An investigation of the reliability of the Shoulder Symptom Modification Procedure in people with shoulder pain

ISRCTN ISRCTN95412360
DOI https://doi.org/10.1186/ISRCTN95412360
Secondary identifying numbers 01
Submission date
15/04/2016
Registration date
22/04/2016
Last edited
10/07/2017
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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 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?
The possible benefit 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

Contact information

Dr Jeremy Lewis
Scientific

Department of Allied Health Professions and Midwifery
School of Health and Social Work
Wright Building
College Lane Campus
University of Hertfordshire
Hatfield
Hertfordshire
AL10 9AB
Tuvalu

Study information

Study designObservational cross-sectional study
Primary study designObservational
Secondary study designCross sectional study
Study setting(s)Other
Study typeDiagnostic
Participant information sheet No participant information sheet available
Scientific titleAn investigation of the reliability of the Shoulder Symptom Modification Procedure in people with shoulder pain: an observational cross-sectional study
Study objectivesThe aim of this study is to assess of the reliability of the Shoulder Symptom Modification Procedure.
Ethics approval(s)Research Ethics Committee Ollscoil Luimnigh / University of Limerick, 06/04/2016, ref: 2015_12_13_EHS
Health condition(s) or problem(s) studiedShoulder pain of musculoskeletal origin
InterventionThe 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 typeOther
Primary outcome measureReliability 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 measuresAn 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 study start date13/12/2015
Completion date31/07/2016

Eligibility

Participant type(s)Mixed
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants11 to 12 people with uniliateral shoulder pain of musculoskeletal origin
Key inclusion criteriaShoulder 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
Key exclusion criteria1. People who have recent shoulder surgery or fracture
2. People with rheumatological or neurological cause for shoulder pain, or potentially serious conditions e.g. systemic disease, neurological disorders, inflammatory conditions or major trauma
3. People who have had physiotherapy treatment resulting in resolution of their pain
Date of first enrolment21/04/2016
Date of final enrolment31/07/2016

Locations

Countries of recruitment

  • Ireland
  • United Kingdom

Study participating centre

University of Limerick
Castletroy
Limerick
-
Ireland

Sponsor information

University of Limerick
University/education

Dept of Clinical Therapies
Castletroy
Limerick
-
Ireland

ROR logo "ROR" https://ror.org/00a0n9e72

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date31/07/2017
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination plan
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 11/11/2016 Yes No

Editorial Notes

10/07/2017: Publication reference added.