search
Back to results

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

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Pilates 1
Pilates 2
Pilates 3
Control
Sponsored by
Universidade Cidade de Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Pilates-based exercises

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Physical Therapy Outpatient Department

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Pilates 1

Pilates 2

Pilates 3

Control

Arm Description

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).

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).

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).

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.

Outcomes

Primary Outcome Measures

Pain intensity
Pain intensity will be measured by an 11-point Pain Numerical Rating Scale
Disability
Disability associated with low back pain will be measured by the 24-item Roland Morris Disability Questionaire

Secondary Outcome Measures

Pain intensity
Pain intensity will be measured by an 11-point Pain Numerical Rating Scale
Disability
Disability associated with low back pain will be measured by the 24-item Roland Morris Disability Questionaire
Global impression of recovery
Global impression of recovery will be measured by an 11-point Global Perceived Effect Scale
Specific disability
Specific disability will be evaluated by an 11-point Patient-specific Functional Scale
Kinesiophobia
Kinesiophobia will be evaluated by the Tampa Scale for Kinesiophobia
Pain-Related Catastrophizing
Pain-related catastrophizing will be evaluated by the Pain-Related Catastrophizing Thoughts Scale
Cost Effectiveness
Assessments of direct costs (patient out-of-pocket costs) by an specific questionnaire.
Quality Adjusted Life Years
Quality adjusted life years will be measured by the SF-6D questionnaire

Full Information

First Posted
September 12, 2014
Last Updated
September 5, 2017
Sponsor
Universidade Cidade de Sao Paulo
search

1. Study Identification

Unique Protocol Identification Number
NCT02241538
Brief Title
Effectiveness of Different Weekly Frequency of Modified Pilates Method Exercises in the Treatment of Chronic Nonspecific Low Back Pain
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 Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Cidade de Sao Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Pilates-based exercises

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
296 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pilates 1
Arm Type
Experimental
Arm Description
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).
Arm Title
Pilates 2
Arm Type
Experimental
Arm Description
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).
Arm Title
Pilates 3
Arm Type
Experimental
Arm Description
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).
Arm Title
Control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Pilates 1
Intervention Description
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).
Intervention Type
Device
Intervention Name(s)
Pilates 2
Intervention Description
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).
Intervention Type
Device
Intervention Name(s)
Pilates 3
Intervention Description
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).
Intervention Type
Device
Intervention Name(s)
Control
Intervention Description
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 Measure Information:
Title
Pain intensity
Description
Pain intensity will be measured by an 11-point Pain Numerical Rating Scale
Time Frame
Six weeks after randomization
Title
Disability
Description
Disability associated with low back pain will be measured by the 24-item Roland Morris Disability Questionaire
Time Frame
Six weeks after randomization
Secondary Outcome Measure Information:
Title
Pain intensity
Description
Pain intensity will be measured by an 11-point Pain Numerical Rating Scale
Time Frame
Six and twelve months after randomization
Title
Disability
Description
Disability associated with low back pain will be measured by the 24-item Roland Morris Disability Questionaire
Time Frame
Six and twelve months after randomization
Title
Global impression of recovery
Description
Global impression of recovery will be measured by an 11-point Global Perceived Effect Scale
Time Frame
Six weeks, six and twelve months after randomization
Title
Specific disability
Description
Specific disability will be evaluated by an 11-point Patient-specific Functional Scale
Time Frame
Six weeks, six and twelve months after randomizaion
Title
Kinesiophobia
Description
Kinesiophobia will be evaluated by the Tampa Scale for Kinesiophobia
Time Frame
Six weeks, six and twelve months after randomization
Title
Pain-Related Catastrophizing
Description
Pain-related catastrophizing will be evaluated by the Pain-Related Catastrophizing Thoughts Scale
Time Frame
Six weeks, six and twelve months after randomization
Title
Cost Effectiveness
Description
Assessments of direct costs (patient out-of-pocket costs) by an specific questionnaire.
Time Frame
Six weeks, six and twelve months after randomization
Title
Quality Adjusted Life Years
Description
Quality adjusted life years will be measured by the SF-6D questionnaire
Time Frame
Six weeks, six and twelve months after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Physical Therapy Outpatient Department
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
03071000
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
31153789
Citation
Silva MLD, Miyamoto GC, Franco KFM, Franco YRDS, Cabral CMN. Different weekly frequencies of Pilates did not accelerate pain improvement in patients with chronic low back pain. Braz J Phys Ther. 2020 May-Jun;24(3):287-292. doi: 10.1016/j.bjpt.2019.05.001. Epub 2019 May 16.
Results Reference
derived
PubMed Identifier
29525763
Citation
Miyamoto GC, Franco KFM, van Dongen JM, Franco YRDS, de Oliveira NTB, Amaral DDV, Branco ANC, da Silva ML, van Tulder MW, Cabral CMN. Different doses of Pilates-based exercise therapy for chronic low back pain: a randomised controlled trial with economic evaluation. Br J Sports Med. 2018 Jul;52(13):859-868. doi: 10.1136/bjsports-2017-098825. Epub 2018 Mar 10.
Results Reference
derived
PubMed Identifier
26294680
Citation
Miyamoto GC, Moura KF, Franco YR, Oliveira NT, Amaral DD, Branco AN, Silva ML, Lin C, Cabral CM. Effectiveness and Cost-Effectiveness of Different Weekly Frequencies of Pilates for Chronic Low Back Pain: Randomized Controlled Trial. Phys Ther. 2016 Mar;96(3):382-9. doi: 10.2522/ptj.20150404. Epub 2015 Aug 20.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs