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

Osteoarthritis of the Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01989117
• Other study ID #: APR102013
• Status: Completed
• Phase: N/A
• First received: November 14, 2013
• Last updated: May 1, 2017
• Start date: November 2013
• Est. completion date: December 2016

Study information

• Verified date: May 2017
• Source: Hospital Ambroise Paré Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of the Knee
• Osteoarthritis, Knee
• Pain, Postoperative
• Preoperative Osteopathic Care
• Total Knee Replacement

Locations

Country	Name	City	State
France	Hopital Ambroise Pare	Boulogne-Billancourt

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Ambroise Paré Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-assessment of knee pain on Visual Analog Scale (VAS)		At one month postoperatively
Secondary	Pain self-assessment during the first postoperative month on Visual analog scale (VAS)		Twice daily during the first postoperative month
Secondary	Functional assessment of the knee with International Knee Society (IKS) score		At six months postoperatively
Secondary	Functional assessment of the knee with International Knee Society (IKS) score		At one year postoperatively