About this trial
There is a lack of effective analgesic treatments to help walking patients with painful hip/knee osteoarthritis. Our team therefore imagined a new strategy lying on a multimodal rehabilitation walking program with the help of a transient intake of nonsteroidal anti-inflammatory drug (NSAID). NSAIDs are indeed known to act specifically on pain at movement, but their continuous intake would induce unacceptable side effects. To optimize the benefit/risk balance, the molecule to be chosen must fit to the patient's profile, and its intake should cover only the period of interest, i.e. planned walks. Our multimodal rehabilitation program will also include physical techniques such as appropriate footwear, a patient's education aiming at reducing fear/avoidance and spotting side effects of NSAIDs, and a prescription frame to avoid any overdosing.
This clinical study is a single-center, non-randomized, open label, one-arm trial, using drugs prescribed according to their label (i.e. osteoarthritis pain), pending a reinforced monitoring of side effects.
The primary endpoint is to evaluate efficacy and tolerance of a tailored and transient administration of NSAID within a rehabilitation walking program in patients with painful hip/knee osteoarthritis.
Secondary endpoints are to evaluate the adherence to the program and the factors influencing adherence; to identify the less well tolerated conditions of treatment (one condition being one molecule for one patient profile); to identify the factors of success among a set of baseline demographic, morphometric and psychometric variables; and to study the role of central sensitization (assessed by temporal summation) on the efficacy of treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Uni- or bilateral hip or knee idiopathic osteoarthrosis (ACR criteria, Kellgren-Lawrence grade 2 or more on recent X-ray), responsible for pain since 3 at least months, and pain at walking which intensity is at least 4/10 on a numerical rating scale.
Less than 3 relevant walks (at least 20 minutes or 1000 km) a week.
Ability to understand and to follow the protocol, and to answer the questionnaires
Disqualifiers
Pregnancy or breastfeeding
Legal protection
Body weight < 40 kg or underweight
Body weight >120 kg or obesity
Trial design
Single group
Treatments tested in this trial
therapeutic program including intermittent drug intake and multimodal rehabilitation program
DrugThe prescribed NSAID molecule shall be chosen according to the patient's risk profile: * gastric/duodenal risk: age \>65, history of ulcer with remission, history of inflammatory event, current low-dose acetylsalicylic acid treatment ; * cardiovascular risk (according to Agostino scale \& SCORE); The molecule with therefore be: * no risk: niflumic acid, 250 mg per intake; * gastric/duodenal risk only: diclofenac, 50-100 mg per intake, plus lansoprazole; * cardiovascular risk only: ketoprofen, 50-100 mg per intake; * double risk: ibuprofen, 200-400 mg per intake, plus lansoprazole. For the walk test, the highest dose of diclofenac or ketoprofen will be used. Then, the patient will be free to half the dose if pain relief is achieved so. One gram of acetaminophen will be added to any NSAID intake. The number of intakes will be limited to twice a day (morning and evening) and to 10 times a week.
Treatment groups
Trial outcomes
Primary outcomes
Success
success of the therapeutic program (defined by a 30%-increase (or more) of the monthly number of target moves from the baseline observation values, with no treatment discontinuation for NSAID side effects)
Secondary outcomes
Self-declared physical activity (efficacy outcome)
Global Physical Activity Questionnaire (GPAQ)
Self-declared physical activity (efficacy outcome)
Global Physical Activity Questionnaire (GPAQ)
Self-declared physical activity (efficacy outcome)
Global Physical Activity Questionnaire (GPAQ)
Actual physical activity (efficacy outcome)
Number of steps per day assessed by pedometer
Other outcomes
impairment of renal function (tolerance outcome)
either a 15%-increase (or more) of creatininemia from baseline, or a glomerular filtration rate \<60 mL.min-1 (MDRD), or creatininemia exceeding 1.5-times the upper limit of the lab's normative values
impairment of renal function (tolerance outcome)
either a 15%-increase (or more) of creatininemia from baseline, or a glomerular filtration rate \<60 mL.min-1 (MDRD), or creatininemia exceeding 1.5-times the upper limit of the lab's normative values
impairment of renal function (tolerance outcome)
either a 15%-increase (or more) of creatininemia from baseline, or a glomerular filtration rate \<60 mL.min-1 (MDRD), or creatininemia exceeding 1.5-times the upper limit of the lab's normative values
impairment of liver function (tolerance outcome)
blood transaminase levels exceeding 2.5-times the upper limit of the lab's normative values, or the occurrence of any relevant abnormality on the liver blood parameters
Sponsors and contacts
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University Hospital, Clermont-Ferrand
Lead sponsor
Fondation Apicil
Collaborator
SARL BOUCHARENC, Saint-Chély d'Apcher, France
Collaborator
Université Clermont-Auvergne, France
Collaborator
NEURO-DOL (UMR 1107 INSERM / UCA)
Collaborator