NCT04538118

Brief Summary

The aim of the study is to examine the relationship between the Patient- Specific Functional Scale (PSFS) and shoulder functions in the physiotherapy and rehabilitation program applied to patients with shoulder problems.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2019

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2019

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 28, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 3, 2020

Completed
Last Updated

September 7, 2020

Status Verified

September 1, 2020

Enrollment Period

2 months

First QC Date

August 28, 2020

Last Update Submit

September 4, 2020

Conditions

Outcome Measures

Primary Outcomes (3)

  • Disability

    Disability was evaluated with Patient-Specific Functional Scale.Patients nominate 3 to 5 activities that they are unable to do or having difficulty doing because of their injury or problem. These activities are rated on an 11-point scale, where 0 is unable to perform the activity and 10 is able to perform the activity at preinjury level.

    6 weeks

  • Activity Limitation

    Activity limitation was evaluated with The Disabilities of the Arm, Shoulder and Hand. Scale score ranges from 0 (no disability) to 100 (most severe disability).

    6 weeks

  • Functional Disorder

    Disability was evaluated with Upper-Extremity Functional Index.Twenty prescribed upper extremity activities are rated by patients according to a 5-point scale, where 0 is extreme difficulty or unable to perform the activity, and 4 is no difficulty. Higher scores mean better outcome scores.

    6 weeks

Secondary Outcomes (2)

  • Pain Intensity

    6 weeks

  • Range of Motion

    6 weeks

Study Arms (1)

Patient with a shoulder problem

Patients with shoulder problems between 18-65 years of age and being volunteered

Behavioral: Shoulder disabilityDevice: Shoulder Range of MotionBehavioral: Pain Intensity

Interventions

Shoulder disability was evaluated with Patient-specific functional scale, the disabilities of the shoulder, arm and hand questionnaire, and the upper extremity functional index. First assessment was applied when patients came to physical therapy clinic at first. Second assessment was repeated after 6 weeks.

Patient with a shoulder problem

Shoulder range of motion was evaluated with universal goniometer. First assessment was applied when patients came to physical therapy clinic at first. Second assessment was repeated after 6 weeks.

Patient with a shoulder problem
Pain IntensityBEHAVIORAL

Pain intensity was evaluated with Numeric Pain Rating Scale. First assessment was applied when patients came to physical therapy clinic at first. Second assessment was repeated after 6 weeks.

Patient with a shoulder problem

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with shoulder problems

You may qualify if:

  • having a shoulder pathology
  • being volunteer
  • having shoulder pain at least 3 months
  • being literate

You may not qualify if:

  • having more than one upper extremity pathology
  • having an upper extremity pathology involving the neck and trunk
  • having a neurological finding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Yıldırım Beyazıt University

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Shoulder Impingement SyndromeBursitisHumeral FracturesRotator Cuff InjuriesShoulder Pain

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and InjuriesArm InjuriesFractures, BoneRuptureTendon InjuriesArthralgiaPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Hidayet Cuha, MSc

    Ankara Yildirim Beyazıt University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Weeks
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2020

First Posted

September 3, 2020

Study Start

January 5, 2019

Primary Completion

February 25, 2019

Study Completion

May 25, 2019

Last Updated

September 7, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations