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

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.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04580069

Enrollment

Registered

2020-10-08

Start date

2019-09-30

Completion date

2020-09-30

Last updated

2020-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Pain Swelling

Keywords

total Knee Arthroplasty (TKA), C-reactive protein (CRP), erythrosedimentation rate (ESR), Over Knee Oedema (EDO), Under Knee Oedema (EDU), MEDIET Questionnaire

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.

Interventions

PROCEDURELymphatic drainage

The interventions follow the validated techniques normally used in international rehabilitation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Intervention model description

Randomized Controlled Trial

Eligibility

Sex/Gender

ALL

Age

50 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026