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Completed

NCT Number: NCT04169477

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

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.

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Key information

Conditions

Neuropathic Pain Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Radiculopathy Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CH Béthune, Béthune, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: day 30, day 60

    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

Secondary outcomes

  1. Patient preference rate

    Time frame: day 60

    After having tested each mode during one month, the patients will be asked to give their preference (c-TENS or m-TENS)

  2. Patient Global Impression of Change (PGIC)

    Time frame: day 30, day 60

    Patient Global Impression of Change is a 7-point scale used by the patient to rate the severity of the patient's illness at the time of assessment being 1 equivalent to no change or worsening and 7 to very much improved, making a difference

  3. Rate of patient compliance

    Time frame: day 30, day 60

    Rate of TENS sessions completed by the patient compared to the number of sessions prescribed for each mode

  4. Rate of patients with adverse events

    Time frame: day 30, day 60, day 180

    Rate of patients with adverse events definitely or possibly attributable to neurostimulation for each type

  5. Brief pain inventory (impact on daily life) (BPI)

    Time frame: day 30, day 60

    The BPI allows patients to rate the severity of their pain and the degree to which their pain interferes with common dimensions of feeling and function. There are line drawings of the front and back of a human body on which patients mark the location of their pain. In addition, patients fill out 11 different questions about pain intensity (present as well as least, most, and average for the past 24 hours) and the effect of the pain on their ability to function during various activities of daily living (pain interference items) rated on 0-10 scales being equivalent to no interference and 10 to complete interference.

  6. Mean of post-effect delay

    Time frame: day 60

    for each mode of TENS, patient estimation between end of a TENS session and return to initial intensity of the pain (calculated from patient journal completed every day during the 2 first months of the study

  7. Visual analog scale for evaluation of radiculalgia one month after

    Time frame: day 30, day 60

    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

  8. Visual analog scale for evaluation of radiculalgia six months after

    Time frame: day 180

    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

  9. Rate of therapeutic persistence according toTENS mode

    Time frame: day 180

Sponsors and collaborators

Lead sponsor

Lille Catholic University

Other

Registry information

Official study title

Superiority, Prospective, Multicentric, Randomized, Single-blind, Cross-over Study Comparing 2 Modes of Transcutaneous Electrical Nerve Stimulation (TENS) in Chronic Neuropathic Radiculalgia

Acronym: CROSS-TENS

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Nov 20, 2019
Registry last updated
Jan 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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