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Comparison of the Strength of Maximum Glute and Medium Glutenum Muscles Of Latin and Active Lombar Guidelines

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03118063
Recruitment Status : Unknown
Verified April 2017 by Claudio Cazarini Junior, Faculdade de Ciências Médicas da Santa Casa de São Paulo.
Recruitment status was:  Recruiting
First Posted : April 18, 2017
Last Update Posted : January 5, 2018
Sponsor:
Information provided by (Responsible Party):
Claudio Cazarini Junior, Faculdade de Ciências Médicas da Santa Casa de São Paulo

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)


Condition or disease Intervention/treatment Phase
Spinal Injuries Low Back Pain Diagnostic Test: Evaluation of pain by algometry Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: Comparison of the Strength of Maximum Glute and Medium Glutenum Muscles Of Latin and Active Lombar Guidelines: A Clinical Test
Actual Study Start Date : February 10, 2017
Actual Primary Completion Date : January 2, 2018
Estimated Study Completion Date : December 10, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

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
Diagnostic Test: Evaluation of pain by algometry
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
Diagnostic Test: Evaluation of pain by algometry
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
Diagnostic Test: Evaluation of pain by algometry
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 Measures :
  1. Pain [ Time Frame: 24 hours ]
    Evaluation of pain by algometry

  2. Function [ Time Frame: 24 hours ]
    Evaluation of Function evaluation by the roland morris questionnaire



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03118063


Contacts
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Contact: Marco Added 55 11 986382316 marcoadded@terra.com.br
Contact: Diego Galace 55 11 999872295

Locations
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Brazil
Claudio Cazarini Júnior Recruiting
Sao Paulo, São Paulo, Brazil, 03156001
Contact: Claudio Cazarini    5511999872295    claudio_cazarini@terra.com.br   
Sponsors and Collaborators
Faculdade de Ciências Médicas da Santa Casa de São Paulo
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Responsible Party: Claudio Cazarini Junior, Physical therapist, Faculdade de Ciências Médicas da Santa Casa de São Paulo
ClinicalTrials.gov Identifier: NCT03118063    
Other Study ID Numbers: 62769916.6.0000.5479
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: January 5, 2018
Last Verified: April 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Low Back Pain
Spinal Injuries
Back Pain
Pain
Neurologic Manifestations
Back Injuries
Wounds and Injuries