Shoulder Symptom Irritability Scale: A Single-Blinded Observational Study (SSIS)

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

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.

Study Overview

• Status: Completed
• Conditions: Pain; 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.

• Study Type: Observational
• Enrollment (Actual): 138

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Washington, New Jersey, United States, 07882
      • Physical Therapy at St. Luke's - Washington
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18104
      • Physical Therapy at St. Luke's - Hamilton
    • Allentown, Pennsylvania, United States, 18104
      • Physical Therapy at St. Luke's - West End Medical Center
    • Bath, Pennsylvania, United States, 18014
      • Physical Therapy at St. Luke's - Bath
    • Bethlehem, Pennsylvania, United States, 18017
      • Physical Therapy at St. Luke's - St. Luke's North
    • Bethlehem, Pennsylvania, United States, 18018
      • Physical Therapy at St. Luke's - Sports Medicine and Rehab Center
    • Center Valley, Pennsylvania, United States, 18034
      • Physical Therapy at St. Luke's - Center Valley
    • Easton, Pennsylvania, United States, 18040
      • Physical Therapy at St. Luke's - Forks
    • Easton, Pennsylvania, United States, 18045
      • Physical Therapy at St. Luke's - Anderson
    • Emmaus, Pennsylvania, United States, 18049
      • Physical Therapy at St. Luke's - Emmaus
    • Hellertown, Pennsylvania, United States, 18015
      • Physical Therapy at St. Luke's - Hellertown
    • Macungie, Pennsylvania, United States, 18062
      • Physical Therapy at St. Luke's - Macungie
    • Northampton, Pennsylvania, United States, 18067
      • Physical Therapy at St. Luke's - Northampton
    • Orefield, Pennsylvania, United States, 18069
      • Physical Therapy at St. Luke's - Orefield
    • Quakertown, Pennsylvania, United States, 18951
      • Physical Therapy at St. Luke's - Quakertown
    • Stroudsburg, Pennsylvania, United States, 18360
      • Physical Therapy at St. Luke's - Stroudsburg
    • Wind Gap, Pennsylvania, United States, 18091
      • Physical Therapy at St. Luke's - Wind Gap

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: St. Luke's Hospital and Health Network, Pennsylvania
• Collaborators: Nova Southeastern University; Arcadia University
• Investigators: Study Chair: Alicia Fernandez-Fernandez, DPT, PhD, Nova Southeastern University; Principal Investigator: Stephen M Kareha, DPT, St. Luke's Hospital and Health Network, Pennsylvania

Publications and helpful links

General Publications

• 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.

Helpful Links

• Shoulder Symptom Irritability Scale Rater Training

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2016
• Primary Completion (ACTUAL): July 1, 2017
• Study Completion (ACTUAL): July 1, 2017

Study Registration Dates

• First Submitted: December 10, 2016
• First Submitted That Met QC Criteria: December 14, 2016
• First Posted (ESTIMATE): December 19, 2016

Study Record Updates

• Last Update Posted (ACTUAL): September 20, 2019
• Last Update Submitted That Met QC Criteria: September 17, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: irritability; validity; intervention; reliability; symptom; classification; intensity
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Shoulder Pain
• Other Study ID Numbers: 2016-61

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Study Data/Documents

1. Study Protocol
2. Individual Participant Data Set
   Information comments: Patient Group Data Forms
3. Individual Participant Data Set
   Information comments: Rater Group Data Form