Chronic PainNCT07779733
BurstDR Spinal Cord Stimulation Versus Sham in Established Responders
A study testing BurstDR Spinal Cord Stimulation in people with Chronic Pain, run by Umeå University at 1 site in Sweden.
Trial summary
This study aims to determine whether ongoing BurstDR spinal cord stimulation (SCS) provides pain relief beyond sham stimulation in patients with chronic pain who are established responders to BurstDR therapy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Pain
- What is being tested?
- BurstDR Spinal Cord Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteSweden
- Study dates
- 30 Sep 2026to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participants must meet all of the following:
- Be 18 years of age or older.
- Have an implanted spinal cord stimulation system that can deliver BurstDR stimulation.
- Have had a good and stable response to BurstDR therapy, defined as at least a 50% reduction in pain compared with pain before implantation or before starting BurstDR therapy, maintained for at least 3 months on stable stimulation settings.
- Have had no major change in pain medication for at least 4 weeks before entering the study.
- Be able to understand the study information and provide written informed consent.
- Be willing and able to complete the study's electronic diaries and follow the study procedures.
Who cannot join
- Participants cannot take part if any of the following apply:
- An active infection, wound problem, or other significant problem at the site of the implanted spinal cord stimulation system.
- A known or suspected problem with the implanted stimulation system that could affect treatment delivery or safety.
- A serious uncontrolled mental health condition, significant problems with memory or thinking, or another condition that could make it difficult to understand the study, provide informed consent, follow the study procedures, or provide reliable study information.
- Planned surgery, planned changes to spinal cord stimulation programming outside the study, or an expected change in pain medication during the study period.
- Pregnancy or breastfeeding.
- Inability to use the electronic diary system when no practical alternative or assistance can be provided.
- Any other medical or personal condition that, in the investigator's judgment, would make participation unsafe or inappropriate.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site
University Hospital of Northern Sweden
Umeå, 90185
Pedram Tabatabaei, MD, PhD, +46707603239, pedram.tabatabaei@umu.se
About this study
Official title: Passive Recharge Burst Spinal Cord Stimulation vs Sham Stimulation in Established Responders: A Randomized, Double-Blind Crossover Clinical Trial
This study aims to determine whether ongoing BurstDR spinal cord stimulation (SCS) provides pain relief beyond sham stimulation in patients with chronic pain who are established responders to BurstDR therapy.
Participants already implanted with an SCS system and experiencing stable clinical benefit from BurstDR will undergo both active stimulation and sham stimulation in a randomized, double-blind crossover design. Each participant will therefore serve as their own control.
The primary question is whether pain intensity is lower during active BurstDR stimulation compared with sham stimulation. The study will also evaluate treatment satisfaction, patient-reported changes in sleep, mood, daily activity and social activity, the effectiveness of blinding, and short-term safety and tolerability.
Read the detailed description
BurstDR spinal cord stimulation is a paresthesia-free neuromodulation therapy used for the treatment of chronic pain. Although clinical studies have demonstrated beneficial outcomes with BurstDR therapy, the specific contribution of ongoing stimulation, separate from contextual effects, expectation, natural symptom variation, and other nonspecific influences, remains incompletely defined.
This study uses a randomized, double-blind, two-period crossover design in patients who are already implanted with a spinal cord stimulation system and have an established clinical response to BurstDR therapy. Studying established responders avoids potential confounding associated with implantation, postoperative recovery, and initial programming and optimization, and allows the effect of ongoing stimulation to be evaluated under controlled conditions.
Before the randomized treatment periods, each participant will complete a baseline observation under their established active BurstDR settings, followed by a washout period with stimulation switched off. Participants will then undergo two randomized treatment periods: one with active BurstDR stimulation and one with sham stimulation, separated by a second washout period. The order of the two conditions will be randomly assigned, allowing each participant to serve as their own control and thereby reducing the influence of between-patient variability.
During the active condition, stimulation will be delivered using the participant's established clinically effective BurstDR program. During the sham condition, stimulation output will be switched off while study procedures, participant contacts, and data collection will otherwise remain comparable between conditions.
Because BurstDR stimulation is intended to be paresthesia-free, it provides an opportunity for blinded comparison with sham stimulation. Before the randomized treatment phase, a standardized perceptibility assessment will be performed to confirm that participants cannot reliably perceive whether stimulation is active. Device access and information that could reveal treatment allocation will be restricted, and treatment programming will be performed by designated study personnel who are not involved in outcome assessment or the primary analysis.
The crossover and washout design is intended to minimize residual stimulation effects and provide a controlled assessment of the specific contribution of ongoing BurstDR therapy in patients who have previously demonstrated clinical benefit from this treatment.
- Conditions
- Chronic Pain
- Being tested
- BurstDR Spinal Cord Stimulation, Sham Spinal Cord Stimulation
- Keywords
- Spinal Cord Stimulation, Passive Recharge Burst Spinal Cord Stimulation, Burst Stimulation, Neuromodulation, Sham Stimulation, Paresthesia-Free Stimulation, Established Responders
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BurstDR Spinal Cord StimulationDevice
Also called Passive Recharge Burst Spinal Cord Stimulation
Active BurstDR spinal cord stimulation is delivered for 7 consecutive days using each participant's established clinically effective stimulation settings. Electrode configuration, pulse pattern, pulse width, frequency structure, and amplitude are maintained according to the participant's established therapeutic program, with any adjustment required to maintain imperceptible stimulation completed before the randomized treatment periods.
Sham Spinal Cord StimulationDevice
During sham stimulation, the implanted spinal cord stimulation system remains in place but stimulation output is switched off for 7 consecutive days. The participant-facing programmer is locked and visible device information that could reveal treatment allocation is masked. Study contacts, diary assessments, and follow-up procedures are otherwise equivalent to those during active stimulation.
| Study group | Role | What they receive |
|---|---|---|
| equence 1: Active BurstDR → Sham | Experimental | Following a 1-day baseline observation under established active BurstDR settings, participants undergo a 4-day washout period with stimulation switched off. They then receive 7 days of active BurstDR spinal cord stimulation using their established clinically effective settings. After a second 4-day washout period with stimulation switched off, participants receive 7 days of sham stimulation, during which stimulation output remains switched off. Receives: Device: BurstDR Spinal Cord Stimulation; Device: Sham Spinal Cord Stimulation |
| Sequence 2: Sham → Active BurstDR | Experimental | Following a 1-day baseline observation under established active BurstDR settings, participants undergo a 4-day washout period with stimulation switched off. They then receive 7 days of sham stimulation, during which stimulation output remains switched off. After a second 4-day washout period with stimulation switched off, participants receive 7 days of active BurstDR spinal cord stimulation using their established clinically effective settings. Receives: Device: BurstDR Spinal Cord Stimulation; Device: Sham Spinal Cord Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Within-Participant Difference in Period-Level Median Numeric Rating Scale Pain Intensity Between Active BurstDR and Sham
Pain intensity is recorded twice daily, morning and evening, using an 11-point Numeric Rating Scale (NRS; 0=no pain to 10=worst pain) for each predefined pain area during each randomized treatment period. All available NRS ratings within each participant and treatment period are pooled, and the period-level median is calculated. The primary outcome is the within-participant paired difference between sham and active BurstDR stimulation (Sham minus Active), with positive values favoring active BurstDR. Baseline-day NRS data are not included in the primary endpoint.
Measured: During each 7-day randomized treatment period (Days 5-11 and Days 16-22 after baseline)
Secondary outcomes (8)
Within-Participant Difference in End-of-Period Treatment Satisfaction Score Between Active BurstDR and Sham
Overall treatment satisfaction is assessed on a 0-10 scale at the end of each 7-day randomized treatment period. Scores obtained following active BurstDR and sham stimulation are compared within each participant.
Measured: At the end of each 7-day randomized treatment period (Day 11 and Day 22 after baseline)
Within-Participant Difference in Period-Level Median Patient Global Impression of Change Score for Sleep Quality
Patient Global Impression of Change for sleep quality is assessed once daily using a 5-point scale during each randomized treatment period. For each participant and treatment period, the median of all available daily sleep ratings is calculated and compared between active BurstDR and sham stimulation.
Measured: Daily during each 7-day randomized treatment period (Days 5-11 and Days 16-22 after baseline)
Within-Participant Difference in Period-Level Median Patient Global Impression of Change Score for Mood
Patient Global Impression of Change for mood is assessed once daily using a 5-point scale during each randomized treatment period. For each participant and treatment period, the median of all available daily mood ratings is calculated and compared between active BurstDR and sham stimulation.
Measured: Daily during each 7-day randomized treatment period (Days 5-11 and Days 16-22 after baseline)
Within-Participant Difference in Period-Level Median Patient Global Impression of Change Score for Daily Activity
Patient Global Impression of Change for daily activity is assessed once daily using a 5-point scale during each randomized treatment period. For each participant and treatment period, the median of all available daily ratings is calculated and compared between active BurstDR and sham stimulation.
Measured: Daily during each 7-day randomized treatment period (Days 5-11 and Days 16-22 after baseline)
Within-Participant Difference in Period-Level Median Patient Global Impression of Change Score for Social Activity
Patient Global Impression of Change for social activity is assessed once daily using a 5-point scale during each randomized treatment period. For each participant and treatment period, the median of all available daily ratings is calculated and compared between active BurstDR and sham stimulation.
Measured: Daily during each 7-day randomized treatment period (Days 5-11 and Days 16-22 after baseline)
Perceptibility of Active BurstDR Stimulation Before Randomized Treatment
A standardized perceptibility assessment using brief randomized stimulation ON/OFF intervals is performed before the first randomized treatment period to verify that the participant cannot reliably perceive active BurstDR stimulation.
Measured: At the baseline/programming visit, before the 1-day baseline diary and before Washout 1
Number of Participants With Adverse Events, Serious Adverse Events, and Stimulation-Related Complaints
Adverse events, serious adverse events, and stimulation- or device-related complaints are recorded during study participation. Events will be summarized descriptively and, where feasible, according to whether they occurred during active BurstDR stimulation, sham stimulation, or washout.
Measured: From baseline through Day 22 after baseline (completion of the second randomized treatment period)
Participant-Reported Perception of Stimulation During Each Randomized Treatment Period
At the end of each randomized treatment period, participants are asked whether they felt stimulation or paresthesia at any time during that treatment period. Responses are summarized by treatment condition to assess the integrity of masking.
Measured: At the end of each 7-day randomized treatment period (Day 11 and Day 22 after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start30 Sep 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe 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
- This is a randomized, double-blind, two-period crossover study. Participants are randomized 1:1 to one of two treatment sequences: active BurstDR spinal cord stimulation followed by sham stimulation, or sham stimulation followed by active BurstDR spinal cord stimulation. Each treatment period lasts 7 days and the two randomized treatment periods are separated by a 4-day washout period during which stimulation is switched off. Before the first randomized treatment period, participants complete a 1-day baseline observation under their established active BurstDR settings followed by an initial 4-day washout period. Each participant receives both study conditions and therefore serves as their own control.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pedram Tabatabaei Shafiei, Umeå University
- Investigators
- Pedram Tabatabaei, MD, PhD, Principal investigator, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07779733
- Sponsor's protocol ID
- Dnr 2026-03871-01
- Status last verified
- Aug 2026
- First submitted
- 13 Aug 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the primary and secondary results of the study will be available to qualified researchers upon reasonable request following publication of the main study results, subject to applicable data protection legislation, institutional governance, participant confidentiality requirements, and approval of the proposed research purpose.
Publications
De Ridder D, Plazier M, Kamerling N, Menovsky T, Vanneste S. Burst spinal cord stimulation for limb and back pain. World Neurosurg. 2013 Nov;80(5):642-649.e1. doi: 10.1016/j.wneu.2013.01.040. Epub 2013 Jan 12.
PubMed 23321375Deer TR, Falowski SM, Moore GA, Hutcheson JK, Pena I, Candido K, Cornidez EG, Fraunberg VUZ, Blomme B, Capobianco RA. Passive Recharge Burst Spinal Cord Stimulation Provides Sustainable Improvements in Pain and Psychosocial Function: 2-year Results From the TRIUMPH Study. Spine (Phila Pa 1976). 2022 Apr 1;47(7):548-556. doi: 10.1097/BRS.0000000000004283.
PubMed 34812195Deer T, Slavin KV, Amirdelfan K, North RB, Burton AW, Yearwood TL, Tavel E, Staats P, Falowski S, Pope J, Justiz R, Fabi AY, Taghva A, Paicius R, Houden T, Wilson D. Success Using Neuromodulation With BURST (SUNBURST) Study: Results From a Prospective, Randomized Controlled Trial Using a Novel Burst Waveform. Neuromodulation. 2018 Jan;21(1):56-66. doi: 10.1111/ner.12698. Epub 2017 Sep 29.
PubMed 28961366Schu S, Slotty PJ, Bara G, von Knop M, Edgar D, Vesper J. A prospective, randomised, double-blind, placebo-controlled study to examine the effectiveness of burst spinal cord stimulation patterns for the treatment of failed back surgery syndrome. Neuromodulation. 2014 Jul;17(5):443-50. doi: 10.1111/ner.12197. Epub 2014 Jun 19.
PubMed 24945621Tabatabaei P, Wanman J, Awad A, Eriksson M, Salomonsson J, Bredemo L, Sjoberg R, Hariz MI, Blomstedt P. Subperception dorsal root ganglion stimulation versus sham stimulation in established responders: a randomized, double-blind crossover clinical trial. Reg Anesth Pain Med. 2026 May 13:rapm-2026-107906. doi: 10.1136/rapm-2026-107906. Online ahead of print.
PubMed 42128597
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Passive Recharge Burst Spinal Cord Stimulation vs Sham Stimulation in Established Responders: A Randomized, Double-Blind Crossover Clinical Trial
- ClinicalTrials.gov ID
- NCT07779733
- Acronym / sponsor ID
- Dnr 2026-03871-01
- Conditions
- Chronic Pain
- Keywords
- Spinal Cord Stimulation, Passive Recharge Burst Spinal Cord Stimulation, Burst Stimulation, Neuromodulation, Sham Stimulation, Paresthesia-Free Stimulation, Established Responders
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 21 Aug 2026 (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 aims to determine whether ongoing BurstDR spinal cord stimulation (SCS) provides pain relief beyond sham stimulation in patients with chronic pain who are established responders to BurstDR therapy.
Participants already implanted with an SCS system and experiencing stable clinical benefit from BurstDR will undergo both active stimulation and sham stimulation in a randomized, double-blind crossover design. Each participant will therefore serve as their own control.
The primary question is whether pain intensity is lower during active BurstDR stimulation compared with sham stimulation. The study will also evaluate treatment satisfaction, patient-reported changes in sleep, mood, daily activity and social activity, the effectiveness of blinding, and short-term safety and tolerability.
Detailed description
BurstDR spinal cord stimulation is a paresthesia-free neuromodulation therapy used for the treatment of chronic pain. Although clinical studies have demonstrated beneficial outcomes with BurstDR therapy, the specific contribution of ongoing stimulation, separate from contextual effects, expectation, natural symptom variation, and other nonspecific influences, remains incompletely defined.
This study uses a randomized, double-blind, two-period crossover design in patients who are already implanted with a spinal cord stimulation system and have an established clinical response to BurstDR therapy. Studying established responders avoids potential confounding associated with implantation, postoperative recovery, and initial programming and optimization, and allows the effect of ongoing stimulation to be evaluated under controlled conditions.
Before the randomized treatment periods, each participant will complete a baseline observation under their established active BurstDR settings, followed by a washout period with stimulation switched off. Participants will then undergo two randomized treatment periods: one with active BurstDR stimulation and one with sham stimulation, separated by a second washout period. The order of the two conditions will be randomly assigned, allowing each participant to serve as their own control and thereby reducing the influence of between-patient variability.
During the active condition, stimulation will be delivered using the participant's established clinically effective BurstDR program. During the sham condition, stimulation output will be switched off while study procedures, participant contacts, and data collection will otherwise remain comparable between conditions.
Because BurstDR stimulation is intended to be paresthesia-free, it provides an opportunity for blinded comparison with sham stimulation. Before the randomized treatment phase, a standardized perceptibility assessment will be performed to confirm that participants cannot reliably perceive whether stimulation is active. Device access and information that could reveal treatment allocation will be restricted, and treatment programming will be performed by designated study personnel who are not involved in outcome assessment or the primary analysis.
The crossover and washout design is intended to minimize residual stimulation effects and provide a controlled assessment of the specific contribution of ongoing BurstDR therapy in patients who have previously demonstrated clinical benefit from this treatment.
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
- This is a randomized, double-blind, two-period crossover study. Participants are randomized 1:1 to one of two treatment sequences: active BurstDR spinal cord stimulation followed by sham stimulation, or sham stimulation followed by active BurstDR spinal cord stimulation. Each treatment period lasts 7 days and the two randomized treatment periods are separated by a 4-day washout period during which stimulation is switched off. Before the first randomized treatment period, participants complete a 1-day baseline observation under their established active BurstDR settings followed by an initial 4-day washout period. Each participant receives both study conditions and therefore serves as their own control.
| Arm | Type | Receives |
|---|---|---|
| equence 1: Active BurstDR → Sham | Experimental | Device: BurstDR Spinal Cord Stimulation, Device: Sham Spinal Cord StimulationFollowing a 1-day baseline observation under established active BurstDR settings, participants undergo a 4-day washout period with stimulation switched off. They then receive 7 days of active BurstDR spinal cord stimulation using their established clinically effective settings. After a second 4-day washout period with stimulation switched off, participants receive 7 days of sham stimulation, during which stimulation output remains switched off. |
| Sequence 2: Sham → Active BurstDR | Experimental | Device: BurstDR Spinal Cord Stimulation, Device: Sham Spinal Cord StimulationFollowing a 1-day baseline observation under established active BurstDR settings, participants undergo a 4-day washout period with stimulation switched off. They then receive 7 days of sham stimulation, during which stimulation output remains switched off. After a second 4-day washout period with stimulation switched off, participants receive 7 days of active BurstDR spinal cord stimulation using their established clinically effective settings. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Be 18 years of age or older.
- Have an implanted spinal cord stimulation system that can deliver BurstDR stimulation.
- Have had a good and stable response to BurstDR therapy, defined as at least a 50% reduction in pain compared with pain before implantation or before starting BurstDR therapy, maintained for at least 3 months on stable stimulation settings.
- Have had no major change in pain medication for at least 4 weeks before entering the study.
- Be able to understand the study information and provide written informed consent.
Key exclusion criteria (8 listed)
- An active infection, wound problem, or other significant problem at the site of the implanted spinal cord stimulation system.
- A known or suspected problem with the implanted stimulation system that could affect treatment delivery or safety.
- A serious uncontrolled mental health condition, significant problems with memory or thinking, or another condition that could make it difficult to understand the study, provide informed consent, follow the study procedures, or provide reliable study information.
- Planned surgery, planned changes to spinal cord stimulation programming outside the study, or an expected change in pain medication during the study period.
- Pregnancy or breastfeeding.
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 |
|---|---|---|
| BurstDR Spinal Cord StimulationAlso: Passive Recharge Burst Spinal Cord StimulationActive BurstDR spinal cord stimulation is delivered for 7 consecutive days using each participant's established clinically effective stimulation settings. Electrode configuration, pulse pattern, pulse width, frequency structure, and amplitude are maintained according to the participant's established therapeutic program, with any adjustment required to maintain imperceptible stimulation completed before the randomized treatment periods. | Device | Sequence 2: Sham → Active BurstDR, equence 1: Active BurstDR → Sham |
| Sham Spinal Cord StimulationDuring sham stimulation, the implanted spinal cord stimulation system remains in place but stimulation output is switched off for 7 consecutive days. The participant-facing programmer is locked and visible device information that could reveal treatment allocation is masked. Study contacts, diary assessments, and follow-up procedures are otherwise equivalent to those during active stimulation. | Device | Sequence 2: Sham → Active BurstDR, equence 1: Active BurstDR → Sham |
Primary outcome
Within-Participant Difference in Period-Level Median Numeric Rating Scale Pain Intensity Between Active BurstDR and Sham
Time frame: During each 7-day randomized treatment period (Days 5-11 and Days 16-22 after baseline)
Pain intensity is recorded twice daily, morning and evening, using an 11-point Numeric Rating Scale (NRS; 0=no pain to 10=worst pain) for each predefined pain area during each randomized treatment period. All available NRS ratings within each participant and treatment period are pooled, and the period-level median is calculated. The primary outcome is the within-participant paired difference between sham and active BurstDR stimulation (Sham minus Active), with positive values favoring active BurstDR. Baseline-day NRS data are not included in the primary endpoint.
8 secondary outcomes
Within-Participant Difference in End-of-Period Treatment Satisfaction Score Between Active BurstDR and Sham
Time frame: At the end of each 7-day randomized treatment period (Day 11 and Day 22 after baseline)
Within-Participant Difference in Period-Level Median Patient Global Impression of Change Score for Sleep Quality
Time frame: Daily during each 7-day randomized treatment period (Days 5-11 and Days 16-22 after baseline)
Within-Participant Difference in Period-Level Median Patient Global Impression of Change Score for Mood
Time frame: Daily during each 7-day randomized treatment period (Days 5-11 and Days 16-22 after baseline)
Within-Participant Difference in Period-Level Median Patient Global Impression of Change Score for Daily Activity
Time frame: Daily during each 7-day randomized treatment period (Days 5-11 and Days 16-22 after baseline)
Within-Participant Difference in Period-Level Median Patient Global Impression of Change Score for Social Activity
Time frame: Daily during each 7-day randomized treatment period (Days 5-11 and Days 16-22 after baseline)
Perceptibility of Active BurstDR Stimulation Before Randomized Treatment
Time frame: At the baseline/programming visit, before the 1-day baseline diary and before Washout 1
Number of Participants With Adverse Events, Serious Adverse Events, and Stimulation-Related Complaints
Time frame: From baseline through Day 22 after baseline (completion of the second randomized treatment period)
Participant-Reported Perception of Stimulation During Each Randomized Treatment Period
Time frame: At the end of each 7-day randomized treatment period (Day 11 and Day 22 after baseline)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Background: PubMed 23321375De Ridder D, Plazier M, Kamerling N, Menovsky T, Vanneste S. Burst spinal cord stimulation for limb and back pain. World Neurosurg. 2013 Nov;80(5):642-649.e1. doi: 10.1016/j.wneu.2013.01.040. Epub 2013 Jan 12.
- Background: PubMed 34812195Deer TR, Falowski SM, Moore GA, Hutcheson JK, Pena I, Candido K, Cornidez EG, Fraunberg VUZ, Blomme B, Capobianco RA. Passive Recharge Burst Spinal Cord Stimulation Provides Sustainable Improvements in Pain and Psychosocial Function: 2-year Results From the TRIUMPH Study. Spine (Phila Pa 1976). 2022 Apr 1;47(7):548-556. doi: 10.1097/BRS.0000000000004283.
- Background: PubMed 28961366Deer T, Slavin KV, Amirdelfan K, North RB, Burton AW, Yearwood TL, Tavel E, Staats P, Falowski S, Pope J, Justiz R, Fabi AY, Taghva A, Paicius R, Houden T, Wilson D. Success Using Neuromodulation With BURST (SUNBURST) Study: Results From a Prospective, Randomized Controlled Trial Using a Novel Burst Waveform. Neuromodulation. 2018 Jan;21(1):56-66. doi: 10.1111/ner.12698. Epub 2017 Sep 29.
- Background: PubMed 24945621Schu S, Slotty PJ, Bara G, von Knop M, Edgar D, Vesper J. A prospective, randomised, double-blind, placebo-controlled study to examine the effectiveness of burst spinal cord stimulation patterns for the treatment of failed back surgery syndrome. Neuromodulation. 2014 Jul;17(5):443-50. doi: 10.1111/ner.12197. Epub 2014 Jun 19.
- Background: PubMed 42128597Tabatabaei P, Wanman J, Awad A, Eriksson M, Salomonsson J, Bredemo L, Sjoberg R, Hariz MI, Blomstedt P. Subperception dorsal root ganglion stimulation versus sham stimulation in established responders: a randomized, double-blind crossover clinical trial. Reg Anesth Pain Med. 2026 May 13:rapm-2026-107906. doi: 10.1136/rapm-2026-107906. Online ahead of print.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the primary and secondary results of the study will be available to qualified researchers upon reasonable request following publication of the main study results, subject to applicable data protection legislation, institutional governance, participant confidentiality requirements, and approval of the proposed research purpose.
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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.
Pedram Tabatabaei, MD, PhD principal investigator
Umeå University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BurstDR Spinal Cord Stimulation in people with Chronic Pain, run by Umeå University at 1 site in Sweden.
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 7 inclusion and 8 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: opening soon, as of the sponsor's last update on 21 Aug 2026. 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 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pedram Tabatabaei, MD, PhD (+46-70-7603239, pedram.tabatabaei@umu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Within-Participant Difference in Period-Level Median Numeric Rating Scale Pain Intensity Between Active BurstDR and Sham (time frame: During each 7-day randomized treatment period (Days 5-11 and Days 16-22 after baseline)). 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 NCT07779733, which also lists 5 linked publications.
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 21 Aug 2026.