Condition category
Musculoskeletal Diseases
Date applied
03/01/2003
Date assigned
03/01/2003
Last edited
11/07/2007
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 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

http://www.arc.org.uk

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

  1. 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.

  2. 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.

Additional files

Editorial Notes