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

Not Applicable

Completed

• Conditions: Neuropathic Pain
• Interventions: Procedure: TENS

• Registration Number: NCT03877016
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-14
• Study First Submitted QC: 2019-03-14
• Study First Posted: 2019-03-15
• Study Start: 2019-09-17
• Primary Completion: 2021-10-01
• Study Completion: 2021-10-01
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-24
• Last Update Posted: 2023-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
actiTENS	TENS	ActiTENS is a new TENS device, that seems less cotraining.
TENS Eco2	TENS	TENS Eco2 is the classical device in patients with chronic neuropathic pain

Primary Outcome Measures

Name	Time	Method
Disconfort of using TENS (Electrical Nerve Stimulation Therapy) Eco2 versus actiTENS	day 35 after patient inclusion	Discomfort evaluation will be determined by using VAS (Visual Analogue Scale)

Secondary Outcome Measures

Name	Time	Method
length of TENS daily use	day 35 after patient inclusion	Length of TENS daily use

Trial Locations

Locations (5)

CHU Amiens Picardie; 🇫🇷 Amiens, France

CHD La Roche Sur Yon; 🇫🇷 La Roche-sur-Yon, France

CHU de Nantes; 🇫🇷 Nantes, France

APHP - Hopital Saint Antoine; 🇫🇷 Paris, France

CHU de Toulouse; 🇫🇷 Toulouse, France