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Clinical Trials/2022-502018-10-00
2022-502018-10-00
Recruiting
Phase 4

Patient Walking Rehabilitation Program with osteoarthritis of the hip or knee helped by a one-off anti-inflammatory treatment (pilot cohort study with short walking objectives) - PERIPATEI

University Hospital Of Clermont-Ferrand1 site in 1 country55 target enrollmentStarted: January 18, 2023Last updated:
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Overview

Phase
Phase 4
Status
Recruiting
Sponsor
University Hospital Of Clermont-Ferrand
Enrollment
55
Locations
1
Primary Endpoint
For a given individual, the main criterion is the success of the therapeutic program, defined by an increase of at least 30% in the monthly number of target movements compared to the month of basal observation, in the absence of treatment discontinuation. NSAIDs for intolerance
OverviewEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

Study the efficacy and tolerance of the reasoned and punctual intake of a non-steroidal anti-inflammatory drug (NSAID), as part of a walking rehabilitation program for patients suffering from osteoarthritis of the hip or knee.

Eligibility Criteria

Ages
18 years to 65+ years (18-64 Years, 65+ Years)
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patient, man or woman aged 50 to 70, suffering from uni- or bilateral idiopathic osteoarthritis of the hip or knee, whose diagnosis is confirmed by compliance with the radio-clinical criteria of the American College of Rheumatology (Altman et al., 1986): Joint pain felt for at least half the time during the last 3 months prior to inclusion /Morning stiffness lasting less than 30 minutes or joint crackling / Kellgren and Lawrence stage ≥ 2 attested by an available x-ray
  • •Walking pain rated at least 4 on a scale of 0 (no pain) to 10 (worst imaginable pain), associated with consequent limitation of walking ability (declarative)
  • •Weekly number of significant trips (walking of at least 20 minutes or 1000 meters) < 3
  • •Ability to comply with protocol requirements and provide informed consent to participate in research
  • •Comprehension and fluent writing of the French language
  • •Coverage by a Social Security scheme

Exclusion Criteria

  • •­Pregnant or breastfeeding woman
  • •­Forecast during the period of the initiation study of a non-pharmacological analgesic treatment different from that proposed by the protocol, such as physiotherapy, behavioral therapy (self-management of pain, hypnosis, sophrology, meditation, mindfulness)
  • •­ Use of a unicompartmental unloading hinged orthosis (indicated for pain predominant in a femoro-tibial compartment of the knee) initiated during the 2 months preceding inclusion, or scheduled during the study period (continuation of older use is possible)
  • •­Intra-articular injection of glucocorticoid into the affected joint(s), during the 2 months preceding inclusion, or scheduled during the study period.
  • •­Visco-supplementation in one or more joints concerned, during the 2 months preceding inclusion, or scheduled during the study period
  • •­Intramuscular injection of glucocorticoid during the month preceding inclusion
  • •­Interventional surgery on one or more joints concerned, in the 6 months preceding the scheduled inclusion during the study period
  • •­Arthroscopy of one or more joints concerned, within 3 months prior to inclusion or scheduled during the study period
  • •Other major surgery scheduled during the study period
  • •­Possible progressive hematological or cancerous pathology (with the exception of a basal cell carcinoma for which total excision was recently performed)

Outcomes

Primary Outcomes

For a given individual, the main criterion is the success of the therapeutic program, defined by an increase of at least 30% in the monthly number of target movements compared to the month of basal observation, in the absence of treatment discontinuation. NSAIDs for intolerance

For a given individual, the main criterion is the success of the therapeutic program, defined by an increase of at least 30% in the monthly number of target movements compared to the month of basal observation, in the absence of treatment discontinuation. NSAIDs for intolerance

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
University Hospital Of Clermont-Ferrand
Sponsor Class
Hospital/Clinic/Other health care facility
Responsible Party
Principal Investigator
Principal Investigator

Lise Laclautre

Scientific

University Hospital Of Clermont-Ferrand

Study Sites (1)

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