The long term effectiveness of steroid injection for shoulder pain; a pragmatic randomised comparison with physiotherapy in primary care

ISRCTN	ISRCTN24540377
DOI	https://doi.org/10.1186/ISRCTN24540377
Secondary identifying numbers	H0563

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr EM Hay
Scientific

Department of Rheumatology
Haywood Hospital
High Lane
Burslem
Stoke-on-Trent
ST6 7AG
United Kingdom

Phone	+44 (0)1782 715444
Email	e.m.hay@cphc.keele.ac.uk

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study objectives	To compare the long term effectiveness of local steroid injections administered by general practitioners with practice based physiotherapy for treating patients presenting in primary care with new episodes of unilateral shoulder pain.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Shoulder pain
Intervention	1. Methyl prednisolone (40 mg) and lignocaine by local injection 2. Physiotherapy
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Methyl prednisolone
Primary outcome measure	The primary outcome was disability at 6 months measured using a shoulder disability Questionnaire.
Secondary outcome measures	Secondary outcomes included: participants global assessment of change compared with baseline; rating of pain severity; impairment of function; severity of main complaint; ranges of movement; co-interventions.
Overall study start date	01/06/1998
Completion date	30/09/2000

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	207
Key inclusion criteria	1. Males and females over 18 years with a clinical diagnosis of unilateral shoulder pain 2. First consultation with GP for this episode 3. Ability to understand and give informed consent
Key exclusion criteria	A history of inflammatory arthritis, polymyalgia rheumatica, or gross structural or neurological abnormality of the shoulder; contraindications to local steroid injection; history or examination leading to a suspicion of potentially serious disease; referred pain from neck or internal organs; clinical findings of ruptured rotator cuff; previous fracture or surgery to shoulder, upper limb, neck, or thorax; previous physical therapy for shoulder pain within the past 12 months; pregnancy or breast feeding.
Date of first enrolment	01/06/1998
Date of final enrolment	30/09/2000

Department of Rheumatology

Stoke-on-Trent
ST6 7AG
United Kingdom

Arthritis Research Campaign (ARC) (UK)
Charity

Copeman House
St Mary's Court
St Mary's Gate
Chesterfield
Derbyshire
S41 7TD
United Kingdom

Charity

Arthritis Research Campaign

No information available

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	01/05/2003		Yes	No
Results article	Results	01/02/2004		Yes	No