FasciaNCT03415438
Assessment of Thoracolumbar Fascia Length
An observational study of Fascia, run by Baskent University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Fascia
- What is being tested?
- Visual Analogue Scale, posterior capsule tightness and shortness tests for lumbar movements
- Type of treatment
- Pill or oral medicine
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2017to 1 May 2018
- Phase
- Observational
- 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 30 patients with Subacromial Impingement Syndrome and 30 volunteers
Who may be able to join
- 30 patients with Subacromial Impingement Syndrome and 30 volunteers
- between ages of 20-40 years
- both sexes
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Fascia
- Being tested
- Visual Analogue Scale, posterior capsule tightness, shortness tests for lumbar movements, range of motion tests for lumbar movements, The thoracolumbar fascia length test
- Keywords
- thoracolumbar fascia, subacromial impingement syndrome
- Medical subject headings
- Shoulder Impingement Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual Analogue ScaleDiagnostic test
intensity of pain perception patients feel
posterior capsule tightnessDiagnostic test
tape measurement for posterior capsule tightness with patients lying at side and horizontally adducting their shoulder.
shortness tests for lumbar movementsDiagnostic test
tape measurement for lumbar movements
range of motion tests for lumbar movementsDiagnostic test
range of motion measurements for lumbar flexion, extension and lateral flexion with goniometer.
The thoracolumbar fascia length testDiagnostic 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
Modify Schober testDiagnostic test
tape measurement of spinal flexion between designated regions
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Assessments will be done for 30 patients diagnosed as subacromial impingement syndrome in physical medicine and rehabilitation department of Baskent University. Receives: Diagnostic Test: Visual Analogue Scale; Diagnostic Test: posterior capsule tightness; Diagnostic Test: shortness tests for lumbar movements; Diagnostic Test: range of motion tests for lumbar movements; Diagnostic Test: The thoracolumbar fascia length test; Diagnostic Test: Modify Schober test | |
| Group 2 | Assessments will be done for 30 healthy volunteers Receives: Diagnostic Test: Visual Analogue Scale; Diagnostic Test: posterior capsule tightness; Diagnostic Test: shortness tests for lumbar movements; Diagnostic Test: range of motion tests for lumbar movements; Diagnostic Test: The thoracolumbar fascia length test; Diagnostic Test: Modify Schober test |
What is being measured
The primary outcome is the main question the study is designed to answer.
thoracolumbar fascia length test
thoracolumbar fascia length
Measured: 1 week
Secondary outcomes (4)
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.
pain intensity
Measured: 1 week
Goniometric measurement
lumbar movements
Measured: 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.
posterior capsule shortness
Measured: 1 week
lumbar extensor shortness test measurement in cm
lumbar extensor shortness
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2018
- Study start1 Nov 2017
- Primary completion1 May 2018
- Study completion1 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FasciaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nihan Ozunlu Pekyavas, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03415438
- Sponsor's protocol ID
- KA17/273
- Status last verified
- Jan 2019
- First submitted
- 10 Jan 2018
- Last updated
- 16 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Thoracolumbar Fascia Length in Patients With Subacromial Impingement Syndrome
- ClinicalTrials.gov ID
- NCT03415438
- Acronym / sponsor ID
- KA17/273
- Conditions
- Fascia
- Keywords
- thoracolumbar fascia, subacromial impingement syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 30 Jan 2018 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Diagnostic Test: Visual Analogue Scale, Diagnostic Test: posterior capsule tightness, Diagnostic Test: shortness tests for lumbar movements, Diagnostic Test: range of motion tests for lumbar movements, Diagnostic Test: The thoracolumbar fascia length test, Diagnostic Test: Modify Schober testAssessments will be done for 30 patients diagnosed as subacromial impingement syndrome in physical medicine and rehabilitation department of Baskent University. |
| Group 2 | – | Diagnostic Test: Visual Analogue Scale, Diagnostic Test: posterior capsule tightness, Diagnostic Test: shortness tests for lumbar movements, Diagnostic Test: range of motion tests for lumbar movements, Diagnostic Test: The thoracolumbar fascia length test, Diagnostic Test: Modify Schober testAssessments will be done for 30 healthy volunteers |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 30 patients with Subacromial Impingement Syndrome and 30 volunteers
Key inclusion criteria (3 listed)
- 30 patients with Subacromial Impingement Syndrome and 30 volunteers
- between ages of 20-40 years
- both sexes
Key exclusion criteria (8 listed)
- having lumbar surgery
- having problem with lumbar region in last 6 months
- having scoliosis
- radiologically diagnosed kiphosis
- MR diagnosed lumbar and thoracic herniation
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 |
|---|---|---|
| Visual Analogue Scaleintensity of pain perception patients feel | Diagnostic test | Group 1, Group 2 |
| posterior capsule tightnesstape measurement for posterior capsule tightness with patients lying at side and horizontally adducting their shoulder. | Diagnostic test | Group 1, Group 2 |
| shortness tests for lumbar movementstape measurement for lumbar movements | Diagnostic test | Group 1, Group 2 |
| range of motion tests for lumbar movementsrange of motion measurements for lumbar flexion, extension and lateral flexion with goniometer. | Diagnostic test | Group 1, Group 2 |
| The thoracolumbar fascia length testpatient 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 | Group 1, Group 2 |
| Modify Schober testtape measurement of spinal flexion between designated regions | Diagnostic test | Group 1, Group 2 |
Primary outcome
thoracolumbar fascia length test
Time frame: 1 week
thoracolumbar fascia length
4 secondary outcomes
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
Goniometric measurement
Time frame: 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
lumbar extensor shortness test measurement in cm
Time frame: 1 week
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 16 Jan 2019.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Fascia, run by Baskent University at 1 site in Turkey (Türkiye).
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 3 inclusion and 8 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 16 Jan 2019. 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 Turkey (Türkiye). 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?
thoracolumbar fascia length test (time frame: 1 week). 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 16 Jan 2019.