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BurstDR Spinal Cord Stimulation Versus Sham in Established Responders

ConditionChronic Pain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUmeå University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Crossover

Treatments tested in this trial

  • BurstDR Spinal Cord Stimulation

    Device

    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 Stimulation

    Device

    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.

Treatment groups

28 Participants
are divided into 2 treatment groups
Group A: equence 1: Active BurstDR → ShamExperimental treatment 2 interventions
Group B: Sequence 2: Sham → Active BurstDRExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
During each 7-day randomized treatment period (Days 5-11 and Days 16-22 after baseline)

Secondary outcomes

1

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.

Time frame
At the end of each 7-day randomized treatment period (Day 11 and Day 22 after baseline)
2

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.

Time frame
Daily during each 7-day randomized treatment period (Days 5-11 and Days 16-22 after baseline)
3

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.

Time frame
Daily during each 7-day randomized treatment period (Days 5-11 and Days 16-22 after baseline)
4

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.

Time frame
Daily during each 7-day randomized treatment period (Days 5-11 and Days 16-22 after baseline)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Umeå University

Lead sponsor

Source ClinicalTrials.gov

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