- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03118063
Comparison of the Strength of Maximum Glute and Medium Glutenum Muscles Of Latin and Active Lombar Guidelines
Comparison of the Strength of Maximum Glute and Medium Glutenum Muscles Of Latin and Active Lombar Guidelines: A Clinical Test
Contextualization: Trigger points are muscle nodules found in muscles. We can observe five different types of trigger point, in clinical practice two of them stand out, the active trigger point; Which is painful; And latent; Asymptomatic; Both of which are sensitive to palpation. Once the individual present these muscle nodules can develop pain and motor dysfunction. Studies indicate that the prevalence of trigger points is 95% of individuals with chronic musculoskeletal pain, but this prevalence is not yet clear in individuals with low back pain.
Objective: To compare the pain and function levels of patients with acute and chronic low back pain who, when asymptomatic, had trigger points compared to the pain and function levels of patients with acute and chronic low back pain who, when asymptomatic, had no trigger points.
Study design: Cohort study, two arms, blind evaluator, prospectively enrolled at baseline.
Location: This research will be conducted in the physiotherapy department at the Rehabilitation Center of the Brotherhood of Santa Casa de Misericórdia de São Paulo (ISCMSP).
Patients: 400 asymptomatic individuals Follow-up: Asymptomatic individuals will be assessed at baseline and over 3 years. You will be asked to contact the research department within 6 weeks of low back pain (acute) and after 12 weeks of low back pain (chronic). Participants will be allocated to two groups, trigger point group (n = 200) and group without trigger point (n = 200).
Outcomes: The pain intensity, function level and trigger point pain intensity outcomes will be evaluated at the baseline, within 6 weeks for the patient to present pain in the lumbar (acute) and after 12 weeks the pain persists (chronic)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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São Paulo
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Sao Paulo, São Paulo, Brazil, 03156001
- Claudio Cazarini Júnior
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Men and women;
- Age between 18 - 40 years;
- Asymptomatic;
- There is no treatment for lumbar spine, hip or knee.
Exclusion Criteria:
- Anterior lumbar spine surgeries;
- Severe spinal diseases (fracture, tumor, ankylosing spondylitis);
- Root conditions (herniated disc, spondylolisthesis);
- Congenital malformation;
- Pregnant women.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Active trigger point
Evaluation of the dynamometry of the maximum and medium gluteus muscles and correlate with the presence or not of trigger point
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Assessment of the level of pain and function of asymptomatic individuals, compared with the time that they evolve with acute and chronic low back pain
|
Active Comparator: Latent trigger point
Assessment of the level of pain and function of asymptomatic individuals, compared with the time that they evolve with acute and chronic low back pain
|
Assessment of the level of pain and function of asymptomatic individuals, compared with the time that they evolve with acute and chronic low back pain
|
Active Comparator: No trigger point
Assessment of the level of pain and function of asymptomatic individuals, compared with the time that they evolve with acute and chronic low back pain
|
Assessment of the level of pain and function of asymptomatic individuals, compared with the time that they evolve with acute and chronic low back pain
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Function
Time Frame: 24 hours
|
Evaluation of Function evaluation by the roland morris questionnaire
|
24 hours
|
Pain scale
Time Frame: 24 hours
|
Evaluation of pain by algometry
|
24 hours
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 62769916.6.0000.5479
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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