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.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03877016

Acronym

QolTENS

Enrollment

Registered

2019-03-15

Start date

2019-09-17

Completion date

2021-10-01

Last updated

2023-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuropathic Pain

Keywords

neuropathic pain, electrical nerve stimulation therapy, patient report outcomes, non-pharmalogical treatment

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.

Interventions

PROCEDURETENS

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Disconfort of using TENS (Electrical Nerve Stimulation Therapy) Eco2 versus actiTENS	day7 after patient inclusion	Discomfort evaluation will be determined by using VAS (Visual Analogue Scale)

Secondary

Measure	Time frame	Description
length of TENS daily use	day7 after patient inclusion	Length of TENS daily use

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026