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
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
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 design | Observational cross-sectional study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Other |
| Study type | Diagnostic |
| Participant information sheet | No participant information sheet available |
| Scientific title | An investigation of the reliability of the Shoulder Symptom Modification Procedure in people with shoulder pain: an observational cross-sectional study |
| Study objectives | The 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) studied | 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 | Other |
| Primary outcome measure | 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 study start date | 13/12/2015 |
| Completion date | 31/07/2016 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 11 to 12 people with uniliateral shoulder pain of musculoskeletal origin |
| Key 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 |
| Key exclusion criteria | 1. 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 enrolment | 21/04/2016 |
| Date of final enrolment | 31/07/2016 |
Locations
Countries of recruitment
- Ireland
- United Kingdom
Study participating centre
Limerick
-
Ireland
Sponsor information
University/education
Dept of Clinical Therapies
Castletroy
Limerick
-
Ireland
"ROR" |
https://ror.org/00a0n9e72 |
|---|
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 31/07/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data 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.
