RecruitingNot ApplicableNCT05421273

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)


Sponsor

Rijnstate Hospital

Enrollment

96 participants

Start Date

Feb 16, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study compares two different settings of a spinal cord stimulator for people who still have back and leg pain after spine surgery. The device delivers small electrical bursts to the spinal cord to reduce pain. The trial compares an "active recharge" mode versus a "passive recharge" mode to see which works better for patients who tend to catastrophize their pain experience. You may be eligible if... - You are between 18 and 70 years old - You have Persistent Spinal Pain Syndrome Type 2 (ongoing pain after back surgery) lasting at least 6 months - Your back and/or leg pain scores 5 or higher on a 0–10 scale - You score at least 20 on the Pain Catastrophizing Scale - A multidisciplinary team including a psychologist has approved you for a spinal cord stimulator implant - You have no significant motor (movement) deficits on neurological exam You may NOT be eligible if... - You are pregnant, nursing, or plan to become pregnant - Your pain has been rapidly escalating or changing in the last month - Your BMI is 35 or higher - You had injection therapy or radiofrequency treatment for your back/leg pain in the last 3 months - You already have an implanted cardiac device (pacemaker, ICD) or a previous spinal cord stimulator or pain pump - You had previous neurostimulation therapy - You are unable to operate the device Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICESpinal cord stimulation using passive recharge burst stimulation

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

DEVICESpinal cord stimulation using active recharge burst stimulation

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


Locations(6)

Rijnstate Hospital

Arnhem, Gelderland, Netherlands

Bravis Hospital

Roosendaal, North Brabant, Netherlands

Elizabeth TweeSteden Hospital

Tilburg, North Brabant, Netherlands

Amsterdam University Medical Hospitals A-UMC

Amsterdam, North Holland, Netherlands

Alrijne Hospital

Leiderdorp, South Holland, Netherlands

Diakonessen Hospital

Zeist, Utrecht, Netherlands

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NCT05421273


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