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
PHASE4
60 participants
INTERVENTIONAL
2010-01-31
2013-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Methods: A randomized controlled trial was carried out, involving 60 consecutively selected patients with chronic low back pain randomly allocated to an intervention group (use of abdominal belt) and control group (non-use of abdominal belt). Patients were evaluated at the baseline of the study (T0) as well as 1 (T1), 3 (T3) and 6 months (T6) after the inclusion. The patients were assessed for: pain (VAS); functional capacity (Roland Morris), patient satisfaction (Likert scale); and number of anti-inflammatory pills ingested. Intention-to-treat analysis was also used.
Hypothesis - abdominal belt will improve pain in chronic low back pain patients
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy of the Mckenzie Method in Patients With Chronic Non-Specific Low Back Pain
NCT02123394
Graded Activity Versus Supervised Exercises in Patients With Chronic Non-specific Low Back Pain
NCT01719276
Visceral Manipulation in Patients With Chronic Low Back Pain
NCT03101020
Comparison of the Effects of Physical Therapy With and Without Magnetic Field Therapy in People With Low Back Pain
NCT05202691
Osteopathic Manipulative Treatment Versus Therapeutic Exercises in Subjects With Chronic Non-specific Low Back Pain
NCT02752620
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
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.
Control group
Patients in the control group did not use an abdominal belt.
No interventions assigned to this group
Experimental group
Patients were instructed in how to use the abdominal belt for activities of physical effort that exacerbated lumbar pain as well as during moments of pain, and not to use it during rest. They should record the number of hours of belt use per day on spreadsheets distributed for this purpose.
Abdominal belt
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Abdominal belt
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* between 18 and 65 years of age,
* who sought medical care for a complaint of lumbar pain,
* diagnosed with Chronic low back pain, with VAS for pain between 4 and 8 cm (0-10),
* who agreed to participate in the study and signed terms of informed consent.
Exclusion Criteria
* fibromyalgia,
* previous spinal surgery,
* litigation (patients on leave from work or in work leave processes due to low back pain);
* having changed physical activity in previous three months;
* body mass index (BMI) higher than 30;
* acupuncture treatment or physiotherapy in the previous three months
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fundação de Amparo à Pesquisa do Estado de São Paulo
OTHER_GOV
Federal University of São Paulo
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Jamil Natour
Head of Rheumatology Division
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-1726/10
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.