Condition category
Musculoskeletal Diseases
Date applied
02/05/2001
Date assigned
02/05/2001
Last edited
25/11/2010
Prospective/Retrospective
Prospectively 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

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 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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial 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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/10/2002

Overall trial end date

31/03/2006

Reason abandoned

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

Patient

Age group

Not Specified

Gender

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

Trial 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 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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

1. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18820310
2. 2009 cost-effective analysis in http://www.ncbi.nlm.nih.gov/pubmed/19258378

Publication citations

  1. Results

    Watson J, Helliwell P, Morton V, Adebajo A, Dickson J, Russell I, Torgerson D, Shoulder acute pain in primary healthcare: is retraining effective for GP principals? SAPPHIRE--a randomized controlled trial., Rheumatology (Oxford), 2008, 47, 12, 1795-1802, doi: 10.1093/rheumatology/ken360.

  2. McKenna C, Bojke L, Manca A, Adebajo A, Dickson J, Helliwell P, Morton V, Russell I, Torgerson D, Watson J, Shoulder acute pain in primary health care: is retraining GPs effective? The SAPPHIRE randomized trial: a cost-effectiveness analysis., Rheumatology (Oxford), 2009, 48, 5, 558-563, doi: 10.1093/rheumatology/kep008.

Additional files

Editorial Notes