Contact information
Type
Scientific
Contact name
Prof Ian Russell
ORCID ID
Contact details
School of Medicine
Swansea University
Swansea
SA2 8PP
United Kingdom
+44 (0)1792 602939
i.t.russell@swansea.ac.uk
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
G0001147
Study information
Scientific title
Acronym
SAPPHIRE
Study hypothesis
Our primary objective is to evaluate whether GP principals should receive extra training in giving injections for shoulder pain. Our secondary objective is to test whether cortisone injections are better than anaesthetic injections.
Ethics approval(s)
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Not specified
Study type
Not Specified
Patient information sheet
Condition
Primary care
Intervention
We shall invite a random sample of GPs to a training day about injecting shoulders. Half will attend before the trial and the other half after.
We shall randomise eligible patients between:
1. Cortisone injection by a trained GP
2. Cortisone injection by a GP who has received an extra day of training
3. Local anaesthetic injection by a trained GP
4. Local anaesthetic injection by a GP who has received an extra day of training
Intervention type
Other
Primary outcome measure
Patients will complete two generic instruments (SF-36 & EQ5D) and two specific instruments (British Shoulder Disability Questionnaire (BSDQ) and the Functional Limitations Profile) 1, 3 and 12 months after randomisation.
Secondary outcome measures
Not provided at time of registration
Overall study start date
01/10/2002
Overall study end date
31/03/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients presenting to GPs with pain in one or both shoulders lasting for less than 3 months who would otherwise have received a steroid injection in primary care
2. Clinical diagnosis of rotator cuff tendonitis based on history of pain in the deltoid area and pain during resisted active movement
3. Patients aged 18 or more
4. Patients who are able and willing and give informed consent
Participant type(s)
Patient
Age group
Not Specified
Sex
Not Specified
Target number of participants
400
Participant exclusion criteria
1. Patients whose pain has lasted for more than 3 months
2. Patients who would normally be referred to a rheumatologist in secondary care
3. Patients aged less than 18
4. Patients who are unable or unwilling to give informed consent
Recruitment start date
01/10/2002
Recruitment end date
31/03/2006
Locations
Countries of recruitment
United Kingdom, Wales
Study participating centre
School of Medicine
Swansea
SA2 8PP
United Kingdom
Sponsor information
Organisation
Medical Research Council (MRC) (UK)
Sponsor details
20 Park Crescent
London
W1B 1AL
United Kingdom
+44 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) (UK)
Alternative name(s)
UK Medical Research Council, MRC
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2008 | Yes | No | |
| Other publications | cost-effective analysis | 01/05/2009 | Yes | No |