Low Back PainNCT02241538
Effectiveness of Different Weekly Frequency of Modified Pilates Method Exercises in the Treatment of Chronic Nonspecific Low Back Pain
A study testing Pilates 1, Pilates 2 and Pilates 3 in people with Low Back Pain, run by Universidade Cidade de Sao Paulo at 1 site in Brazil.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Pilates 1, Pilates 2 and Pilates 3
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 296 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2014to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with chronic nonspecific low back pain longer 12 weeks
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Physical Therapy Outpatient Department
São Paulo, São Paulo, 03071000
About this study
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
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.
- Conditions
- Low Back Pain
- Being tested
- Pilates 1, Pilates 2, Pilates 3, Control
- Keywords
- Pilates-based exercises
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilates 1Device
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).
Pilates 2Device
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).
Pilates 3Device
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).
ControlDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Pilates 1 | Experimental | 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). Receives: Device: Pilates 1 |
| Pilates 2 | Experimental | 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). Receives: Device: Pilates 2 |
| Pilates 3 | Experimental | 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). Receives: Device: Pilates 3 |
| Control | Active comparator | 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. Receives: Device: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Pain intensity will be measured by an 11-point Pain Numerical Rating Scale
Measured: Six weeks after randomization
Disability
Disability associated with low back pain will be measured by the 24-item Roland Morris Disability Questionaire
Measured: Six weeks after randomization
Secondary outcomes (8)
Pain intensity
Pain intensity will be measured by an 11-point Pain Numerical Rating Scale
Measured: Six and twelve months after randomization
Disability
Disability associated with low back pain will be measured by the 24-item Roland Morris Disability Questionaire
Measured: Six and twelve months after randomization
Global impression of recovery
Global impression of recovery will be measured by an 11-point Global Perceived Effect Scale
Measured: Six weeks, six and twelve months after randomization
Specific disability
Specific disability will be evaluated by an 11-point Patient-specific Functional Scale
Measured: Six weeks, six and twelve months after randomizaion
Kinesiophobia
Kinesiophobia will be evaluated by the Tampa Scale for Kinesiophobia
Measured: Six weeks, six and twelve months after randomization
Pain-Related Catastrophizing
Pain-related catastrophizing will be evaluated by the Pain-Related Catastrophizing Thoughts Scale
Measured: Six weeks, six and twelve months after randomization
Cost Effectiveness
Assessments of direct costs (patient out-of-pocket costs) by an specific questionnaire.
Measured: Six weeks, six and twelve months after randomization
Quality Adjusted Life Years
Quality adjusted life years will be measured by the SF-6D questionnaire
Measured: Six weeks, six and twelve months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 296 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Cidade de Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cristina Maria Nunes Cabral, Universidade Cidade de Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02241538
- Sponsor's protocol ID
- 29303014.7.0000.0064
- Status last verified
- Sep 2017
- First submitted
- 12 Sep 2014
- Last updated
- 6 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 31153789Miyamoto 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.
PubMed 29525763Miyamoto 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.
PubMed 26294680
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02241538
- Acronym / sponsor ID
- 29303014.7.0000.0064
- Conditions
- Low Back Pain
- Keywords
- Pilates-based exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 296 participants (actual)
- Lead sponsor
- Universidade Cidade de Sao PauloUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 16 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pilates 1 | Experimental | Device: Pilates 1Combination 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). |
| Pilates 2 | Experimental | Device: Pilates 2Combination 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). |
| Pilates 3 | Experimental | Device: Pilates 3Combination 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). |
| Control | Active comparator | Device: ControlPatients 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with chronic nonspecific low back pain longer 12 weeks
Key exclusion criteria (6 listed)
- Contra indications to physical exercise
- Serious spinal pathologies (e. g. tumors, fractures and inflammatory diseases)
- Nerve root compromise
- Pregnancy
- Previous surgery on spine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pilates 1Combination 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 |
| Pilates 2Combination 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 |
| Pilates 3Combination 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 |
| ControlPatients 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. | Device | Control |
Primary outcome
Pain intensity
Time frame: Six weeks after randomization
Pain intensity will be measured by an 11-point Pain Numerical Rating Scale
Disability
Time frame: Six weeks after randomization
Disability associated with low back pain will be measured by the 24-item Roland Morris Disability Questionaire
8 secondary outcomes
Pain intensity
Time frame: Six and twelve months after randomization
Disability
Time frame: Six and twelve months after randomization
Global impression of recovery
Time frame: Six weeks, six and twelve months after randomization
Specific disability
Time frame: Six weeks, six and twelve months after randomizaion
Kinesiophobia
Time frame: Six weeks, six and twelve months after randomization
Pain-Related Catastrophizing
Time frame: Six weeks, six and twelve months after randomization
Cost Effectiveness
Time frame: Six weeks, six and twelve months after randomization
Quality Adjusted Life Years
Time frame: Six weeks, six and twelve months after randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2017.
- Derived from this study: PubMed 31153789Silva 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.
- Derived from this study: PubMed 29525763Miyamoto 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.
- Derived from this study: PubMed 26294680Miyamoto 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pilates 1, Pilates 2 and Pilates 3 in people with Low Back Pain, run by Universidade Cidade de Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: Six weeks after randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02241538, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2017.