NCT03415438

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2017

Shorter than P25 for all trials

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

November 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2018

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 30, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

January 16, 2019

Status Verified

January 1, 2019

Enrollment Period

6 months

First QC Date

January 10, 2018

Last Update Submit

January 15, 2019

Conditions

Fascia

Keywords

thoracolumbar fasciasubacromial impingement syndrome

Outcome Measures

Primary Outcomes (1)

  • thoracolumbar fascia length test

    thoracolumbar fascia length

    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.

    1 week

  • Goniometric measurement

    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.

    1 week

  • lumbar extensor shortness test measurement in cm

    1 week

Study Arms (2)

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 ScaleDiagnostic Test: posterior capsule tightnessDiagnostic Test: shortness tests for lumbar movementsDiagnostic Test: range of motion tests for lumbar movementsDiagnostic Test: The thoracolumbar fascia length testDiagnostic Test: Modify Schober test

Group 2

Assessments will be done for 30 healthy volunteers

Diagnostic Test: Visual Analogue ScaleDiagnostic Test: posterior capsule tightnessDiagnostic Test: shortness tests for lumbar movementsDiagnostic Test: range of motion tests for lumbar movementsDiagnostic Test: The thoracolumbar fascia length testDiagnostic Test: Modify Schober test

Interventions

Visual Analogue ScaleDIAGNOSTIC_TEST

intensity of pain perception patients feel

Group 1Group 2
posterior capsule tightnessDIAGNOSTIC_TEST

tape measurement for posterior capsule tightness with patients lying at side and horizontally adducting their shoulder.

Group 1Group 2
shortness tests for lumbar movementsDIAGNOSTIC_TEST

tape measurement for lumbar movements

Group 1Group 2
range of motion tests for lumbar movementsDIAGNOSTIC_TEST

range of motion measurements for lumbar flexion, extension and lateral flexion with goniometer.

Group 1Group 2
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

Group 1Group 2
Modify Schober testDIAGNOSTIC_TEST

tape measurement of spinal flexion between designated regions

Group 1Group 2

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

30 patients with Subacromial Impingement Syndrome and 30 volunteers

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baskent University

Ankara, 06810, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Interventions

Pain Measurement

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Neurologic ExaminationPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated Professor

Study Record Dates

First Submitted

January 10, 2018

First Posted

January 30, 2018

Study Start

November 1, 2017

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

January 16, 2019

Record last verified: 2019-01

Locations

TU(1)