Shoulder Symptom Irritability Scale: A Single-Blinded Observational Study

Pain Clinical Trial

— SSIS  

Official title:

Shoulder Symptom Irritability: A Single-Blinded Observational Study of Reliability and Construct Validity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02995941
• Other study ID #: 2016-61
• Status: Completed
• Start date: December 2016
• Est. completion date: July 2017

Study information

• Verified date: September 2019
• Source: St. Luke's Hospital and Health Network, Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain
• Shoulder Pain

Locations

Country	Name	City	State
United States	Physical Therapy at St. Luke's - Hamilton	Allentown	Pennsylvania
United States	Physical Therapy at St. Luke's - West End Medical Center	Allentown	Pennsylvania
United States	Physical Therapy at St. Luke's - Bath	Bath	Pennsylvania
United States	Physical Therapy at St. Luke's - Sports Medicine and Rehab Center	Bethlehem	Pennsylvania
United States	Physical Therapy at St. Luke's - St. Luke's North	Bethlehem	Pennsylvania
United States	Physical Therapy at St. Luke's - Center Valley	Center Valley	Pennsylvania
United States	Physical Therapy at St. Luke's - Anderson	Easton	Pennsylvania
United States	Physical Therapy at St. Luke's - Forks	Easton	Pennsylvania
United States	Physical Therapy at St. Luke's - Emmaus	Emmaus	Pennsylvania
United States	Physical Therapy at St. Luke's - Hellertown	Hellertown	Pennsylvania
United States	Physical Therapy at St. Luke's - Macungie	Macungie	Pennsylvania
United States	Physical Therapy at St. Luke's - Northampton	Northampton	Pennsylvania
United States	Physical Therapy at St. Luke's - Orefield	Orefield	Pennsylvania
United States	Physical Therapy at St. Luke's - Quakertown	Quakertown	Pennsylvania
United States	Physical Therapy at St. Luke's - Stroudsburg	Stroudsburg	Pennsylvania
United States	Physical Therapy at St. Luke's - Washington	Washington	New Jersey
United States	Physical Therapy at St. Luke's - Wind Gap	Wind Gap	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
St. Luke's Hospital and Health Network, Pennsylvania	Arcadia University, Nova Southeastern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Focus On Therapeutic Outcomes (FOTO) Functional Score	The FOTO functional scale for shoulder disorders27 has a standard error of the mean (SEM) of 1. with a minimal detectable change with 95% confidence (MDC95) of 3.60-10.88 functional score units.	Day 1 of data collection for each subject
Secondary	Penn Shoulder Score (PSS)	The Penn Shoulder Score (PSS)has demonstrated good test-retest reliability (ICC2,1 = 0.94) with a SEM90 of 8.5. The MDC90 is 12.1, and the minimal clinically important difference (MCID) was found to be 11.4.	Day 1 of data collection for each subject
Secondary	American Shoulder and Elbow Surgeons (ASES) Shoulder Score	The ASES Shoulder Score has demonstrated good to excellent test-retest reliability (ICC = 0.61-0.96) with an SEM of 6.7. The MDC95 is 11.2,32 and the MCID was found to be 12.0.	Day 1 of data collection for each subject
Secondary	Numeric Pain Rating scale	The Numeric Pain Rating Scale (NPRS) has demonstrated good reliability (ICC2,1=0.74)and responsiveness (MDC = 2.5, MCID = 1.1) in subjects with shoulder pain34 and excellent reliability in an upper extremity orthopaedic population.	Day 1 of data collection for each subject
Secondary	Intervention intensity	This project will analyze intervention choices from the primary raters for each of the 90 subjects utilizing PABAK-OS for correlation and independent t-test for group differences. It is expected that those subjects with high irritability will be prescribed interventions aimed at minimizing the physical stress to the affected tissue(s), while those subjects with low irritability will be prescribed interventions at a higher intensity to address the physical impairments.	Day 1 of data collection for each subject

External Links

•   Shoulder Symptom Irritability Scale Rater Training