Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
60 participants
INTERVENTIONAL
2008-06-30
2011-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Hypothesis - the Pilates group will have best results than the control group (usual medicament treatment).
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Pilates Group
This group keep their usual treatment and did a Pilates treatment twice a week (one hour each class) during 90 days.
Pilates
Pilates training - twice a week (one hour per class) during 90 days
Control Groups
This group keep their usual treatment and can do the Pilates training after the end of the study.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Pilates
Pilates training - twice a week (one hour per class) during 90 days
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* visual analogue scale for pain ranging from 4 to 7
Exclusion Criteria
* spinal tumor
* spinal fracture
* pregnancy
* fibromyalgia
* inflammatory or infectious spinal diseases
* litigant patients
18 Years
50 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Federal University of São Paulo
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Anamaria Jones
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Anamaria Jones, PT
Role: PRINCIPAL_INVESTIGATOR
Federal University of São Paulo
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Universidade Federal de Sao Paulo
São Paulo, São Paulo, Brazil
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CEP UNIFESP 0208/11
Identifier Type: -
Identifier Source: org_study_id