Contact information
Type
Scientific
Primary contact
Dr EM Hay
ORCID ID
Contact details
Department of Rheumatology
Haywood Hospital
High Lane
Burslem
Stoke-on-Trent
ST6 7AG
United Kingdom
+44 (0)1782 715444
e.m.hay@cphc.keele.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
H0563
Study information
Scientific title
Acronym
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Shoulder pain
Intervention
1. Methyl prednisolone (40 mg) and lignocaine by local injection
2. Physiotherapy
Intervention type
Drug
Phase
Not Specified
Drug names
Methyl prednisolone
Primary outcome measures
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 trial start date
01/06/1998
Overall trial end date
30/09/2000
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
207
Participant 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.
Recruitment start date
01/06/1998
Recruitment end date
30/09/2000
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Rheumatology
Stoke-on-Trent
ST6 7AG
United Kingdom
Sponsor information
Organisation
Arthritis Research Campaign (ARC) (UK)
Sponsor details
Copeman House
St Mary's Court
St Mary's Gate
Chesterfield
Derbyshire
S41 7TD
United Kingdom
-
info@arc.org.uk
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
Arthritis Research Campaign
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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. 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
Publication citations
-
Results
Hay EM, Thomas E, Paterson SM, Dziedzic K, Croft PR, A pragmatic randomised controlled trial of local corticosteroid injection and physiotherapy for the treatment of new episodes of unilateral shoulder pain in primary care., Ann. Rheum. Dis., 2003, 62, 5, 394-399.
-
Results
Thomas E, Croft PR, Paterson SM, Dziedzic K, Hay EM, What influences participants' treatment preference and can it influence outcome? Results from a primary care-based randomised trial for shoulder pain., Br J Gen Pract, 2004, 54, 499, 93-96.