Lymphodreinage Integrated With Kinesio Tape in TKA Patients

NCT03452995 | Completed

• 1 other identifier: 0009494
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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).

Conditions

TOTAL KNEE ARTHROPLASTY; Edema Secondary; Pain; Joint Dysfunction

Outcome Measures

Primary Outcomes (1)

• Pain severity

  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

  Change between baseline and the end of treatment (6 days)

Secondary Outcomes (2)

• Edema

  Change between baseline and the end of treatment (6 days)

• KNEE ROM

  Change between baseline and the end of treatment (6 days)

Study Arms (3)

Physiotherapy: LYMPHO DRAINAGE

ACTIVE COMPARATOR

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

Physiotherapy: KINESIOTAPING

ACTIVE COMPARATOR

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

Physiotherapy:LYMPHO+KINESIO

EXPERIMENTAL

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

Interventions

PHYSIOTHERAPY PROCEDURE

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.

Also known as: Lymphodreinage, kinesiotaping

Physiotherapy: KINESIOTAPING; Physiotherapy: LYMPHO DRAINAGE; Physiotherapy:LYMPHO+KINESIO

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Istituto Ortopedico Rizzoli DRS

Bagheria, Palermo, 90011, Italy

Location

MeSH Terms

Conditions

Pain; Joint Diseases

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Laura Tornatore, PT

  Istituto Ortopedico Rizzoli DRS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Therapist

Study Record Dates

• First Submitted: February 20, 2018
• First Posted: March 2, 2018
• Study Start: November 30, 2017
• Primary Completion: March 31, 2019
• Study Completion: March 31, 2019
• Last Updated: January 13, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)