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
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
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
NCT ID
NCT02922322
First Posted
June 5, 2016
Last Updated
September 30, 2016
Sponsor
Federal University of Paraíba
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
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Effectiveness of Mat Pilates Exercises in Individuals With Chronic Nonspecific Low Back Pain
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