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

Knee Osteoarthritis Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

Osteoarthritis (OA) is a debilitating chronic condition requiring long-term treatment of pain and inducing functional impairment. More specifically knee osteoarthritis (KOA) is a common disease associated with significant morbidity. Its prevalence increases with age dramatically. KOA is frequently associated with pain which can worsen with daily activities. The goals of KOA treatments are to provide pain relief and to improve function and quality of life. For the American college of Rheumatology and despite the frequent use of TENS in treating patients with KOA, questions remained regarding its efficacy. Consequently TENS needs additional clinical studies to demonstrate its efficacy in management of painful osteoarthritis.

The main objective of this study is to demonstrate the efficacy and to the safety of TENS in the management of chronic, nociceptive pain in patient suffering from KOA. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03902340
Study type Interventional
Source Sublimed
Contact Patricia Abraham Briffod
Phone +33 4 76 37 17 58
Email contact@subli-med.com
Status Recruiting
Phase N/A
Start date December 19, 2018
Completion date October 31, 2019
View Details
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