Shoulder PainSSISNCT02995941
Shoulder Symptom Irritability Scale: A Single-Blinded Observational Study
An observational study of Shoulder Pain and Pain, run by St. Luke's Hospital and Health Network, Pennsylvania at 17 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Pain, Pain
- How many people
- 138 participants
- Where
- 17 sitesUnited States
- Study dates
- Dec 2016to Jul 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
- Presenting with a chief complaint of shoulder pain, not extending to the neck, for outpatient physical therapy consultation
Who cannot join
- not meeting inclusion criteria
- Patient Group
- 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
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Physical Therapy at St. Luke's - Hamilton
Allentown, Pennsylvania, 18104
Physical Therapy at St. Luke's - West End Medical Center
Allentown, Pennsylvania, 18104
Physical Therapy at St. Luke's - Bath
Bath, Pennsylvania, 18014
Physical Therapy at St. Luke's - St. Luke's North
Bethlehem, Pennsylvania, 18017
Physical Therapy at St. Luke's - Sports Medicine and Rehab Center
Bethlehem, Pennsylvania, 18018
Physical Therapy at St. Luke's - Center Valley
Center Valley, Pennsylvania, 18034
Physical Therapy at St. Luke's - Forks
Easton, Pennsylvania, 18040
Physical Therapy at St. Luke's - Anderson
Easton, Pennsylvania, 18045
Physical Therapy at St. Luke's - Emmaus
Emmaus, Pennsylvania, 18049
Physical Therapy at St. Luke's - Hellertown
Hellertown, Pennsylvania, 18015
Physical Therapy at St. Luke's - Macungie
Macungie, Pennsylvania, 18062
Physical Therapy at St. Luke's - Northampton
Northampton, Pennsylvania, 18067
Physical Therapy at St. Luke's - Orefield
Orefield, Pennsylvania, 18069
Physical Therapy at St. Luke's - Quakertown
Quakertown, Pennsylvania, 18951
Physical Therapy at St. Luke's - Stroudsburg
Stroudsburg, Pennsylvania, 18360
Physical Therapy at St. Luke's - Washington
Washington, New Jersey, 07882
Physical Therapy at St. Luke's - Wind Gap
Wind Gap, Pennsylvania, 18091
About this study
Official title: 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.
Read the 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.
- Conditions
- Shoulder Pain, Pain
- Keywords
- reliability, validity, classification, irritability, symptom, intensity, intervention
- Medical subject headings
- Shoulder Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1 of data collection for each subject
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 1 of data collection for each subject
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Luke's Hospital and Health Network, Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Arcadia University, Nova Southeastern University
- Responsible party
- Principal investigator, Stephen Kareha, DPT, St. Luke's Hospital and Health Network, Pennsylvania
- Investigators
- Alicia Fernandez-Fernandez, DPT, PhD, Study chair, Nova Southeastern UniversityStephen M Kareha, DPT, Principal investigator, St. Luke's Hospital and Health Network, Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02995941
- Sponsor's protocol ID
- 2016-61
- Acronym
- SSIS
- Status last verified
- Sep 2019
- First submitted
- 10 Dec 2016
- Last updated
- 20 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 33481995
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shoulder Symptom Irritability: A Single-Blinded Observational Study of Reliability and Construct Validity
- ClinicalTrials.gov ID
- NCT02995941
- Acronym / sponsor ID
- SSIS / 2016-61
- Conditions
- Shoulder Pain, Pain
- Keywords
- reliability, validity, classification, irritability, symptom, intensity, intervention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- St. Luke's Hospital and Health Network, PennsylvaniaUniversity, hospital or other
- Collaborators
- Arcadia University, Nova Southeastern University
- Study start
- Dec 2016 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 19 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
- Presenting with a chief complaint of shoulder pain, not extending to the neck, for outpatient physical therapy consultation
Key exclusion criteria (3 listed)
- not meeting inclusion criteria
- Patient Group
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
5 secondary outcomes
Focus On Therapeutic Outcomes (FOTO) Functional Score
Time frame: Day 1 of data collection for each subject
Penn Shoulder Score (PSS)
Time frame: Day 1 of data collection for each subject
American Shoulder and Elbow Surgeons (ASES) Shoulder Score
Time frame: Day 1 of data collection for each subject
Numeric Pain Rating scale
Time frame: Day 1 of data collection for each subject
Intervention intensity
Time frame: Day 1 of data collection for each subject
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2019.
- Derived from this study: PubMed 33481995Kareha 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.
- Shoulder Symptom Irritability Scale Rater TrainingLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alicia Fernandez-Fernandez, DPT, PhD study chair
Nova Southeastern University
Stephen M Kareha, DPT principal investigator
St. Luke's Hospital and Health Network, Pennsylvania
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shoulder Pain and Pain, run by St. Luke's Hospital and Health Network, Pennsylvania at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reliability of Shoulder Symptom Irritability Scale (time frame: Day 1 of data collection for each subject). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02995941, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2019.