Passive Recharge Burst Spinal Cord Stimulation vs Sham Stimulation in Established Responders: A Randomized, Double-Blind Crossover Clinical Trial
Sponsor study identifier
interventional
28
1 country
1
Study Start
September 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
March 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 13, 2026
Actual (reported)August 21, 2026
Actual (reported)September 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
March 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
During each 7-day randomized treatment period (Days 5-11 and Days 16-22 after baseline)
Within-Participant Difference in End-of-Period Treatment Satisfaction Score Between Active BurstDR and Sham
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
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
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
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
Daily during each 7-day randomized treatment period (Days 5-11 and Days 16-22 after baseline)
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.
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.
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.
University Hospital of Northern Sweden
Umeå, 90185, Sweden
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.
Deer 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.
Pedram Tabatabaei, MD, PhD
Umeå University
First Submitted
August 13, 2026
Internet-based Acceptance Based Psychotherapy As an Adjunct to Chronic Pain Rehabilitation
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Deer 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.
Schu 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.
Tabatabaei 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.
First Posted
August 21, 2026
Study Start
September 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
March 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
August 21, 2026
Record last verified: 2026-08
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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Source: ClinicalTrials.gov.
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