| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN24540377 |
| Date ISRCTN assigned | 03/01/2003 |
| Local reference number(s) | H0563 |
| 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 |
| Disease/condition/study domain | Shoulder pain |
| 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. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| 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. |
| Patient information material |
|
| Anticipated start date | 01/06/1998 |
| Anticipated end date | 30/09/2000 |
| Status of trial | Completed |
| 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. |
| 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 |
| Sources of funding | Arthritis Research Campaign |
| Sponsor name | Arthritis Research Campaign (UK) |
| Sponsor details | Copeman House
St Mary's Court
St Mary's Gate
Chesterfield
Derbyshire
United Kingdom
S41 7TD |
| Sponsor email | info@arc.org.uk |
| Sponsor website | http://www.arc.org.uk |
| Contact name | Dr EM Hay |
| Contact details | Department of Rheumatology
Haywood Hospital
High Lane
Burslem
Stoke-on-Trent
United Kingdom
ST6 7AG |
| Contact telephone | +44 (0)1782 715444 |
| Contact email | e.m.hay@cphc.keele.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN24540377 |
| Date last extracted from ISRCTN register | 17/04/2008 |
