Assessment of Thoracolumbar Fascia Length

January 15, 2019 updated by: Nihan Ozunlu Pekyavas, Baskent University

Assessment of Thoracolumbar Fascia Length in Patients With Subacromial Impingement Syndrome

The purpose of the study is to compare the elasticity of thoracolumbar fascia in patients with and without subacromial impingement syndrome.

30 patients diagnosed as subacromial impingement syndrome in physical medicine and rehabilitation department of Baskent University will be recruited as group 1. 30 healthy volunteers will be recruited as group 2. Visual Analogue Scale (VAS) with the aim of assessing pain severity, tape measurement for posterior capsule shortness; body lateral flexion, rotation and extensor movements and lumbar extensor shortness will be observed for correlation with thoracalumbal fascia flexibility. Lateral flexion, flexion, and extension movements will be measured using goniometry for trunk normal joint movements. The thoracolumbar fascia length test and Modify Schober test will be used for thoracolumbar fascia length.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06810
        • Baskent University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

30 patients with Subacromial Impingement Syndrome and 30 volunteers

Description

Inclusion Criteria:

  • 30 patients with Subacromial Impingement Syndrome and 30 volunteers
  • between ages of 20-40 years
  • both sexes

Exclusion Criteria:

  • having lumbar surgery
  • having problem with lumbar region in last 6 months
  • having scoliosis
  • radiologically diagnosed kiphosis
  • MR diagnosed lumbar and thoracic herniation
  • positive sacroiliac tests
  • restricted pelvic motion
  • having scapular dyskinesia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Group 1
Assessments will be done for 30 patients diagnosed as subacromial impingement syndrome in physical medicine and rehabilitation department of Baskent University.
Diagnostic test: Visual Analogue Scale
intensity of pain perception patients feel
Diagnostic test: posterior capsule tightness
tape measurement for posterior capsule tightness with patients lying at side and horizontally adducting their shoulder.
Diagnostic test: shortness tests for lumbar movements
tape measurement for lumbar movements
Diagnostic test: range of motion tests for lumbar movements
range of motion measurements for lumbar flexion, extension and lateral flexion with goniometer.
Diagnostic test: The thoracolumbar fascia length test
patient sitting straight with shoulders at horizontal plane, both the arms are asked to rotated with primarily spinal rotation. the degree of rotation gives idea about the thoracolumbar fascia length
Diagnostic test: Modify Schober test
tape measurement of spinal flexion between designated regions
Group 2
Assessments will be done for 30 healthy volunteers
Diagnostic test: Visual Analogue Scale
intensity of pain perception patients feel
Diagnostic test: posterior capsule tightness
tape measurement for posterior capsule tightness with patients lying at side and horizontally adducting their shoulder.
Diagnostic test: shortness tests for lumbar movements
tape measurement for lumbar movements
Diagnostic test: range of motion tests for lumbar movements
range of motion measurements for lumbar flexion, extension and lateral flexion with goniometer.
Diagnostic test: The thoracolumbar fascia length test
patient sitting straight with shoulders at horizontal plane, both the arms are asked to rotated with primarily spinal rotation. the degree of rotation gives idea about the thoracolumbar fascia length
Diagnostic test: Modify Schober test
tape measurement of spinal flexion between designated regions

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
thoracolumbar fascia length test
Time Frame: 1 week
thoracolumbar fascia length
1 week

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale measurement in cm with 0 pointing no pain and 10 pointing worst pain. patient marks the intensity of his/her pain in a 10 cm line and researcher measures the intensity of the pain with a tape.
Time Frame: 1 week
pain intensity
1 week
Goniometric measurement
Time Frame: 1 week
lumbar movements
1 week
Shortness measurement with tape measurement in cm. patient stretches the posterior capsule and the beginning and the end positions are measured with tape.
Time Frame: 1 week
posterior capsule shortness
1 week
lumbar extensor shortness test measurement in cm
Time Frame: 1 week
lumbar extensor shortness
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Baskent University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 10, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 30, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 16, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KA17/273

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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