Effects of Functional Taping on Static Postural Control in Patients With Non-specific Chronic Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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).
    

Intervention name(s): Functional Star-shape taping (SFT); Sham Functional Taping (Sham-FT); Minimal Intervention Strategy (MIS)
Intervention type(s): Procedure; Procedure; Behavioral
Intervention description(s): For the SFT procedure, four tapes will be applied in the form of an elastic ''I'' with the aim of facilitating muscle activation. The taping will be applied when the participant is in a seated position. The taping will be positioned covering the entire lumbar region and lower part of the thoracic region (T11, T12), and placed first at the center and then on the ends (Castro-Sanchez et al. 2012).The tension of the taping was 25%, this protocol being recommended by the Kinesio taping manual to facilitate muscle activation (Castro-Sanchez et al. 2012; Kase et al. 2003). The participant will remain for on week with FT.; For the Sham-FT procedure, a single bandage 20 cm in length was positioned horizontally, passing through the spinous process of the second lumbar vertebra (Castro-Sanchez et al. 2012). The tension of the taping was 25%, this protocol being recommended by the Kinesio taping manual to facilitate muscle activation (Castro-Sanchez et al. 2012; Kase et al. 2003). The participant will remain for on week with FT.; The MIS group will receive an educational and counseling booklet (The Back Book) as recommend by Dupeyron et al. (2011) containing information about the low back pain clinical features, risk factors and prognosis, fear avoidance beliefs, how to deal with an acute pain crisis, the early resumption of normal or vocational activities, even when still experiencing pain, and the importance of improvement in functional activity levels and posture, not just pain relief (Delitto et al. 2012). Participants from this group will not receive FT intervention and the investigator will encourage participants to not receive any kind of treatment during the one month epoch after the initial assessment. They will be followed by one of the investigators that will make phone calls to clarify doubts and reinforce the counseling.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: low back pain; functional taping; balance; posture; rehabilitation; psychosocial factors; minimal intervention strategy