Plain English Summary
Background and study aims
Subacromial impingement syndrome (SIS) is a condition that involves pain and weakness in the shoulder muscle. It is the most common cause of shoulder problems, affecting 1 in 3 adults. It is usually treated with a combination of exercises and medications including corticosteroids (which reduce inflammation (swelling)). Exercises meant to treat the SIS are usually standard for everyone and not customised for each patient and it would be interesting to see whether personalised exercises work better, and whether using ultrasound (a scan that uses soundwaves to create an image of the inside of the body on a screen) can improve the accuracy of corticosteroid injections. There is a lack of evidence on the impact of exercise and corticosteroid injection for treating SIS. The aim of this study is to find out if corticosteroid injections in combination with individualised exercise are the most effective treatment for SIS.
Who can participate?
Adults with a diagnosis of SIS
What does the study involve?
Participants are randomly allocated to one of four treatment groups. Group one participants take part in an individualised exercise program run by a physiotherapist and receive corticosteroid injections guided by ultrasound. This involves using an ultrasound probe to show the area in question so that the injection can be given accurately. Group two participants receive an information sheet with advice about exercises and receive an injection guided by an ultrasound. Group three participants take part in an individualised exercise program run by a physiotherapist and have an injection which is not guided by ultrasound. Group four participants receive an information sheet with advice about exercises and their injection is unguided. Participants complete a number of questionnaires in order to assess their shoulder pain at the start of the study, 6 weeks, 6 months and 12 months after treatment.
What are the possible benefits and risks of participating?
Participants may experience pain relief or improvement to their shoulder symptoms. There are very few risks with steroid injections and participants will be given information on how to manage risks. Due to the exercise treatment, there is risk of temporary soreness in the shoulder.
Where is the study run from?
Primary Care Sciences Research Centre (lead centre) and two musculoskeletal Clinical Assessment and Treatment Services in Staffordshire (UK)
When is the study starting and how long is it expected to run for?
March 2011 to March 2014
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Dr Nadine Foster
n.foster@keele.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Nadine Foster
ORCID ID
Contact details
Primary Care Sciences Research Centre
Keele
Newcastle
ST5 5BG
United Kingdom
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n.foster@keele.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
9731
Study information
Scientific title
Subacromial impingement syndrome and pain: a randomised controlled trial of exercise and injection (the SUPPORT trial)
Acronym
SUPPORT
Study hypothesis
The SUPPORT trial is a factorial (2x2) trial, that will investigate the clinical and cost-effectiveness of exercise and injection for subacromial impingement syndrome (SIS).
Ethics approval
10/H1202/72; First MREC approval date 15/10/2010
Study design
Randomised; Interventional; Design type: Not specified
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a patient information sheet
Condition
Topic: Primary Care Research Network for England, Musculoskeletal; Subtopic: Not Assigned, Musculoskeletal (all Subtopics); Disease: Musculoskeletal, All Diseases
Intervention
Patients who provide written informed consent for trial participation will be randomised to one of four treatment groups, namely:
1. Ultrasound-guided corticosteroid injection, with physiotherapist-led individualised, supervised and progressed exercise
2. Ultrasound-guided corticosteroid injection, with an advice and exercise leaflet
3. Unguided (blind) corticosteroid injection, with physiotherapist-led individualised, supervised and progressed exercise
4. Unguided (blind) corticosteroid injection, with an advice and exercise leaflet.
The trial is organised and sponsored by the Arthritis Research UK Primary Care Centre, at Keele University, and is funded by the National Institute for Health Research: Research for Patient Benefit Programme. We plan to recruit 252 patients from within North and South Staffordshire to this trial.
Ultrasound-guided subacromial, Interface clinicians within the musculoskeletal interface service shoulder clinics will deliver ultrasound (US)-guided subacromial injection using a standard technique. Ultrasound examinations will be performed using the LOGIQe system with a 12MHz transducer.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
The Shoulder Pain and Disability Index (SPADI); Timepoint(s): Baseline questionnaire, 6 weeks follow-up questionnaire, 6 months follow-up questionnaire and 12 months
Secondary outcome measures
1. 11-item Tampa scale of kinesophobia; Timepoint(s): Baseline questionnaire, 6 weeks follow-up questionnaire, 6 months follow-up questionnaire and 12 months
2. Brief Illness Perception Questionnaire (5-items); Timepoint(s): Baseline questionnaire, 6 weeks follow-up questionnaire, 6 months follow-up questionnaire and 12 months
3. Confidence in treatment; Timepoint(s): 6 weeks follow-up questionnaire, 6 months follow-up questionnaire and 12 months follow-up questionnaire
4. Consultation in primary and secondary care; Timepoint(s): 6 weeks follow-up questionnaire, 6 months follow-up questionnaire and 12 months follow-up questionnaire
5. Current employment status; Timepoint(s): : Baseline questionnaire, 6 weeks follow-up questionnaire, 6 months follow-up questionnaire and 12 months 6. Effect of shoulder disability on typical everyday activities; Timepoint(s): Baseline questionnaire, 6 weeks follow-up questionnaire, 6 months follow-up questionnaire and 12 months
7. EURO-QOL (EQ5D); Timepoint(s): Baseline questionnaire, 6 weeks follow-up questionnaire, 6 months follow-up questionnaire and 12 months
8. Exercise adherence; Timepoint(s): 6 weeks follow-up questionnaire, 6 months follow-up questionnaire and 12 months follow-up questionnaire
9. Global Change; Timepoint(s): 6 weeks follow-up questionnaire, 6 months follow-up questionnaire and 12 months follow-up questionnaire
10. Hospital Admission; Timepoint(s): 6 weeks follow-up questionnaire, 6 months follow-up questionnaire and 12 months follow-up questionnaire
11. Medical investigations; Timepoint(s): 6 weeks follow-up questionnaire, 6 months follow-up questionnaire and 12 months follow-up questionnaire 12. Medication use (prescribed and over-the-counter); Timepoint(s): 6 weeks follow-up questionnaire, 6 months follow-up questionnaire and 12 months follow-up questionnaire
13. MOS-Short Form 12 (SF-12); Timepoint(s): Baseline questionnaire, 6 weeks follow-up questionnaire, 6 months follow-up questionnaire and 12 months
14. Pain manikin; Timepoint(s): Baseline questionnaire, 6 weeks follow-up questionnaire, 6 months follow-up questionnaire and 12 months
15. Pain self-efficacy questionnaire; Timepoint(s): Baseline questionnaire, 6 weeks follow-up questionnaire, 6 months follow-up questionnaire and 12 mon
16. Potential Adverse Events; Timepoint(s): 6 weeks follow-up questionnaire, case report form from physiotherapists, General Practitioner (GP) 17. Receipt of benefits, if not working; Timepoint(s): Baseline questionnaire, 6 weeks follow-up questionnaire, 6 months follow-up questionnaire and 12 months
17.Repeat injections; Timepoint(s): 6 weeks follow-up questionnaire, 6 months follow-up questionnaire and 12 months follow-up questionnaire
18. Shoulder pain at night; Timepoint(s): Baseline questionnaire, 6 weeks follow-up questionnaire, 6 months follow-up questionnaire and 12 months 19.Shoulder Pain Severity; Timepoint(s): Baseline questionnaire, 1 week follow-up telephone contact, 6 weeks follow-up questionnaire, 6 month; 20. Stanford presenteeism scale (SPS-6); Timepoint(s): Baseline questionnaire, 6 weeks follow-up questionnaire, 6 months follow-up questionnaire and 12 months
20. Treatment satisfaction; Timepoint(s): 6 weeks follow-up questionnaire, 6 months follow-up questionnaire and 12 months follow-up questionnaire
21. Work absence; Timepoint(s): Baseline questionnaire, 6 weeks follow-up questionnaire, 6 months follow-up questionnaire and 12 months
22. Work performance; Timepoint(s): Baseline questionnaire, 6 weeks follow-up questionnaire, 6 months follow-up questionnaire and 12 months
Overall trial start date
01/03/2011
Overall trial end date
31/03/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. 18 years and over, referred to interface service shoulder clinics with shoulder problems
2. No history of significant shoulder trauma, for example, fracture or full thickness cuff tear
3. A clinical diagnosis of subacromial impingement syndrome (SIS) i.e. pain in deltoid insertion area, positive Neer and HawkinsKennedy tests, pain on shoulder abduction
Accurate diagnosis of SIS is challenging, but a combination of the patients history and response to Neer and HawkinsKennedy tests (to rule SIS out with a negative test) and pain on shoulder abduction (to rule SIS in with a positive test) provides optimal sensitivity and specificity. Patients will not be required to undergo diagnostic imaging (eg MRI) to reflect current practice where treatment choices are informed by clinical findings;
Target Gender: Male & Female ; Lower Age Limit 18 years
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 252; UK Sample Size: 252
Participant exclusion criteria
·1. Below 18 years old
2. Those whose main complaint is due to neck problems, acromioclavicular pathology, or other primary shoulder disorders including adhesive capsulitis or full thickness cuff tear
3. Potentially serious pathology (inflammatory arthritis, polymyalgia rheumatica, malignancy etc) or ipsilateral shoulder surgery/replacement
4. Those already on a surgical waiting list for shoulder surgery
5. Contraindications to local corticosteroid injection (known blood coagulation disorders, warfarin therapy)
6. Participation in a shoulderfocused exercise programme or shoulder injection in the last month
7. Inability to provide written informed consent, complete written questionnaires, or read instruction leaflets written in English
Recruitment start date
08/06/2011
Recruitment end date
31/03/2014
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Primary Care Sciences Research Centre, Keele
Newcastle
ST5 5BG
United Kingdom
Funders
Funder type
Government
Funder name
National Institute for Health Research (NIHR) (UK) - Central commissioning facility (CCF)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
31/12/2017
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24625273
2017 development and delivery in: http://www.ncbi.nlm.nih.gov/pubmed/28818450
Publication citations
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Protocol
Roddy E, Zwierska I, Hay EM, Jowett S, Lewis M, Stevenson K, van der Windt D, Foster NE, , Subacromial impingement syndrome and pain: protocol for a randomised controlled trial of exercise and corticosteroid injection (the SUPPORT trial)., BMC Musculoskelet Disord, 2014, 15, 81, doi: 10.1186/1471-2474-15-81.