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Lymphodreinage Integrated With Kinesio Tape in TKA Patients (LINFOTAPE)

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ClinicalTrials.gov Identifier: NCT03452995
Recruitment Status : Recruiting
First Posted : March 2, 2018
Last Update Posted : February 28, 2019
Sponsor:
Information provided by (Responsible Party):
Laura Tornatore, Istituto Ortopedico Rizzoli

Brief Summary:

Aim of the study: To evaluate the efficacy of lymphatic drainage treatment associated with the application of kinesiotaping in the reduction of lymphedema, pain and in the recovery of knee joint ROM in patients undergoing surgery of total knee arthroplasty in osteoarthritis.

Inclusion criteria: Operated patients of total primary knee arthroplasty in osteoarthritis not later than 5 days after surgery, Patients of both sexes aged between 65 and 85, Presence of lymphedema and volumetric difference with the contralateral limb of the cirtometry equal or greater than 3 cm.

Exclusion criteria: Patients operated for re-implantation or revision, presence of inflammatory, neurological, important cardiological diseases and active tumor pathologies, absence of DVT of the lower limb.

Study design: Prospective, open, randomized, lasting 12 months GROUP 1 (33 pts) KINESIOTAPING + STANDARD REHABILITATION GROUP 2 (33 pts) LYMPHODRAINAGE+ STANDARD REHABILITATION GROUP 3 (33 pts) KINESIOTAPING + LYMPHODRAINAGE + STANDARD REHABILITATION Outcome measures: Pain: evaluation with NRS scale 0-10, Edema: cirtometric evaluation (in 4 standard points), ROM: goniometric measurement of the knee joint excursion. All measures at the beginning and end of treatment (6 days).


Condition or disease Intervention/treatment Phase
TOTAL KNEE ARTHROPLASTY Edema Secondary Pain Joint Dysfunction Procedure: PHYSIOTHERAPY Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Manual Lymphatic Drainage Integrated With Kinesio Tape and Traditional Rehabilitation Techniques in Patients Operated for Knee Arthroplasty in Osteoarthritis
Actual Study Start Date : November 30, 2017
Estimated Primary Completion Date : March 31, 2019
Estimated Study Completion Date : March 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
Active Comparator: Physiotherapy: LYMPHO DRAINAGE
Patients will be treated on the second postoperative day, on the 4th postoperative day and on the 6th post-operative day by means of Manual lymphodrainage consisting in special massage technique that allows lymphatic drainage, or removal of interstitial fluid stagnation according to Vodder, in association to the standard rehabilitation protocol for TKA (Kinetec, functional rehabilitation and walking training
Procedure: PHYSIOTHERAPY
Lymphodreinage and kinesiotaping are current methods of treatment of edema, pain and indirectly recovery of the knee ROM in TKA. Edema, pain and knee ROM are strictly corelated and, by reducing edema, we reduce the pressure by relieving pain, and allowing an improvement in movement.
Other Name: Lymphodreinage, kinesiotaping

Active Comparator: Physiotherapy: KINESIOTAPING
Patients will be treated on the second postoperative day, on the 4th postoperative day and on the 6th post-operative day through the use of patches acting through the sensory system giving stimuli to receptors on the skin, in association to the standard rehabilitation protocol for TKA (kinetec, functional rehabilitation and walking training .
Procedure: PHYSIOTHERAPY
Lymphodreinage and kinesiotaping are current methods of treatment of edema, pain and indirectly recovery of the knee ROM in TKA. Edema, pain and knee ROM are strictly corelated and, by reducing edema, we reduce the pressure by relieving pain, and allowing an improvement in movement.
Other Name: Lymphodreinage, kinesiotaping

Experimental: Physiotherapy:LYMPHO+KINESIO
Patients will ne treated with both kinesiotaping and lymphodreinage on the second post-operative day, on 4 days post-operative and on the 6th post-operative day, in association to the standard rehabilitation protocol for TKA (kinetec, functional rehabilitation and walking training
Procedure: PHYSIOTHERAPY
Lymphodreinage and kinesiotaping are current methods of treatment of edema, pain and indirectly recovery of the knee ROM in TKA. Edema, pain and knee ROM are strictly corelated and, by reducing edema, we reduce the pressure by relieving pain, and allowing an improvement in movement.
Other Name: Lymphodreinage, kinesiotaping




Primary Outcome Measures :
  1. Pain severity [ Time Frame: Change between baseline and the end of treatment (6 days) ]

    NRS Pain: the Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain.

    Pain Level rating:

    0 No Pain 1-3 Mild Pain 4-6 Moderate Pain 7-10 Severe Pain



Secondary Outcome Measures :
  1. Edema [ Time Frame: Change between baseline and the end of treatment (6 days) ]
    cirtometric evaluation (in 3 standard points (above the knee: 10 cm above the upper patellar pole, 10 cm below the inferior patellar pole, ankle).

  2. KNEE ROM [ Time Frame: Change between baseline and the end of treatment (6 days) ]
    goniometric measurement of the knee joint excursion operated at the beginning and end of treatment



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Ages Eligible for Study:   65 Years to 85 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Operated patients of total primary knee arthroplasty in osteoarthritis not later than 5 days after surgery
  • Patients of both sexes aged between 65 and 85;
  • Presence of lymphedema and volumetric difference with the contralateral limb of the cirtometry equal or greater than 3cm.

Exclusion Criteria:

  • Patients operated for re-implantation or revision
  • Presence of inflammatory, neurological, important cardiological diseases and active tumor pathologies.
  • Absence of DVT of the lower limb.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03452995


Contacts
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Contact: Laura Tornatore, PT +390919297033 laura.tornatore@ior.it
Contact: Maria Grazia Benedetti, MD +390516366236 benedetti@ior.it

Locations
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Italy
Istituto Ortopedico Rizzoli DRS Recruiting
Bagheria, Palermo, Italy, 90011
Contact: Laura Tornatore, PT    +39 091/9297033    laura.tornatore@ior.it   
Contact: Maria Grazia Benedetti, MD    +39 0516366236    benedetti@ior.it   
Sponsors and Collaborators
Istituto Ortopedico Rizzoli
Investigators
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Principal Investigator: Laura Tornatore, PT Istituto Ortopedico Rizzoli DRS

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Responsible Party: Laura Tornatore, Physical Therapist, Istituto Ortopedico Rizzoli
ClinicalTrials.gov Identifier: NCT03452995     History of Changes
Other Study ID Numbers: 0009494
First Posted: March 2, 2018    Key Record Dates
Last Update Posted: February 28, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases