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

Centre Hospitalier Universitaire, Amiens

Status: Completed

Conditions: Neuropathic Pain

Treatments: Procedure: TENS

Study type: Interventional

Funder types: Other

Identifiers

NCT03877016

PI2018_843_0028

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

TENS Eco2

Active Comparator group

Description:

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

Treatment:

Procedure: TENS

actiTENS

Experimental group

Description:

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

Treatment:

Procedure: TENS