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

Lille Catholic University

Status: Completed

Conditions: Radiculopathy; Neuropathic Pain

Treatments: Device: CEFAR Primo Pro (TENS device)

Study type: Interventional

Funder types: Other

Identifiers

NCT04169477

RC-P0080

2018-A03074-51 ID RCB (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 74 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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74 participants in 2 patient groups

cTENS-mTENS

Experimental group

Description:

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

Treatment:

Device: CEFAR Primo Pro (TENS device)

mTENS-cTENS

Experimental group

Description:

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

Treatment:

Device: CEFAR Primo Pro (TENS device)