RecruitingPhase 4NCT05761015

Helping Osteoarthritis Patients to Walk With NSAID

A Rehabilitation Walking Program With the Help of a Transient Intake of Nonsteroidal Anti-inflammatory Drug for Patients With Painful Hip/Knee Osteoarthritis - A Pilot Cohort Study With Objectives of Short Walks in the Real Life.

Sponsor

University Hospital, Clermont-Ferrand

Enrollment

55 participants

Start Date

Dec 14, 2023

Study Type

INTERVENTIONAL

Conditions

Chronic Pain Osteoarthritis, Knee Osteoarthritis, Hip

Summary

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

Min Age: 50 YearsMax Age: 70 Years

Inclusion Criteria3

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

Exclusion Criteria20

Pregnancy or breastfeeding
Legal protection
Body weight \< 40 kg or underweight
Body weight \>120 kg or obesity
Unability to walk, or unability to walk without support devices (sticks, crutches, orthoses and knee pads are allowed)
Secondary osteoarthrosis (rheumatism, septic arthritis, recent osteonecrosis, hemochromatosis, gout, acromegalia…).
Concomitant general bone disease (Paget, Reiter…).
Concomitant and relevant painful disease else than due to osteoarthrosis (e.g. neuropathic pain, fibromyalgia…)
Previous recent intervention (e.g. surgery, arthroscopy, joint infiltration) expected to relief osteoarthrosis pain throughout the study period.
Planned intervention similar to those abovementioned, during the study period.
Recent initiation of any new analgesic treatment (including systemic steroids).
Planned initiation of any program expected to relief osteoarthrosis pain during the study period, such as physiotherapy, cognitive behavioral therapy…).
Planned major surgery during the study period.
Current cancer disease.
Immunosuppression.
Autoimmune disease.
Concomitant topical or systemic NSAID treatment.
Chronic strong opioid intake.
Concomitant insulin therapy.
Any absolute or relevant contraindication to NSAIDs or acetaminophen, according to the French drug agency

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Interventions

DRUGtherapeutic program including intermittent drug intake and multimodal rehabilitation program

The 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.