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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
Sponsor:
Information provided by (Responsible Party):
Prof. Rodrigo Luiz Carregaro, University of Brasilia

Brief Summary:
The aim will be to compare the effectiveness and cost-effectiveness of home-based exercises with a Pilates program in individuals with chronic non-specific low back pain. A second objective will be to assess the cost of interventions, associated with effects on outcomes. This is a randomized controlled clinical trial, characterized by the application of therapeutic exercises, in two modalities: Pilates Method and Home-Based Exercises. Participants will be sequentially enrolled and will be randomly allocated into two groups: 1) Pilates: which will be submitted to Mat Pilates sessions, 2x / week, for 6 weeks; 2) Home-Based Exercise: 2 sessions of exercise supervised by a physiotherapist and, after, all participants will receive a booklet with the prescription of home therapeutic exercises, to be performed in the period of 6 weeks (2x/week) and monitored in a diary. Participants will be evaluated in three different moments: 1) Baseline (pre-intervention); 2) At the end of the intervention period (6 weeks); And 3) After six months of follow-up. Primary outcomes will be pain intensity (measured by VAS) and disability (measured by the Quebec Questionnaire - QDS). Secondary outcomes will be the perception of recovery (likert scale of 6-points), postural balance and quality of life (measured by the EuroQol questionnaire - EQ-5D-3L). An economic evaluation will be carried out, from the economic perspective of the society, with a survey of direct and indirect costs, associated to the effects of the interventions. Data analysis will be performed through SPSS software version 22.0. The data normality assumptions will be evaluated using the Shapiro Wilk test. If the test confirms the assumptions, a mixed ANOVA with repeated measures will be used, based on the outcomes (pain, disability, postural balance, quality of life, perception of recovery) and independent variables (Pilates and Home-Based Exercises), for the comparisons between pre-intervention, post-intervention and follow-up. It is hypothesized that the home-based exercise program will be more cost-effective compared to Pilates.

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
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)
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.
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Other: Pilates

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




Primary Outcome Measures :
  1. Pain [ Time Frame: Change from Pre-Intervention (baseline) compared to Post-Intervention (6 weeks) and Follow-up (6 months) ]
    Visual Analog Scale, in centimeters

  2. 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


Secondary Outcome Measures :
  1. 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).

  2. 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

  3. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Presence of chronic non-specific back pain for more than 12 consecutive weeks;
  • Not having attended Pilates or physiotherapy sessions for at least 6 months prior to enrollment.

Exclusion Criteria:

  • History of trauma or fractures in the spine;;
  • Diagnosis of osteoarthritis, disc herniation or spondylolisthesis;
  • Referred pain (visceral, abdominoplasty, appendicitis, abdominal and pelvic surgeries);
  • Previous surgery on the spine;
  • Presence of root symptoms;
  • Pregnancy.

Information from the National Library of Medicine

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


Contacts
Contact: Caroline Ribeiro, BS +55981000590 fisiounb.lombalgia@gmail.com

Locations
Brazil
Campus UnB Ceilândia Enrolling by invitation
Brasília, Brazil
Sponsors and Collaborators
University of Brasilia
Investigators
Principal Investigator: Rodrigo L Carregaro, PhD University of Brasilia, School of Physical Therapy

Responsible Party: Prof. Rodrigo Luiz Carregaro, Prof. Dr., University of Brasilia
ClinicalTrials.gov Identifier: NCT03113292     History of Changes
Other Study ID Numbers: COmEBACK Trial
CAAE68870317.0.0000.8093 ( Other Identifier: Ethics Commitee FCE/UnB )
First Posted: April 13, 2017    Key Record Dates
Last Update Posted: June 7, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Prof. Rodrigo Luiz Carregaro, University of Brasilia:
physical therapy
therapeutic exercises
low back pain

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms