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

Primary Purpose

Knee Pain Swelling

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Lymphatic drainage
Sponsored by
Presidio Ospedaliero di Asiago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Pain Swelling focused on measuring total Knee Arthroplasty (TKA), C-reactive protein (CRP), erythrosedimentation rate (ESR), Over Knee Oedema (EDO), Under Knee Oedema (EDU), MEDIET Questionnaire

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • presidio ospedaliero di Asiago
  • ULSS 7 Pedemontana

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Lymphatic drainage

Connective tissue

control group

Arm Description

Patients subjected to manual lymphatic drainage

Patients subjected to connective tissue massage

Subjects hat followed standard rehabilitative treatment

Outcomes

Primary Outcome Measures

CRP variation
blood test
ESR variation
blood test
lower limb oedema
leg circumference

Secondary Outcome Measures

Full Information

First Posted
September 30, 2020
Last Updated
October 7, 2020
Sponsor
Presidio Ospedaliero di Asiago
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1. Study Identification

Unique Protocol Identification Number
NCT04580069
Brief Title
Role of Two Rehabilitative Treatments and Diet in the Modulation of Inflammation in Patients With Knee Prosthesis.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
September 30, 2019 (Actual)
Primary Completion Date
September 30, 2020 (Actual)
Study Completion Date
September 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Presidio Ospedaliero di Asiago

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Trial
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lymphatic drainage
Arm Type
Experimental
Arm Description
Patients subjected to manual lymphatic drainage
Arm Title
Connective tissue
Arm Type
Experimental
Arm Description
Patients subjected to connective tissue massage
Arm Title
control group
Arm Type
Active Comparator
Arm Description
Subjects hat followed standard rehabilitative treatment
Intervention Type
Procedure
Intervention Name(s)
Lymphatic drainage
Other Intervention Name(s)
Connective tissue massage
Intervention Description
The interventions follow the validated techniques normally used in international rehabilitation
Primary Outcome Measure Information:
Title
CRP variation
Description
blood test
Time Frame
21 days
Title
ESR variation
Description
blood test
Time Frame
21 days
Title
lower limb oedema
Description
leg circumference
Time Frame
21 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sergio Rigoni
Organizational Affiliation
Presidio Ospedaliero di Asiago
Official's Role
Study Director
Facility Information:
Facility Name
presidio ospedaliero di Asiago
City
Asiago
State/Province
Vicenza
ZIP/Postal Code
36012
Country
Italy
Facility Name
ULSS 7 Pedemontana
City
Asiago
State/Province
Vicenza
ZIP/Postal Code
36012
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34099953
Citation
Rigoni S, Tagliaro L, Bau D, Scapin M. Effectiveness of two rehabilitation treatments in the modulation of inflammation during the acute phase in patients with knee prostheses and assessment of the role of the diet in determining post-surgical inflammation. J Orthop. 2021 May 15;25:237-243. doi: 10.1016/j.jor.2021.05.016. eCollection 2021 May-Jun.
Results Reference
derived

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

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