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Completed

NCT Number: NCT02995941

Shoulder Symptom Irritability Scale: A Single-Blinded Observational Study

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Physical Therapy at St. Luke's - Washington, Washington, New Jersey, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Reliability of Shoulder Symptom Irritability Scale

    Time frame: Day 1 of data collection for each subject

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

Secondary outcomes

  1. Focus On Therapeutic Outcomes (FOTO) Functional Score

    Time frame: Day 1 of data collection for each subject

    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.

  2. Penn Shoulder Score (PSS)

    Time frame: Day 1 of data collection for each subject

    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.

  3. American Shoulder and Elbow Surgeons (ASES) Shoulder Score

    Time frame: Day 1 of data collection for each subject

    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.

  4. Numeric Pain Rating scale

    Time frame: Day 1 of data collection for each subject

    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.

  5. Intervention intensity

    Time frame: Day 1 of data collection for each subject

    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.

Sponsors and collaborators

Lead sponsor

St. Luke's Hospital and Health Network, Pennsylvania

Other

Collaborators

  • Arcadia University
  • Nova Southeastern University

Registry information

Official study title

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

Acronym: SSIS

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 19, 2016
Registry last updated
Sep 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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