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Clinical Trials/NCT04580069
NCT04580069
Completed
N/A

Effectiveness of Two Rehabilitative Treatments in the Modulation of Inflammation During the Acute Phase in Patients With Knee Prosthesis and Assessment of the Role of the Diet in Determining Post-surgical Inflammation.

Presidio Ospedaliero di Asiago2 sites in 1 country34 target enrollmentSeptember 30, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Knee Pain Swelling
Sponsor
Presidio Ospedaliero di Asiago
Enrollment
34
Locations
2
Primary Endpoint
ESR variation
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

The investigators studied the influence of two aproved rehabilitative treatments, connective tissue techniques and lymphatic drainage, on acute inflammation markers. Furthermore, the role of mediterranean diet on the same values was investigated in the first postoperative period

Detailed Description

The main objective of this study is to demonstrate the effectiveness of lymphatic drainage and connective tissue techniques in modulating systemic inflammation. Another objective is to evaluate the existence, at baseline, of a correlation between the inflammation indices and the level of adherence to the Mediterranean diet. Methods. 34 patients were recruited, and divided into three groups. The control group followed the normal rehabilitation protocol. The other two groups were subjected, in addition to the standard treatment, to manual lymphatic drainage treatment or connective tissue techniques. The outcomes (PCR, ESR, Oedema) were recorded in three stages: upon entering the hospital, 1 week after entry and at follow-up 21 days after surgery.

Registry
clinicaltrials.gov
Start Date
September 30, 2019
End Date
September 30, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Presidio Ospedaliero di Asiago
Responsible Party
Principal Investigator
Principal Investigator

Sergio Rigoni

Sergio Rigoni

Presidio Ospedaliero di Asiago

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Joint replacements from other Units
  • Inflammatory arthropathies
  • Autoimmune / rheumatic diseases
  • Diabetes mellitus
  • Infections

Outcomes

Primary Outcomes

ESR variation

Time Frame: 21 days

blood test

CRP variation

Time Frame: 21 days

blood test

lower limb oedema

Time Frame: 21 days

leg circumference

Study Sites (2)

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