Knee Osteoarthritis
Conditions
Keywords
Pain, Knee osteoarthritis (KOA), Nociceptive pain, TENS, Step 2 analgesics
Brief 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.
Detailed 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.
Interventions
DEVICEActiTENS
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.
DRUGLevel 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): * 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.
Sponsors
Eurofins Optimed
Sublimed
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy : pain intensity evaluated by a numerus scale from 0 to 10 | 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 | 3 months after dosing | Number of adverse events (AE) occurred during the 3 months of follow-up and due to studied treatments. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy : pain relief (PAR) evaluated by the pain visual analogue scale (VAS) | 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 | 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. | 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 | Through study completion, an average of 6 months | Evaluation of the number of patient drop outs because of treatment inefficacy in each arm |
| Efficacy : pain intensity evaluated by a numerus scale from 0 to 10 | 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 |
| Safety : occurrence of Adverse Events (AE) | 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 | 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. | Through study completion, an average of 6 months | Comparison of treatment costs between the two arms |
| Efficacy : prolongation of studied treatment | Through study completion, an average of 6 months | Evaluation of the number of patient wishes to continue the studied treatment. |
| Efficacy : functional status evaluated by the WOMAC score (Western Onatario McMaster score) | 1, 3 and 6 months after dosing | Functional status (pain, function, stiffness) at M1, M3 and M6. |
Countries
France
Contacts
Primary ContactPatricia Abraham Briffod
Outcome results
None listed