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

Complex Regional Pain Syndrome Type I Clinical Trial

— STIMBURST  

Official title:

Observational, Prospective, Monocentric Study Aimed at Studying the Efficacy of Spinal Cord Stimulation in Burst Mode in the Treatment of Complex Regional Pain Syndromes (CRPS) Type 1 of the Upper Limbs Evaluation Protocol by Quantitative and Qualitative Method

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05877612
• Other study ID #: 2023-A00638-37
• Status: Recruiting
• Start date: September 12, 2023
• Est. completion date: September 2025

Study information

• Verified date: September 2023
• Source: Elsan
• Contact: Vincent WYART, MSc
• Phone: 0240958176
• Email: vincent.wyart[@]elsan.care
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Complex Regional Pain Syndrome Type I
• Complex Regional Pain Syndromes
• Reflex Sympathetic Dystrophy
• Somatoform Disorders
• Syndrome

Intervention

Device:
• 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.

Locations

Country	Name	City	State
France	Clinique BRETECHE	Nantes

Sponsors (2)

Lead Sponsor	Collaborator
Elsan	Abbott

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain assessment at 3 months after implant	The analgesic outcome of spinal cord stimulation will be assessed by comparing the preoperative visual analogue pain scales (VAS) (ranging from 0: "No pain" to 100: "Maximum pain imaginable") to those performed at the 3rd month visit (3 months). Patients with a VAS score of 50% or more improvement will be considered "improved". The VAS value retained corresponds to the average of 3 values taken during the day (morning, noon and evening).	3 months
Secondary	procedure assesment	By using: - VAS (ranging from 0: "No pain" to 100: "Maximum pain imaginable")	1 month, 3 months, 6 months and 12 months
Secondary	Assessing attention and working memory	By using: - Trail Making Test (Reitan RM 1958) (2 parts A and B measured in seconds: The maximum score for part A is 100", 101" indicating that the test was not completed. The maximum score for Part B is 300", 301" indicating that the test was not completed)	3 months and 12 months
Secondary	qualitatively evaluate the effectiveness of the procedure	Semi-structured interviews with patients and their families oriented towards the evaluation of attention, affectivity and emotions.	3 months
Secondary	Medication use	Medication quantification scale (MQS) (Harden RN 2005): ranging from 0 (no antalgic medication used) to 126 (maximum antalgic medication used)	1 month, 3 months, 6 months and 12 months
Secondary	procedure assesment	By using: - Hospital Anxiety and Depression scale (HAD) (Mykletun A 2001) (2 columns ranging from 0 " no or few anxiety" to 21 "high anxiety"	1 month, 3 months, 6 months and 12 months
Secondary	procedure assesment	By using: - Global Perceived Effect scale (GPE, Kamper SJ 2010) (ranging from 1 "very bad" to 7 "very good")	1 month, 3 months, 6 months and 12 months
Secondary	Assessing attention and working memory	By using: - WAIS-IV (Benson N 2010) ( 4 subtests submited with 10 items in all (ranging 0 to 19 each), to calculate intelligence quotient with a minimum at 0 and a maximum at 190)	3 months and 12 months