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Completed

NCT Number: NCT03877016

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

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.

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Key information

Conditions

Neuropathic Pain Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Amiens Picardie, Amiens, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TENS

Procedure

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

Primary outcomes

  1. 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)

  2. 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)

Secondary outcomes

  1. length of TENS daily use

    Time frame: day7 after patient inclusion

    Length of TENS daily use

  2. length of TENS daily use

    Time frame: day 35 after patient inclusion

    Length of TENS daily use

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Official study 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.

Acronym: QolTENS

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Mar 15, 2019
Registry last updated
Jan 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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