Pilot Study in Order to Evaluate Disconfort Among Outpatients Using actiTENS for Neuropathic Pain vs TENS ECO 2.

Study Overview
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Brief Summary
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Non-pharmacological treatments for pain relief are more and more used in clinical care although any scientific validation. Among the non-pharmacological treatments of neuropathic pain relief, TENS (Electrical Nerve Stimulation Therapy) is the major treatment with the best benefit. Unfortunately, the use of TENS by patients appears very difficult. Because of this inconvenience, more than 40% of TENS users interrupt the treatment despite treatment benefit. A new TENS device: actiTENS that seems to be less constraining than TENS is now available in France. ActiTENS efficacy and safety compared to TENS need to be investigated. The main objective is to evaluate and to compare the use of actiTENS, with TENS Eco 2, the classical device in patients with chronic neuropathic pain.

Official Title
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Prospective, Multicentric, Randomized on Two Arms, Controlled, by Cross-over, Pilot Study, in Order to Evaluate Disconfort Among Outpatients Using actiTENS for Neuropathic Pain vs TENS ECO 2.

Conditions
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Neuropathic Pain

Intervention / Treatment
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* Procedure: TENS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult Patient covered by national health insurance Patient able to express consent Patient with neuropathic pain with DN4 (Douleur Neuropathique 4 Questions) > or = 4/10. Actual or potential neurologic lesion Patient still using a TENS device Exclusion Criteria: Planned surgery in the next two months Modification of the reatment in the next two motnhs Other study ongoing for the patient Medical contraindication for TENS

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TENS Eco2<br>TENS Eco2 is the classical device in patients with chronic neuropathic pain | Procedure: TENS<br>* TENS Eco2 or actiTENS, both admitted and reimbursed in FRANCE according to regulation<br>|
| Experimental: actiTENS<br>ActiTENS is a new TENS device, that seems less cotraining. | Procedure: TENS<br>* TENS Eco2 or actiTENS, both admitted and reimbursed in FRANCE according to regulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disconfort of using TENS (Electrical Nerve Stimulation Therapy) Eco2 versus actiTENS | Discomfort evaluation will be determined by using VAS (Visual Analogue Scale) | day7 after patient inclusion | 
| Disconfort of using TENS (Electrical Nerve Stimulation Therapy) Eco2 versus actiTENS | Discomfort evaluation will be determined by using VAS (Visual Analogue Scale) | day 35 after patient inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of TENS daily use | Length of TENS daily use | day7 after patient inclusion | 
| length of TENS daily use | Length of TENS daily use | day 35 after patient inclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neuropathic pain, electrical nerve stimulation therapy, patient report outcomes, non-pharmalogical treatment