STIMBURST: Efficacy of Spinal Cord Stimulation in Burst Mode in the Treatment of Complex Regional Pain Syndromes Type 1 of the Upper Limbs
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Burst stimulation Patients treated by Spinal Cord Stimulation in Burst Mode for their Complex Regional Pain Syndromes (CRPS) Type 1 of the Upper Limbs |
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.
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Outcome Measures
Primary Outcome Measures
- Pain assessment at 3 months after implant [3 months]
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).
Secondary Outcome Measures
- procedure assesment [1 month, 3 months, 6 months and 12 months]
By using: - VAS (ranging from 0: "No pain" to 100: "Maximum pain imaginable")
- Assessing attention and working memory [3 months and 12 months]
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)
- qualitatively evaluate the effectiveness of the procedure [3 months]
Semi-structured interviews with patients and their families oriented towards the evaluation of attention, affectivity and emotions.
- Medication use [1 month, 3 months, 6 months and 12 months]
Medication quantification scale (MQS) (Harden RN 2005): ranging from 0 (no antalgic medication used) to 126 (maximum antalgic medication used)
- procedure assesment [1 month, 3 months, 6 months and 12 months]
By using: - Hospital Anxiety and Depression scale (HAD) (Mykletun A 2001) (2 columns ranging from 0 " no or few anxiety" to 21 "high anxiety"
- procedure assesment [1 month, 3 months, 6 months and 12 months]
By using: - Global Perceived Effect scale (GPE, Kamper SJ 2010) (ranging from 1 "very bad" to 7 "very good")
- Assessing attention and working memory [3 months and 12 months]
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)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients between 18 and 75 years of age
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Patient with CRPS of at least one upper limb
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Patient affiliated to a Social Security plan
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Patient who has signed and dated the no-objection form
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Patient with the cognitive ability to understand the treatment and complete the questionnaires
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Patient who can be followed for a minimum of 1 year
Exclusion Criteria:
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Patient with an uncontrolled infection
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Pregnant or breastfeeding patient
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Patient who has already undergone treatment by spinal cord stimulation
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Patient with a contraindication to the percutaneous technique (cervical spine surgery, infection...)
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Patient who cannot be followed regularly for psychological, social, family or geographical reasons
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Protected participant: adult under guardianship, curatorship or other legal protection, deprived of freedom by judicial or administrative decision.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Elsan
- Abbott
Investigators
- Study Director: Jean-Paul NGUYEN, Prof, Clinique Bretéché ELSAN
- Principal Investigator: Sylvain DURAND, Dr, Clinique Bretéché ELSAN
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2023-A00638-37