NCT03118063

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 10, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 18, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2018

Completed
4.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2022

Completed
Last Updated

May 2, 2022

Status Verified

February 1, 2021

Enrollment Period

11 months

First QC Date

April 10, 2017

Last Update Submit

April 26, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • Function

    Evaluation of Function evaluation by the roland morris questionnaire

    24 hours

  • Pain scale

    Evaluation of pain by algometry

    24 hours

Study Arms (3)

Active trigger point

EXPERIMENTAL

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

Latent trigger point

ACTIVE COMPARATOR

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

No trigger point

ACTIVE COMPARATOR

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

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 trigger pointLatent trigger pointNo trigger point

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Claudio Cazarini Júnior

São Paulo, São Paulo, 03156001, Brazil

Location

MeSH Terms

Conditions

Spinal InjuriesLow Back Pain

Condition Hierarchy (Ancestors)

Back InjuriesWounds and InjuriesBack PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physical therapist

Study Record Dates

First Submitted

April 10, 2017

First Posted

April 18, 2017

Study Start

February 10, 2017

Primary Completion

January 2, 2018

Study Completion

April 10, 2022

Last Updated

May 2, 2022

Record last verified: 2021-02

Locations