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Effectiveness of Different Weekly Frequency of Modified Pilates Method Exercises in the Treatment of Chronic Nonspecific Low Back Pain

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ClinicalTrials.gov Identifier: NCT02241538
Recruitment Status : Completed
First Posted : September 16, 2014
Last Update Posted : September 6, 2017
Sponsor:
Information provided by (Responsible Party):
Cristina Maria Nunes Cabral, Universidade Cidade de Sao Paulo

Brief Summary:
Low back pain is a major cause of disability and absenteeism and the supervised exercise is a recommended treatment by the guidelines and has been cost-effective. Currently, the Pilates method has shown to be effective in improving pain and disability in patients with chronic low back pain (CLBP). However, there is still no evidence about the ideal number of sessions for the treatment and the interval between sessions to achieve better efficacy of this method for these patients. Thus, the aim of this study is to investigate the effectiveness of the Pilates method with different weekly frequency of sessions in the treatment of patients with nonspecific CLBP. Investigators will assess 296 patients of both genders, with nonspecific CLBP lasting more than three months and aged between 18 and 80 years. Participants will be randomly divided into four groups (n = 74 patients per group): Control Group will receive an educational booklet and no additional exercise, Pilates 1 Group will receive a program of exercises based on Pilates method once a week for six weeks, Pilates 2 Group will receive the same program of exercises twice a week for six weeks and Pilates 3 Group will receive the same program of exercises three times a week for six weeks. The outcomes overall disability (Roland Morris Disability questionnaire), specific disability (Patient-Specific Functional scale), kinesiophobia (Tampa scale for kinesiophobia), pain intensity (Pain Numerical Rating scale) and global perceived effect (Global Perceived Effect scale) will be assessed by a blinded assessor before, six weeks, six and 12 months after randomization. Investigators expect that the largest number of weekly sessions of Pilates method may influence the results in all analyzes (short, medium and long term), since there is a relationship between frequency of exercises and effect size of the treatment.

Condition or disease Intervention/treatment Phase
Low Back Pain Device: Pilates 1 Device: Pilates 2 Device: Pilates 3 Device: Control Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 296 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cost Effectiveness and Effectiveness of the Addition of Different Weekly Frequency of Modified Pilates Method Exercises to a Minimal Intervention in the Treatment of Chronic Nonspecific Low Back Pain: A Randomized Controlled Trial
Study Start Date : September 2014
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pilates 1
Combination of an educational booklet with exercises of the Pilates method. Patients will receive 6 sessions of treatment over a period of 6 weeks (1 session/week). The exercises of the Pilates method will be individualized to each patient´s needs (pragmatic treatment).
Device: Pilates 1
Combination of an educational booklet with exercises of the Pilates method. Patients will receive 6 sessions of treatment over a period of 6 weeks (1 session/week). The exercises of the Pilates method will be individualized to each patient´s needs (pragmatic treatment).

Experimental: Pilates 2
Combination of an educational booklet with exercises of the Pilates method. Patients will receive 12 sessions of treatment over a period of 6 weeks (2 sessions/week). The exercises of the Pilates method will be individualized to each patient´s needs (pragmatic treatment).
Device: Pilates 2
Combination of an educational booklet with exercises of the Pilates method. Patients will receive 12 sessions of treatment over a period of 6 weeks (2 sessions/week). The exercises of the Pilates method will be individualized to each patient´s needs (pragmatic treatment).

Experimental: Pilates 3
Combination of an educational booklet with exercises of the Pilates method. Patients will receive 18 sessions of treatment over a period of 6 weeks (3 sessions/week). The exercises of the Pilates method will be individualized to each patient´s needs (pragmatic treatment).
Device: Pilates 3
Combination of an educational booklet with exercises of the Pilates method. Patients will receive 18 sessions of treatment over a period of 6 weeks (3 sessions/week). The exercises of the Pilates method will be individualized to each patient´s needs (pragmatic treatment).

Active Comparator: Control
Patients will receive an educational booklet containing information about the anatomy of the spine and pelvis and the low back pain and recommendations regarding posture and movements involved in activities of daily living. The participants in this group will not receive additional exercise.
Device: Control
Patients will receive an educational booklet containing information about the anatomy of the spine and pelvis and the low back pain and recommendations regarding posture and movements involved in activities of daily living. The participants in this group did not receive additional exercise.




Primary Outcome Measures :
  1. Pain intensity [ Time Frame: Six weeks after randomization ]
    Pain intensity will be measured by an 11-point Pain Numerical Rating Scale

  2. Disability [ Time Frame: Six weeks after randomization ]
    Disability associated with low back pain will be measured by the 24-item Roland Morris Disability Questionaire


Secondary Outcome Measures :
  1. Pain intensity [ Time Frame: Six and twelve months after randomization ]
    Pain intensity will be measured by an 11-point Pain Numerical Rating Scale

  2. Disability [ Time Frame: Six and twelve months after randomization ]
    Disability associated with low back pain will be measured by the 24-item Roland Morris Disability Questionaire

  3. Global impression of recovery [ Time Frame: Six weeks, six and twelve months after randomization ]
    Global impression of recovery will be measured by an 11-point Global Perceived Effect Scale

  4. Specific disability [ Time Frame: Six weeks, six and twelve months after randomizaion ]
    Specific disability will be evaluated by an 11-point Patient-specific Functional Scale

  5. Kinesiophobia [ Time Frame: Six weeks, six and twelve months after randomization ]
    Kinesiophobia will be evaluated by the Tampa Scale for Kinesiophobia

  6. Pain-Related Catastrophizing [ Time Frame: Six weeks, six and twelve months after randomization ]
    Pain-related catastrophizing will be evaluated by the Pain-Related Catastrophizing Thoughts Scale

  7. Cost Effectiveness [ Time Frame: Six weeks, six and twelve months after randomization ]
    Assessments of direct costs (patient out-of-pocket costs) by an specific questionnaire.

  8. Quality Adjusted Life Years [ Time Frame: Six weeks, six and twelve months after randomization ]
    Quality adjusted life years will be measured by the SF-6D questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with chronic nonspecific low back pain longer 12 weeks

Exclusion Criteria:

  • Contra indications to physical exercise
  • Serious spinal pathologies (e. g. tumors, fractures and inflammatory diseases)
  • Nerve root compromise
  • Pregnancy
  • Previous surgery on spine
  • Pilates treatment for low back pain in the last three months

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): NCT02241538


Locations
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Brazil
Physical Therapy Outpatient Department
Sao Paulo, SP, Brazil, 03071000
Sponsors and Collaborators
Universidade Cidade de Sao Paulo
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Cristina Maria Nunes Cabral, Associate Professor, Universidade Cidade de Sao Paulo
ClinicalTrials.gov Identifier: NCT02241538    
Other Study ID Numbers: 29303014.7.0000.0064
First Posted: September 16, 2014    Key Record Dates
Last Update Posted: September 6, 2017
Last Verified: September 2017
Keywords provided by Cristina Maria Nunes Cabral, Universidade Cidade de Sao Paulo:
Pilates-based exercises
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations