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 |
| Protocol serial number | H0563 |
| Sponsor | Arthritis Research Campaign (ARC) (UK) |
| Funder | Arthritis Research Campaign |
- Submission date
- 03/01/2003
- Registration date
- 03/01/2003
- Last edited
- 11/07/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr EM Hay
Scientific
Scientific
Department of Rheumatology
Haywood Hospital
High Lane
Burslem
Stoke-on-Trent
ST6 7AG
United Kingdom
| Phone | +44 (0)1782 715444 |
|---|---|
| e.m.hay@cphc.keele.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Methyl prednisolone |
| Primary outcome measure(s) |
The primary outcome was disability at 6 months measured using a shoulder disability Questionnaire. |
| Key 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. |
| Completion date | 30/09/2000 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| 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 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Department of Rheumatology
Stoke-on-Trent
ST6 7AG
United Kingdom
ST6 7AG
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| 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 |
