Pilates to Treat Low Back Pain (PTLBP)
Primary Purpose
Pain, Quality of Life
Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Pilates
Sponsored by
About this trial
This is an interventional treatment trial for Pain focused on measuring Pilates, Exercise, Treatment, Low back pain, Pain, Function
Eligibility Criteria
Inclusion Criteria:
- non specific mechanical low back pain
- visual analogue scale for pain ranging from 4 to 7
Exclusion Criteria:
- previous back surgery
- spinal tumor
- spinal fracture
- pregnancy
- fibromyalgia
- inflammatory or infectious spinal diseases
- litigant patients
Sites / Locations
- Universidade Federal de Sao Paulo
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Pilates Group
Control Groups
Arm Description
This group keep their usual treatment and did a Pilates treatment twice a week (one hour each class) during 90 days.
This group keep their usual treatment and can do the Pilates training after the end of the study.
Outcomes
Primary Outcome Measures
Change in pain
Measured with the visual analogue scale ranging from 0 to 10
Secondary Outcome Measures
Change in function
Measured by the questionnaire Roland Morris
Change in quality of life
Measured by the SF-36 questionnaire
Change in nonsteroidal antiinflammatory drugs (NSAIDs) consumption
Measured by counting the number of tablets consumed per month
Full Information
NCT ID
NCT01502059
First Posted
December 27, 2011
Last Updated
December 29, 2011
Sponsor
Federal University of São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT01502059
Brief Title
Pilates to Treat Low Back Pain
Acronym
PTLBP
Official Title
The Effectiveness of Pilates to Treat Low Back Pain: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a randomized controlled trial, with blinded assessor to evaluate the effectiveness of Pilates to treat low back pain.
Hypothesis - the Pilates group will have best results than the control group (usual medicament treatment).
Detailed Description
Background:
Low back pain (LBP) is a common problem among adults. Approximately 70-85% of the adult population experiences this painful complaint at some point in their lives, making LBP the second most common reason for a visit to a clinician. Despite the frequency of this diagnosis, conventional treatment does not always provide patients the desired results of reduced pain and return of normal function. For these patients, alternative modalities are available to assist in the control of pain. These options include chiropractic care, physical therapy, massage therapy, and modalities that fall under the auspices of complementary and alternative medicine, such as acupuncture. Unfortunately, Clinical trials evaluating the efficacy of a variety of interventions for chronic non-specific low back pain indicate limited effectiveness for most commonly applied interventions and approaches.
Objectives:
To evaluate the effectiveness of a mat and studio Pilates program on pain, function, quality of life and NHAI consumption for chronic non-specific low back pain patients.
Methods:
Eligible patient include: chronic non-specific low back pain; age between 18 and 65 years; pain ranging from 4 to 8 in a numerical pain scale. Patients with previous surgery, other causes of low back pain, fibromyalgia, regular physical activity (three or more times per week for at least three months); labor lawsuit and body mass index more than 30. Sixty patients were randomized to the Experimental Group (EG) or Control Group (CG). Patients in EG participated in 90 days of mat and studio Pilates program twice a week (50 minutes per class) and the CG remained with their usual medicament treatment and were included in a waiting list for physiotherapy. Assessment for pain (VAS), function (Roland Morris questionnaire), quality of life (SF-36) and NHAI consumption were done at baseline, after 45 days (T45), after 90 days (T90 - end of the program), after 90 days (T180 - follow up) by a blinded assessor.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Quality of Life
Keywords
Pilates, Exercise, Treatment, Low back pain, Pain, Function
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pilates Group
Arm Type
Experimental
Arm Description
This group keep their usual treatment and did a Pilates treatment twice a week (one hour each class) during 90 days.
Arm Title
Control Groups
Arm Type
No Intervention
Arm Description
This group keep their usual treatment and can do the Pilates training after the end of the study.
Intervention Type
Other
Intervention Name(s)
Pilates
Intervention Description
Pilates training - twice a week (one hour per class) during 90 days
Primary Outcome Measure Information:
Title
Change in pain
Description
Measured with the visual analogue scale ranging from 0 to 10
Time Frame
Baseline, after 45, 90 and 180 days
Secondary Outcome Measure Information:
Title
Change in function
Description
Measured by the questionnaire Roland Morris
Time Frame
Baseline, after 45, 90 and 180 days
Title
Change in quality of life
Description
Measured by the SF-36 questionnaire
Time Frame
Baseline, after 45, 90 and 180 days
Title
Change in nonsteroidal antiinflammatory drugs (NSAIDs) consumption
Description
Measured by counting the number of tablets consumed per month
Time Frame
Baseline, after 45, 90 and 180 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
non specific mechanical low back pain
visual analogue scale for pain ranging from 4 to 7
Exclusion Criteria:
previous back surgery
spinal tumor
spinal fracture
pregnancy
fibromyalgia
inflammatory or infectious spinal diseases
litigant patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anamaria Jones, PT
Organizational Affiliation
Federal University of São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidade Federal de Sao Paulo
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04329010
Country
Brazil
12. IPD Sharing Statement
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