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
-
-
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
|
The interventions follow the validated techniques normally used in international rehabilitation
Other Names:
|
|
EXPERIMENTAL: Connective tissue
Patients subjected to connective tissue massage
|
The interventions follow the validated techniques normally used in international rehabilitation
Other Names:
|
|
ACTIVE_COMPARATOR: control group
Subjects hat followed standard rehabilitative treatment
|
The interventions follow the validated techniques normally used in international rehabilitation
Other Names:
|
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
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.
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.