Shoulder acute pain in primary healthcare: injection retraining effective?

ISRCTN	ISRCTN58537244
DOI	https://doi.org/10.1186/ISRCTN58537244
Secondary identifying numbers	G0001147

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Ian Russell
Scientific

School of Medicine
Swansea University
Swansea
SA2 8PP
United Kingdom

Phone	+44 (0)1792 602939
Email	i.t.russell@swansea.ac.uk

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title
Study acronym	SAPPHIRE
Study objectives	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
Health condition(s) or problem(s) studied	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
Completion date	31/03/2006

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	400
Key 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
Key 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
Date of first enrolment	01/10/2002
Date of final enrolment	31/03/2006

School of Medicine

Swansea
SA2 8PP
United Kingdom

Medical Research Council (MRC) (UK)
Research council

20 Park Crescent
London
W1B 1AL
United Kingdom

Phone	+44 (0)20 7636 5422
Email	clinical.trial@headoffice.mrc.ac.uk
Website	http://www.mrc.ac.uk

Research council

Medical Research Council (MRC) (UK)
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location: United Kingdom

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

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