PainPhase 3PTLBPNCT01502059
Pilates to Treat Low Back Pain
A Phase 3 study testing Pilates in people with Pain and Quality of Life, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
This is a randomized controlled trial, with blinded assessor to evaluate the effectiveness of Pilates to treat low back pain. Hypothesis - the Pilates group will have best results than the control group (usual medicament treatment). Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Pain, Quality of Life
- What is being tested?
- Pilates
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2008to Jun 2011
- Phase
- Phase 3
- 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
- non specific mechanical low back pain
- visual analogue scale for pain ranging from 4 to 7
Who cannot join
- previous back surgery
- spinal tumor
- spinal fracture
- pregnancy
- fibromyalgia
- inflammatory or infectious spinal diseases
- litigant patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Pilates to Treat Low Back Pain: A Randomized Controlled Trial
This is a randomized controlled trial, with blinded assessor to evaluate the effectiveness of Pilates to treat low back pain.
Hypothesis - the Pilates group will have best results than the control group (usual medicament treatment).
Read the detailed description
Background:
Low back pain (LBP) is a common problem among adults. Approximately 70-85% of the adult population experiences this painful complaint at some point in their lives, making LBP the second most common reason for a visit to a clinician. Despite the frequency of this diagnosis, conventional treatment does not always provide patients the desired results of reduced pain and return of normal function. For these patients, alternative modalities are available to assist in the control of pain. These options include chiropractic care, physical therapy, massage therapy, and modalities that fall under the auspices of complementary and alternative medicine, such as acupuncture. Unfortunately, Clinical trials evaluating the efficacy of a variety of interventions for chronic non-specific low back pain indicate limited effectiveness for most commonly applied interventions and approaches.
Objectives:
To evaluate the effectiveness of a mat and studio Pilates program on pain, function, quality of life and NHAI consumption for chronic non-specific low back pain patients.
Methods:
Eligible patient include: chronic non-specific low back pain; age between 18 and 65 years; pain ranging from 4 to 8 in a numerical pain scale. Patients with previous surgery, other causes of low back pain, fibromyalgia, regular physical activity (three or more times per week for at least three months); labor lawsuit and body mass index more than 30. Sixty patients were randomized to the Experimental Group (EG) or Control Group (CG). Patients in EG participated in 90 days of mat and studio Pilates program twice a week (50 minutes per class) and the CG remained with their usual medicament treatment and were included in a waiting list for physiotherapy. Assessment for pain (VAS), function (Roland Morris questionnaire), quality of life (SF-36) and NHAI consumption were done at baseline, after 45 days (T45), after 90 days (T90 - end of the program), after 90 days (T180 - follow up) by a blinded assessor.
- Conditions
- Pain, Quality of Life
- Being tested
- Pilates
- Keywords
- Pilates, Exercise, Treatment, Low back pain, Pain, Function
- Medical subject headings
- Pain, Motor Activity, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PilatesOther
Pilates training - twice a week (one hour per class) during 90 days
| Study group | Role | What they receive |
|---|---|---|
| Pilates Group | Experimental | This group keep their usual treatment and did a Pilates treatment twice a week (one hour each class) during 90 days. Receives: Other: Pilates |
| Control Groups | No intervention | This group keep their usual treatment and can do the Pilates training after the end of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain
Measured with the visual analogue scale ranging from 0 to 10
Measured: Baseline, after 45, 90 and 180 days
Secondary outcomes (3)
Change in function
Measured by the questionnaire Roland Morris
Measured: Baseline, after 45, 90 and 180 days
Change in quality of life
Measured by the SF-36 questionnaire
Measured: Baseline, after 45, 90 and 180 days
Change in nonsteroidal antiinflammatory drugs (NSAIDs) consumption
Measured by counting the number of tablets consumed per month
Measured: Baseline, after 45, 90 and 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2011 (estimated)
- Study startJun 2008
- Primary completionDec 2010
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anamaria Jones, Federal University of São Paulo
- Investigators
- Anamaria Jones, PT, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01502059
- Sponsor's protocol ID
- CEP UNIFESP 0208/11
- Acronym
- PTLBP
- Status last verified
- Dec 2011
- First submitted
- 27 Dec 2011
- Last updated
- 30 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Pilates to Treat Low Back Pain: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01502059
- Acronym / sponsor ID
- PTLBP / CEP UNIFESP 0208/11
- Conditions
- Pain, Quality of Life
- Keywords
- Pilates, Exercise, Treatment, Low back pain, Pain, Function
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 30 Dec 2011 (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.
This is a randomized controlled trial, with blinded assessor to evaluate the effectiveness of Pilates to treat low back pain.
Hypothesis - the Pilates group will have best results than the control group (usual medicament treatment).
Detailed description
Background:
Low back pain (LBP) is a common problem among adults. Approximately 70-85% of the adult population experiences this painful complaint at some point in their lives, making LBP the second most common reason for a visit to a clinician. Despite the frequency of this diagnosis, conventional treatment does not always provide patients the desired results of reduced pain and return of normal function. For these patients, alternative modalities are available to assist in the control of pain. These options include chiropractic care, physical therapy, massage therapy, and modalities that fall under the auspices of complementary and alternative medicine, such as acupuncture. Unfortunately, Clinical trials evaluating the efficacy of a variety of interventions for chronic non-specific low back pain indicate limited effectiveness for most commonly applied interventions and approaches.
Objectives:
To evaluate the effectiveness of a mat and studio Pilates program on pain, function, quality of life and NHAI consumption for chronic non-specific low back pain patients.
Methods:
Eligible patient include: chronic non-specific low back pain; age between 18 and 65 years; pain ranging from 4 to 8 in a numerical pain scale. Patients with previous surgery, other causes of low back pain, fibromyalgia, regular physical activity (three or more times per week for at least three months); labor lawsuit and body mass index more than 30. Sixty patients were randomized to the Experimental Group (EG) or Control Group (CG). Patients in EG participated in 90 days of mat and studio Pilates program twice a week (50 minutes per class) and the CG remained with their usual medicament treatment and were included in a waiting list for physiotherapy. Assessment for pain (VAS), function (Roland Morris questionnaire), quality of life (SF-36) and NHAI consumption were done at baseline, after 45 days (T45), after 90 days (T90 - end of the program), after 90 days (T180 - follow up) by a blinded assessor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pilates Group | Experimental | Other: PilatesThis group keep their usual treatment and did a Pilates treatment twice a week (one hour each class) during 90 days. |
| Control Groups | No intervention | –This group keep their usual treatment and can do the Pilates training after the end of the study. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- non specific mechanical low back pain
- visual analogue scale for pain ranging from 4 to 7
Key exclusion criteria (7 listed)
- previous back surgery
- spinal tumor
- spinal fracture
- pregnancy
- fibromyalgia
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 |
|---|---|---|
| PilatesPilates training - twice a week (one hour per class) during 90 days | Other | Pilates Group |
Primary outcome
Change in pain
Time frame: Baseline, after 45, 90 and 180 days
Measured with the visual analogue scale ranging from 0 to 10
3 secondary outcomes
Change in function
Time frame: Baseline, after 45, 90 and 180 days
Change in quality of life
Time frame: Baseline, after 45, 90 and 180 days
Change in nonsteroidal antiinflammatory drugs (NSAIDs) consumption
Time frame: Baseline, after 45, 90 and 180 days
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 30 Dec 2011.
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
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.
Anamaria Jones, PT principal investigator
Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pilates in people with Pain and Quality of Life, run by Federal University of São 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 2 inclusion and 7 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 30 Dec 2011. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in pain (time frame: Baseline, after 45, 90 and 180 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Dec 2011.