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CompletedNCT03118063Updated May 2, 2022

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

An interventional study of Evaluation of pain by algometry in Spinal Injuries and Low Back Pain, sponsored by Faculdade de Ciências Médicas da Santa Casa de São Paulo. Completed at 1 site in Brazil. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2022-05-02.

Sponsored by Faculdade de Ciências Médicas da Santa Casa de São Paulo · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
600
Allocation
Non-randomized
Ages
18 Years to 40 Years
Sex
All
01

Study 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)

02

Conditions studied

  • Spinal Injuries
  • Low Back Pain
03

In context

Spinal Injuries

57 studies on the registry are indexed under Spinal Injuries; 15 are open to participants now.

This study's enrollment of 600 is above the median of 52 across 31 interventional studies indexed under Spinal Injuries.

Browse Spinal Injuries studies →

Lead sponsor

Faculdade de Ciências Médicas da Santa Casa de São Paulo is the lead sponsor of 41 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Men and women;
  • Age between 18 - 40 years;
  • Asymptomatic;
  • There is no treatment for lumbar spine, hip or knee.

Exclusion criteria

Exclusion Criteria:

  • Anterior lumbar spine surgeries;
  • Severe spinal diseases (fracture, tumor, ankylosing spondylitis);
  • Root conditions (herniated disc, spondylolisthesis);
  • Congenital malformation;
  • Pregnant women.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
600 participants (actual)

Study arms

  • 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

  • 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

  • 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

Interventions

  • Diagnostic testEvaluation 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

06

What researchers measure

Primary outcomes

  1. Function

    Evaluation of Function evaluation by the roland morris questionnaire

    Time frame: 24 hours

  2. Pain scale

    Evaluation of pain by algometry

    Time frame: 24 hours

07

Study locations

1 site
  • Claudio Cazarini Júnior
    Sao Paulo, São Paulo 03156001, Brazil
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2017 to primary completion in Jan 2018, 10 months.

Of 23 interventional studies with no phase under Spinal Injuries, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 75. This study's 10 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 10, 2017
First posted
Apr 18, 2017
StartActual
Feb 10, 2017
Primary completionActual
Jan 2, 2018
CompletionActual
Apr 10, 2022
Last update
May 2, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 2, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03118063
Lead sponsor
Faculdade de Ciências Médicas da Santa Casa de São Paulo
Responsible party
Claudio Cazarini Junior (Physical therapist, Faculdade de Ciências Médicas da Santa Casa de São Paulo) — Principal investigator
First posted
Apr 18, 2017
Start date
Feb 10, 2017
Primary completion
Jan 2, 2018
Completion
Apr 10, 2022
Last update
May 2, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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