Pilot Study in Order to Evaluate Disconfort Among Outpatients Using actiTENS for Neuropathic Pain vs TENS ECO 2. (QolTENS)
Primary Purpose
Neuropathic Pain
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
TENS
Sponsored by
About this trial
This is an interventional other trial for Neuropathic Pain focused on measuring neuropathic pain, electrical nerve stimulation therapy, patient report outcomes, non-pharmalogical treatment
Eligibility Criteria
Inclusion Criteria:
- Adult
- Patient covered by national health insurance
- Patient able to express consent
- Patient with neuropathic pain with DN4 (Douleur Neuropathique 4 Questions) > or = 4/10.
- Actual or potential neurologic lesion
- Patient still using a TENS device
Exclusion Criteria:
- Planned surgery in the next two months
- Modification of the reatment in the next two motnhs
- Other study ongoing for the patient
- Medical contraindication for TENS
Sites / Locations
- CHU Amiens Picardie
- CHD La Roche Sur Yon
- CHU de Nantes
- APHP - Hopital Saint Antoine
- CHU de Toulouse
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
TENS Eco2
actiTENS
Arm Description
TENS Eco2 is the classical device in patients with chronic neuropathic pain
ActiTENS is a new TENS device, that seems less cotraining.
Outcomes
Primary Outcome Measures
Disconfort of using TENS (Electrical Nerve Stimulation Therapy) Eco2 versus actiTENS
Discomfort evaluation will be determined by using VAS (Visual Analogue Scale)
Disconfort of using TENS (Electrical Nerve Stimulation Therapy) Eco2 versus actiTENS
Discomfort evaluation will be determined by using VAS (Visual Analogue Scale)
Secondary Outcome Measures
length of TENS daily use
Length of TENS daily use
length of TENS daily use
Length of TENS daily use
Full Information
NCT ID
NCT03877016
First Posted
March 14, 2019
Last Updated
January 24, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
1. Study Identification
Unique Protocol Identification Number
NCT03877016
Brief Title
Pilot Study in Order to Evaluate Disconfort Among Outpatients Using actiTENS for Neuropathic Pain vs TENS ECO 2.
Acronym
QolTENS
Official Title
Prospective, Multicentric, Randomized on Two Arms, Controlled, by Cross-over, Pilot Study, in Order to Evaluate Disconfort Among Outpatients Using actiTENS for Neuropathic Pain vs TENS ECO 2.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
September 17, 2019 (Actual)
Primary Completion Date
October 1, 2021 (Actual)
Study Completion Date
October 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
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
Non-pharmacological treatments for pain relief are more and more used in clinical care although any scientific validation. Among the non-pharmacological treatments of neuropathic pain relief, TENS (Electrical Nerve Stimulation Therapy) is the major treatment with the best benefit. Unfortunately, the use of TENS by patients appears very difficult. Because of this inconvenience, more than 40% of TENS users interrupt the treatment despite treatment benefit. A new TENS device: actiTENS that seems to be less constraining than TENS is now available in France. ActiTENS efficacy and safety compared to TENS need to be investigated.
The main objective is to evaluate and to compare the use of actiTENS, with TENS Eco 2, the classical device in patients with chronic neuropathic pain.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pain
Keywords
neuropathic pain, electrical nerve stimulation therapy, patient report outcomes, non-pharmalogical treatment
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TENS Eco2
Arm Type
Active Comparator
Arm Description
TENS Eco2 is the classical device in patients with chronic neuropathic pain
Arm Title
actiTENS
Arm Type
Experimental
Arm Description
ActiTENS is a new TENS device, that seems less cotraining.
Intervention Type
Procedure
Intervention Name(s)
TENS
Intervention Description
TENS Eco2 or actiTENS, both admitted and reimbursed in FRANCE according to regulation
Primary Outcome Measure Information:
Title
Disconfort of using TENS (Electrical Nerve Stimulation Therapy) Eco2 versus actiTENS
Description
Discomfort evaluation will be determined by using VAS (Visual Analogue Scale)
Time Frame
day7 after patient inclusion
Title
Disconfort of using TENS (Electrical Nerve Stimulation Therapy) Eco2 versus actiTENS
Description
Discomfort evaluation will be determined by using VAS (Visual Analogue Scale)
Time Frame
day 35 after patient inclusion
Secondary Outcome Measure Information:
Title
length of TENS daily use
Description
Length of TENS daily use
Time Frame
day7 after patient inclusion
Title
length of TENS daily use
Description
Length of TENS daily use
Time Frame
day 35 after patient inclusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult
Patient covered by national health insurance
Patient able to express consent
Patient with neuropathic pain with DN4 (Douleur Neuropathique 4 Questions) > or = 4/10.
Actual or potential neurologic lesion
Patient still using a TENS device
Exclusion Criteria:
Planned surgery in the next two months
Modification of the reatment in the next two motnhs
Other study ongoing for the patient
Medical contraindication for TENS
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric SERRA, MD
Organizational Affiliation
CHU Amiens
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Amiens Picardie
City
Amiens
ZIP/Postal Code
80000
Country
France
Facility Name
CHD La Roche Sur Yon
City
La Roche-sur-Yon
ZIP/Postal Code
85000
Country
France
Facility Name
CHU de Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
APHP - Hopital Saint Antoine
City
Paris
ZIP/Postal Code
75571
Country
France
Facility Name
CHU de Toulouse
City
Toulouse
ZIP/Postal Code
31059
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pilot Study in Order to Evaluate Disconfort Among Outpatients Using actiTENS for Neuropathic Pain vs TENS ECO 2.
We'll reach out to this number within 24 hrs