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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-30

Study Completion Date

2020-09-30

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

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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.

Conditions

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Knee Pain Swelling

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Controlled Trial

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Lymphatic drainage

Patients subjected to manual lymphatic drainage

Group Type EXPERIMENTAL

Lymphatic drainage

Intervention Type PROCEDURE

The interventions follow the validated techniques normally used in international rehabilitation

Connective tissue

Patients subjected to connective tissue massage

Group Type EXPERIMENTAL

Lymphatic drainage

Intervention Type PROCEDURE

The interventions follow the validated techniques normally used in international rehabilitation

control group

Subjects hat followed standard rehabilitative treatment

Group Type ACTIVE_COMPARATOR

Lymphatic drainage

Intervention Type PROCEDURE

The interventions follow the validated techniques normally used in international rehabilitation

Interventions

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Lymphatic drainage

The interventions follow the validated techniques normally used in international rehabilitation

Intervention Type PROCEDURE

Other Intervention Names

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Connective tissue massage

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