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Effectiveness of Mat Pilates Exercises in Individuals With Chronic Nonspecific Low Back Pain

Primary Purpose

Nonspecific Chronic Low Back Pain, Chronic Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pilates Group
Sponsored by
Federal University of Paraíba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nonspecific Chronic Low Back Pain focused on measuring Mat Pilates, Chronic Nonspecific low back pain, Quality of life, Disability, transverse abdominal muscle

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Complaining of non-specific low back pain for more than three months without radicular symptoms for a period exceeding 12 months.
  • Pain intensity equal to or more than 3 points evaluated by the Pain Numerical Rating Scale in the last seven days.
  • Eligibility to practice physical activity responding to the Physical Activity Readiness Questionnaire - PAR-Q

Exclusion Criteria:

  • Degenerative or inflammatory pathologies of the spine,
  • Acute crisis of pain in the shoulders, knees, ankles and spine
  • Spinal tumors
  • Recent surgery on the spine, lower and upper limbs
  • Herniated disc
  • Spondylolysis or spondylolisthesis
  • Rheumatologic diseases
  • Patients who are in labor dispute
  • In treatment involving Pilates, physiotherapy or medication.
  • Do not understand the writing and speaking Portuguese.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    Pilates Group

    Control Group

    Arm Description

    The Pilates Group was composed by 15 participants evaluated before and after 16 sessions of intervention with mat Pilates exercises.

    The control group was composed by 15 participants that received no intervention

    Outcomes

    Primary Outcome Measures

    Questionnaire on Pain Intensity
    The pain intensity was evaluated using an 11-point pain numerical rating scale.

    Secondary Outcome Measures

    Questionnaire on Quality of Life
    The quality of life assessment was measured through the SF-36 questionnaire.
    Questionnaire on Disability
    The index of disability was assessed trough the 2.0 version of the Oswestry questionnaire, which is a specific questionnaire to evaluate levels of disability in people who suffer with low back pain.
    Questionnaire on Pain Describers
    The pain describers were evaluated through the MCGill questionnaire.

    Full Information

    First Posted
    June 5, 2016
    Last Updated
    September 30, 2016
    Sponsor
    Federal University of Paraíba
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02922322
    Brief Title
    Effectiveness of Mat Pilates Exercises in Individuals With Chronic Nonspecific Low Back Pain
    Official Title
    Effectiveness of Mat Pilates Exercises in Individuals With Chronic Nonspecific Low Back Pain: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2016 (undefined)
    Primary Completion Date
    May 2016 (Actual)
    Study Completion Date
    May 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Federal University of Paraíba

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    To analyze the effectiveness of mat Pilates compared to no intervention in individuals with chronic nonspecific low back pain.
    Detailed Description
    There is evidence that exercises based on the Pilates method reduce pain in chronic nonspecific low back pain (CNLBP). However, is noticed the lack of studies that compare the effectiveness of mat Pilates to no intervention in the treatment of individual with CNLBP. Therefore, the main objective of the study is to analyze the effectiveness of mat Pilates compared to no intervention in patients with chronic nonspecific low back pain. It is a randomized controlled trial with two arms and double blinded (caregiver, assessor and outcome assessor), composed of 30 patients, aged between 18- 65 years (±22,47) of both sexes, diagnosed with chronic non-specific low back pain persisting for more than three months and pain intensity greater than 3 points in the Pain Numerical Rating Scale. The participants were randomly divided into two groups: Pilates Group (n = 15), intervention based on mat Pilates exercises, and Control Group (n =15) with no intervention. The mat Pilates group performed 16 sessions, twice a week in 60-minute duration each throughout eight weeks, whereas the control group participants kept usual cares until the end of the intervention. Both groups were evaluated before and after the program by a researcher who was unaware of the patients' allocation. The primary assessed outcomes: pain intensity (Pain numerical rating scale, and McGill questionnaire), quality of life (SF-36), and disability (Oswestry Low Back Pain Disability Questionnaire). In addition, the strength and muscle activation of transverse abdominal as secondary outcome assessed through the Stabilizer Pressure Biofeedback Unit test. As a result, the study infers that mat Pilates exercises have significantly improved all the evaluated outcomes. Thus, supporting clinical decisions for the treatment of chronic nonspecific low back pain.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Nonspecific Chronic Low Back Pain, Chronic Low Back Pain
    Keywords
    Mat Pilates, Chronic Nonspecific low back pain, Quality of life, Disability, transverse abdominal muscle

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Care ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Pilates Group
    Arm Type
    Active Comparator
    Arm Description
    The Pilates Group was composed by 15 participants evaluated before and after 16 sessions of intervention with mat Pilates exercises.
    Arm Title
    Control Group
    Arm Type
    No Intervention
    Arm Description
    The control group was composed by 15 participants that received no intervention
    Intervention Type
    Other
    Intervention Name(s)
    Pilates Group
    Intervention Description
    The Pilates group program (PG) was composed of 16 sessions, 2x per week, 60 minute session each for 8 weeks. The intervention was based on 20 out of the 34 original mat exercises proposed by the Pilates method, classified into basic, intermediate or advanced levels divided into 4 cycles of 5 exercises each. The exercises were performed during two series of 10 repetitions respecting the patients skills.
    Primary Outcome Measure Information:
    Title
    Questionnaire on Pain Intensity
    Description
    The pain intensity was evaluated using an 11-point pain numerical rating scale.
    Time Frame
    8 weeks
    Secondary Outcome Measure Information:
    Title
    Questionnaire on Quality of Life
    Description
    The quality of life assessment was measured through the SF-36 questionnaire.
    Time Frame
    8 weeks
    Title
    Questionnaire on Disability
    Description
    The index of disability was assessed trough the 2.0 version of the Oswestry questionnaire, which is a specific questionnaire to evaluate levels of disability in people who suffer with low back pain.
    Time Frame
    8 weeks
    Title
    Questionnaire on Pain Describers
    Description
    The pain describers were evaluated through the MCGill questionnaire.
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Complaining of non-specific low back pain for more than three months without radicular symptoms for a period exceeding 12 months. Pain intensity equal to or more than 3 points evaluated by the Pain Numerical Rating Scale in the last seven days. Eligibility to practice physical activity responding to the Physical Activity Readiness Questionnaire - PAR-Q Exclusion Criteria: Degenerative or inflammatory pathologies of the spine, Acute crisis of pain in the shoulders, knees, ankles and spine Spinal tumors Recent surgery on the spine, lower and upper limbs Herniated disc Spondylolysis or spondylolisthesis Rheumatologic diseases Patients who are in labor dispute In treatment involving Pilates, physiotherapy or medication. Do not understand the writing and speaking Portuguese.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    IDEMAR R DOS SANTOS JUNIOR, BPhty
    Organizational Affiliation
    Federal University of Paraíba
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    CARINA CC COUTINHO, MD
    Organizational Affiliation
    FEDERAL UNIVERSITY OF PARAIBA
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
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    21856719
    Citation
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    Effectiveness of Mat Pilates Exercises in Individuals With Chronic Nonspecific Low Back Pain

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