Clinical trial NCT02604290: Kinesio Taping Efficacy in Chronic Low Back Pain Treatment (KITALO)
Official title: Kinesio Taping Method for Chronic Mechanical Low Back Pain: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low Back Pain
Keywords: Kinesio taping
Neuromuscular taping
Targeted treatment
Chronic low back pain
Randomised controlled trial
Lead sponsor: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Sponsor class: OTHER
Collaborators: name: Cardenal Herrera University
name: Hospital Arnau de Vilanova
First posted: 2015-11-13
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Age between 18 and 65 years.
* Chronic low back pain least 6 months duration.
* Improvement of pain with mobilization of skin/fascias in physical examination.
* Signature of informed consent.

Exclusion Criteria:

* Having had previous treatment experience with kinesio taping method.
* Presence of components of neuropathic pain (radiculopathy, lumbar canal stenosis).
* Specific origin pain (vertebral fracture, tumor or nerve column structures, spondyloarthropathy, spondylodiscitis).
* Prior spine surgery.
* Mental retardation, severe mental illness, substance abuse or dependency, illiteracy.

Primary outcomes:
measure: Change in "Roland Morris Disability Questionnaire"
timeFrame: pretreatment, 4 weeks, 6 month
Secondary outcomes:
measure: Change in "Fear Avoidance Beliefs Questionnaire"
timeFrame: pretreatment, 4 weeks, 6 month
measure: Change in "Pain Catastrophizing Scale"
timeFrame: pretreatment, 4 weeks, 6 month
measure: Change in "Hospital Anxiety and Depression subscale"
timeFrame: pretreatment, 4 weeks, 6 month
Other outcomes:
measure: Charlson Comorbidity Index
timeFrame: pretreatment
measure: Adverse effects
timeFrame: 4 weeks
measure: Change in "EuroQol-5D-5L (EuroQol 5 dimensions and 5 levels)"
timeFrame: pretreatment, 4 weeks, 6 month
measure: Change in "Numerical Rating Scale"
timeFrame: pretreatment, 4 weeks, 6 month
Locations:
city: Valencia
country: Spain
facility: Hospital Arnau de Vilanova
Study officials:
affiliation: Hospital Arnau de Vilanova, Valencia, Spain
name: María Lourdes Peñalver Barrios, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Arnau de Vilanova, Valencia, Spain
name: Julio Domenech Fernández, MD, PhD
role: STUDY_DIRECTOR
affiliation: Cardenal Herrera CEU University
name: Juan Francisco Lisón Párraga, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Kent P, Mjosund HL, Petersen DH. Does targeting manual therapy and/or exercise improve patient outcomes in nonspecific low back pain? A systematic review. BMC Med. 2010 Apr 8;8:22. doi: 10.1186/1741-7015-8-22.
citation: Parreira Pdo C, Costa Lda C, Hespanhol LC Jr, Lopes AD, Costa LO. Current evidence does not support the use of Kinesio Taping in clinical practice: a systematic review. J Physiother. 2014 Mar;60(1):31-9. doi: 10.1016/j.jphys.2013.12.008. Epub 2014 Apr 24.
citation: Paoloni M, Bernetti A, Fratocchi G, Mangone M, Parrinello L, Del Pilar Cooper M, Sesto L, Di Sante L, Santilli V. Kinesio Taping applied to lumbar muscles influences clinical and electromyographic characteristics in chronic low back pain patients. Eur J Phys Rehabil Med. 2011 Jun;47(2):237-44. Epub 2011 Mar 24.
citation: Castro-Sanchez AM, Lara-Palomo IC, Mataran-Penarrocha GA, Fernandez-Sanchez M, Sanchez-Labraca N, Arroyo-Morales M. Kinesio Taping reduces disability and pain slightly in chronic non-specific low back pain: a randomised trial. J Physiother. 2012;58(2):89-95. doi: 10.1016/S1836-9553(12)70088-7.
citation: Kachanathu SJ, Alenazi AM, Seif HE, Hafez AR, Alroumim MA. Comparison between Kinesio Taping and a Traditional Physical Therapy Program in Treatment of Nonspecific Low Back Pain. J Phys Ther Sci. 2014 Aug;26(8):1185-8. doi: 10.1589/jpts.26.1185. Epub 2014 Aug 30.
citation: Parreira Pdo C, Costa Lda C, Takahashi R, Hespanhol Junior LC, Luz Junior MA, Silva TM, Costa LO. Kinesio taping to generate skin convolutions is not better than sham taping for people with chronic non-speci fi c low back pain: a randomised trial. J Physiother. 2014 Jun;60(2):90-6. doi: 10.1016/j.jphys.2014.05.003. Epub 2014 Jun 10.