NCT02361359

Brief Summary

Psychologic status is associated with poor outcome after joint arthroplasty and perhaps chronic pain. To enhance the therapeutic effect of a psychologic intervention, the specific disorders or pain-related beliefs that contributed to chronic pain should be identified. We therefore determined whether specific psychologic disorders (depression, anxiety disorder) or health-related beliefs (self-efficacy, pain catastrophizing) are associated with chronic pain after joint arthroplasty for osteoarthritis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 6, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 11, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

May 2, 2017

Status Verified

May 1, 2017

Enrollment Period

3.2 years

First QC Date

February 6, 2015

Last Update Submit

May 1, 2017

Conditions

OsteoarthritisChronic PainCatastrophization

Keywords

Arthroplasty

Outcome Measures

Primary Outcomes (1)

  • Pain score

    1 year postoperatively

Secondary Outcomes (1)

  • Functional score

    1 year postoperatively

Interventions

Psychological questionnairesOTHER

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who undergo joint arthroplasty (shoulder, hip ou knee) for osteoarthritis

You may qualify if:

  • joint arthgroplasty (shoulder, hip ou knee)
  • osteoarthritis

You may not qualify if:

  • previous surgery in the same joint

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Ambroise Paré Paris

Boulogne-Billancourt, 92000, France

Location

Related Publications (1)

  • Hardy A, Sandiford MH, Menigaux C, Bauer T, Klouche S, Hardy P. Pain catastrophizing and pre-operative psychological state are predictive of chronic pain after joint arthroplasty of the hip, knee or shoulder: results of a prospective, comparative study at one year follow-up. Int Orthop. 2022 Nov;46(11):2461-2469. doi: 10.1007/s00264-022-05542-7. Epub 2022 Aug 23.

    PMID: 35999466DERIVED

MeSH Terms

Conditions

OsteoarthritisChronic Pain

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician responsible of clinical research

Study Record Dates

First Submitted

February 6, 2015

First Posted

February 11, 2015

Study Start

January 1, 2014

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

May 2, 2017

Record last verified: 2017-05

Locations

FR(1)