Effects of Functional Taping on Static Postural Control in Patients With Non-specific Chronic Low Back Pain
Effects of Functional Taping on Static Postural Control in Patients With Non-specific Chronic Low Back Pain
Background: Low back pain is a major public health problem that affects most people at some
 point in life, and results in major psychosocial, economic, functional and physical
 consequences that can last for days and months. Most cases are undiagnosed and become chronic
 non-specific low back pain. Studies showed that these patients presented changes in postural
 control, yet the information is inconsistent, as well as the effects of Functional Taping
 (FT).

 Objectives: The aim of this study will be to investigate the immediate and one-month
 follow-up effects of the use of Functional Taping to lumbar spine on pain intensity and
 postural control in patients with chronic nonspecific low back pain (CLBP).

 Methods: This study will be a sham-controlled and randomized clinical trial. Participants:
 One hundred and twenty participants (18 and 50 years) both genders. Interventions:
 Participants will be randomly allocated to receive three possible interventions: Functional
 Star-shape Taping, Sham Functional Taping (both interventions during seven days) and a
 Minimal Intervention (MI) (one session). Main outcome measures: Primary outcomes will be pain
 intensity and posturography to assess balance parameters. Low back pain related disability,
 global perceived effect of treatment and fear avoidance beliefs will be considered as
 secondary outcomes. Four measurements of static posturography will be conducted:
 pre-intervention, immediately after application of the tape, after seven days
 post-intervention (after removal of the tape) and after one month follow-up period. Secondary
 and primary outcomes will be assessed on three occasions: pre-intervention, seven days
 post-intervention and after one month follow-up period. All statistical analysis will be
 conducted following the principles of intention to treat, and the effects of treatment will
 be calculated using linear mixed models.
BACKGROUND

 Considering that evidence suggests that patients with CLBP have changes in postural control,
 we highlight the importance of conduct studies to identify treatment strategies that can
 influence postural control like as FT. In this way, the objective of the present study is to
 compare the effects of Functional Star-shape Taping (FST) vs. Sham-FT vs. MI on pain
 intensity and postural control (primary outcomes) in CLBP patients. The secondary outcomes
 will be low back pain related disability, global perceived effect of treatment and fear
 avoidance beliefs.

 METHODS

 Study design

 This study will be a sham-controlled, randomized, three-arm parallel-group clinical Study
 participants

 The sample will be composed of 120 participants (both genders) with nonspecific CLBP, who
 will be referred to the physiotherapy clinic of the UENP Center for Health Sciences (Paraná
 state, Brazil).

 Allergy test

 Firstly, an assessor blinded to the treatment allocation collected the baseline data and
 performed an allergy test on all participants. This allergy test consisted of applying a
 small patch of FT over the skin. Participants kept this patch on for 24 hours and will be
 instructed to remove the patch and call the researchers if any allergic reaction occurred.
 Only patients without allergic reaction to the patch test were then scheduled to undergo
 randomization.

 Randomisation and allocation

 The proposed study will follow the recommendations described in Consolidated Standards of
 Reporting Trials (CONSORT) statement (Moher et al., 2010). Once the patient has accepted an
 invitation to participate, they will give written consent before being assessed for
 eligibility. Firstly, one researcher will gather the clinical assessment and allergy test to
 exclude noneligible participants. Only patients without allergic reaction to the patch test
 will be scheduled to randomisation. After this initial assessment, participants will be
 randomly assigned following simple randomisation procedures (computerized random numbers) to
 1 of 3 treatment groups (opaque sealed envelopes containing cards will be used): (1)
 Functional Star-shape Taping (FST), (2) Sham-FT and (3) (MI). The allocation sequence will be
 generated by a researcher not involved in the assessment and interventions, and one research
 assistant will assign participants to interventions.

 Procedures

 Following the allocation process, a blinded investigator will conduct clinical assessments
 and collect primary and secondary outcomes and psychosocial variables. In the same session,
 another investigator who is a certified Kinesio tape practitioner, will proceed with the
 treatment according to the group assignment, and will be therefore responsible for applying
 the functional tape and MI. Patients in the FST and Sham-FT groups will be blinded to
 interventions (sham or not) and will be advised to leave the tape in situ for one week. The
 MI group will receive a booklet with biopsychosocial education and orientations.

 Initial evaluation

 The evaluations will be carried out according to the recommendations of the Initiative on
 Methods, Measurement and Pain Assessment in Clinical Trials (IMMPACT) for chronic pain.

 Primary Outcomes

 Pain intensity

 Measurement of pain intensity will accomplish using the application of the NPRS, which
 consists of a sequence of numbers from 0 to 10, in which 0 represents "no pain" and 10
 represents "worst pain imaginable".

 Postural control on force platform - Static Posturography with and without a secondary task

 Static posturography will be evaluated using a force platform (400 Biomec, EMG system of
 Brazil Ltda®, São José dos Campos, Brazil), with frequency acquisition of 100 Hz and a
 second-order 35 Hz low pass Butterworth filter. Posturography analysis of the COP will be
 carried out by four main parameters of balance: (1) ellipse (95%) of the COP in square
 centimeters (A-COP in cm2); (2) Root Mean Square of oscillation of the COP (RMS in cm2); (3)
 mean speed (MVeloc in cm/s) of the displacement of the COP in anteroposterior (A/P) and
 medial-lateral (M/L) directions; and (4) mean frequency (MF in Hz) of the displacement of the
 COP in anteroposterior (A/P) and medial-lateral (M/L) directions.

 A modified clinical test of sensory interaction for balance (CTSIBm) will be used by
 measuring the static balance in four sensory conditions: (1) eyes open on stable surface; (2)
 eyes closed on stable surface; (3) eyes open on unstable surface; (4) eyes closed on unstable
 surface. For each condition, the participant will be evaluated three times for 40 seconds
 with a 30-second interval between assessments.

 For the assessment of static posturography with a secondary task, volunteers will be
 requested to perform a fast movement of shoulder flexion (bilateral). Participants will be
 trained to carry out the tests with maximum arm speed (approximately 120º/seg) and amplitude
 at about 60º immediately after the auditory stimulus. Participants will perform five
 movements (open and closed eyes), with a time interval of 30 seconds between each repetition
 and an auditory stimulus will precede the trigger by a random period of 0.5-2 s.

 Secondary Outcomes

 Disability and Participant ratings of global improvement and satisfaction with treatment -
 Global perceived effect Fear avoidance beliefs questionnaire (FABQ).

 Psychosocial Measures - Baseline measure

 Hospital anxiety and depression scale - HADS and Pain catastrophizing scale - PCS and Chronic
 Pain Self-Efficacy Scale - CPSS.

 Interventions

 Functional Taping Intervention

 Participants will be subjected to one of two possible intervention procedures with FT: 1)
 Functional Star-shape Taping (FST); 2) Sham Functional Taping (Sham-FT). The participants
 will be blinded as to whether they received SFT, or Sham-FT, and the two interventions will
 be performed in the lumbar region. The elastic adhesive bandage used will have 5.0 cm wide
 and 0.5 mm thick (Kinesio Tex Gold® brand, Kinesio Holding Corporation, Albuquerque, USA) and
 resistant to contact with water. All participants will be informed that they would receive
 one of the two types of FT application. During this period of application, the participants
 will be directed to maintain their daily life activities, and will be blinded with respect to
 which intervention procedure they received (if sham or not).

 Minimal Intervention Strategy (MI)

 The MI group will receive an educational and counseling booklet (a booklet based on The Back
 Book).

 Data analysis

 The two primary outcome variables (posturography and pain intensity) were considered for
 calculation of sample size. For posturography, we will consider an improvement of at least
 20% mean speed of oscillation of the COP pre- and immediate post-treatment. The sample size
 was 27 participants. The following specifications were considered: α=5% and 95% statistical
 power and effect size of 0.76 for F-test. For pain intensity, an improvement of at least 20%
 on the NPRS (pre-treatment: 5.6 and post-treatment and follow-up: 4, SD = 1.8). The sample
 size obtained was 93 (31 participants per group). The following specifications were
 considered: α=5% and statistical power of 95% and effect size of 0.41 for F-test. Thus, to
 ensure a power suitable and assuming sample losses, 120 participants will be considered (at
 least #9 losses per group) (GPower 3.0.10, University of Kiel, Germany).

 The statistician will be given grouped data, but data will be coded so that the statistician
 will remain blinded to patients' group allocation and to protect patient confidentiality. The
 mean effects of the interventions and the group differences for all outcomes (primary and
 secondary) will be calculated using linear mixed models that incorporated terms for the
 treatment groups, time (post-intervention and follow-up), and interaction terms (treatment
 subgroups and time) as well as psychosocial variables, sex and age as covariates. Secondary
 analysis will be conducted using regression models to determine whether baseline scores of
 psychosocial variables (HADS, PCS, CPSS) will moderate the effect of treatments (FT, sham FT
 or MI). The analyzes will follow the intention-to-treat principles.

 Additionally, analyzes will be performed on subgroups of patients with worse and better
 postural control parameters by determining cut-off values for instability based on data
 previously published in the literature. These analyzes will be carried out to identify
 potential subgroups of better and worse rates of postural control and possible effects of FT.
 The same procedure will be performed to analyze psychosocial subgroups.

 For all of these analyzes, we will use the IBM SPSS software package, version 22 (IBM Corp,
 Armonk, New York).
Inclusion Criteria:

 -  (1) aged between 18 and 50 years;

 -  (2) medical diagnosis of chronic non-specific low back pain in the last 3 months
 and/or pain during at least half of the days in the past 6 months (Deyo et al. 2014),
 that is located between T12 and the gluteal folds;

 -  (3) pain intensity equal to or greater than three;

 -  (4) pain caused by certain postures, activities and movements; and

 -  (5) score greater than 14% on the Oswestry Lumbar Disability Index (Vibe Fersum et al.
 2013).

 Exclusion Criteria:

 -  (1) red flags (neoplastic diseases or tumors in the spine, inflammatory diseases,
 infections and fractures);

 -  (2) serious neurological (or central and peripheral neurological) symptoms,
 psychiatric, rheumatologic and cardiac diseases;

 -  (3) disc herniation;

 -  (4) lumbar stenosis;

 -  (5) spondylolisthesis;

 -  (6) history of spinal surgeries;

 -  (7) pregnancy;

 -  (8) menstrual period;

 -  (9) underwent physical therapy treatments (less than 6 months before the evaluation
 period);

 -  (10) participants with previously diagnosed balance disorders or with disorders that
 may interfere with balance (vestibular diseases, whiplash injuries, functional ankle
 instability or report of "giving" way sensation in ankle during the past 6 months);
 and

 -  (11) using medications that alter or cause suppression of sensory perception.