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

NCT01918826 | Unknown

• 1 other identifier: 11-AOI-06
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

CHARCOT MARIE TOOTH DISEASE

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale

  At 3 month

Study Arms (2)

TENS active

ACTIVE COMPARATOR

NEUROSTIMULATION TRANSCUTANEE AIMED ANALGESIC ACTIVE

Device: TENS

TENS placebo

PLACEBO COMPARATOR

NEUROSTIMULATION TRANSCUTANEE AIMED ANALGESIC PLACEBO

Device: TENS

Interventions

TENS DEVICE

TENS active; TENS placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 under guardianship or deprived of all his liberties

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice

Nice, 06000, France

RECRUITING

MeSH Terms

Conditions

Charcot-Marie-Tooth Disease

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Hereditary Sensory and Motor Neuropathy; Nervous System Malformations; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Cécile RIBIERE

  CHU NICE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cécile RIBIERE, Dr

CONTACT

04 92 03 55 05; ribiere.c@chu-nice.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2012
• First Posted: August 8, 2013
• Study Start: June 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: August 8, 2013

Record last verified: 2012-07

Locations

FR (1)