Clinical trial NCT02817880: Comparison of the Analgesic Effect Between the Motor Cortex Stimulation and the Trans-spinal Stimulation in the Algoneurodystrophy.
Official title: Comparison of the Analgesic Effect Between the Motor Cortex Stimulation (tDCS and rTMS) and the Trans-spinal Stimulation (tsDCS ) in the Algoneurodystrophy of Members. A Randomised Clinical Trial. tDCS : Transcranial Direct-current Stimulation rTMS : Repetitive Transcranial Magnetic Stimulation tsDCS : Transcutaneous Spinal Direct Current Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Algoneurodystrophy
Keywords: rTMS, tDCS, tsDCS, pain, algoneurodystrophy , neurostimulation
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2016-06-29
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the analgesic effectiveness of two motor cortex neurostimulations (tDCS and rTMS) and the trans-spinal neurostimulation (tsDCS ) in the algoneurodystrophy.

Detailed description: * Entry into the study : After informed consent, patients will be randomised into three groups : tDCS, rTMS, tsDCS. The physician responsible for conducting neurostimulation sessions will make the randomization via an interactive web response system (IWRS).
* Baseline : Participants, will record on a book, a daily Visual Numeric Scale(VNS) of Pain Intensity for 1 month.
* The beginning of the treatment : after the baseline, sessions of neurostimulation will begin. Sessions of neurostimulation will have a decreasing rhythm. Five sessions per week during the two first weeks, two sessions per week during the third week, one session during the fourth week and then two sessions per month for four months.
* After the end of neurostimulation sessions, patients will be followed for 1month.

Throughout their participation in the study, patients will complete their VNS report book (1month of baseline before the treatment, 3 months during neurostimulation, 1 month after neurostimulation).

Patients will have 5 evaluation examinations:

* The first, one just before the beginning of the neurostimulation,
* The second, 1 month after the beginning of neurostimulation
* The third, 3 months after the beginning of neurostimulation
* And the last one, 1 month after the end of neurostimulation.

Eligibility criteria: Inclusion Criteria:

* Patient's written consent
* Patient suffering from an algoneurodystrophy for more than a year.
* Diagnosis of algoneurodystrophy confirmed by an osseous scintigraphy
* Stable treatment for at least 1 month
* Patient non-responsive to pharmacological treatments
* VNS \> 3 at the time of screening

Exclusion Criteria:

* Drug addiction
* History of epilepsy, head trauma, Psychiatric pathology likely to hamper the progress of the study.
* Intracranial ferromagnetic material or an implanted stimulator
* MRI contraindication
* Algoneurodystrophy due to a nervous lesion
* Pregnant women, parturient women, breast-feeding mother. Lack of effective contraception

Primary outcomes:
measure: The Visual numeric scale of pain between the three groups
timeFrame: Baseline to 1 month
Secondary outcomes:
measure: The Clinical Global Impression scale (CGI) between the three groups
timeFrame: Baseline, 3 months after the beginning of the treatment (day 90), and 1 month after the end of the treatment (Day 180)
measure: The SF12 quality of life questionnaire between the three groups
timeFrame: Baseline, 3 months after the beginning of the treatment (day 90), and 1 month after the end of the treatment (Day 180)
measure: The Hospital Anxiety and Depression scale (HAD) between the three groups
timeFrame: Baseline, 3 months after the beginning of the treatment (day 90), and 1 month after the end of the treatment (Day 180)
measure: The Neuropathic Pain Symptom Inventory scale (NPSI) between the three groups
timeFrame: Baseline, 3 months after the beginning of the treatment (day 90), and 1 month after the end of the treatment (Day 180)
measure: Evolution of the conductance of feet and hands by using Sudoscan
timeFrame: Baseline, 3 months after the beginning of the treatment (day 90), and 1 month after the end of the treatment (Day 180)
measure: Modifications of the sensori-motor cortical cards by using a MRI
timeFrame: Baseline, and 1 month after the end of the treatment (Day 180)
Other outcomes:
Locations:
city: Créteil
country: France
facility: Service de Physiologie - Explorations Fonctionnelles, Hôpital Henri Mondor
state: Ile De France
city: Grenoble
country: France
facility: Centre de la douleur, CHU Grenoble Alpes
state: Isere
Study officials:
References:
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