Lymphodreinage Integrated With Kinesio Tape in TKA Patients

NCT ID: NCT03452995

Last Updated: 2020-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 99 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-30
• Study Completion Date: 2019-03-31

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).

Detailed Description

Background In the days following knee arthroplasty, the presence of a strong local inflammatory component is associated with pain and functional limitation, which usually resolves within a few months; however, sometimes it can take longer, and sometimes result in a condition of chronic inflammation, albeit modest, that lasts for years. Lymphodrainage and Kinesiotaping have been indicated as effective treatments to reduce edema and alleviate pain. However it is not clear which of these techniques is more effective and if their effectiveness increases when combined.

Objective of the study The objective of the study is to evaluate the effectiveness of lymphatic drainage treatment associated with the application of kinesiotaping in the reduction of lymphedema, pain and in the recovery of knee joint excursion (ROM) in patients undergoing total arthroplasty knee in osteoarthritis. The hypothesis is that the associated treatment of kinesiotaping and lymphatic drainage produces better results than the individual treatments.

Methods

Patients will be divided in 3 groups according to the type of treatment:

GROUP 1 Lymphatic drainage + standard rehabilitation GROUP 2 Kinesiotaping + standard rehabilitation GROUP 3 Lymphatic drainage + Kinesiotaping + standard rehabilitation For each patient the duration of the study will be 6 days, the total duration of the study will be 12 months.

Statistics Considering the NRS for the evaluation of pain as a primary outcome, the determination of the sample was made on the basis of the following assumptions: level of significance (α) = 0.05, (2) type 2 error (β) = 0.2; with an 80% test power ,.

For the calculation of the sample G * Power 3.1.7 was used based on an effect size of 0.8 (Large effect size according to Cohen) and the Bonferroni correction for multiple comparisons. The calculated dimension of the sample was thus determined of 30 patients per group. Considering a drop-out of 10% the total sample should be 99 patients (33 per group). All continuous variables will be expressed in terms of mean ± standard deviation (SD) and range. To analyze the data collected, one-way analysis will be used with a post hoc comparison test for paired Sidak data. Statistical analysis will be performed with SAS / Stat software (version 9.3; SAS Institute, Cary, North Carolina). For all tests a P <0.05 will be considered significant.

Treatment All enrolled patients will receive a standard rehabilitation treatment consisting of

• KINETEC 1 h / day
• Functional rehabilitation 30 min for 2 times/day
• Walking training 15 min for 2 times/day

For each of the three groups experimental treatments will be added

GROUP 1 Lymphodrainage + elastic containment (postoperative compression stockings), 3 treatments: in the second postoperative day, in 4th postoperative day and in 6th post-operative day

GROUP 2 Kinesiotaping, 3 treatments: in the second postoperative day, in 4th postoperative day and in 6th post-operative day

GROUP 3 Lymphodrainage and Kinesiotaping, 3 treatments: on the second post-operative day, on 4 days post-operative and on the 6th post-operative day

The Vodder massage technique will be used for lymphatic drainage. The peculiarity of this method is the absolute respect of the lymphatic directions, of the operative pressures, of the frequency, of the rhythm and of the gesture. The various manoevers on the different body districts are performed in a proximal-distal sense, to respect the lymphatic course in directions of the lymph node stations and are performed with harmonic, slow and rhythmic movements. Manual pressures should not exceed 30-40 mmHg, but may vary depending on the consistency of the edema. In the specific case of the project, drainage is followed in the lower limb of the anterior and posterior part by placing the neck ganglia empty, which is peculiar to the original Volder method, used for about 30 minutes.

As for the Kinesiotaping as a lymphatic application the fan technique applied in the back of the thigh and the leg, and in the front of the foot (back of the foot) will be used with the aim of activating the cutaneous mechanoreceptors, reduce the pressure at the level interstitial in order to promote lymphatic drainage and ensure that this application leads to the reduction of swelling of post-operative soft tissues.

Adverse events The expected techniques do not foresee adverse events therefore, considering the good tolerance of the patients and the scarcity of known contraindications, we can state that the treatment is safe and can be an additional measure for pain reduction as well as edema. However, it is possible that the areas treated with neuromuscular tape may show skin irritations caused by the glue of the tape in case of very delicate skin.

Conditions

TOTAL KNEE ARTHROPLASTY; Edema Secondary; Pain; Joint Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

PHYSIOTHERAPY

Intervention Type: 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.

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 .

Group Type: ACTIVE_COMPARATOR

PHYSIOTHERAPY

Intervention Type: 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.

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

Group Type: EXPERIMENTAL

PHYSIOTHERAPY

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Other Intervention Names

Lymphodreinage, kinesiotaping

Eligibility 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.

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Ortopedico Rizzoli

OTHER

Sponsor Role: lead

Responsible Party

Laura Tornatore

Physical Therapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Laura Tornatore, PT

Role: PRINCIPAL_INVESTIGATOR

Istituto Ortopedico Rizzoli DRS

Locations

Istituto Ortopedico Rizzoli DRS

Bagheria, Palermo, Italy

Countries

Italy

Other Identifiers

0009494

Identifier Type: -

Identifier Source: org_study_id