NCT04169477

Brief Summary

This study will compare 2 types of Transcutaneous Electrical Nerve Stimulation (TENS) to treat chronic neuropathic pain. TENS involves the application of electrical stimulation to the skin via surface electrodes to stimulate nerve fibres for pain relief.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2019

Typical duration for not_applicable

Geographic Reach
1 country

4 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

Study Start

First participant enrolled

October 8, 2019

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

November 5, 2019

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 20, 2019

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2022

Completed
Last Updated

January 11, 2023

Status Verified

January 1, 2023

Enrollment Period

2.6 years

First QC Date

November 5, 2019

Last Update Submit

January 10, 2023

Conditions

Neuropathic PainRadiculopathy

Keywords

TENS

Outcome Measures

Primary Outcomes (1)

  • Change in the visual analog scale for evaluation of radiculalgia (from 0 to 100)

    Visual analogue scales are 10-cm lines anchored at the ends by words that define the bounds of various pain dimensions. The patient is asked to place a vertical mark on the scale to indicate the level of intensity of his or her pain being 0 equivalent to no pain and 100 to the worst possible pain

    day 30, day 60

Secondary Outcomes (9)

  • Patient preference rate

    day 60

  • Patient Global Impression of Change (PGIC)

    day 30, day 60

  • Rate of patient compliance

    day 30, day 60

  • Rate of patients with adverse events

    day 30, day 60, day 180

  • Brief pain inventory (impact on daily life) (BPI)

    day 30, day 60

  • +4 more secondary outcomes

Study Arms (2)

cTENS-mTENS

EXPERIMENTAL

Patients randomized in this arm will test cTENS mode first, the subjects will be crossed over to the mTENS form

Device: CEFAR Primo Pro (TENS device)

mTENS-cTENS

EXPERIMENTAL

Patients randomized in this arm will test mTENS mode first, the subjects will be cross over to the cTENS mode

Device: CEFAR Primo Pro (TENS device)

Interventions

CEFAR Primo Pro (TENS device)DEVICE

During the first month: Patients will have to test 3 sessions of TENS 1 hour/day. Depending on their arm assigned by randomization, patients will begin with c-TENS or m-TENS. \[Cross-over\] During the second month: Patients will test the other type they do not have used yet according to the following scheme: 3 sessions of 1 hour, each day. In this way, all patients will test successively the 2 different modes. After the end of the second month and up to the end of their participation (6 months after randomization) patients will be free to use the mode of TENS they prefer.

cTENS-mTENSmTENS-cTENS

Eligibility Criteria

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

You may qualify if:

  • Patients aged 18 years old or older
  • Patients with chronic neuropathic radiculalgia from at least 3 months of evolution
  • Radiculalgia VAS \> or egal to 40/100
  • Neuropathic pain diagnostic (DN4) score \> or egal to 4
  • Patient who has accepted to participate in the study by signing the informed consent form

You may not qualify if:

  • Pregnancy
  • Dermatosis in the painful dermatome
  • Venous or arterial thrombosis of the lower limbs
  • Patient with active implantable medical device
  • Severe cognitive disorders
  • Patient under a legal protection regime(guardianship/curatorship/guardianship of justice)
  • Previous use of TENS to treat radiculalgia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

CH Béthune

Béthune, 62408, France

Location

CHU Lille

Lille, 59037, France

Location

GHICL

Lomme, 59462, France

Location

CH Roubaix

Roubaix, 59100, France

Location

MeSH Terms

Conditions

NeuralgiaRadiculopathy

Condition Hierarchy (Ancestors)

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

Study Officials

  • Vincent Ducoulombier, MD

    GHICL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2019

First Posted

November 20, 2019

Study Start

October 8, 2019

Primary Completion

May 5, 2022

Study Completion

October 5, 2022

Last Updated

January 11, 2023

Record last verified: 2023-01

Locations

FR(4)