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

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.

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.

Study Overview

• Status: Completed
• Conditions: Neuropathic Pain
• Intervention / Treatment: Procedure: TENS

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eric SERRA, MD; Phone Number: (33)322668820; Email: serra.eric@chu-amiens.fr

Study Locations

• France
  • Amiens, France, 80000
    • CHU Amiens Picardie
  • La Roche-sur-Yon, France, 85000
    • CHD La Roche sur Yon
  • Nantes, France, 44093
    • CHU de Nantes
  • Paris, France, 75571
    • APHP - Hopital Saint Antoine
  • Toulouse, France, 31059
    • CHU de Toulouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens
• Investigators: Principal Investigator: Eric Serra, MD, CHU Amiens

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2019
• Primary Completion (Actual): October 1, 2021
• Study Completion (Actual): October 1, 2021

Study Registration Dates

• First Submitted: March 14, 2019
• First Submitted That Met QC Criteria: March 14, 2019
• First Posted (Actual): March 15, 2019

Study Record Updates

• Last Update Posted (Estimate): January 25, 2023
• Last Update Submitted That Met QC Criteria: January 24, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: neuropathic pain; electrical nerve stimulation therapy; patient report outcomes; non-pharmalogical treatment
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia
• Other Study ID Numbers: PI2018_843_0028

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No