Effects of the Pilates Method Versus Home Exercise in Individuals With Chronic Non-specific Back Pain
Condition: Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The aim is to compare the effectiveness and cost-effectiveness of a Pilates program versus
      home-based exercises in individuals with chronic non-specific low back pain. This is a
      randomized controlled trial with economic evaluation. Participants will be sequentially
      enrolled and randomly allocated into two groups: 1) Pilates: Mat Pilates sessions, supervised
      by a physiotherapist (2x/week for 6 weeks); 2) Home-Based Exercise: face-to-face
      familiarization (two sessions), supervised by another physiotherapist. After familiarization,
      the exercises will be prescribed using a booklet containing descriptions of sets/repetitions,
      as well as guidelines and precautions, to be performed during 6 weeks (2x/week) and monitored
      in a diary. Participants will be supervised by the physiotherapist (telephone/text
      messaging). Participants will be evaluated in three different moments: 1) Baseline
      (pre-intervention); 2) At the end of the intervention (post-intervention, 6 weeks); and 3)
      After six months follow-up (from post-intervention). Primary outcomes: pain intensity and
      disability. Secondary outcomes: perception of recovery, postural balance, and quality of
      life. Concurrently, a cost-effectiveness study will be conducted comparing the Pilates vs
      Home-Based Exercise, from the perspectives of public healthcare and society. In the first
      perspective, only costs incurred by the public healthcare system will be included (direct
      costs related to consultations, medications, tests, hospitalizations, and professional fees).
      In the second perspective, private health care expenses, costs incurred by patients
      (transportation and support by caregivers, when applicable), as well as indirect costs
      (missed workdays and loss of productivity) will be included. The incremental
      cost-effectiveness ratios for the primary outcomes and cost-utility ratios will be calculated
      for both perspectives. The cost-utility ratio will express the incremental costs per
      quality-adjusted life year (QALY). In addition, the absolute and incremental net monetary
      benefit will be calculated. Sensitivity analyses will be conducted. Data normality
      assumptions will be evaluated using the Shapiro Wilk test. If confirmed, a mixed model will
      be used, for the comparisons between groups and moments. It is hypothesized that the Pilates
      will be more cost-effective compared to the home-based exercise program.
    


Intervention name(s): Pilates; Home Exercises
Intervention type(s): Other; Other
Intervention description(s): The protocol will be composed by the following exercises, structured in each session according to progression, difficulty and focus (respiration, stability, muscle strength and joint mobility): Arm Arcs, Bent Knee Opening, Sidelying, Dead Bug, Femur Arcs, Quadruped Series, Single Leg Stretch, Prone Press Up, Sidekick (Front to Back 1 e 2), Leg Pull Front, Mermaid, Spine Stretch, The Hundred, Pelvic Clock, Bridging, Stanging Roll Down, Swan, Saw, Dart, Swimming, Book Opening.
.; The protocol will be divided into 3 phases, each one composed by the following exercises and structured according to difficulty progression and focus (postural reeducation, muscle strength, balance, joint flexibility): Muscle strength exercises composed by abdominal exercises; back extension exercises; gluteus maximus exercises. Stretching exercises for the lower back, pelvis, iliopsoas muscle, tensor fascia latae muscle).
Other intervention name(s): Therapeutic exercise; Therapeutic exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a randomized controlled clinical trial, characterized by the application of therapeutic exercises, in which subjects will be randomly allocated into two groups: Pilates Method and Home-Based Exercises. The participantes will be individuals with non-specific chronic low back pain. The study will be reported following the recommendations of the CONSORT Statement. For the present study, chronic non-specific back pain was defined as uninterrupted low back pain for more than 12 weeks, with unknown causes.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: physical therapy; therapeutic exercises; low back pain