An interventional study of CEFAR Primo Pro (TENS device) in Neuropathic Pain and Radiculopathy, sponsored by Lille Catholic University. Completed at 4 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-01-11.
Sponsored by Lille Catholic University · Not applicable, Interventional, and Treatment
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.
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.
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This study's enrollment of 74 is above the median of 52 across 973 interventional studies indexed under Neuralgia.
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Exclusion Criteria:
Patients randomized in this arm will test cTENS mode first, the subjects will be crossed over to the mTENS form
Device: 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
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.
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
Time frame: day 30, day 60
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)
Time frame: day 60
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
Time frame: day 30, day 60
Rate of patient compliance
Rate of TENS sessions completed by the patient compared to the number of sessions prescribed for each mode
Time frame: day 30, day 60
Rate of patients with adverse events
Rate of patients with adverse events definitely or possibly attributable to neurostimulation for each type
Time frame: day 30, day 60, day 180
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.
Time frame: day 30, day 60
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
Time frame: day 60
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
Time frame: day 30, day 60
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
Time frame: day 180
Rate of therapeutic persistence according toTENS mode
Time frame: day 180
This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Lille Catholic University