Effects of the Pilates Method Versus Home Exercise in Individuals With Chronic Non-specific Back Pain (COmEBACK)
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|ClinicalTrials.gov Identifier: NCT03113292|
Recruitment Status : Not yet recruiting
First Posted : April 13, 2017
Last Update Posted : June 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Chronic Low Back Pain||Other: Pilates Other: Home Exercises||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||126 participants|
|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)|
|Masking Description:||The outcome assessor won't have any knowledge about the study purposes and will be unaware of the group allocation. The statistical analysis will also be performed blinded for group allocation.|
|Official Title:||Cost-effectiveness of the Pilates Method Versus Home-based Exercises in Individuals With Chronic Non-specific Low Back Pain: a Randomized Controlled Trial|
|Estimated Study Start Date :||June 2018|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||July 2020|
Experimental: Pilates Method
Mat Pilates Program, 2x/week, for 6 weeks, supervised by a Physiotherapist. Sessions will last forty five min, with 4 individuals per session. On average, 10 to 15 exercises will be performed per session, with repetitions ranging from 10 to 20 times, according subject's limitations. If necessary, the exercises will be adapted individually for the three levels of difficulty: basic, intermediate and advanced. Progress will be dependent on the absence of postural compensations when performing the repetitions of the exercises.
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.
Other Name: Therapeutic exercise
Active Comparator: Home Exercise Prescription
Composed by two familiarization sessions, supervised by a Physiotherapist. The protocol include postural reeducation exercises, stretching and muscle strengthening, stabilization and mobilization of the spine. Subsequently, participants will receive an educational booklet containing information on low back pain, anatomy of the spine and its relation to the muscular chain, care during daily life activities and the importance of regular physical exercises. Also, it will include a booklet with the prescription of therapeutic home exercises to be performed during the next 6 weeks. It will be recommended that the participants perform the exercises 2x/week. Participants will also be contacted weekly by email and/or telephone, for remote supervision and for checking the prescribed exercises.
Other: Home Exercises
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 Name: Therapeutic exercise
- Pain [ Time Frame: Change from Pre-Intervention (baseline) compared to Post-Intervention (6 weeks) and Follow-up (6 months) ]Visual Analog Scale, in centimeters
- Disability [ Time Frame: Change from Pre-Intervention (baseline) compared to Post-Intervention (6 weeks) and Follow-up (6 months) ]Quebec Back Pain Disability Scale, scores ranging from 0 to 100
- Quality of Life [ Time Frame: Change from Pre-Intervention (baseline) compared to Post-Intervention (6 weeks) and Follow-up (6 months) ]EuroQol (EQ-5D-3L), consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take one of five responses. The responses record five levels of severity (no problems/slight problems/moderate problems/severe problems/extreme problems).
- Balance [ Time Frame: Change from Pre-Intervention (baseline) compared to Post-Intervention (6 weeks) and Follow-up (6 months) ]Balance Platform, variation of the platform displacement
- Perception of Recovery [ Time Frame: Change from Pre-Intervention (baseline) compared to Post-Intervention (6 weeks) and Follow-up (6 months) ]Likert scale (6-points)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03113292
|Contact: Caroline Ribeiro, BSemail@example.com|
|Campus UnB Ceilândia||Enrolling by invitation|
|Principal Investigator:||Rodrigo L Carregaro, PhD||University of Brasilia, School of Physical Therapy|