Comparison of the Analgesic Effect Between the Motor Cortex Stimulation and the Trans-spinal Stimulation in the Algoneurodystrophy. (ALGOSTIM)

Grenoble Alpes University Hospital Center (CHU)

Status: Completed

Conditions: Algoneurodystrophy

Treatments: Device: tsDCS; Device: rTMS; Device: tDCS

Study type: Interventional

Funder types: Other

Identifiers

NCT02817880

38RC15.158

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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36 participants in 3 patient groups

rTMS (repetitive transcranial magnetic stimulation)

Experimental group

Description:

rTMS (repetitive transcranial magnetic stimulation)

Treatment:

Device: rTMS

tDCS (transcranial direct-current stimulation)

Experimental group

Description:

tDCS (transcranial direct-current stimulation)

Treatment:

Device: tDCS

tsDCS (transcutaneous spinal Direct Current Stimulation)

Experimental group

Description:

tsDCS (transcutaneous spinal Direct Current Stimulation)

Treatment:

Device: tsDCS