Spinal InjuriesNCT03118063
Comparison of the Strength of Maximum Glute and Medium Glutenum Muscles Of Latin and Active Lombar Guidelines
A study testing Evaluation of pain by algometry in people with Spinal Injuries and Low Back Pain, run by Faculdade de Ciências Médicas da Santa Casa de São Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Spinal Injuries, Low Back Pain
- What is being tested?
- Evaluation of pain by algometry
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteBrazil
- Study dates
- 10 Feb 2017to 10 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Men and women;
- Age between 18 - 40 years;
- Asymptomatic;
- There is no treatment for lumbar spine, hip or knee.
Who cannot join
- Anterior lumbar spine surgeries;
- Severe spinal diseases (fracture, tumor, ankylosing spondylitis);
- Root conditions (herniated disc, spondylolisthesis);
- Congenital malformation;
- Pregnant women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Strength of Maximum Glute and Medium Glutenum Muscles Of Latin and Active Lombar Guidelines: A Clinical Test
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.
Read more
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)
- Conditions
- Spinal Injuries, Low Back Pain
- Being tested
- Evaluation of pain by algometry
- Medical subject headings
- Spinal Injuries, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of pain by algometryDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Diagnostic Test: Evaluation of pain by algometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Function
Evaluation of Function evaluation by the roland morris questionnaire
Measured: 24 hours
Pain scale
Evaluation of pain by algometry
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study start10 Feb 2017
- Primary completion2 Jan 2018
- Study completion10 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculdade de Ciências Médicas da Santa Casa de São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudio Cazarini Junior, Faculdade de Ciências Médicas da Santa Casa de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03118063
- Sponsor's protocol ID
- 62769916.6.0000.5479
- Status last verified
- Feb 2021
- First submitted
- 10 Apr 2017
- Last updated
- 2 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Strength of Maximum Glute and Medium Glutenum Muscles Of Latin and Active Lombar Guidelines: A Clinical Test
- ClinicalTrials.gov ID
- NCT03118063
- Acronym / sponsor ID
- 62769916.6.0000.5479
- Conditions
- Spinal Injuries, Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Faculdade de Ciências Médicas da Santa Casa de São PauloUniversity, hospital or other
- Study start
- 10 Feb 2017 (actual)
- Primary completion
- 2 Jan 2018 (actual)
- Study completion
- 10 Apr 2022 (actual)
- First posted
- 18 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active trigger point | Experimental | Diagnostic Test: Evaluation of pain by algometryEvaluation of the dynamometry of the maximum and medium gluteus muscles and correlate with the presence or not of trigger point |
| Latent trigger point | Active comparator | Diagnostic Test: Evaluation of pain by algometryAssessment of the level of pain and function of asymptomatic individuals, compared with the time that they evolve with acute and chronic low back pain |
| No trigger point | Active comparator | Diagnostic Test: Evaluation of pain by algometryAssessment of the level of pain and function of asymptomatic individuals, compared with the time that they evolve with acute and chronic low back pain |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Men and women;
- Age between 18 - 40 years;
- Asymptomatic;
- There is no treatment for lumbar spine, hip or knee.
Key exclusion criteria (5 listed)
- Anterior lumbar spine surgeries;
- Severe spinal diseases (fracture, tumor, ankylosing spondylitis);
- Root conditions (herniated disc, spondylolisthesis);
- Congenital malformation;
- Pregnant women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation of pain by algometryAssessment 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 | Active trigger point, Latent trigger point, No trigger point |
Primary outcome
Function
Time frame: 24 hours
Evaluation of Function evaluation by the roland morris questionnaire
Pain scale
Time frame: 24 hours
Evaluation of pain by algometry
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evaluation of pain by algometry in people with Spinal Injuries and Low Back Pain, run by Faculdade de Ciências Médicas da Santa Casa de São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Function (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2022.