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

CHARCOT MARIE TOOTH DISEASE Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01918826
• Other study ID #: 11-AOI-06
• Status: Recruiting
• Phase: N/A
• First received: July 20, 2012
• Last updated: August 7, 2013
• Start date: June 2012
• Est. completion date: August 2013

Study information

• Verified date: July 2012
• Source: Centre Hospitalier Universitaire de Nice
• Contact: Cécile RIBIERE, Dr
• Phone: 04 92 03 55 05
• Email: ribiere.c[@]chu-nice.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• CHARCOT MARIE TOOTH DISEASE
• Charcot-Marie-Tooth Disease
• Hereditary Sensory and Motor Neuropathy
• Intermittent Claudication
• Nerve Compression Syndromes
• Tooth Diseases

Intervention

Device:
• TENS

Locations

Country	Name	City	State
France	CHU de Nice	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogue Scale		At 3 month	No