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

Knee Pain Swelling Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04580069
• Other study ID #: POAsiago
• Status: Completed
• Phase: N/A
• Start date: September 30, 2019
• Est. completion date: September 30, 2020

Study information

• Verified date: October 2020
• Source: Presidio Ospedaliero di Asiago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: September 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammation
• Knee Pain Swelling

Intervention

Procedure:
• Lymphatic drainage
The interventions follow the validated techniques normally used in international rehabilitation

Locations

Country	Name	City	State
Italy	presidio ospedaliero di Asiago	Asiago	Vicenza
Italy	ULSS 7 Pedemontana	Asiago	Vicenza

Sponsors (1)

Lead Sponsor	Collaborator
Presidio Ospedaliero di Asiago

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CRP variation	blood test	21 days
Primary	ESR variation	blood test	21 days
Primary	lower limb oedema	leg circumference	21 days