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Effects of Active Versus Passive Recharge Burst Spinal Cord Stimulation on Pain Experience in Persistent Spinal Pain Syndrome Type 2: a Multicenter Randomized Trial (BURST-RAP Study)

ConditionsPersistent Spinal Pain Syndrome Type 2Failed Back Surgery Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorRijnstate Hospital

About this trial

Spinal cord stimulation (SCS) has shown to be an effective treatment for patients with persistent spinal pain syndrome Type 2 (PSPS Type 2). The method used to deliver electrical charge in SCS is important. One such method is burst stimulation. Two variations of burst waveforms are currently in use: one that employs active recharge and one that uses passive recharge. It is still unknown if there are clinical differences between active recharge and passive recharge burst SCS. To date, no clinical studies have been performed that directly compared these two burst stimulation waveforms. The objective of this Randomized Clinical Trial (RCT) is to assess and compare effect of passive recharge burst SCS with active recharge burst SCS on pain relief and motivational-emotional facets of pain

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects between 18 and 70 years of age

At least moderate level of catastrophizing as measured with the Pain catastrophizing scale (PCS) of at least 20 at first visit of the pain clinic.

Chronic pain diagnoses as PSPS Type 2 of at least 6 months

Neurologic exam without marked motor deficit.

Disqualifiers

Subject has been screened by a multi-disciplinary panel including a psychologist and deemed suitable for implantation

Subject is able and willing to comply with the follow-up schedule and protocol

Subject is able to provide written informed consent

Female subject of childbearing potential is pregnant/nursing or plans to become pregnant during the course of the study

Trial design

Design model

Parallel

Treatments tested in this trial

  • Spinal cord stimulation using passive recharge burst stimulation

    Device

    Passive recharge burst is marked by a recharge pattern that passively compensates for charge differences.

  • Spinal cord stimulation using active recharge burst stimulation

    Device

    Active recharge burst is characterized by negative pulses that directly compensate for charge differences.

Treatment groups

96 Participants
are divided into 2 treatment groups
Group A: Active recharge burst stimulationExperimental treatment 1 intervention
Group B: Passive recharge burst stimulationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Pain catastrophizing score

Time frame
6 months

Secondary outcomes

1

Numeric pain rating scale

Time frame
3, 6, 12 months
2

Patient vigilance and awareness questionnaire

Time frame
3, 6, 12 months
3

Hospital anxiety and depression scale

Time frame
3, 6, 12 months
4

EQ-5D questionnaire

Quality of life questionnaire

Time frame
3, 6, 12 months

Other outcomes

Sponsors and contacts

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

Rijnstate Hospital

Lead sponsor

Source ClinicalTrials.gov
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