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

NCT ID: NCT01918826

Last Updated: 2013-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2013-08-31

Brief Summary

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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).

Detailed Description

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Conditions

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CHARCOT MARIE TOOTH DISEASE

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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TENS active

NEUROSTIMULATION TRANSCUTANEE AIMED ANALGESIC ACTIVE

Group Type ACTIVE_COMPARATOR

TENS

Intervention Type DEVICE

TENS placebo

NEUROSTIMULATION TRANSCUTANEE AIMED ANALGESIC PLACEBO

Group Type PLACEBO_COMPARATOR

TENS

Intervention Type DEVICE

Interventions

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TENS

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cécile RIBIERE

Role: PRINCIPAL_INVESTIGATOR

CHU NICE

Locations

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CHU de Nice

Nice, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Cécile RIBIERE, Dr

Role: CONTACT

Phone: 04 92 03 55 05

Email: [email protected]

Facility Contacts

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Cécile RIBIERE, Dr

Role: primary

Other Identifiers

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11-AOI-06

Identifier Type: -

Identifier Source: org_study_id