Comparison of the Strength of Maximum Glute and Medium Glutenum Muscles Of Latin and Active Lombar Guidelines
Primary Purpose
Spinal Injuries, Low Back Pain
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Evaluation of pain by algometry
Sponsored by
About this trial
This is an interventional diagnostic trial for Spinal Injuries
Eligibility Criteria
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.
Sites / Locations
- Claudio Cazarini Júnior
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Active trigger point
Latent trigger point
No trigger point
Arm Description
Evaluation of the dynamometry of the maximum and medium gluteus muscles and correlate with the presence or not of 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
Outcomes
Primary Outcome Measures
Function
Evaluation of Function evaluation by the roland morris questionnaire
Pain scale
Evaluation of pain by algometry
Secondary Outcome Measures
Full Information
NCT ID
NCT03118063
First Posted
April 10, 2017
Last Updated
April 26, 2022
Sponsor
Faculdade de Ciências Médicas da Santa Casa de São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT03118063
Brief Title
Comparison of the Strength of Maximum Glute and Medium Glutenum Muscles Of Latin and Active Lombar Guidelines
Official Title
Comparison of the Strength of Maximum Glute and Medium Glutenum Muscles Of Latin and Active Lombar Guidelines: A Clinical Test
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
February 10, 2017 (Actual)
Primary Completion Date
January 2, 2018 (Actual)
Study Completion Date
April 10, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Faculdade de Ciências Médicas da Santa Casa de São Paulo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Injuries, Low Back Pain
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
600 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active trigger point
Arm Type
Experimental
Arm Description
Evaluation of the dynamometry of the maximum and medium gluteus muscles and correlate with the presence or not of trigger point
Arm Title
Latent trigger point
Arm Type
Active Comparator
Arm Description
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
Arm Title
No trigger point
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Diagnostic Test
Intervention Name(s)
Evaluation of pain by algometry
Intervention Description
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
Primary Outcome Measure Information:
Title
Function
Description
Evaluation of Function evaluation by the roland morris questionnaire
Time Frame
24 hours
Title
Pain scale
Description
Evaluation of pain by algometry
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Claudio Cazarini Júnior
City
Sao Paulo
State/Province
São Paulo
ZIP/Postal Code
03156001
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Comparison of the Strength of Maximum Glute and Medium Glutenum Muscles Of Latin and Active Lombar Guidelines
We'll reach out to this number within 24 hrs