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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 72
- Locations
- 5
- Primary Endpoint
- Disconfort of using TENS (Electrical Nerve Stimulation Therapy) Eco2 versus actiTENS
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient covered by national health insurance
- •Patient able to express consent
- •Patient with neuropathic pain with DN4 (Douleur Neuropathique 4 Questions) > or = 4/
- •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
Arms & Interventions
TENS Eco2
TENS Eco2 is the classical device in patients with chronic neuropathic pain
Intervention: TENS (Procedure)
actiTENS
ActiTENS is a new TENS device, that seems less cotraining.
Intervention: TENS (Procedure)
Outcomes
Primary Outcomes
Disconfort of using TENS (Electrical Nerve Stimulation Therapy) Eco2 versus actiTENS
Time Frame: day 35 after patient inclusion
Discomfort evaluation will be determined by using VAS (Visual Analogue Scale)
Disconfort of using TENS (Electrical Nerve Stimulation Therapy) Eco2 versus actiTENS
Time Frame: day7 after patient inclusion
Discomfort evaluation will be determined by using VAS (Visual Analogue Scale)
Secondary Outcomes
- length of TENS daily use(day 35 after patient inclusion)
- length of TENS daily use(day7 after patient inclusion)