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Completed

NCT Number: NCT04580069

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

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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Key information

Conditions

Knee Pain Swelling

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ULSS 7 Pedemontana, Asiago, Vicenza, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lymphatic drainage

Procedure

The interventions follow the validated techniques normally used in international rehabilitation

Other names: Connective tissue massage

Primary outcomes

  1. CRP variation

    Time frame: 21 days

    blood test

  2. ESR variation

    Time frame: 21 days

    blood test

  3. lower limb oedema

    Time frame: 21 days

    leg circumference

Sponsors and collaborators

Lead sponsor

Presidio Ospedaliero di Asiago

Other

Registry information

Official study 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.

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 8, 2020
Registry last updated
Oct 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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