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

Neuropathic Pain Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03877016
• Other study ID #: PI2018_843_0028
• Status: Completed
• Phase: N/A
• Start date: September 17, 2019
• Est. completion date: October 1, 2021

Study information

• Verified date: January 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: October 1, 2021
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain

Intervention

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

Locations

Country	Name	City	State
France	CHU Amiens Picardie	Amiens
France	CHD La Roche Sur Yon	La Roche-sur-Yon
France	CHU de Nantes	Nantes
France	APHP - Hopital Saint Antoine	Paris
France	CHU de Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disconfort of using TENS (Electrical Nerve Stimulation Therapy) Eco2 versus actiTENS	Discomfort evaluation will be determined by using VAS (Visual Analogue Scale)	day7 after patient inclusion
Primary	Disconfort of using TENS (Electrical Nerve Stimulation Therapy) Eco2 versus actiTENS	Discomfort evaluation will be determined by using VAS (Visual Analogue Scale)	day 35 after patient inclusion
Secondary	length of TENS daily use	Length of TENS daily use	day7 after patient inclusion
Secondary	length of TENS daily use	Length of TENS daily use	day 35 after patient inclusion