Kinesio Taping Efficacy in Chronic Low Back Pain Treatment (KITALO) (KITALO)

Kinesio Taping Method for Chronic Mechanical Low Back Pain: a Randomised Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Chronic Low Back Pain
• Intervention / Treatment: Device: Kinesio Taping method; Device: Kinesio Taping sham

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.

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Valencia, Spain, 46015
    • Hospital Arnau de Vilanova

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Kinesio Taping method; 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.	Device: Kinesio Taping method; 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.
Sham Comparator: Kinesio Taping sham; The tape is applied with 0% tension, horizontally over two non-tender to palpation spinal segmental levels. The patient is kept in neutral position.	Device: Kinesio Taping sham; The tape is applied with 0% tension, horizontally over two non-tender to palpation spinal segmental levels. The patient is kept in neutral position.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in "Roland Morris Disability Questionnaire"	Assess activity limitations due to back pain. Consists of 24 statements. Patients were asked to answer yes or no to each statement. Each positive answer is worth one point with scores ranging from 0 (no disability) to 24 (severely disabled). The Spanish version has been validated.	pretreatment, 4 weeks, 6 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in "Fear Avoidance Beliefs Questionnaire"	measure fear and avoidance beliefs related to low back pain. It consists of 16 sentences related to physical activity (first 5 items) and work (last 11 items). The patient has to rate each sentence from 0 (totally disagree) to 6 (totally agree). The score range is 0 to 96, with a higher value reflecting a higher degree of fear avoidance beliefs. Two subscales are defined. "Factor 1" is composed of items 6, 7, 9, 10, 11, and 12 and reflects fear-avoidance beliefs about work. "Factor 2" is composed of items 2 to 5 and reflects fear-avoidance beliefs about physical activities. The Spanish version has been validated.	pretreatment, 4 weeks, 6 month
Change in "Pain Catastrophizing Scale"	This scale assess patient negative and exaggerated orientation to painful stimuli. It has 13 item and comprises three dimensions: a) rumination; b) magnification, and c) hopelessness. Each item scores on a 5-point Likert scale (0 not at all 1 a little, 2 moderately, 3 very much, 4 all the time. The score range is 0 to 52, with a higher value reflecting a higher degree of pain catastrophizing. The Spanish version has been validated	pretreatment, 4 weeks, 6 month
Change in "Hospital Anxiety and Depression subscale"	This scale is used for screening mood and anxiety disorders. Consists of a 7-item anxiety subscale and a 7-item depression subscale. Each item scores on a 4-point Likert scale (0 as much as I always do; 1 not quite so much; 2 definitely not so much; 3 not at all ), giving maximum subscale scores of 21 for depression and anxiety, respectively. The Spanish version has been validated.	pretreatment, 4 weeks, 6 month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Charlson Comorbidity Index		pretreatment
Adverse effects		4 weeks
Change in "EuroQol-5D-5L (EuroQol 5 dimensions and 5 levels)"	This scale is a generic measure of health. Comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The digits for 5 dimensions can be combined in a 5-digit number describing the respondent's health state.The EuroQol VAS records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'. The Spanish version is available.	pretreatment, 4 weeks, 6 month
Change in "Numerical Rating Scale"	Assess pain intensity, involves asking patients to rate the pain from 0 to 10 (an 11-point scale), with the understanding that 0 represents one end of the pain intensity continuum (" no pain") and 10 represents the other extreme of pain intensity (" pain as bad as it could be").	pretreatment, 4 weeks, 6 month

Collaborators and Investigators

• Sponsor: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
• Collaborators: Cardenal Herrera University; Hospital Arnau de Vilanova
• Investigators: Principal Investigator: María Lourdes Peñalver Barrios, MD, Hospital Arnau de Vilanova, Valencia, Spain; Study Director: Julio Domenech Fernández, MD, PhD, Hospital Arnau de Vilanova, Valencia, Spain; Study Director: Juan Francisco Lisón Párraga, MD, PhD, Cardenal Herrera CEU University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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. Erratum In: J Physiother. 2012;58(3):143.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2015
• Primary Completion (Actual): September 15, 2016
• Study Completion (Actual): November 14, 2016

Study Registration Dates

• First Submitted: November 10, 2015
• First Submitted That Met QC Criteria: November 10, 2015
• First Posted (Estimate): November 13, 2015

Study Record Updates

• Last Update Posted (Actual): April 16, 2019
• Last Update Submitted That Met QC Criteria: April 11, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Randomised controlled trial; Chronic low back pain; Kinesio taping; Neuromuscular taping; Targeted treatment
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: MSK063