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

P

Presidio Ospedaliero di Asiago

Status

Completed

Conditions

Knee Pain Swelling

Treatments

Procedure: Lymphatic drainage

Study type

Interventional

Funder types

Other

Identifiers

NCT04580069
POAsiago

Details and patient eligibility

About

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

Full 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.

Enrollment

34 patients

Sex

All

Ages

50 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

34 participants in 3 patient groups

Lymphatic drainage
Experimental group
Description:
Patients subjected to manual lymphatic drainage
Treatment:
Procedure: Lymphatic drainage
Connective tissue
Experimental group
Description:
Patients subjected to connective tissue massage
Treatment:
Procedure: Lymphatic drainage
control group
Active Comparator group
Description:
Subjects hat followed standard rehabilitative treatment
Treatment:
Procedure: Lymphatic drainage

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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