NCT03877016

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2019

Typical duration for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 15, 2019

Completed
6 months until next milestone

Study Start

First participant enrolled

September 17, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

January 25, 2023

Status Verified

January 1, 2023

Enrollment Period

2 years

First QC Date

March 14, 2019

Last Update Submit

January 24, 2023

Conditions

Neuropathic Pain

Keywords

neuropathic painelectrical nerve stimulation therapypatient report outcomesnon-pharmalogical treatment

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • length of TENS daily use

    day7 after patient inclusion

  • length of TENS daily use

    day 35 after patient inclusion

Study Arms (2)

TENS Eco2

ACTIVE COMPARATOR

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

Procedure: TENS

actiTENS

EXPERIMENTAL

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

Procedure: TENS

Interventions

TENSPROCEDURE

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

TENS Eco2actiTENS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

CHU Amiens Picardie

Amiens, 80000, France

Location

CHD La Roche Sur Yon

La Roche-sur-Yon, 85000, France

Location

CHU de Nantes

Nantes, 44093, France

Location

APHP - Hopital Saint Antoine

Paris, 75571, France

Location

CHU de Toulouse

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Neuralgia

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and Analgesia

Study Officials

  • Eric SERRA, MD

    CHU Amiens

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2019

First Posted

March 15, 2019

Study Start

September 17, 2019

Primary Completion

October 1, 2021

Study Completion

October 1, 2021

Last Updated

January 25, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(5)