Comparison of the Efficacy, Tolerability and Safety of actiTENS to Those of Level 2 Analgesic Treatments. (ArthroTENS)
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|ClinicalTrials.gov Identifier: NCT03902340|
Recruitment Status : Recruiting
First Posted : April 4, 2019
Last Update Posted : April 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Knee Osteoarthritis||Device: ActiTENS Drug: Level 2 Analgesic Treatments||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||110 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
|Actual Study Start Date :||December 19, 2018|
|Estimated Primary Completion Date :||June 30, 2019|
|Estimated Study Completion Date :||October 31, 2019|
Treatment by non-pharmacological transcutaneous electric nerve stimulation (TENS)
ActiTENS is a rechargeable box, weighing 64g attached by Velcro to an adhesive support, which can be positioned on the skin at any position chosen by the patient. The patient will use the programme (P4) prescribed by his doctor and will regulate the intensity of stimulation using an application downloaded to his smartphone which will communicate with the box via Bluetooth.
Active Comparator: level 2 systemic analgesic treatments
Treatment by level 2 analgesic pharmacological treatment indicated in the treatment of chronic nociceptive pain of moderate to severe intensity.
Drug: Level 2 Analgesic Treatments
There are 4 level 2 oral analgesic treatments indicated for chronic nociceptive pain of moderate to severe intensity (between 4 and 7 on a simple numerical scale of 11 points) (12):
- Efficacy : pain intensity evaluated by a numerus scale from 0 to 10 [ Time Frame: 3 months after dosing ]Pain intensity (PI) at M3 between both treatment groups. Numerus scale with a minimum of 0 (no pain) to a maximum of 10 (maximum pain).
- Safety : occurence of adverse events [ Time Frame: 3 months after dosing ]Number of adverse events (AE) occurred during the 3 months of follow-up and due to studied treatments.
- Efficacy : pain intensity evaluated by a numerus scale from 0 to 10 [ Time Frame: 1, 3 and 6 months after dosing ]Minimum, maximum,median and difference of pain intensity (PI) during movement and at rest at M1, M3 and M6 between both treatment groups
- Efficacy : functional status evaluated by the WOMAC score (Western Onatario McMaster score) [ Time Frame: 1, 3 and 6 months after dosing ]Functional status (pain, function, stiffness) at M1, M3 and M6.
- Efficacy : pain relief (PAR) evaluated by the pain visual analogue scale (VAS) [ Time Frame: 1, 3 and 6 months after dosing ]Pain relief at M1, M3 and M6. VAS from 0 to 10 with 0 = no relief and 10 = total relief). Scale of 100 mm.
- Efficacy : quality of life evaluated by the questionnaire EuroQol-5D [ Time Frame: 1, 3 and 6 months after dosing ]Evaluation of the quality of life at M1, M3 and M6
- Efficacy : patient global impression of change evaluated by a global impression questionnaire. [ Time Frame: 1, 3 and 6 months after dosing ]Evaluation of the change on activity, symptoms, emotions, quality of life regarding the pain of patient at M1, M3 and M6
- Efficacy : drop-outs for inefficacy [ Time Frame: Through study completion, an average of 6 months ]Evaluation of the number of patient drop outs because of treatment inefficacy in each arm
- Efficacy : prolongation of studied treatment [ Time Frame: Through study completion, an average of 6 months ]Evaluation of the number of patient wishes to continue the studied treatment.
- Safety : occurrence of Adverse Events (AE) [ Time Frame: Through study completion, an average of 6 months ]Evaluation by the type of AE and the date of occurence
- Safety : drop-outs for AE and corrective treatments [ Time Frame: Through study completion, an average of 6 months ]Evaluation of the number of patient drop outs because of the occurence of adverse events in each arm
- Estimation of direct costs. [ Time Frame: Through study completion, an average of 6 months ]Comparison of treatment costs between the two arms
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03902340
|Contact: Patricia Abraham Briffod||+33 4 76 37 17 email@example.com|
|Hôpital Roger Salengro||Recruiting|
|Contact: Bernard Cortet, PhD, MD|
|Principal Investigator:||Bernard CORTET, Pr||Hôpital Roger Salengro - Service de Rhumatologie|