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

Neuropathic Pain Clinical Trial

— CROSS-TENS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04169477
• Other study ID #: RC-P0080
• Secondary ID: 2018-A03074-51 I
• Status: Completed
• Phase: N/A
• Start date: October 8, 2019
• Est. completion date: October 5, 2022

Study information

• Verified date: January 2023
• Source: Lille Catholic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: October 5, 2022
• Est. primary completion date: May 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain
• Radiculopathy

Intervention

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.

Locations

Country	Name	City	State
France	CH Béthune	Béthune
France	CHU Lille	Lille
France	GHICL	Lomme
France	CH Roubaix	Roubaix

Sponsors (1)

Lead Sponsor	Collaborator
Lille Catholic University

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Rate of therapeutic persistence according toTENS mode		day 180