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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Knee Pain Swelling

Intervention / Treatment
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* Procedure: Lymphatic drainage


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Controlled Trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lymphatic drainage<br>Patients subjected to manual lymphatic drainage | Procedure: Lymphatic drainage<br>* The interventions follow the validated techniques normally used in international rehabilitation<br>* Other names: Connective tissue massage;|
| Experimental: Connective tissue<br>Patients subjected to connective tissue massage | Procedure: Lymphatic drainage<br>* The interventions follow the validated techniques normally used in international rehabilitation<br>* Other names: Connective tissue massage;|
| Active Comparator: control group<br>Subjects hat followed standard rehabilitative treatment | Procedure: Lymphatic drainage<br>* The interventions follow the validated techniques normally used in international rehabilitation<br>* Other names: Connective tissue massage;|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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total Knee Arthroplasty (TKA), C-reactive protein (CRP), erythrosedimentation rate (ESR), Over Knee Oedema (EDO), Under Knee Oedema (EDU), MEDIET Questionnaire