Plain English Summary
Background and study aims
Determining the cause of symptoms for people with musculoskeletal problems of the shoulder (that is problems involving the bone and/or muscles of the shoulder) is complicated and fraught with difficulty. Many people without symptoms have tears of the tendons and have problems involving the structures (for example, the bones and connective tissues making up the shoulder joint, or the muscles) associated with the shoulder. As such many clinicians have started to use assessment techniques that change and improve the patient’s symptoms as a method of determining how best to treat the person with shoulder symptoms. One such method is the Shoulder Symptom Modification Procedure. The reliability of these procedures is largely unknown. The aim of this study is to assess how reliable clinicians find the Shoulder Symptom Modification Procedure in identifying and being able to treat the cause of shoulder pain in their patients.
Who can participate?
Patients should be over 18 years old with diagnosed shoulder pain.
What does the study involve?
Patients recruited into the study identify a movement, posture or activity that causes or reproduces their symptoms. Physiotherapists apply the procedures of the Shoulder Symptom Modification Procedure to these symptoms and the patients report the response, for example, can they carry out a procedure that is asked, or does a procedure improve their symptoms, does a procedure make their symptoms worse, or does it make no difference to them at all. The assessment that the physiotherapist makes as to what is causing a patients shoulder problems is then looked at to see whether they agree with other physiotherapists.
What are the possible benefits and risks of participating?
Possible benefits is to see whether the techniques associated with the Shoulder Symptom Modification Procedure are reliable. The techniques used are commonly used in clinical practice and as such there are no identifiable risks associated with participation for the patient participant’s involvement with the investigation.
Where is the study run from?
University of Limerick
When is the study starting and how long is it expected to run for?
December 2015 to July 2016
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Jeremy Lewis
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
01
Study information
Scientific title
An investigation of the reliability of the Shoulder Symptom Modification Procedure in people with shoulder pain: an observational cross-sectional study
Acronym
Study hypothesis
The aim of this study is to assess of the reliability of the Shoulder Symptom Modification Procedure
Ethics approval
Research Ethics Committee Ollscoil Luimnigh / University of Limerick, 06/04/2016, ref: 2015_12_13_EHS
Study design
Observational cross-sectional study
Primary study design
Observational
Secondary study design
Cross sectional study
Trial setting
Other
Trial type
Diagnostic
Patient information sheet
No participant information sheet available
Condition
Shoulder pain of musculoskeletal origin
Intervention
The study involves taking videos of people with shoulder pain undergoing a clinical examination, followed by viewing and scoring of this clinical examination by a number of physiotherapists, in order to determine the inter-rater reliability.
Immediately following direct observation of the patient participant’s response to the Shoulder Symptom Modification Procedure each physiotherapist participant will record on a dedicated data sheet one of the following responses:
1. No change
2. Worse
3. Partial improvement
4. Complete improvement
Inter-rater reliability will then be assessed by determining the agreement between the physiotherapist participants on each assessment procedure using Kappa statistics.
Intervention type
Phase
Drug names
Primary outcome measures
Reliability of physiotherapist participants to determine the effect of a series of procedures (that comprise the Shoulder Symptom Modification Procedure) on the patient participant’s shoulder symptoms. This will be achieved by independent observation of the assessment and patient participant’s responses. This will be assessed on one occasion immediately after observing the response.
Secondary outcome measures
An assessment of the influence of years in practice, number of shoulder patients assessed and treated each week, and previous training (if any) in the use of the Shoulder Symptoms Modification Procedure.
Overall trial start date
13/12/2015
Overall trial end date
31/07/2016
Reason abandoned
Eligibility
Participant inclusion criteria
Shoulder pain participants:
Inclusion criteria: over 18 years, shoulder pain is reproduced by one or more shoulder movements, provision of informed written consent.
Physiotherapists:
A group of up to 30 registered qualified physiotherapists will act as the raters
Participant type
Mixed
Age group
Adult
Gender
Both
Target number of participants
11 to 12 people with uniliateral shoulder pain of musculoskeletal origin
Participant exclusion criteria
Exclusion criteria: People who have recent shoulder surgery or fracture, people with rheumatological or neurological cause for shoulder pain, or potentially serious conditions e.g. systemic disease, neurological disorders, inflammatory conditions or major trauma, people who have had physiotherapy treatment resulting in resolution of their pain.
Recruitment start date
21/04/2016
Recruitment end date
31/07/2016
Locations
Countries of recruitment
Ireland, United Kingdom
Trial participating centre
University of Limerick
Castletroy
Limerick
-
Ireland
Funders
Funder type
University/education
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Intention to publish date
31/07/2017
Participant level data
To be made available at a later date
Results - basic reporting
Publication summary