Comparison of Two Modes of Transcutaneous Electrical Nerve Stimulation (TENS) in Chronic Neuropathic Radiculalgia

  • STATUS
    Recruiting
  • End date
    Oct 24, 2021
  • participants needed
    74
  • sponsor
    Lille Catholic University
Updated on 24 January 2021
Investigator
Amélie lansiaux, MD, PhD
Primary Contact
GHICL (0.1 mi away) Contact
+4 other location
pain relief
electrical stimulation
transcutaneous electrical nerve stimulation

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.

Description

TENS is already recommended in clinical practice to treat chronic neuropathic pain. The objective of this study is to compare the efficacy of 2 different modes of TENS: conventional TENS (c-TENS) and mixed-frequency TENS (m-TENS). Randomization will determine the mode that the patient has to test during the first month.

Each patient will test successively each mode during 1 month at home (3 sessions 1 hour/day). Then, the patient will test the other mode during the second month. Up to 6 months, the patient will be free to use the mode of TENS he wants.

Details
Condition Radiculopathy, Peripheral Neuropathy, Neuralgia, Pain, Post-Surgical Pain, Pain (Pediatric), neuropathic pain
Treatment CEFAR Primo Pro (TENS device)
Clinical Study IdentifierNCT04169477
SponsorLille Catholic University
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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