Effects of Self-Stretching Posture and Segmental Stabilization in Patients With 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 problem for public health that affects about 60-85% of
      the population at some point in life. Approximately 10-40% of individuals with low back pain
      develop the chronic form. International guidelines consider three groups of treatment options
      for low back pain: medication, invasive and conservative treatments in which conservative
      approach is the most recommended. The European Guidelines for Management of Chronic
      Non-specific Low Back Pain recommends that supervised exercise programs should be used as
      front-line treatment for chronic low back pain, such as stabilization exercises, conventional
      stretching and other active exercise, but there is no consensus on literature on the most
      effective form of treatment. However, there is limited evidence about the effects of a global
      stretching intervention using self-stretching postures for chronic low back pain.

      Objectives: The aim of this research is to compare the effects of an active global stretching
      program (GSP) using self-management of posture versus stabilization exercises on pain
      intensity and disability for patients with chronic non-specific low back pain.

      Methods: This study is a randomized controlled three arm clinical trial with examiner
      blinding. A sample of 100 patients with chronic non-specific low back pain will be randomly
      assigned to two treatment groups (GSP or Stabilization Exercises). The eligibility criteria
      will be 18 and 50 years, pain in the last three months and/or pain in at least half of the
      days in the past six months, pain located between T12 and the gluteal folds, pain intensity
      greater than or equal to three, and score greater than 14% on Oswestry Disability Index.
      Patients will be assessed in baseline, immediately after treatment and after one and
      three-months follow-up. Sessions will be provided weekly for eight weeks by a single
      therapist lasting 40 minutes. The primary outcomes will be pain intensity and low back pain
      related disability and the secondary outcomes will be fear avoidance, global perceived effect
      of treatment and muscle flexibility. All statistical analysis will be conducted following
      principles of intention to treat, and the treatment effects will be calculated using linear
      mixed models.
    

Detailed description: 
      Study design

      This study will be a randomized controlled with two arm clinical trial and examiner blinding.

      The sample will consist of 100 participants (both genders) with nonspecific chronic low back
      pain.

      Randomization and allocation

      Patients will be randomly assigned through a randomization process involving opaque envelopes
      containing cards stipulating one of the three following groups: (1) Global Stretching Program
      (GSP) and (2) Stabilization Exercises (SE). An assistant researcher not involved in the
      recruitment of patients will allocate the randomly using data generated by a group allocation
      software.

      Procedures

      The proposed study will follow the recommendations described on Consolidated Standards of
      Reporting Trials (CONSORT) statement to ensure transparency and quality of the findings.

      Each participant will be supervised by a single physical therapist, who will not be involved
      in the assessment of the patients and/or randomization. A second researcher will conduct the
      following evaluation in baseline assessment: pain intensity, low back pain related disability
      and psychosocial factors using questionnaires validated to Brazilian Portuguese.

      During the treatment and follow-up periods, the use of drugs will be discouraged. Patients
      who require rescue medication during the study will be encouraged to register the use.

      Initial evaluation and follow-up

      After eligibility assessment, participants will be asked to complete a questionnaire with
      personal data. Subsequently, the psychosocial evaluation will be conducted in accordance with
      the recommendations of the Initiative on Methods, Measurement and Pain Assessment in Clinical
      Trials (IMMPACT) for chronic pain. The volunteers will be re-assessed immediately after
      treatment and after one and three-months follow-up. The main outcome measures will be pain
      intensity and low back pain related disability. Secondary outcomes will be fear avoidance,
      global perceived treatment effect and muscle flexibility.

      The hypothesis of this study is that patients with chronic low back pain submitted to global
      stretching exercises will show greater effects to pain intensity and disability than patients
      submitted to interventions separated.

      Primary Outcomes

      The pain intensity measurement will be accomplished by application of a numerical pain rating
      scale - PNRS, which consists of a sequence of eleven numbers from 0 to 10, in which 0
      represents "no pain" and 10 represents "worst pain imaginable". Volunteers will rate their
      pain based on these parameters.

      To assess disability related to chronic low back pain, the Oswestry Low Back Disability
      Index, adapted to Brazilian Portuguese will be used. The result is converted into a
      percentage by multiplying the total score by two. This instrument consists of 10 items, each
      of which has six response options. The total score will be calculated by summing up the
      points, the largest possible sum being #50. Previous research has found ODI showed
      responsiveness to change for patients with CLBP, with MCID of #8 points.

      Secondary Outcomes

      Fingertip-to-Floor Test, Fear avoidance beliefs questionnaire - FABQ and Global Perceived
      Effect of Treatment will be assessed pre and post treatment.

      The FABQ adapted for Brazilian Portuguese consists of 16 self- response items, rated on a
      seven-point Likert scale from 0 (completely disagree) to 6 (completely agree). The score is
      obtained for each separate subscale: one that addressed the fears and beliefs of individuals
      in relation to work and one that addressed their fears and beliefs about physical activities.

      Global Perceived Effect of Treatment is recommended for use in clinical trials of chronic
      pain as a measure of the perception of global improvement/worsening regarding to treatment.
      Global Perceived Effect of Treatment is an 11-point scale that ranges from -5 ("vastly
      worse") through 0 ("no change") to +5 ("completely recovered"). A higher score indicates
      higher recovery from the condition.

      The Fingertip-to-floor test showed excellent levels of validity compared to the radiological
      measurement (r=0.96) and reproducibility (intra and interexaminer - ICC = 0.99). The test is
      known for full mobility in the tilted forward position when standing, corresponding to
      flexion of the spine and pelvis. It is a measure of relevance in rehabilitation results
      probably because patients simultaneously increase the pelvic and lumbar flexion post
      treatment.

      As baseline intervention the investigators will assess pain catastrophising, anxiety and
      depression scale and pain self efficacy. Hospital Anxiety and Depression Scale will be used
      to identify anxiety disorders and depression in physically ill patients. The HADS was
      translated and validated into Portuguese. Then divided into the anxiety subscale (HADS-A) and
      the depression subscale (HADS-D), both containing seven interspersed items. It is composed of
      seven items for depression and seven items for anxiety, each item including four response
      options ranging from 0 to 3. The cutoff scores are 8 points for anxiety, 9 for depression.
      Change in depressive symptoms significantly predicted change in pain severity and intensity.

      Pain catastrophising scale (PCS) will be used to assess catastrophising thoughts. The scale
      is composed of 13 items staggered on a Likert scale, ranging from 0 to 5 points. The total
      score is the sum of the items divided by the number of items answered, with the minimum score
      being 0 and the maximum being 5 for each item. Higher scores indicated a greater presence of
      catastrophic thoughts. The total score of the scale could vary between 0 and 52 points. A
      recent systematic review found that found catastrophising to be associated with pain and
      disability at follow-up in CLBP patients.

      The Chronic Pain Self-Efficacy Scale (CPSS) will be used to assess self-efficacy perception
      related to chronic pain, which can be defined as an individual's personal conviction that
      they can successfully execute an action to produce desirable results related to living with
      chronic pain. The scale has 22 items and was adapted and validated to Brazilian Portuguese.
      Previous research suggested that rehabilitation programs for CLBP should target pain
      self-efficacy which mediates the relationship between depressive symptoms and pain severity.

      Interventions

      Participants will be randomly assigned to two possible interventions: GPS and Stabilization
      Exercises intervention group. Treatment protocol will be conducted by eight weeks, one time
      per week. The session will last for 40 minutes.

      Data Analysis

      The pain intensity outcome was considered for sample size calculation. A change of at least 2
      units on NPRS was considered for analysis. The sample size obtained was 78 (39 subjects
      each). The following specifications were considered: α = 5%, statistical power of 90% and
      0.61 effect size for F-test. The GPower software was used to calculate the sample size
      (GPower 3.0.10 of the University of Kiel, Germany). Thus, to ensure a power suitable and
      assuming sample losses, 100 (50 subjects per group) participants will be considered (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. The analyzes
      will follow the intention-to-treat principles. For all of these analyzes, IBM SPSS software
      package will be used, version 22 (IBM Corp, New York).

      The Statistical Package for the Social Sciences (SPSS) software version 22 (Chicago, IL, USA)
      will be used for analysis, and the significance level was established at 0.05.
    

Intervention name(s): Global Stretching Program; Stabilization Exercises
Intervention type(s): Procedure; Procedure
Intervention description(s): Participants will be submitted to a GSP in self-management postures weekly for 40 minutes session conducted by one one physical therapist, certified to use the technique (Stretching Global Active). The GSP will last for a period of 8 weeks. The protocol is based on the study of Lawand et al (2015) who used all postures global therapeutic stretching. The investigators will use six self-management postures in a standardized manner, each of which will last for 10 to 20 minutes.; The exercise protocol and criteria to increase exercise progression was previously described by Hicks et al (2005). It will be directed by a single therapist one to one session based on specific criteria (being able to maintain muscle contraction eight seconds during 30 repetitions in bilateral exercises or during 20 repetitions for unilateral exercises). Each session will be conducted weekly for 40 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Low Back Pain; Back Pain; Muscle Stretching Exercises; Stabilization Exercise; Exercise Therapy; Exercise Movement; Exercise Movement Tecniques; Pain; Disability