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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02922322
Recruitment Status : Completed
First Posted : October 4, 2016
Last Update Posted : October 4, 2016
Sponsor:
Information provided by (Responsible Party):
Carina Carvalho Correia Coutinho, Federal University of Paraíba

Brief Summary:
To analyze the effectiveness of mat Pilates compared to no intervention in individuals with chronic nonspecific low back pain.

Condition or disease Intervention/treatment Phase
Nonspecific Chronic Low Back Pain Chronic Low Back Pain Other: Pilates Group Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Mat Pilates Exercises in Individuals With Chronic Nonspecific Low Back Pain: A Randomized Controlled Trial
Study Start Date : February 2016
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Pilates Group
The Pilates Group was composed by 15 participants evaluated before and after 16 sessions of intervention with mat Pilates exercises.
Other: Pilates Group
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.

No Intervention: Control Group
The control group was composed by 15 participants that received no intervention



Primary Outcome Measures :
  1. Questionnaire on Pain Intensity [ Time Frame: 8 weeks ]
    The pain intensity was evaluated using an 11-point pain numerical rating scale.


Secondary Outcome Measures :
  1. Questionnaire on Quality of Life [ Time Frame: 8 weeks ]
    The quality of life assessment was measured through the SF-36 questionnaire.

  2. Questionnaire on Disability [ Time Frame: 8 weeks ]
    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.

  3. Questionnaire on Pain Describers [ Time Frame: 8 weeks ]
    The pain describers were evaluated through the MCGill questionnaire.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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): NCT02922322


Sponsors and Collaborators
Federal University of Paraíba
Investigators
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Principal Investigator: IDEMAR R DOS SANTOS JUNIOR, BPhty Federal University of Paraíba
Study Director: CARINA CC COUTINHO, MD FEDERAL UNIVERSITY OF PARAIBA

Publications:

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Responsible Party: Carina Carvalho Correia Coutinho, Adjunct Professor, Head of the Federal University of Paraiba Clinical School of Physical Therapy, Federal University of Paraíba
ClinicalTrials.gov Identifier: NCT02922322    
Other Study ID Numbers: CAAE: 51317315.2.0000.5188
First Posted: October 4, 2016    Key Record Dates
Last Update Posted: October 4, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Carina Carvalho Correia Coutinho, Federal University of Paraíba:
Mat Pilates
Chronic Nonspecific low back pain
Quality of life
Disability
transverse abdominal muscle
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms