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Clinical Trials/NCT03118063
NCT03118063CompletedNot Applicable

Comparison of the Strength of Maximum Glute and Medium Glutenum Muscles Of Latin and Active Lombar Guidelines: A Clinical Test

Faculdade de Ciências Médicas da Santa Casa de São Paulo2 sites in 1 country600 target enrollmentStarted: February 10, 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
600
Locations
2
Primary Endpoint
Pain scale

Study Overview

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)

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Diagnostic
Masking
Single (Investigator)

Eligibility Criteria

Ages
18 Years to 40 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Pain scale

Time Frame: 24 hours

Evaluation of pain by algometry

Function

Time Frame: 24 hours

Evaluation of Function evaluation by the roland morris questionnaire

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Faculdade de Ciências Médicas da Santa Casa de São Paulo
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Claudio Cazarini Junior

Physical therapist

Faculdade de Ciências Médicas da Santa Casa de São Paulo

Study Sites (2)

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