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Completed

NCT Number: NCT03118063

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

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)

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Claudio Cazarini Júnior

São Paulo, 03156001, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Evaluation of pain by algometry

Diagnostic Test

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 outcomes

  1. Function

    Time frame: 24 hours

    Evaluation of Function evaluation by the roland morris questionnaire

  2. Pain scale

    Time frame: 24 hours

    Evaluation of pain by algometry

Sponsors and collaborators

Lead sponsor

Faculdade de Ciências Médicas da Santa Casa de São Paulo

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2022
First posted
Apr 18, 2017
Registry last updated
May 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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