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

Not Applicable

Completed

• Conditions: Neuropathic Pain; Radiculopathy
• Interventions: Device: CEFAR Primo Pro (TENS device)

• Registration Number: NCT04169477
• Lead Sponsor: Lille Catholic University

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.

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 Timeline

• Study Start: 2019-10-08
• Study First Submitted: 2019-11-05
• Study First Submitted QC: 2019-11-18
• Study First Posted: 2019-11-20
• Primary Completion: 2022-05-05
• Study Completion: 2022-10-05
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-10
• Last Update Posted: 2023-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
cTENS-mTENS	CEFAR Primo Pro (TENS device)	Patients randomized in this arm will test cTENS mode first, the subjects will be crossed over to the mTENS form
mTENS-cTENS	CEFAR Primo Pro (TENS device)	Patients randomized in this arm will test mTENS mode first, the subjects will be cross over to the cTENS mode

Primary Outcome Measures

Name	Time	Method
Change in the visual analog scale for evaluation of radiculalgia (from 0 to 100)	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 Outcome Measures

Name	Time	Method
Patient preference rate	day 60	After having tested each mode during one month, the patients will be asked to give their preference (c-TENS or m-TENS)
Patient Global Impression of Change (PGIC)	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
Rate of patient compliance	day 30, day 60	Rate of TENS sessions completed by the patient compared to the number of sessions prescribed for each mode
Rate of patients with adverse events	day 30, day 60, day 180	Rate of patients with adverse events definitely or possibly attributable to neurostimulation for each type
Brief pain inventory (impact on daily life) (BPI)	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.
Mean of post-effect delay	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
Visual analog scale for evaluation of radiculalgia one month after	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
Visual analog scale for evaluation of radiculalgia six months after	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
Rate of therapeutic persistence according toTENS mode	day 180

Trial Locations

Locations (4)

CHU Lille; 🇫🇷 Lille, France

CH Béthune; 🇫🇷 Béthune, France

GHICL; 🇫🇷 Lomme, France

CH Roubaix; 🇫🇷 Roubaix, France