Condition category
Musculoskeletal Diseases
Date applied
15/04/2016
Date assigned
22/04/2016
Last edited
22/04/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Dr Jeremy Lewis

ORCID ID

Contact details

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

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

Sponsor information

Organisation

University of Limerick

Sponsor details

Dept of Clinical Therapies
Castletroy
Limerick
-
Ireland

Sponsor type

University/education

Website

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

Publication citations

Additional files

Editorial Notes