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Neuropathic PainCROSS-TENSNCT04169477

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

A study testing CEFAR Primo Pro (TENS device) in people with Neuropathic Pain and Radiculopathy, run by Lille Catholic University at 4 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neuropathic Pain, Radiculopathy
What is being tested?
CEFAR Primo Pro (TENS device)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
74 participants
Where
4 sitesFrance
Study dates
8 Oct 2019to 5 Oct 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

4 sites in 1 country.

France4 sites

  • CH Béthune

    Béthune, 62408

  • CHU Lille

    Lille, 59037

  • GHICL

    Lomme, 59462

  • CH Roubaix

    Roubaix, 59100

Other trials in France

About this study

Official title: Superiority, Prospective, Multicentric, Randomized, Single-blind, Cross-over Study Comparing 2 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.

Read the detailed 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.

Being tested
CEFAR Primo Pro (TENS device)
Keywords
TENS
Medical subject headings
Neuralgia, Radiculopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT04169477
Study groupRoleWhat they receive
cTENS-mTENSExperimentalPatients randomized in this arm will test cTENS mode first, the subjects will be crossed over to the mTENS form
Receives: Device: CEFAR Primo Pro (TENS device)
mTENS-cTENSExperimentalPatients randomized in this arm will test mTENS mode first, the subjects will be cross over to the cTENS mode
Receives: Device: CEFAR Primo Pro (TENS device)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: day 30, day 60

Secondary outcomes (9)

  1. Patient preference rate

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

    Measured: day 60

  2. Patient Global Impression of Change (PGIC)

    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

    Measured: day 30, day 60

  3. Rate of patient compliance

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

    Measured: day 30, day 60

  4. Rate of patients with adverse events

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

    Measured: day 30, day 60, day 180

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

    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.

    Measured: day 30, day 60

  6. Mean of post-effect delay

    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

    Measured: day 60

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

    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

    Measured: day 30, day 60

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

    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

    Measured: day 180

  9. Rate of therapeutic persistence according toTENS mode

    Measured: day 180

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2019
  2. Study start8 Oct 2019
  3. Primary completion5 May 2022
  4. Study completion5 Oct 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04169477
Sponsor's protocol ID
RC-P0080
Other IDs
2018-A03074-51 ID RCB
Acronym
CROSS-TENS
Status last verified
Jan 2023
First submitted
5 Nov 2019
Last updated
11 Jan 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing CEFAR Primo Pro (TENS device) in people with Neuropathic Pain and Radiculopathy, run by Lille Catholic University at 4 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the visual analog scale for evaluation of radiculalgia (from 0 to 100) (time frame: day 30, day 60). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04169477.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2023.

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