An interventional study of ActiTENS and Level 2 Analgesic Treatments in Knee Osteoarthritis, sponsored by Sublimed. Status unknown at 1 site in France. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2019-04-04.
Sponsored by Sublimed · Not applicable, Interventional, and Treatment
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.
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.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's planned enrollment of 110 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Sublimed is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Presenting nociceptive pain:
In a situation of analgesic therapy failure for level 1 analgesics:
Exclusion Criteria:
Treatment by non-pharmacological transcutaneous electric nerve stimulation (TENS)
Device: ActiTENS
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
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.
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): * Tramadol immediate release formulation (IR, one intake every 6 hours) or prolonged release formulation (PR, one intake every 12 hours); maximum posology 400mg/24h. * Dihydrocodeine: 60mg every 12 hours; maximum posology 120mg/24h. * Combination of paracetamol and codeine in a fixed combination every 6 hours; maximum posology of codeine: 300mg/24h. * Combination of paracetamol and tramadol in a fixed combination; maximum posology of tramadol: 8 tablets/24h ie 300mg/24h.
Efficacy : pain intensity evaluated by a numerus scale from 0 to 10
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).
Time frame: 3 months after dosing
Safety : occurence of adverse events
Number of adverse events (AE) occurred during the 3 months of follow-up and due to studied treatments.
Time frame: 3 months after dosing
Efficacy : pain intensity evaluated by a numerus scale from 0 to 10
Minimum, maximum,median and difference of pain intensity (PI) during movement and at rest at M1, M3 and M6 between both treatment groups
Time frame: 1, 3 and 6 months after dosing
Efficacy : functional status evaluated by the WOMAC score (Western Onatario McMaster score)
Functional status (pain, function, stiffness) at M1, M3 and M6.
Time frame: 1, 3 and 6 months after dosing
Efficacy : pain relief (PAR) evaluated by the pain visual analogue scale (VAS)
Pain relief at M1, M3 and M6. VAS from 0 to 10 with 0 = no relief and 10 = total relief). Scale of 100 mm.
Time frame: 1, 3 and 6 months after dosing
Efficacy : quality of life evaluated by the questionnaire EuroQol-5D
Evaluation of the quality of life at M1, M3 and M6
Time frame: 1, 3 and 6 months after dosing
Efficacy : patient global impression of change evaluated by a global impression questionnaire.
Evaluation of the change on activity, symptoms, emotions, quality of life regarding the pain of patient at M1, M3 and M6
Time frame: 1, 3 and 6 months after dosing
Efficacy : drop-outs for inefficacy
Evaluation of the number of patient drop outs because of treatment inefficacy in each arm
Time frame: Through study completion, an average of 6 months
Efficacy : prolongation of studied treatment
Evaluation of the number of patient wishes to continue the studied treatment.
Time frame: Through study completion, an average of 6 months
Safety : occurrence of Adverse Events (AE)
Evaluation by the type of AE and the date of occurence
Time frame: Through study completion, an average of 6 months
Safety : drop-outs for AE and corrective treatments
Evaluation of the number of patient drop outs because of the occurence of adverse events in each arm
Time frame: Through study completion, an average of 6 months
Estimation of direct costs.
Comparison of treatment costs between the two arms
Time frame: Through study completion, an average of 6 months
Plan to share: No
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