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Completed

NCT Number: NCT02922322

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

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

pilates group

Other

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 outcomes

  1. Questionnaire on Pain Intensity

    Time frame: 8 weeks

    The pain intensity was evaluated using an 11-point pain numerical rating scale.

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Federal University of Paraíba

Other

Registry information

Official study title

Effectiveness of Mat Pilates Exercises in Individuals With Chronic Nonspecific Low Back Pain: A Randomized Controlled Trial

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Oct 4, 2016
Registry last updated
Oct 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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