Pilot Study in Order to Evaluate Disconfort Among Outpatients Using actiTENS for Neuropathic Pain vs TENS ECO 2.

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.

Sponsors

Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Source Centre Hospitalier Universitaire, Amiens
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.

Overall Status Recruiting
Start Date September 17, 2019
Completion Date October 2021
Primary Completion Date October 2021
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Disconfort of using TENS (Electrical Nerve Stimulation Therapy) Eco2 versus actiTENS day7 after patient inclusion
Disconfort of using TENS (Electrical Nerve Stimulation Therapy) Eco2 versus actiTENS day 35 after patient inclusion
Secondary Outcome
Measure Time Frame
length of TENS daily use day7 after patient inclusion
length of TENS daily use day 35 after patient inclusion
Enrollment 72
Condition
Intervention

Intervention Type: Procedure

Intervention Name: TENS

Description: TENS Eco2 or actiTENS, both admitted and reimbursed in FRANCE according to regulation

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Eric SERRA, MD Principal Investigator CHU Amiens
Overall Contact

Last Name: Eric SERRA, MD

Phone: (33)322668820

Email: [email protected]

Location
Facility: Status: Contact: CHU Amiens Picardie ERIC SERRA [email protected]
Location Countries

France

Verification Date

July 2020

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: TENS Eco2

Type: Active Comparator

Description: TENS Eco2 is the classical device in patients with chronic neuropathic pain

Label: actiTENS

Type: Experimental

Description: ActiTENS is a new TENS device, that seems less cotraining.

Acronym QolTENS
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Primary Purpose: Other

Masking: None (Open Label)

Source: ClinicalTrials.gov