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

Not Applicable

Completed

• Conditions: Knee Pain Swelling
• Interventions: Procedure: Lymphatic drainage

• Registration Number: NCT04580069
• Lead Sponsor: Presidio Ospedaliero di Asiago

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.

Study Timeline

• Study Start: 2019-09-30
• Primary Completion: 2020-09-30
• Study Completion: 2020-09-30
• Study First Submitted: 2020-09-30
• Status Verified: 2020-10
• Study First Submitted QC: 2020-10-07
• Last Update Submitted: 2020-10-07
• Study First Posted: 2020-10-08
• Last Update Posted: 2020-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

Not provided

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lymphatic drainage	Lymphatic drainage	Patients subjected to manual lymphatic drainage
Connective tissue	Lymphatic drainage	Patients subjected to connective tissue massage
control group	Lymphatic drainage	Subjects hat followed standard rehabilitative treatment

Primary Outcome Measures

Name	Time	Method
ESR variation	21 days	blood test
CRP variation	21 days	blood test
lower limb oedema	21 days	leg circumference

Trial Locations

Locations (2)

presidio ospedaliero di Asiago; 🇮🇹 Asiago, Vicenza, Italy

ULSS 7 Pedemontana; 🇮🇹 Asiago, Vicenza, Italy