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Comparison of the Efficacy, Tolerability and Safety of actiTENS to Those of Level 2 Analgesic Treatments.

Unknown statusNot applicableNCT03902340
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

This is a phase 3, multicentre, prospective, single-blind on principal efficacy criterion, 2 parallel groups, randomized, controlled clinical study comparing efficacy and safety of actiTENS versus systemic level 2 analgesics recommended for the treatment of moderate or severe, nociceptive, chronic pain in patients suffering from osteoarthritis of the knee.

Study details

Official title
Multicentre, Phase 3, Prospective Study With On-line Randomization, in Single Blind Conditions for the Primary Efficacy Endpoint, Controlled, in Two Parallel Groups, Comparing the Efficacy, Tolerability and Safety of actiTENS Versus Level 2 Systemic Analgesics Recommended for the Treatment of Chronic Nociceptive Pain of Moderate to Severe Intensity in Patients Suffering From Osteoarthritis of the Knee
Interventions
  • Device: ActiTENS
  • Drug: Level 2 Analgesic Treatments
Sponsor
Sublimed
Collaborators
Eurofins Optimed
Start date
2018-12-19
Primary completion
2019-06-30
Sex
All
Age range
from 18 Years to 55 Years
Results posted
No results posted in this snapshot
Countries
France
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Adult \> or = 55 years. * Being monitored by a rheumatologist in private practice or in a hospital. * Presenting nociceptive pain: * chronic (for at least 3 months), * secondary to knee osteoarthritis confirmed by x-ray: stage 2 and over according to Kellgren and Lawrence. * Of moderate to severe intensity equal to or above 4 on a numerical scale of 0-10. * In a situation of analgesic therapy failure for level 1 analgesics: * paracetamol and NSAIDS, * Prescribed at therapeutic dose : 4 g/d of paracetamol and 1200 mg/d of ibuprofen or equivalent (analgesic dose), * For at least 2 weeks, * Requiring a level 2 prescription. * Affiliated to social security insurance. * Informed of the concept and agreeing to use the TENS as a non-medicinal analgesic treatment. * Capable of understanding how to use the TENS and the level 2 analgesic treatments. * Intellectually and physically able to participate in the study in the opinion of the investigator. * Owns a Smartphone to be able to download the actiTENS application. Exclusion Criteria: * Current or previous allergy to the actiTENS electrodes. * On-going or planned pregnancy and absence of effective contraception (except for menopausal women). * Neuropathic pain with a DN4 result \> 4/10 or with a positive response to one or more questions in the DN4 clinical examination. * Osteoarthritis flare. * Surgery planned in the following 6 months. * History of multiple operations on the knee concerned. * Medicinal or non-medicinal treatments which could influence the pathology being studied. * Modification of medicinal or non-medicinal treatments planned in the following 6 months. * Current participation in another study. * Presence of another painful condition which could perturb the evaluation. * Patient with an absolute contraindication to TENS or level 2 systemic analgesic treatments recommended for the treatment of chronic pain of moderate or severe intensity. * Patient unable to express his/her consent or deprived of liberty. * Patient with cognitive disorder or behaviour rendering him/her unsuitable to follow the instructions for this study. * Patient not affiliated to a social security system.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03902340