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

• ClinicalTrials.gov Identifier: NCT03118063
• Recruitment Status: Unknown
• First Posted: April 18, 2017
• Last Update Posted: January 5, 2018
• Sponsor: Faculdade de Ciências Médicas da Santa Casa de São Paulo
• Information provided by (Responsible Party): Claudio Cazarini Junior, Faculdade de Ciências Médicas da Santa Casa de São Paulo

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)

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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.

Contacts and Locations

Contacts

Contact: Marco Added; 55 11 986382316; marcoadded@terra.com.br

Contact: Diego Galace; 55 11 999872295

Locations

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

More Information

• 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
• Last Update Posted: January 5, 2018
• Last Verified: April 2017

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Low Back Pain; Spinal Injuries; Back Pain; Pain; Neurologic Manifestations; Back Injuries; Wounds and Injuries