Clinical trial NCT04169477: Comparison of Two Modes of Transcutaneous Electrical Nerve Stimulation (TENS) in Chronic Neuropathic Radiculalgia
Official title: Superiority, Prospective, Multicentric, Randomized, Single-blind, Cross-over Study Comparing 2 Modes of Transcutaneous Electrical Nerve Stimulation (TENS) in Chronic Neuropathic Radiculalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuropathic Pain
Radiculopathy
Keywords: TENS
Lead sponsor: Lille Catholic University
Sponsor class: OTHER
First posted: 2019-11-20
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in the visual analog scale for evaluation of radiculalgia (from 0 to 100)
timeFrame: day 30, day 60
Secondary outcomes:
measure: Patient preference rate
timeFrame: day 60
measure: Patient Global Impression of Change (PGIC)
timeFrame: day 30, day 60
measure: Rate of patient compliance
timeFrame: day 30, day 60
measure: Rate of patients with adverse events
timeFrame: day 30, day 60, day 180
measure: Brief pain inventory (impact on daily life) (BPI)
timeFrame: day 30, day 60
measure: Mean of post-effect delay
timeFrame: day 60
measure: Visual analog scale for evaluation of radiculalgia one month after
timeFrame: day 30, day 60
measure: Visual analog scale for evaluation of radiculalgia six months after
timeFrame: day 180
measure: Rate of therapeutic persistence according toTENS mode
timeFrame: day 180
Other outcomes:
Locations:
city: Béthune
country: France
facility: CH Béthune
city: Lille
country: France
facility: CHU Lille
city: Lomme
country: France
facility: GHICL
city: Roubaix
country: France
facility: CH Roubaix
Study officials:
affiliation: GHICL
name: Vincent Ducoulombier, MD
role: PRINCIPAL_INVESTIGATOR
References: