|
ISRCTN
|
ISRCTN24540377
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
The long term effectiveness of steroid injection for shoulder pain; a pragmatic randomised comparison with physiotherapy in primary care
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
H0563
|
|
Study hypothesis
|
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
|
Not provided at time of registration
|
|
Study design
|
Randomised controlled trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Shoulder pain
|
|
Participants - 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
|
|
Participants - 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.
|
|
Anticipated start date
|
01/06/1998
|
|
Anticipated end date
|
30/09/2000
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
Target number of participants
|
207
|
|
Interventions
|
1. Methyl prednisolone (40 mg) and lignocaine by local injection
2. Physiotherapy
|
|
Primary outcome measure(s)
|
The primary outcome was disability at 6 months measured using a shoulder disability Questionnaire.
|
|
Secondary outcome measure(s)
|
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.
|
|
Sources of funding
|
Arthritis Research Campaign
|
|
Trial website
|
|
|
Publications
|
1. Results in http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=12695148
2. Results in http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=14965386
|
|
Contact name
|
Dr
EM
Hay
|
|
Address
|
Department of Rheumatology
Haywood Hospital
High Lane
Burslem
|
|
City/town
|
Stoke-on-Trent
|
|
Zip/Postcode
|
ST6 7AG
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)1782 715444
|
|
Email
|
e.m.hay@cphc.keele.ac.uk
|
|
Sponsor
|
Arthritis Research Campaign (ARC) (UK)
|
|
Address
|
Copeman House
St Mary's Court
St Mary's Gate
Chesterfield
|
|
City/town
|
Derbyshire
|
|
Zip/Postcode
|
S41 7TD
|
|
Country
|
United Kingdom
|
|
Email
|
info@arc.org.uk
|
|
Sponsor website:
|
http://www.arc.org.uk
|
|
Date applied
|
03/01/2003
|
|
Last edited
|
11/07/2007
|
|
Date ISRCTN assigned
|
03/01/2003
|
