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

Chronic Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02922322
• Other study ID #: CAAE: 51317315.2.0000.5188
• Status: Completed
• Phase: N/A
• First received: June 5, 2016
• Last updated: September 30, 2016
• Start date: February 2016
• Est. completion date: May 2016

Study information

• Verified date: September 2016
• Source: Federal University of Paraíba
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain
• Nonspecific Chronic Low Back Pain

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Paraíba

References & Publications (13)

da Luz MA Jr, Costa LO, Fuhro FF, Manzoni AC, de Oliveira NT, Cabral CM. Effectiveness of mat Pilates or equipment-based Pilates in patients with chronic non-specific low back pain: a protocol of a randomised controlled trial. BMC Musculoskelet Disord. 2013 Jan 9;14:16. doi: 10.1186/1471-2474-14-16. — View Citation

da Luz MA Jr, Costa LO, Fuhro FF, Manzoni AC, Oliveira NT, Cabral CM. Effectiveness of mat Pilates or equipment-based Pilates exercises in patients with chronic nonspecific low back pain: a randomized controlled trial. Phys Ther. 2014 May;94(5):623-31. doi: 10.2522/ptj.20130277. Epub 2014 Jan 16. — View Citation

Franco YR, Liebano RE, Moura KF, de Oliveira NT, Miyamoto GC, Santos MO, Cabral CM. Efficacy of the addition of interferential current to Pilates method in patients with low back pain: a protocol of a randomized controlled trial. BMC Musculoskelet Disord. 2014 Dec 10;15:420. doi: 10.1186/1471-2474-15-420. — View Citation

Hodges PW, Richardson CA. Inefficient muscular stabilization of the lumbar spine associated with low back pain. A motor control evaluation of transversus abdominis. Spine (Phila Pa 1976). 1996 Nov 15;21(22):2640-50. — View Citation

Kamioka H, Tsutani K, Katsumata Y, Yoshizaki T, Okuizumi H, Okada S, Park SJ, Kitayuguchi J, Abe T, Mutoh Y. Effectiveness of Pilates exercise: A quality evaluation and summary of systematic reviews based on randomized controlled trials. Complement Ther Med. 2016 Apr;25:1-19. doi: 10.1016/j.ctim.2015.12.018. Epub 2016 Jan 4. Review. — View Citation

La Touche R, Escalante K, Linares MT. Treating non-specific chronic low back pain through the Pilates Method. J Bodyw Mov Ther. 2008 Oct;12(4):364-70. doi: 10.1016/j.jbmt.2007.11.004. Epub 2008 Feb 1. Review. — View Citation

Lim EC, Poh RL, Low AY, Wong WP. Effects of Pilates-based exercises on pain and disability in individuals with persistent nonspecific low back pain: a systematic review with meta-analysis. J Orthop Sports Phys Ther. 2011 Feb;41(2):70-80. doi: 10.2519/jospt.2011.3393. Epub 2010 Oct 22. Review. — View Citation

Miyamoto GC, Costa LO, Cabral CM. Efficacy of the Pilates method for pain and disability in patients with chronic nonspecific low back pain: a systematic review with meta-analysis. Braz J Phys Ther. 2013 Nov-Dec;17(6):517-32. doi: 10.1590/S1413-35552012005000127. Review. English, Portuguese. — View Citation

Miyamoto GC, Costa LO, Galvanin T, Cabral CM. The efficacy of the addition of the Pilates method over a minimal intervention in the treatment of chronic nonspecific low back pain: a study protocol of a randomized controlled trial. J Chiropr Med. 2011 Dec;10(4):248-54. — View Citation

Pereira LM, Obara K, Dias JM, Menacho MO, Guariglia DA, Schiavoni D, Pereira HM, Cardoso JR. Comparing the Pilates method with no exercise or lumbar stabilization for pain and functionality in patients with chronic low back pain: systematic review and meta-analysis. Clin Rehabil. 2012 Jan;26(1):10-20. doi: 10.1177/0269215511411113. Epub 2011 Aug 19. Review. — View Citation

Rydeard R, Leger A, Smith D. Pilates-based therapeutic exercise: effect on subjects with nonspecific chronic low back pain and functional disability: a randomized controlled trial. J Orthop Sports Phys Ther. 2006 Jul;36(7):472-84. — View Citation

Turner L, Shamseer L, Altman DG, Weeks L, Peters J, Kober T, Dias S, Schulz KF, Plint AC, Moher D. Consolidated standards of reporting trials (CONSORT) and the completeness of reporting of randomised controlled trials (RCTs) published in medical journals. Cochrane Database Syst Rev. 2012 Nov 14;11:MR000030. doi: 10.1002/14651858.MR000030.pub2. Review. — View Citation

Wajswelner H, Metcalf B, Bennell K. Clinical pilates versus general exercise for chronic low back pain: randomized trial. Med Sci Sports Exerc. 2012 Jul;44(7):1197-205. doi: 10.1249/MSS.0b013e318248f665. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Questionnaire on Pain Intensity	The pain intensity was evaluated using an 11-point pain numerical rating scale.	8 weeks	No
Secondary	Questionnaire on Quality of Life	The quality of life assessment was measured through the SF-36 questionnaire.	8 weeks	No
Secondary	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.	8 weeks	No
Secondary	Questionnaire on Pain Describers	The pain describers were evaluated through the MCGill questionnaire.	8 weeks	No