Evaluation of the Analgesic Efficiency of the Transcutaneous Neurostimulation in the Charcot Syndrome Marie Tooth on the Pains of Lower Limbs

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Centre Hospitalier Universitaire de Nice.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT01918826
First received: July 20, 2012
Last updated: August 7, 2013
Last verified: July 2012
  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

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nice:

Primary Outcome Measures:
  • 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
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01918826

Contacts
Contact: Cécile RIBIERE, Dr 04 92 03 55 05 ribiere.c@chu-nice.fr

Locations
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         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
Principal Investigator: Cécile RIBIERE CHU Nice
  More Information

No publications provided

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
Tooth Diseases
Nervous System Diseases
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Genetic Diseases, Inborn
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Stomatognathic Diseases
Hereditary Sensory and Motor Neuropathy
Intermittent Claudication
Nervous System Malformations
Polyneuropathies
Congenital Abnormalities
Arteriosclerosis
Signs and Symptoms
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014