Evaluation of the Analgesic Efficiency of the Transcutaneous Neurostimulation in the Charcot Syndrome Marie Tooth on the Pains of Lower Limbs
Primary Purpose
CHARCOT MARIE TOOTH DISEASE
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
TENS
Sponsored by
About this trial
This is an interventional treatment trial for CHARCOT MARIE TOOTH DISEASE
Eligibility 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
Sites / Locations
- CHU de NiceRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
TENS active
TENS placebo
Arm Description
NEUROSTIMULATION TRANSCUTANEE AIMED ANALGESIC ACTIVE
NEUROSTIMULATION TRANSCUTANEE AIMED ANALGESIC PLACEBO
Outcomes
Primary Outcome Measures
Visual Analogue Scale
Secondary Outcome Measures
Full Information
NCT ID
NCT01918826
First Posted
July 20, 2012
Last Updated
August 7, 2013
Sponsor
Centre Hospitalier Universitaire de Nice
1. Study Identification
Unique Protocol Identification Number
NCT01918826
Brief Title
Evaluation of the Analgesic Efficiency of the Transcutaneous Neurostimulation in the Charcot Syndrome Marie Tooth on the Pains of Lower Limbs
Official Title
Evaluation of the Analgesic Efficiency of the Transcutaneous Neurostimulation in the Charcot Syndrome Marie Tooth on the Pains of Lower Limbs
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Unknown status
Study Start Date
June 2012 (undefined)
Primary Completion Date
August 2013 (Anticipated)
Study Completion Date
August 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CHARCOT MARIE TOOTH DISEASE
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TENS active
Arm Type
Active Comparator
Arm Description
NEUROSTIMULATION TRANSCUTANEE AIMED ANALGESIC ACTIVE
Arm Title
TENS placebo
Arm Type
Placebo Comparator
Arm Description
NEUROSTIMULATION TRANSCUTANEE AIMED ANALGESIC PLACEBO
Intervention Type
Device
Intervention Name(s)
TENS
Primary Outcome Measure Information:
Title
Visual Analogue Scale
Time Frame
At 3 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cécile RIBIERE, Dr
Phone
04 92 03 55 05
Email
ribiere.c@chu-nice.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cécile RIBIERE
Organizational Affiliation
CHU Nice
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Nice
City
Nice
ZIP/Postal Code
06000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cécile RIBIERE, Dr
Phone
04 92 03 55 05
Email
ribiere.c@chu-nice.fr
First Name & Middle Initial & Last Name & Degree
Cécile RIBIERE, Dr
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Analgesic Efficiency of the Transcutaneous Neurostimulation in the Charcot Syndrome Marie Tooth on the Pains of Lower Limbs
We'll reach out to this number within 24 hrs