Evaluation of the Analgesic Efficiency of the Transcutaneous Neurostimulation in the Charcot Syndrome Marie Tooth on the Pains of Lower Limbs
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Purpose
The Charcot syndrome Marie Tooth is the most frequent hereditary neuromuscular diseases: there is no curative treatment at present, on the other hand precautionary measures can be taken (physiotherapy, port of splints, orthopaedic surgery and technical assistants). In the literature and in our recent study (evaluation of the pain in the disease of CMT - Reference center of the neuromuscular diseases - CHU Bow) the frequency of the pain is important varying from 66 to 96 % cases, affecting especially hands and lower limbs. The care of the pain in the Charcot syndrome Marie Tooth is not codified. The transcutaneous neurostimulation(TENS) is a not medicinal and not invasive therapeutics, without any brought back collateral effect, used at the same time in the chronic pain and acute since 1960, as well for the neuropathic pains that musculo-scrawny. No study was realized this day on the use of the TENS with analgesic aim in the CMT. We suggest studying the analgesic efficiency of the TENS in the Charcot syndrome Marie Tooth on the pains of lower limbs, the most frequent painful location in our recent works.
The main objective will be to analyze the improvement of the pain of lower limbs, based on the decrease of the analogical visual scale(ladder) (EVA), at least 30 %.
The secondary objectives will be to estimate repercussions on the functional capacities ( ONLS), the quality of life (SF(sci-fi) 12), the satisfaction (EVA), the global impression(printing) of change ( PGIC), the consumption of analgesic, DN4, NPSI (Neuropathic Pain Symptom Inventory), Concise Questionnaire of the Pains ( QCD), HAD (Hospital Anxiety and Depression scale).
| Condition | Intervention |
|---|---|
|
CHARCOT MARIE TOOTH DISEASE |
Device: TENS |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Evaluation of the Analgesic Efficiency of the Transcutaneous Neurostimulation in the Charcot Syndrome Marie Tooth on the Pains of Lower Limbs |
- Visual Analogue Scale [ Time Frame: At 3 month ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: TENS active
NEUROSTIMULATION TRANSCUTANEE AIMED ANALGESIC ACTIVE
|
Device: TENS |
|
Placebo Comparator: TENS placebo
NEUROSTIMULATION TRANSCUTANEE AIMED ANALGESIC PLACEBO
|
Device: TENS |
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age included between 18 and 75 years
- Affected by CMT confirmed on clinical, family criteria, electrophysiological and / or genetics
- pain ≥ 3 months
- EVA pain ≥ 4/10
- patient having given his written consent and lit(enlightened)
- patient susceptible to be followed regularly during at least 3 months
- Patient member to the Social Security
Exclusion Criteria:
- Expanding patients of associated neurological pathology
- Patients having resorted to the TENS in the last 3 months
- Medical history of cancers, collagen and quite other pathology which can interfere with the experimental procedure
- Patient carrier of a pacemaker or an active implantable medical device
- Cutaneous hurt on the territory to be stimulated
- Venous or arterial thrombosis or thrombophlebitis in the territory to be stimulated
- Patient participant in another biomedical research on the pain or the period of exclusion of which in a study is not ended
- Patient under guardianship or deprived of all his liberties
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01918826
| Contact: Cécile RIBIERE, Dr | 04 92 03 55 05 | ribiere.c@chu-nice.fr |
| France | |
| CHU de Nice | Recruiting |
| Nice, France, 06000 | |
| Contact: Cécile RIBIERE, Dr 04 92 03 55 05 ribiere.c@chu-nice.fr | |
| Principal Investigator: Cécile RIBIERE, Dr | |
| Principal Investigator: | Cécile RIBIERE | CHU Nice |
More Information
| Responsible Party: | Centre Hospitalier Universitaire de Nice |
| ClinicalTrials.gov Identifier: | NCT01918826 History of Changes |
| Other Study ID Numbers: | 11-AOI-06 |
| Study First Received: | July 20, 2012 |
| Last Updated: | August 7, 2013 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) France: Committee for the Protection of Personnes |
Additional relevant MeSH terms:
|
Charcot-Marie-Tooth Disease Nerve Compression Syndromes Hereditary Sensory and Motor Neuropathy Tooth Diseases Intermittent Claudication Stomatognathic Diseases Nervous System Malformations Nervous System Diseases Heredodegenerative Disorders, Nervous System Neurodegenerative Diseases Polyneuropathies Peripheral Nervous System Diseases |
Neuromuscular Diseases Congenital Abnormalities Genetic Diseases, Inborn Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases Signs and Symptoms Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on September 27, 2016