Efficacy of Spinal Cord Stimulation in Burst Mode in the Treatment of Complex Regional Pain Syndromes Type 1 of the Upper Limbs

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-12

Study Completion Date

2025-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

In this study, it is the procedure of spinal cord stimulation in Burst mode, its results and the experience of the patients that are evaluated.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Burst Spinal Cord Stimulation (Burst-SCS) Study

NCT03718325

Pain, Chronic Failed Back Surgery Syndrome

TERMINATED NA

Spinal Cord Stimulation vs. Medical Management for Low Back Pain (DISTINCT)

NCT04479787

Chronic Low-Back Pain Refractory Pain Neuropathic Pain

COMPLETED NA

Study to Characterize Effects of Programming in SCS Patients Undergoing a Temporary Trial

NCT02988713

Chronic Pain

COMPLETED NA

Efficacy of the Spinal Cord Stimulation System as Salvage Therapy

NCT00387244

Pain Intractable Pain Chronic Pain

TERMINATED NA

Spinal Cord Stimulation Versus Nerve Blocks and Physical Therapy

NCT00414804

Complex Regional Pain Syndrome Chronic Pain Pain

WITHDRAWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

There is 1 "classic" spinal cord stimulation setting that can be problematic in the case of cervical spinal cord stimulation because neck movements tend to trigger paresthesias. It is therefore possible, in a certain number of cases, that these side effects prevent the treatment from being effective. Thus, the development of new modes of spinal cord stimulation, mainly aiming at eliminating these side effects, has proven to be particularly interesting.

There are 3 new modes of stimulation: high frequency stimulation which uses very short pulse durations and a stimulation frequency of the order of 1000 Hz, high density stimulation which uses long duration pulses and an intermediate stimulation frequency, and "Burst" stimulation which uses stimulation trains repeated 40 times per second.

The Burst stimulation mode preferentially activates pathways in the medial part of the pain matrix, leading mainly to the cingulate cortex involved in modulating the affective, emotional and attentional side of pain. This result should theoretically be felt positively by the patient and his entourage, and the benefit should persist, or even improve with time, contrary to what is often observed with other stimulation modes.

In addition, the Burst mode consumes little energy, theoretically less than conventional stimulation. It is therefore not necessary to use rechargeable stimulators, which provides greater comfort for the patient.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Complex Regional Pain Syndrome Type I

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Burst stimulation

Patients treated by Spinal Cord Stimulation in Burst Mode for their Complex Regional Pain Syndromes (CRPS) Type 1 of the Upper Limbs

Implantable spinal cord stimulator

Intervention Type DEVICE

Spinal cord stimulation is possible thanks to implantable spinal cord neurostimulators. These are medical devices, which include a stimulation electrode and an implantable box, designed to deliver electrical stimulation for pain relief. The electrode is implanted in the epidural space in order to stimulate the posterior cords of the spinal cord through the dura mater, at the dorsal or cervical level.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Implantable spinal cord stimulator

Spinal cord stimulation is possible thanks to implantable spinal cord neurostimulators. These are medical devices, which include a stimulation electrode and an implantable box, designed to deliver electrical stimulation for pain relief. The electrode is implanted in the epidural space in order to stimulate the posterior cords of the spinal cord through the dura mater, at the dorsal or cervical level.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients between 18 and 75 years of age
* Patient with CRPS of at least one upper limb
* Patient affiliated to a Social Security plan
* Patient who has signed and dated the no-objection form
* Patient with the cognitive ability to understand the treatment and complete the questionnaires
* Patient who can be followed for a minimum of 1 year

Exclusion Criteria

* Patient with an uncontrolled infection
* Pregnant or breastfeeding patient
* Patient who has already undergone treatment by spinal cord stimulation
* Patient with a contraindication to the percutaneous technique (cervical spine surgery, infection...)
* Patient who cannot be followed regularly for psychological, social, family or geographical reasons
* Protected participant: adult under guardianship, curatorship or other legal protection, deprived of freedom by judicial or administrative decision.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No