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

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.

Study Overview

• Status: Completed
• Conditions: Radiculopathy; Neuropathic Pain
• Intervention / Treatment: Device: CEFAR Primo Pro (TENS device)

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.

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Melody Plets, MSc; Phone Number: +33 03 20 22 57 33; Email: plets.melody@ghicl.net

Study Locations

• France
  • Béthune, France, 62408
    • CH Bethune
  • Lille, France, 59037
    • CHU Lille
  • Lomme, France, 59462
    • GHICL
  • Roubaix, France, 59100
    • CH Roubaix

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: cTENS-mTENS; 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); 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.
Experimental: mTENS-cTENS; 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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	day 60
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	day 30, day 60
Rate of patient compliance	Rate of TENS sessions completed by the patient compared to the number of sessions prescribed for each mode	day 30, day 60
Rate of patients with adverse events	Rate of patients with adverse events definitely or possibly attributable to neurostimulation for each type	day 30, day 60, day 180
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.	day 30, day 60
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	day 60
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	day 30, day 60
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	day 180
Rate of therapeutic persistence according toTENS mode		day 180

Collaborators and Investigators

• Sponsor: Lille Catholic University
• Investigators: Principal Investigator: Vincent Ducoulombier, MD, GHICL

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2019
• Primary Completion (Actual): May 5, 2022
• Study Completion (Actual): October 5, 2022

Study Registration Dates

• First Submitted: November 5, 2019
• First Submitted That Met QC Criteria: November 18, 2019
• First Posted (Actual): November 20, 2019

Study Record Updates

• Last Update Posted (Estimate): January 11, 2023
• Last Update Submitted That Met QC Criteria: January 10, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: TENS
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia; Radiculopathy
• Other Study ID Numbers: RC-P0080; 2018-A03074-51 ID RCB (Other Identifier: ANSM France)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No