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

• Status: Unknown status
• Trial end date: 2019-10-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sublimed
• Collaborator: Eurofins Optimed
• Treatments: Analgesics

Criteria

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.