Informations générales (source: ClinicalTrials.gov)
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 (ArthroTENS)
Interventional
N/A
Sublimed (Voir sur ClinicalTrials)
décembre 2018
octobre 2019
29 juin 2024
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.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Hôpital Roger Salengro - Lille - France | Bernard Cortet, PhD, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
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.
- 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.
- 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.