Condition category
Signs and Symptoms
Date applied
17/10/2012
Date assigned
17/10/2012
Last edited
12/12/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Christy Toms

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

2012-000147-27

ClinicalTrials.gov number

Protocol/serial number

13310

Study information

Scientific title

A single blind randomised controlled pilot trial of corticosteroid injection for shoulder pain

Acronym

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

ref: 12/SC/0233

Study design

Randomised interventional trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

31/08/2012

Overall trial end date

31/12/2012

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

UK Sample Size: 50

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

United Kingdom

Trial participating centre

University of Oxford
Oxford
OX3 7LF
United Kingdom

Sponsor information

Organisation

University of Oxford (UK)

Sponsor details

CTRG
Joint Research Office
Block 60 Churchill Hospital
Headington
OX3 7LJ
United Kingdom

Sponsor type

University/education

Website

http://www.ox.ac.uk/

Funders

Funder type

Government

Funder name

NIHR School for Primary Care Research (UK)

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

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24325987

Publication citations

  1. Results

    Holt TA, Mant D, Carr A, Gwilym S, Beard D, Toms C, Yu LM, Rees J, Corticosteroid injection for shoulder pain: single-blind randomized pilot trial in primary care., Trials, 2013, 14, 425, doi: 10.1186/1745-6215-14-425.

Additional files

Editorial Notes