Role of Two Rehabilitative Treatments and Diet in the Modulation of Inflammation in Patients With Knee Prosthesis.

October 7, 2020 updated by: Sergio Rigoni, Presidio Ospedaliero di Asiago

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.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

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

  • Italy
    • Vicenza
      • Asiago, Vicenza, Italy, 36012
        • presidio ospedaliero di Asiago
      • Asiago, Vicenza, Italy, 36012
        • ULSS 7 Pedemontana

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

50 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria

  • 50<age<80 years
  • Bicompartmental knee arthroplasty
  • Weight bearing 7 days after surgery
  • Transfusions according to hospital protocol
  • Alteration of the indices at T0
  • Standard analgesic therapy

Exclusion Criteria:

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

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

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Lymphatic drainage
Patients subjected to manual lymphatic drainage
Procedure: Lymphatic drainage
The interventions follow the validated techniques normally used in international rehabilitation
Other Names:
  • Connective tissue massage
EXPERIMENTAL: Connective tissue
Patients subjected to connective tissue massage
Procedure: Lymphatic drainage
The interventions follow the validated techniques normally used in international rehabilitation
Other Names:
  • Connective tissue massage
ACTIVE_COMPARATOR: control group
Subjects hat followed standard rehabilitative treatment
Procedure: Lymphatic drainage
The interventions follow the validated techniques normally used in international rehabilitation
Other Names:
  • Connective tissue massage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CRP variation
Time Frame: 21 days
blood test
21 days
ESR variation
Time Frame: 21 days
blood test
21 days
lower limb oedema
Time Frame: 21 days
leg circumference
21 days

Collaborators and Investigators

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

Sponsor

Presidio Ospedaliero di Asiago

Investigators

  • Study Director: Sergio Rigoni, presidio ospedaliero di Asiago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (ACTUAL)

September 30, 2019

Primary Completion (ACTUAL)

September 30, 2020

Study Completion (ACTUAL)

September 30, 2020

Study Registration Dates

First Submitted

September 30, 2020

First Submitted That Met QC Criteria

October 7, 2020

First Posted (ACTUAL)

October 8, 2020

Study Record Updates

Last Update Posted (ACTUAL)

October 8, 2020

Last Update Submitted That Met QC Criteria

October 7, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • POAsiago

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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