will be available to other researchers who provide a methodologically sound proposal, and who fulfill institutional guidelines.
Publications
O'Connell NE, Ferraro MC, Gibson W, Rice AS, Vase L, Coyle D, Eccleston C. Implanted spinal neuromodulation interventions for chronic pain in adults. Cochrane Database Syst Rev. 2021 Dec 2;12(12):CD013756. doi: 10.1002/14651858.CD013756.pub2.
PubMed 34854473
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Sham-controlled Double-blinded Study of Burst Spinal Cord Stimulation for Chronic Peripheral Neuropathic Pain.
- ClinicalTrials.gov ID
- NCT03733886
- Acronym / sponsor ID
- 2017/402/REK nord
- Conditions
- Peripheral Neuropathic Pain, Radiculopathy, Lower Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Uppsala University Hospital
- Study start
- 9 Sep 2019 (actual)
- Primary completion
- 22 Jun 2023 (actual)
- Study completion
- 22 Jun 2023 (actual)
- First posted
- 7 Nov 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 evaluate the effect of Burst spinal cord stimulation (SCS) in the treatment of painful radiculopathy in lower extremity(ies) with or without lower back pain. It is a multicenter double-blinded "n-of-1" RCT with repeated two-week periods of Burst SCS or sham in randomised order.
Detailed description
SCS is a treatment offered to patients with peripheral neuropathic pain, and involves electrical stimulation of the spinal cord. The analgesic effect is possibly mediated via both spinal and supra-spinal mechanisms.
Traditional "tonic" SCS causes paresthesia during treatment, but the newer burst technique (five electrical pulses at 500Hz delivered in intermittent packets of 40 Hz) can be performed below detection level. Thus, it is possible to do double-blinded sham-controlled studies.
In this study, we will study the effect of burst SCS compared with sham on pain intensity and function (Patient-Specific Functional Scale). In addition, we will use several questionnaires (psychometric data, health-related quality of life, sleep, global impression of change, use of analgesics, blinding).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- N-of-1-study. Each patient will go through three treatment cycles each consisting of two weeks of active treatment and two weeks of sham in randomised order. In total the study period will be 12 weeks.
| Arm | Type | Receives |
|---|---|---|
| Burst SCS | Active comparator | Device: Burst SCS (Abbott Proclaim IPG and single lead Abbott Octrode at level Th9/10)In the active comparator the burst SCS system will be turned on according to randomisation. A treatment period is a 2-week period where the patient receives either active treatment or sham. Each patient will go through 6 treatment periods (in total 12 weeks). A treatment cycle is a 4-week period with two treatment periods, one of active treatment and one of sham. Each patient will go through three treatment cycles. |
| Sham | Sham comparator | Device: Burst SCS (Abbott Proclaim IPG and single lead Abbott Octrode at level Th9/10)In the sham comparator the burst SCS system will be turned off according to randomisation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- History, symptoms and clinical findings consistent with painful radiculopathy in lower extremity(ies) ("probable" or "definite") for at least 3 months, with or without lower back pain. The pain in the extremity(ies) must dominate.
- Understand Norwegian or Swedish language (written and spoken).
- Usual pain intensity ≥ 3.5 / 10 (NRS 0-10)
Key exclusion criteria (12 listed)
- Absolute
- Opioid dose > 100 mg morphine equivalents / day
- Ongoing litigation
- Mental / psychiatric disorder that may affect treatment
- Chronic generalized pain
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 |
|---|---|---|
| Burst SCS (Abbott Proclaim IPG and single lead Abbott Octrode at level Th9/10)Burst SCS implies high frequency SCS treatment in intermittent packets with stimulation below detection level. Abbott BurstDR at default setting: Pulse width 1000 microseconds, frequency 500 Hz/40 Hz, continuous stimulation (no cycling). Pulse amplitude at maximum 60% of sensory threshold | Device | Burst SCS, Sham |
Primary outcome
Usual pain intensity in lower extremity(ies)
Time frame: Will be measured at day 7 to day 13 in each period (to avoid carry-over effects from previous treatment period)
Numeric rating scale (0-10); usual pain intensity over the last 24 h (day 7-13) with anchor points 0 = No pain and 10 = Worst imaginable pain.
12 secondary outcomes
Highest pain intensity in lower extremity(ies)
Time frame: Will be measured at day 7 to day 13 in each period (to avoid carry-over effects from previous treatment period)
Lowest pain intensity in lower extremity(ies)
Time frame: Time Frame: Will be measured at day 7 to day 13 in each period (to avoid carry-over effects from previous treatment period)
Pain intensity in lower extremity(ies)"now"
Time frame: Time Frame: Will be measured at day 7 to day 13 in each period (to avoid carry-over effects from previous treatment period)
Pain unpleasantness
Time frame: Time Frame: Will be measured at day 7 to day 13 in each period (to avoid carry-over effects from previous treatment period)
Three individually chosen functions that are inhibited by the pain
Time frame: Time Frame: Will be measured at day 7 to day 13 in each 14-day treatment period (to avoid carry-over effects from previous treatment period)
Insomnia
Time frame: Time Frame: Will be measured at the end of each 14-day treatment period
EQ-5D index values
Time frame: Time Frame: Will be measured at the end of each 14-day treatment period
EQ-5D self-rated health
Time frame: Time Frame: Will be measured at the end of each 14-day treatment period
Patient impression of change
Time frame: Time Frame: Will be measured at the end of each 14-day treatment period
Patient blinding questionnaire
Time frame: Time Frame: Will be measured at the end of each 14-day treatment period
Synptoms of anxiety and depression
Time frame: Time Frame: Will be measured at the end of each 14-day treatment period
Usual pain intensity in lower back
Time frame: Will be measured at day 7 to day 13 in each period (to avoid carry-over effects from previous treatment period)
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 30 Aug 2023.
- Derived from this study: PubMed 34854473O'Connell NE, Ferraro MC, Gibson W, Rice AS, Vase L, Coyle D, Eccleston C. Implanted spinal neuromodulation interventions for chronic pain in adults. Cochrane Database Syst Rev. 2021 Dec 2;12(12):CD013756. doi: 10.1002/14651858.CD013756.pub2.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data collected during the trial will be available to other researchers who provide a methodologically sound proposal, and who fulfill institutional guidelines.
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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.
Bård Lundeland, PhD principal investigator
Department of Pain Management and Research, Oslo University Hospital
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Burst SCS (Abbott Proclaim IPG and single lead Abbott Octrode at level Th9/10) in people with Peripheral Neuropathic Pain and Radiculopathy, run by Oslo University Hospital at 2 sites in 2 countries.
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 3 inclusion and 12 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 30 Aug 2023. 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 Norway, Sweden. 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. Some participants in this study may receive a placebo. 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?
Usual pain intensity in lower extremity(ies) (time frame: Will be measured at day 7 to day 13 in each period (to avoid carry-over effects from previous treatment period)). 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 NCT03733886, 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 30 Aug 2023.