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

NCT ID: NCT04169477

Last Updated: 2023-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-08
• Study Completion Date: 2022-10-05

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.

Conditions

Neuropathic Pain; Radiculopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

cTENS-mTENS

Patients randomized in this arm will test cTENS mode first, the subjects will be crossed over to the mTENS form

Group Type: EXPERIMENTAL

CEFAR Primo Pro (TENS device)

Intervention Type: 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.

mTENS-cTENS

Patients randomized in this arm will test mTENS mode first, the subjects will be cross over to the cTENS mode

Group Type: EXPERIMENTAL

CEFAR Primo Pro (TENS device)

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lille Catholic University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vincent Ducoulombier, MD

Role: PRINCIPAL_INVESTIGATOR

GHICL

Locations

CH Béthune

Béthune, , France

CHU Lille

Lille, , France

GHICL

Lomme, , France

CH Roubaix

Roubaix, , France

Countries

France

Other Identifiers

2018-A03074-51 ID RCB

Identifier Type: OTHER

Identifier Source: secondary_id

RC-P0080

Identifier Type: -

Identifier Source: org_study_id