Condition category
Musculoskeletal Diseases
Date applied
22/03/2011
Date assigned
22/03/2011
Last edited
17/03/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

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
n.foster@keele.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

9731

Study information

Scientific title

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 below 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 measures

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

01/09/2013

Reason abandoned

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

01/03/2011

Recruitment end date

01/09/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Primary Care Sciences Research Centre, Keele
Newcastle
ST5 5BG
United Kingdom

Sponsor information

Organisation

Keele University (UK)

Sponsor details

Keele
Newcastle
ST5 5BG
United Kingdom

Sponsor type

University/education

Website

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24625273

Publication citations

  1. 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.

Additional files

Editorial Notes