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

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

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-17

Study Completion Date

2021-10-01

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.

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Detailed Description

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Conditions

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Neuropathic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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TENS Eco2

TENS Eco2 is the classical device in patients with chronic neuropathic pain

Group Type ACTIVE_COMPARATOR

TENS

Intervention Type PROCEDURE

TENS Eco2 or actiTENS, both admitted and reimbursed in FRANCE according to regulation

actiTENS

ActiTENS is a new TENS device, that seems less cotraining.

Group Type EXPERIMENTAL

TENS

Intervention Type PROCEDURE

TENS Eco2 or actiTENS, both admitted and reimbursed in FRANCE according to regulation

Interventions

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TENS

TENS Eco2 or actiTENS, both admitted and reimbursed in FRANCE according to regulation

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No