Kinesio Taping Efficacy in Chronic Low Back Pain Treatment (KITALO)
Condition: Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether the kinesio taping method is effective in
      the treatment of chronic (more than six months duration) low back pain.
    

Detailed description: 
      Hypothesis: Kinesio taping treatment in patients with chronic low back pain, in which fascial
      mobilisation represents a treatment effect modifier, reduces pain and disability and improves
      quality of live, in comparison with simulated kinesio taping.

      Objective:

        -  Primary objective: To evaluate kinesio taping method effectiveness at short term (1
           month) and medium term (6 months) - pain, disability and quality of live - in patients
           with chronic low back pain.

        -  Secondary objective: To analyze the influence of fear-avoidance beliefs, catastrophizing
           ideas and anxiety-depression presence in kinesio taping method effectiveness for chronic
           low back pain patients.

      Method:

      Chronic low back pain patients are recruited from the outpatient rehabilitation service of a
      health area of Valencia which serves a population of 320,000 inhabitants.

      The study has been planned for a difference of 3 points in the Roland Morris questionnaire,
      as these values have been recognized as clinically relevant . Considering an alpha of 0.05
      and beta of 0.9 for comparison of means of two tails , 24 patients per group is the required
      sample size to detect changes in disability. Considering a loss of 20 % of the participants,
      the study sample is set to 62 patients.

      Addressing the CONSORT guidelines, a flow chart describing the situation during the course of
      the trial is draw; including all patients invited , the number of those who refuse to
      participate before randomization , the assignment to each treatment arm, losses during
      follow-up and possible crosslinking.

      Patients who agree to participate in the study are randomly assigned to one of two
      intervention groups. The allocation was made by a list generated by computer using the
      Statistical Package for the Social Sciences (SPSS 19), supervised by an statistical outside
      of the investigator team . Concealment of randomization sequence is maintained with hidden
      cards in numbered opaque envelopes.

      The duration of treatment is 4 weeks , changing the tape with a weekly frequency. Basic rules
      of postural control and stabilization and the pattern of exercises proposed by the Spanish
      Society for Rehabilitation and Physical Medicine are given prior to randomization.

      The evaluation of results is done through self-administered questionnaires to be completed by
      the patients ever before clinic visits .

      The primary results will be obtained by intention to treat analysis. Descriptive statistics
      will be obtained expressing continuous variables in mean (standard deviation) or median
      (quartiles) according to their normal or not, categorical variables in number (percentage)
      and expressing in all cases the confidence interval of 95%. The normal distribution was
      checked by Kolmogorov test to determine the use of parametric or non-parametric tests. For
      comparison of continuous variables between groups the Student t test or the Mann-Whitney test
      will be used according to the type of distribution. For comparison of categorical variables
      the chi-square test or Fisher will be used test according to the type of distribution.
      Changes in intra-group in continued variables at 4 weeks and 6 months will be analyzed with
      the Student t test for paired samples variables. To assess whether there are differences
      between the two groups in pain, disability and different variables analysis of covariance
      (ANCOVA) will be held, one for each dependent variable. In all tests, the independent
      variable is the group, while the covariate variable will be the baseline for each dependent
      variable. It will be necessary to have comparable levels in both groups to correctly
      interpret the results of ANCOVA. Therefore, several Student t tests, one for each dependent
      variable considering each group as an independent variable in each case, will be made. To
      assess whether changes in the 2 groups are produced differently, multiple ANOVA analysis for
      each dependent variable will be performed. In all cases, the independent variable is the
      group and the time data are collected. This analysis examines only the possible presence of
      interactions. In addition, correlations between the study variables will be evaluated, using
      Pearson's r or Rho Spearman according to the type of distribution. Two models of multiple
      linear regression will be applied with pain and disability as dependent variables and age,
      sex, pain catastrophizing, fear-avoidance, sick leave, time to progression,
      anxiety-depression as independent variables.

      The project will follow existing in Spain and the European Union guidelines for the
      protection of patients in clinical trials with respect to collection, storage and custody of
      personal data.

      All eligible patients are given oral and written information ( informed consent) about the
      study and the two treatment modalities. Specifically they are informed about they can leave
      the study at any time without giving any explanation and that this decision will not affect
      the continuation of his regular treatment.
    

Intervention name(s): Kinesio Taping method; Kinesio Taping sham
Intervention type(s): Device; Device
Intervention description(s): The tape is applied depending on the physical examination:
Muscular technique is placed along paravertebral muscles if back pain in flexion or extension improves when skin/fascial mobilisation is applied in the direction of paravertebral muscle fibers; the base is placed up or down if the mobilisation direction is up or down respectively.
Space technique is placed horizontally over the painful spinal segmental level if back pain in flexion or extension improves when skin/fascial mobilisation is applied approaching to a central point.
Fascia technique is placed horizontally over the painful area in paravertebral muscles if back pain in flexion or extension improves when skin/fascial mobilisation is applied transverse to the paravertebral muscle fibers.; The tape is applied with 0% tension, horizontally over two non-tender to palpation spinal segmental levels. The patient is kept in neutral position.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Kinesio taping; Neuromuscular taping; Targeted treatment; Chronic low back pain; Randomised controlled trial