Chronic Low Back PainCOmEBACKNCT03113292
Effects of the Pilates Method Versus Home Exercise in Individuals With Chronic Non-specific Back Pain
A study testing Pilates and Home Exercises in people with Chronic Low Back Pain, run by University of Brasilia at 1 site in Brazil.
Trial summary
The aim is to compare the effectiveness and cost-effectiveness of a Pilates program versus home-based exercises in individuals with chronic non-specific low back pain. This is a randomized controlled trial with economic evaluation. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Pilates and Home Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 1 siteBrazil
- Study dates
- 2 Apr 2019to 15 Feb 2022
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Presence of chronic non-specific back pain for more than 12 consecutive weeks;
- Not having attended Pilates or physiotherapy sessions for at least 6 months prior to enrollment.
Who cannot join
- History of trauma or fractures in the spine;;
- Diagnosis of osteoarthritis, disc herniation or spondylolisthesis;
- Referred pain (visceral, abdominoplasty, appendicitis, abdominal and pelvic surgeries);
- Previous surgery on the spine;
- Presence of root symptoms;
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness and Cost-effectiveness of the Pilates Method Versus Home-based Exercises in Individuals With Chronic Non-specific Low Back Pain: a Randomized Controlled Trial
The aim is to compare the effectiveness and cost-effectiveness of a Pilates program versus home-based exercises in individuals with chronic non-specific low back pain. This is a randomized controlled trial with economic evaluation. Participants will be sequentially enrolled and randomly allocated into two groups: 1) Pilates: Mat Pilates sessions, supervised by a physiotherapist (2x/week for 6 weeks); 2) Home-Based Exercise: face-to-face familiarization (two sessions), supervised by another physiotherapist. After familiarization, the exercises will be prescribed using a booklet containing descriptions of sets/repetitions, as well as guidelines and precautions, to be performed during 6 weeks (2x/week) and monitored in a diary. Participants will be supervised by the physiotherapist (telephone/text messaging). Participants will be evaluated in three different moments: 1) Baseline (pre-intervention); 2) At the end of the intervention (post-intervention, 6 weeks); and 3) After six months follow-up (from post-intervention). Primary outcomes: pain intensity and disability. Secondary outcomes: perception of recovery, postural balance, and quality of life. Concurrently, a cost-effectiveness study will be conducted comparing the Pilates vs Home-Based Exercise, from the perspectives of public healthcare and society. In the first perspective, only costs incurred by the public healthcare system will be included (direct costs related to consultations, medications, tests, hospitalizations, and professional fees). In the second perspective, private health care expenses, costs incurred by patients (transportation and support by caregivers, when applicable), as well as indirect costs (missed workdays and loss of productivity) will be included. The incremental cost-effectiveness ratios for the primary outcomes and cost-utility ratios will be calculated for both perspectives. The cost-utility ratio will express the incremental costs per quality-adjusted life year (QALY). In addition, the absolute and incremental net monetary benefit will be calculated. Sensitivity analyses will be conducted. Data normality assumptions will be evaluated using the Shapiro Wilk test. If confirmed, a mixed model will be used, for the comparisons between groups and moments. It is hypothesized that the Pilates will be more cost-effective compared to the home-based exercise program.
- Conditions
- Chronic Low Back Pain
- Being tested
- Pilates, Home Exercises
- Keywords
- physical therapy, therapeutic exercises, low back pain
- 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.
PilatesOther
Also called Therapeutic exercise
The protocol will be composed by the following exercises, structured in each session according to progression, difficulty and focus (respiration, stability, muscle strength and joint mobility): Arm Arcs, Bent Knee Opening, Sidelying, Dead Bug, Femur Arcs, Quadruped Series, Single Leg Stretch, Prone Press Up, Sidekick (Front to Back 1 e 2), Leg Pull Front, Mermaid, Spine Stretch, The Hundred, Pelvic Clock, Bridging, Stanging Roll Down, Swan, Saw, Dart, Swimming, Book Opening.
.
Home ExercisesOther
Also called Therapeutic exercise
The protocol will be divided into 3 phases, each one composed by the following exercises and structured according to difficulty progression and focus (postural reeducation, muscle strength, balance, joint flexibility): Muscle strength exercises composed by abdominal exercises; back extension exercises; gluteus maximus exercises. Stretching exercises for the lower back, pelvis, iliopsoas muscle, tensor fascia latae muscle).
| Study group | Role | What they receive |
|---|---|---|
| Pilates Method | Experimental | Mat Pilates Program, 2x/week, for 6 weeks, supervised by a Physiotherapist. Sessions will last forty five min, with 4 individuals per session. On average, 10 to 15 exercises will be performed per session, with repetitions ranging from 10 to 20 times, according subject's limitations. If necessary, the exercises will be adapted individually for the three levels of difficulty: basic, intermediate and advanced. Progress will be dependent on the absence of postural compensations when performing the repetitions of the exercises. Receives: Other: Pilates |
| Home Exercise Prescription | Active comparator | Composed by two familiarization sessions, supervised by a Physiotherapist. The protocol include postural reeducation exercises, stretching and muscle strengthening, stabilization and mobilization of the spine. Subsequently, participants will receive an educational booklet containing information on low back pain, anatomy of the spine and its relation to the muscular chain, care during daily life activities and the importance of regular physical exercises. Also, it will include a booklet with the prescription of therapeutic home exercises to be performed during the next 6 weeks. It will be recommended that the participants perform the exercises 2x/week. Participants will also be contacted weekly by email and/or telephone, for remote supervision and for checking the prescribed exercises. Receives: Other: Home Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensiy
Pain Intensity measured on a Visual Analog Scale (VAS, in centimeters)
Measured: Change from Pre-Intervention (baseline) compared to Post-Intervention (6 weeks) and Follow-up (6 months)
Disability
Quebec Back Pain Disability Scale, scores ranging from 0 to 100
Measured: Change from Pre-Intervention (baseline) compared to Post-Intervention (6 weeks) and Follow-up (6 months)
Secondary outcomes (3)
Health status
Measure of health status by the EQ-5D-3L questionnaire, consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take one of five responses. The responses record five levels of severity (no problems/slight problems/moderate problems/severe problems/extreme problems).
Measured: Change from Pre-Intervention (baseline) compared to Post-Intervention (6 weeks) and Follow-up (6 months)
Balance
Balance Platform, variation of the platform displacement
Measured: Change from Pre-Intervention (baseline) compared to Post-Intervention (6 weeks) and Follow-up (6 months)
Perception of Recovery
Perception of Recovery measured by a Global Perceived Effect Scale (11-point scale), ranging from -5 ("much worse"), 0 ("no change"), to 5 ("completely recovered")
Measured: Change from Pre-Intervention (baseline) compared to Post-Intervention (6 weeks) and Follow-up (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2017
- Study start2 Apr 2019
- Primary completion20 Dec 2020
- Study completion15 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic 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
- Model description
- This is a randomized controlled clinical trial, characterized by the application of therapeutic exercises, in which subjects will be randomly allocated into two groups: Pilates Method and Home-Based Exercises. The participantes will be individuals with non-specific chronic low back pain. The study will be reported following the recommendations of the CONSORT Statement. For the present study, chronic non-specific back pain was defined as uninterrupted low back pain for more than 12 weeks, with unknown causes.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Brasilia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Rodrigo Luiz Carregaro, University of Brasilia
- Investigators
- Rodrigo L Carregaro, PhD, Principal investigator, University of Brasilia, School of Physical Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03113292
- Sponsor's protocol ID
- COmEBACK Trial
- Other IDs
- CAAE68870317.0.0000.8093
- Acronym
- COmEBACK
- Status last verified
- May 2022
- First submitted
- 2 Apr 2017
- Last updated
- 31 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tottoli CR, Ben AJ, da Silva EN, E Bosmans J, van Tulder M, Carregaro RL. Cost-effectiveness of Pilates compared with home-based exercises for people with chronic non-specific low back pain: a trial-based economic evaluation. BMC Musculoskelet Disord. 2026 Jul 13. doi: 10.1186/s12891-026-10202-7. Online ahead of print.
PubMed 42437906Boff TA, Pasinato F, Ben AJ, Bosmans JE, van Tulder M, Carregaro RL. Effectiveness of spinal manipulation and myofascial release compared with spinal manipulation alone on health-related outcomes in individuals with non-specific low back pain: randomized controlled trial. Physiotherapy. 2020 Jun;107:71-80. doi: 10.1016/j.physio.2019.11.002. Epub 2019 Nov 18.
PubMed 32026838
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Cost-effectiveness of the Pilates Method Versus Home-based Exercises in Individuals With Chronic Non-specific Low Back Pain: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03113292
- Acronym / sponsor ID
- COmEBACK / COmEBACK Trial
- Conditions
- Chronic Low Back Pain
- Keywords
- physical therapy, therapeutic exercises, low back pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- University of BrasiliaUniversity, hospital or other
- Study start
- 2 Apr 2019 (actual)
- Primary completion
- 20 Dec 2020 (actual)
- Study completion
- 15 Feb 2022 (actual)
- First posted
- 13 Apr 2017 (actual)
- 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.
The aim is to compare the effectiveness and cost-effectiveness of a Pilates program versus home-based exercises in individuals with chronic non-specific low back pain. This is a randomized controlled trial with economic evaluation. Participants will be sequentially enrolled and randomly allocated into two groups: 1) Pilates: Mat Pilates sessions, supervised by a physiotherapist (2x/week for 6 weeks); 2) Home-Based Exercise: face-to-face familiarization (two sessions), supervised by another physiotherapist. After familiarization, the exercises will be prescribed using a booklet containing descriptions of sets/repetitions, as well as guidelines and precautions, to be performed during 6 weeks (2x/week) and monitored in a diary. Participants will be supervised by the physiotherapist (telephone/text messaging). Participants will be evaluated in three different moments: 1) Baseline (pre-intervention); 2) At the end of the intervention (post-intervention, 6 weeks); and 3) After six months follow-up (from post-intervention). Primary outcomes: pain intensity and disability. Secondary outcomes: perception of recovery, postural balance, and quality of life. Concurrently, a cost-effectiveness study will be conducted comparing the Pilates vs Home-Based Exercise, from the perspectives of public healthcare and society. In the first perspective, only costs incurred by the public healthcare system will be included (direct costs related to consultations, medications, tests, hospitalizations, and professional fees). In the second perspective, private health care expenses, costs incurred by patients (transportation and support by caregivers, when applicable), as well as indirect costs (missed workdays and loss of productivity) will be included. The incremental cost-effectiveness ratios for the primary outcomes and cost-utility ratios will be calculated for both perspectives. The cost-utility ratio will express the incremental costs per quality-adjusted life year (QALY). In addition, the absolute and incremental net monetary benefit will be calculated. Sensitivity analyses will be conducted. Data normality assumptions will be evaluated using the Shapiro Wilk test. If confirmed, a mixed model will be used, for the comparisons between groups and moments. It is hypothesized that the Pilates will be more cost-effective compared to the home-based exercise program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized controlled clinical trial, characterized by the application of therapeutic exercises, in which subjects will be randomly allocated into two groups: Pilates Method and Home-Based Exercises. The participantes will be individuals with non-specific chronic low back pain. The study will be reported following the recommendations of the CONSORT Statement. For the present study, chronic non-specific back pain was defined as uninterrupted low back pain for more than 12 weeks, with unknown causes.
| Arm | Type | Receives |
|---|---|---|
| Pilates Method | Experimental | Other: PilatesMat Pilates Program, 2x/week, for 6 weeks, supervised by a Physiotherapist. Sessions will last forty five min, with 4 individuals per session. On average, 10 to 15 exercises will be performed per session, with repetitions ranging from 10 to 20 times, according subject's limitations. If necessary, the exercises will be adapted individually for the three levels of difficulty: basic, intermediate and advanced. Progress will be dependent on the absence of postural compensations when performing the repetitions of the exercises. |
| Home Exercise Prescription | Active comparator | Other: Home ExercisesComposed by two familiarization sessions, supervised by a Physiotherapist. The protocol include postural reeducation exercises, stretching and muscle strengthening, stabilization and mobilization of the spine. Subsequently, participants will receive an educational booklet containing information on low back pain, anatomy of the spine and its relation to the muscular chain, care during daily life activities and the importance of regular physical exercises. Also, it will include a booklet with the prescription of therapeutic home exercises to be performed during the next 6 weeks. It will be recommended that the participants perform the exercises 2x/week. Participants will also be contacted weekly by email and/or telephone, for remote supervision and for checking the prescribed exercises. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Presence of chronic non-specific back pain for more than 12 consecutive weeks;
- Not having attended Pilates or physiotherapy sessions for at least 6 months prior to enrollment.
Key exclusion criteria (6 listed)
- History of trauma or fractures in the spine;;
- Diagnosis of osteoarthritis, disc herniation or spondylolisthesis;
- Referred pain (visceral, abdominoplasty, appendicitis, abdominal and pelvic surgeries);
- Previous surgery on the spine;
- Presence of root symptoms;
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 |
|---|---|---|
| PilatesAlso: Therapeutic exerciseThe protocol will be composed by the following exercises, structured in each session according to progression, difficulty and focus (respiration, stability, muscle strength and joint mobility): Arm Arcs, Bent Knee Opening, Sidelying, Dead Bug, Femur Arcs, Quadruped Series, Single Leg Stretch, Prone Press Up, Sidekick (Front to Back 1 e 2), Leg Pull Front, Mermaid, Spine Stretch, The Hundred, Pelvic Clock, Bridging, Stanging Roll Down, Swan, Saw, Dart, Swimming, Book Opening. . | Other | Pilates Method |
| Home ExercisesAlso: Therapeutic exerciseThe protocol will be divided into 3 phases, each one composed by the following exercises and structured according to difficulty progression and focus (postural reeducation, muscle strength, balance, joint flexibility): Muscle strength exercises composed by abdominal exercises; back extension exercises; gluteus maximus exercises. Stretching exercises for the lower back, pelvis, iliopsoas muscle, tensor fascia latae muscle). | Other | Home Exercise Prescription |
Primary outcome
Pain Intensiy
Time frame: Change from Pre-Intervention (baseline) compared to Post-Intervention (6 weeks) and Follow-up (6 months)
Pain Intensity measured on a Visual Analog Scale (VAS, in centimeters)
Disability
Time frame: Change from Pre-Intervention (baseline) compared to Post-Intervention (6 weeks) and Follow-up (6 months)
Quebec Back Pain Disability Scale, scores ranging from 0 to 100
3 secondary outcomes
Health status
Time frame: Change from Pre-Intervention (baseline) compared to Post-Intervention (6 weeks) and Follow-up (6 months)
Balance
Time frame: Change from Pre-Intervention (baseline) compared to Post-Intervention (6 weeks) and Follow-up (6 months)
Perception of Recovery
Time frame: Change from Pre-Intervention (baseline) compared to Post-Intervention (6 weeks) and Follow-up (6 months)
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 31 May 2022.
- Derived from this study: PubMed 42437906Tottoli CR, Ben AJ, da Silva EN, E Bosmans J, van Tulder M, Carregaro RL. Cost-effectiveness of Pilates compared with home-based exercises for people with chronic non-specific low back pain: a trial-based economic evaluation. BMC Musculoskelet Disord. 2026 Jul 13. doi: 10.1186/s12891-026-10202-7. Online ahead of print.
- Derived from this study: PubMed 32026838Boff TA, Pasinato F, Ben AJ, Bosmans JE, van Tulder M, Carregaro RL. Effectiveness of spinal manipulation and myofascial release compared with spinal manipulation alone on health-related outcomes in individuals with non-specific low back pain: randomized controlled trial. Physiotherapy. 2020 Jun;107:71-80. doi: 10.1016/j.physio.2019.11.002. Epub 2019 Nov 18.
- Individual participant dataSharing planned: No
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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.
Rodrigo L Carregaro, PhD principal investigator
University of Brasilia, School of Physical Therapy
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 and Home Exercises in people with Chronic Low Back Pain, run by University of Brasilia 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 2 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 31 May 2022. 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 Intensiy (time frame: Change from Pre-Intervention (baseline) compared to Post-Intervention (6 weeks) and Follow-up (6 months)). 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 NCT03113292, which also lists 2 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 31 May 2022.