Lymphodreinage Integrated With Kinesio Tape in TKA Patients
Condition: TOTAL KNEE ARTHROPLASTY; Edema Secondary; Pain; Joint Dysfunction
MeSH terms: Joint Diseases
Study type: Interventional

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.
    

Intervention name(s): PHYSIOTHERAPY
Intervention type(s): Procedure
Intervention description(s): 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 intervention name(s): Lymphodreinage, kinesiotaping
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment