Back to resultsComparison of Two Modes of Transcutaneous Electrical Nerve Stimulation (TENS) in Chronic Neuropathic Radiculalgia (CROSS-TENS)
Primary Purpose
Neuropathic Pain, Radiculopathy
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
CEFAR Primo Pro (TENS device)
Sponsored by
About this trial
This is an interventional treatment trial for Neuropathic Pain focused on measuring TENS
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
Sites / Locations
- CH Béthune
- CHU Lille
- GHICL
- CH Roubaix
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
cTENS-mTENS
mTENS-cTENS
Arm Description
Patients randomized in this arm will test cTENS mode first, the subjects will be crossed over to the mTENS form
Patients randomized in this arm will test mTENS mode first, the subjects will be cross over to the cTENS mode
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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)
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
Rate of patient compliance
Rate of TENS sessions completed by the patient compared to the number of sessions prescribed for each mode
Rate of patients with adverse events
Rate of patients with adverse events definitely or possibly attributable to neurostimulation for each type
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.
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
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
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
Rate of therapeutic persistence according toTENS mode
Full Information
NCT ID
NCT04169477
First Posted
November 5, 2019
Last Updated
January 10, 2023
Sponsor
Lille Catholic University
1. Study Identification
Unique Protocol Identification Number
NCT04169477
Brief Title
Comparison of Two Modes of Transcutaneous Electrical Nerve Stimulation (TENS) in Chronic Neuropathic Radiculalgia
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
October 8, 2019 (Actual)
Primary Completion Date
May 5, 2022 (Actual)
Study Completion Date
October 5, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lille Catholic University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pain, Radiculopathy
Keywords
TENS
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
cTENS-mTENS
Arm Type
Experimental
Arm Description
Patients randomized in this arm will test cTENS mode first, the subjects will be crossed over to the mTENS form
Arm Title
mTENS-cTENS
Arm Type
Experimental
Arm Description
Patients randomized in this arm will test mTENS mode first, the subjects will be cross over to the cTENS mode
Intervention Type
Device
Intervention Name(s)
CEFAR Primo Pro (TENS device)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the visual analog scale for evaluation of radiculalgia (from 0 to 100)
Description
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
Secondary Outcome Measure Information:
Title
Patient preference rate
Description
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
Title
Patient Global Impression of Change (PGIC)
Description
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
Title
Rate of patient compliance
Description
Rate of TENS sessions completed by the patient compared to the number of sessions prescribed for each mode
Time Frame
day 30, day 60
Title
Rate of patients with adverse events
Description
Rate of patients with adverse events definitely or possibly attributable to neurostimulation for each type
Time Frame
day 30, day 60, day 180
Title
Brief pain inventory (impact on daily life) (BPI)
Description
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
Title
Mean of post-effect delay
Description
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
Title
Visual analog scale for evaluation of radiculalgia one month after
Description
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
Title
Visual analog scale for evaluation of radiculalgia six months after
Description
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
Title
Rate of therapeutic persistence according toTENS mode
Time Frame
day 180
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincent Ducoulombier, MD
Organizational Affiliation
GHICL
Official's Role
Principal Investigator
Facility Information:
Facility Name
CH Béthune
City
Béthune
ZIP/Postal Code
62408
Country
France
Facility Name
CHU Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
GHICL
City
Lomme
ZIP/Postal Code
59462
Country
France
Facility Name
CH Roubaix
City
Roubaix
ZIP/Postal Code
59100
Country
France
12. IPD Sharing Statement
Learn more about this trial
Comparison of Two Modes of Transcutaneous Electrical Nerve Stimulation (TENS) in Chronic Neuropathic Radiculalgia
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