Shoulder Symptom Irritability Scale: A Single-Blinded Observational Study

NCT02995941 | Completed

• 1 other identifier: 2016-61
• Study Type: observational
• Target: 138
• Locations: 1 country
• Sites: 17

Brief Summary

The purpose of this study is to examine the reliability and use of the shoulder symptom irritability classification system for the purposes of determining an appropriate treatment intensity to better help people with shoulder pain.

Conditions

Shoulder Pain; Pain

Keywords

reliability; validity; classification; irritability; symptom; intensity; intervention

Outcome Measures

Primary Outcomes (1)

• Reliability of Shoulder Symptom Irritability Scale

  Two different raters will individually rate the shoulder symptom irritability of each patient. Raters will be blinded to the other's rating.

  Day 1 of data collection for each subject

Secondary Outcomes (5)

• Focus On Therapeutic Outcomes (FOTO) Functional Score

  Day 1 of data collection for each subject

• Penn Shoulder Score (PSS)

  Day 1 of data collection for each subject

• American Shoulder and Elbow Surgeons (ASES) Shoulder Score

  Day 1 of data collection for each subject

• Numeric Pain Rating scale

  Day 1 of data collection for each subject

• Intervention intensity

  Day 1 of data collection for each subject

Study Arms (2)

Raters

No interventions will be administered. Raters will be state licensed as physical therapists working as outpatient physical therapists in the St. Luke's University Health Network.

Patients

No interventions will be administered as a component of this study. Patients will be recruited from a convenience sample of consecutive patients presenting for physical therapy consultation for shoulder pain.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Raters will be recruited from outpatient physical therapists in the St. Luke's University Health Network. Patient subjects will be recruited from a convenience sample of consecutive patients presenting for physical therapy consultation for shoulder pain.

You may qualify if:

• State licensure as a physical therapist and regular clinical practice with patients with shoulder disorders, defined as a minimum of 500 clinical hours per year in an orthopaedic setting with \>10% of patients with shoulder disorders

You may not qualify if:

• Patient Group
• Presenting with a chief complaint of shoulder pain, not extending to the neck, for outpatient physical therapy consultation
• Illiteracy in English and age less than 18 years. Additionally, subjects will be excluded from the study if they present with pain or symptoms distal to elbow, have had shoulder surgery on the symptomatic side in the past year, if active or passive cervical spine ROM reproduces shoulder pain, have a positive Spurling's test, or if they are unable to complete the patient reported functional questionnaires

Sponsors & Collaborators

• St. Luke's Hospital and Health Network, Pennsylvania: lead
• Arcadia University: collaborator
• Nova Southeastern University: collaborator

Study Sites (17)

Physical Therapy at St. Luke's - Washington

Washington, New Jersey, 07882, United States

Location

Physical Therapy at St. Luke's - Hamilton

Allentown, Pennsylvania, 18104, United States

Location

Physical Therapy at St. Luke's - West End Medical Center

Allentown, Pennsylvania, 18104, United States

Location

Physical Therapy at St. Luke's - Bath

Bath, Pennsylvania, 18014, United States

Location

Physical Therapy at St. Luke's - St. Luke's North

Bethlehem, Pennsylvania, 18017, United States

Location

Physical Therapy at St. Luke's - Sports Medicine and Rehab Center

Bethlehem, Pennsylvania, 18018, United States

Location

Physical Therapy at St. Luke's - Center Valley

Center Valley, Pennsylvania, 18034, United States

Location

Physical Therapy at St. Luke's - Forks

Easton, Pennsylvania, 18040, United States

Location

Physical Therapy at St. Luke's - Anderson

Easton, Pennsylvania, 18045, United States

Location

Physical Therapy at St. Luke's - Emmaus

Emmaus, Pennsylvania, 18049, United States

Location

Physical Therapy at St. Luke's - Hellertown

Hellertown, Pennsylvania, 18015, United States

Location

Physical Therapy at St. Luke's - Macungie

Macungie, Pennsylvania, 18062, United States

Location

Physical Therapy at St. Luke's - Northampton

Northampton, Pennsylvania, 18067, United States

Location

Physical Therapy at St. Luke's - Orefield

Orefield, Pennsylvania, 18069, United States

Location

Physical Therapy at St. Luke's - Quakertown

Quakertown, Pennsylvania, 18951, United States

Location

Physical Therapy at St. Luke's - Stroudsburg

Stroudsburg, Pennsylvania, 18360, United States

Location

Physical Therapy at St. Luke's - Wind Gap

Wind Gap, Pennsylvania, 18091, United States

Location

Related Publications (1)

• Kareha SM, McClure PW, Fernandez-Fernandez A. Reliability and Concurrent Validity of Shoulder Tissue Irritability Classification. Phys Ther. 2021 Mar 3;101(3):pzab022. doi: 10.1093/ptj/pzab022.

  PMID: 33481995 DERIVED

Related Links

• Shoulder Symptom Irritability Scale Rater Training

MeSH Terms

Conditions

Shoulder Pain; Pain

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Alicia Fernandez-Fernandez, DPT, PhD

  Nova Southeastern University

  STUDY CHAIR

• Stephen M Kareha, DPT

  St. Luke's Hospital and Health Network, Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Orthopaedic Physical Therapy Residency

Study Record Dates

• First Submitted: December 10, 2016
• First Posted: December 19, 2016
• Study Start: December 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: September 20, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (17)