Algoneurodystrophy
Conditions
Keywords
rTMS, tDCS, tsDCS, pain, algoneurodystrophy , neurostimulation
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.
Interventions
Sponsors
University Hospital, Grenoble
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Visual numeric scale of pain between the three groups | Baseline to 1 month |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The SF12 quality of life questionnaire between the three groups | Baseline, 3 months after the beginning of the treatment (day 90), and 1 month after the end of the treatment (Day 180) | — |
| The Hospital Anxiety and Depression scale (HAD) between the three groups | Baseline, 3 months after the beginning of the treatment (day 90), and 1 month after the end of the treatment (Day 180) | — |
| The Clinical Global Impression scale (CGI) between the three groups | Baseline, 3 months after the beginning of the treatment (day 90), and 1 month after the end of the treatment (Day 180) | — |
| Evolution of the conductance of feet and hands by using Sudoscan | Baseline, 3 months after the beginning of the treatment (day 90), and 1 month after the end of the treatment (Day 180) | The body conductance will be used to assess the evolution of the Impact of the neurostimulation on the sympathetic nervous system and on the small fiber neuropathy. |
| Modifications of the sensori-motor cortical cards by using a MRI | Baseline, and 1 month after the end of the treatment (Day 180) | — |
| The Neuropathic Pain Symptom Inventory scale (NPSI) between the three groups | Baseline, 3 months after the beginning of the treatment (day 90), and 1 month after the end of the treatment (Day 180) | — |
Countries
France
Outcome results
None listed