Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04580069
Recruitment Status : Completed
First Posted : October 8, 2020
Last Update Posted : October 8, 2020
Sponsor:
Information provided by (Responsible Party):
Sergio Rigoni, Presidio Ospedaliero di Asiago

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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

Condition or disease Intervention/treatment Phase
Knee Pain Swelling Procedure: Lymphatic drainage Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Controlled Trial
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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.
Actual Study Start Date : September 30, 2019
Actual Primary Completion Date : September 30, 2020
Actual Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Name: 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 Name: 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 Name: Connective tissue massage


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. CRP variation [ Time Frame: 21 days ]
    blood test

  2. ESR variation [ Time Frame: 21 days ]
    blood test

  3. lower limb oedema [ Time Frame: 21 days ]
    leg circumference


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04580069


Locations
Layout table for location information
Italy
presidio ospedaliero di Asiago
Asiago, Vicenza, Italy, 36012
ULSS 7 Pedemontana
Asiago, Vicenza, Italy, 36012
Sponsors and Collaborators
Presidio Ospedaliero di Asiago
Investigators
Layout table for investigator information
Study Director: Sergio Rigoni Presidio Ospedaliero di Asiago
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Sergio Rigoni, Presidio Ospedaliero di Asiago
ClinicalTrials.gov Identifier: NCT04580069    
Other Study ID Numbers: POAsiago
First Posted: October 8, 2020    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sergio Rigoni, Presidio Ospedaliero di Asiago:
total Knee Arthroplasty (TKA)
C-reactive protein (CRP)
erythrosedimentation rate (ESR)
 Over Knee Oedema (EDO)
Under Knee Oedema (EDU)
MEDIET Questionnaire
Additional relevant MeSH terms:
Layout table for MeSH terms
Inflammation
Pathologic Processes