Pilot trial of steroid injection for shoulder pain
| ISRCTN | ISRCTN82357435 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN82357435 |
| EudraCT/CTIS number | 2012-000147-27 |
| Secondary identifying numbers | 13310 |
- Submission date
- 17/10/2012
- Registration date
- 17/10/2012
- Last edited
- 12/12/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Dr Christy Toms
Scientific
Scientific
University of Oxford
Department of Primary Health Care
Institute of Health Sciences
Old Road
Headington
Oxford
OX3 7LF
United Kingdom
| christy.toms@dphpc.ox.ac.uk |
Study information
| Study design | Randomised interventional trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A single blind randomised controlled pilot trial of corticosteroid injection for shoulder pain |
| Study hypothesis | Painful shoulders are a common problem frequently seen in general practice, and a widley used treatment is an injection of a steroid and a local anaesthetic. However, whilst people often seem to benefit from such injections, it is not known for certain whether the steroid itself is actually affective. To be able to answer this definitively a large scale clinical trial is required. However to ensure the success or reliability of such a study and its results we plan to conduct a pilot trial using a small number of participants to identify any feasibility issues that may be encountered. We will recruit participants presenting to their GPs with shoulder pain. Eligible participants will be randomised to receive an injection of the steroid methylprednisolone plus a local anaesthetic (lidocaine) to their shoulder, or just local anaesthetic alone. Both of these medications are currently used for the treatment of shoulder pain. Over a period of three months participants will complete three Oxford Shoulder Score questionnaires, a tool frequently used by clinicians to assess shoulder symptoms. They will also be asked to answer thee 'satisfaction' questions and to report any unexpected effects, good or bad, during the period of their trial participation. This pilot study will be conducted within the Oxfordshire region and will help us to plan and design a larger trial that will take place over a much wider region with a large number of participants to determine the efficacy of steroid injections in the treatment of shoulder pain. More details can be found at: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=13310 |
| Ethics approval(s) | ref: 12/SC/0233 |
| Condition | Shoulder pain |
| Intervention | Baseline Assessment: Medical History - details of shoulder problem Eligibility assessment: Screening and Consent Completion of follow up questionnaires Trial injection: either methylprednisolone mixed with lignocaine or lignocaine alone |
| Intervention type | Other |
| Primary outcome measure | Proportion of screened patients eligible to enter the study |
| Secondary outcome measures | 1. Adherence to the allocation treatment 2. Loss to follow up including withdrawal 3. Proportion of eligible patients willing to provide consent 4. Rates of recruitment |
| Overall study start date | 31/08/2012 |
| Overall study end date | 31/12/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | UK Sample Size: 50 |
| Participant inclusion criteria | 1. Aged 35-74 years old (inclusive) 2. Diagnosed with either rotator cuff tendinopathy or adhesive capsulitis of duration of no more than 6 months 3. Able to complete follow up questionnaires at 2, 4 and 12 weeks |
| Participant exclusion criteria | 1. Pregnancy 2. Breastfeeding 3. The individual has taken part in another research study within the last 12 weeks 4. The individual has already received an injection to the affected shoulder within the last 12 months 5. Established chronic shoulder disorder 6. Previous shoulder surgery on the affected side 7. Evidence of an active infection 8. Currently prescribed anticoagulants 9. Currently prescribed or likely to need systemic corticosteroids for any reason 10. Immuno-compromised 11. Diagnosis of heart failure 12. Uncontrolled diabetes or hypertension 13. Unable to complete follow up questionnaires 14. Allergy to corticosteroids and/or lidocaine 15. Significant disease or disorder which may put the participant at risk |
| Recruitment start date | 31/08/2012 |
| Recruitment end date | 31/12/2012 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University of Oxford
Oxford
OX3 7LF
United Kingdom
OX3 7LF
United Kingdom
Sponsor information
University of Oxford (UK)
University/education
University/education
CTRG
Joint Research Office
Block 60 Churchill Hospital
Headington
OX3 7LJ
England
United Kingdom
| Website | http://www.ox.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/052gg0110 |
Funders
Funder type
Government
NIHR School for Primary Care Research (UK)
No information available
Results and Publications
| 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 10/12/2013 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
