Clinical trial NCT02922322: 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
Overall status: COMPLETED
Phase: NA
Conditions: Nonspecific Chronic Low Back Pain
Chronic Low Back Pain
Keywords: Mat Pilates
Chronic Nonspecific low back pain
Quality of life
Disability
transverse abdominal muscle
Lead sponsor: Federal University of Paraíba
Sponsor class: OTHER
First posted: 2016-10-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Questionnaire on Pain Intensity
timeFrame: 8 weeks
Secondary outcomes:
measure: Questionnaire on Quality of Life
timeFrame: 8 weeks
measure: Questionnaire on Disability
timeFrame: 8 weeks
measure: Questionnaire on Pain Describers
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Federal University of Paraíba
name: IDEMAR R DOS SANTOS JUNIOR, BPhty
role: PRINCIPAL_INVESTIGATOR
affiliation: FEDERAL UNIVERSITY OF PARAIBA
name: CARINA CC COUTINHO, MD
role: STUDY_DIRECTOR
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