Clinical trial NCT02995941: Shoulder Symptom Irritability Scale: A Single-Blinded Observational Study
Official title: Shoulder Symptom Irritability: A Single-Blinded Observational Study of Reliability and Construct Validity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Shoulder Pain
Pain
Keywords: reliability
validity
classification
irritability
symptom
intensity
intervention
Lead sponsor: St. Luke's Hospital and Health Network, Pennsylvania
Sponsor class: OTHER
Collaborators: name: Arcadia University
name: Nova Southeastern University
First posted: 2016-12-19
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

Detailed description: Background Physical therapists regularly make decisions regarding intervention intensity based upon pathoanatomy, symptom irritability, and impairment identification, but the reliability and validity of classifying patients by symptom irritability is unknown.

Purpose Examine the reliability and use of the shoulder symptom irritability classification system for the purposes of determining an appropriate treatment intensity.

Design Prospective repeated-measures single-blinded design to determine reliability and a cross-sectional design will be utilized to aid in determining construct validity.

Methods Twenty-five (25) raters will be trained to make paired ratings in 90 subjects with primary complaints of shoulder pain. Raters will record the shoulder symptom irritability level and also select the appropriate intervention intensities for the subjects. Raters will also be asked to choose anticipated interventions for subjects.

Data Analysis Prevalence-adjusted, bias-adjusted Kappa for ordinal scales (PABAK-OS) will be the primary measure of reliability. Dependent upon the distribution of the data, other forms of Kappa may be utilized to analyze the data most appropriately. To determine differences in reliability between groups with and without clinical specialization, an independent t test will be utilized with α = 0.05. Lastly, analysis of variance with post-hoc analysis will be used to compare functional disability across different levels of irritability.

Significance This study addresses key gaps in the understanding of symptom irritability and how it relates to clinical decision making. It is expected that symptom irritability should logically drive intervention selection and intensity of rehabilitation interventions.

Eligibility criteria: Rater Group

Inclusion Criteria:

* 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

Exclusion Criteria:

* not meeting inclusion criteria

Patient Group

Inclusion Criteria:

* Presenting with a chief complaint of shoulder pain, not extending to the neck, for outpatient physical therapy consultation

Exclusion Criteria:

* 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

Primary outcomes:
measure: Reliability of Shoulder Symptom Irritability Scale
timeFrame: Day 1 of data collection for each subject
Secondary outcomes:
measure: Focus On Therapeutic Outcomes (FOTO) Functional Score
timeFrame: Day 1 of data collection for each subject
measure: Penn Shoulder Score (PSS)
timeFrame: Day 1 of data collection for each subject
measure: American Shoulder and Elbow Surgeons (ASES) Shoulder Score
timeFrame: Day 1 of data collection for each subject
measure: Numeric Pain Rating scale
timeFrame: Day 1 of data collection for each subject
measure: Intervention intensity
timeFrame: Day 1 of data collection for each subject
Other outcomes:
Locations:
city: Washington
country: United States
facility: Physical Therapy at St. Luke's - Washington
state: New Jersey
city: Allentown
country: United States
facility: Physical Therapy at St. Luke's - Hamilton
state: Pennsylvania
city: Allentown
country: United States
facility: Physical Therapy at St. Luke's - West End Medical Center
state: Pennsylvania
city: Bath
country: United States
facility: Physical Therapy at St. Luke's - Bath
state: Pennsylvania
city: Bethlehem
country: United States
facility: Physical Therapy at St. Luke's - St. Luke's North
state: Pennsylvania
city: Bethlehem
country: United States
facility: Physical Therapy at St. Luke's - Sports Medicine and Rehab Center
state: Pennsylvania
city: Center Valley
country: United States
facility: Physical Therapy at St. Luke's - Center Valley
state: Pennsylvania
city: Easton
country: United States
facility: Physical Therapy at St. Luke's - Forks
state: Pennsylvania
city: Easton
country: United States
facility: Physical Therapy at St. Luke's - Anderson
state: Pennsylvania
city: Emmaus
country: United States
facility: Physical Therapy at St. Luke's - Emmaus
state: Pennsylvania
city: Hellertown
country: United States
facility: Physical Therapy at St. Luke's - Hellertown
state: Pennsylvania
city: Macungie
country: United States
facility: Physical Therapy at St. Luke's - Macungie
state: Pennsylvania
city: Northampton
country: United States
facility: Physical Therapy at St. Luke's - Northampton
state: Pennsylvania
city: Orefield
country: United States
facility: Physical Therapy at St. Luke's - Orefield
state: Pennsylvania
city: Quakertown
country: United States
facility: Physical Therapy at St. Luke's - Quakertown
state: Pennsylvania
city: Stroudsburg
country: United States
facility: Physical Therapy at St. Luke's - Stroudsburg
state: Pennsylvania
city: Wind Gap
country: United States
facility: Physical Therapy at St. Luke's - Wind Gap
state: Pennsylvania
Study officials:
affiliation: Nova Southeastern University
name: Alicia Fernandez-Fernandez, DPT, PhD
role: STUDY_CHAIR
affiliation: St. Luke's Hospital and Health Network, Pennsylvania
name: Stephen M Kareha, DPT
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.