Effectiveness of Osteopathy in the Preoperative Treatment of Postoperative Pain in Patients Undergoing Total Knee Replacement

May 1, 2017 updated by: Shahnaz Klouche, MD, Hospital Ambroise Paré Paris

Prospective Non-randomized Comparative Study Evaluating the Effectiveness of Osteopathy in the Preoperative Treatment of Postoperative Pain in Patients Undergoing Total Knee Replacement in Osteoarthritis Indication

Osteopathy is an alternative healthcare that seems effective in relieving the pain of patients. The main purpose of this study is to evaluate the efficacy of preoperative osteopathic care in patients undergoing total knee arthroplasty (TKA) for osteoarthritis. The secondary objectives are to assess pain during the first postoperative month on a VAS and knee function and quality of life at 6 months and 1 year. Our hypothesis is that osteopathy will decrease postoperative pain and increase knee function.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Boulogne-Billancourt, France, 92100
        • Hôpital Ambroise Paré

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients scheduled for primary total knee arthroplasty (TKA) for osteoarthritis.

Description

Inclusion Criteria:

  • Primary total knee arthroplasty (TKA)
  • For osteoarthritis of the knee
  • Without surgical history on the operated knee

Exclusion Criteria:

  • Previous surgery on the operated knee
  • Bilateral TKA
  • Patient refusal

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Osteopathy
No osteopathy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Self-assessment of knee pain on Visual Analog Scale (VAS)
Time Frame: At one month postoperatively
At one month postoperatively

Secondary Outcome Measures

Outcome Measure
Time Frame
Pain self-assessment during the first postoperative month on Visual analog scale (VAS)
Time Frame: Twice daily during the first postoperative month
Twice daily during the first postoperative month
Functional assessment of the knee with International Knee Society (IKS) score
Time Frame: At six months postoperatively
At six months postoperatively
Functional assessment of the knee with International Knee Society (IKS) score
Time Frame: At one year postoperatively
At one year postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Ambroise Paré Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

November 14, 2013

First Submitted That Met QC Criteria

November 14, 2013

First Posted (Estimate)

November 20, 2013

Study Record Updates

Last Update Posted (Actual)

May 2, 2017

Last Update Submitted That Met QC Criteria

May 1, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APR102013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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