Condition category
Musculoskeletal Diseases
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
04/02/2010
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 M Doherty

ORCID ID

Contact details

Rheumatology Unit
Nottingham City Hospital NHS Trust
Hucknall Road
Nottingham
NG5 1PB
United Kingdom
+44 (0)115 8404 733
michael.doherty@nottingham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

95XX2

Study information

Scientific title

Acronym

Study hypothesis

The researchers will test the hypothesis that chronic oral NSAID requirement may be eliminated or reduced in the majority of community based patients by the use of simple, alternative management strategies.

Ethics approval

Received from local medical ethics committee

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Osteoarthritis; regional locomotor pain

Intervention

Patients will be randomised, stratified according to joint or non-joint disorder, to receive either:
1. General advice on NSAIDs (group 1)
2. Reduced NSAIDs plus advice on alternative treatments for their painful locomotor condition (group 2). Group 2 patients will be asked to stop or at least reduce, their NSAID use. For each patient in group 2, appropriate alternative treatment options will be chosen from a defined list.
A six week follow-up assessment will be made of which interventions were utilised.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/10/1995

Overall trial end date

31/03/1997

Reason abandoned

Eligibility

Participant inclusion criteria

Two general practices with computer generated register data will be invited to participate. Up to 260 patients receiving regular prescriptions for NSAIDs for regional locomotor pain will be identified according to the following criteria.
1. Adult (18 years or older, no upper age limit)
2. Oral NSAID prescriptions to cover at least 6 of the previous 12 months
3. Last prescription within 6 weeks of induction into study
4. Osteoarthritis or regional locomotor pain (e.g. shoulder lesion, neck pain, back pain) as the reason for prescription

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

260

Participant exclusion criteria

Defined inflammatory arthritis (e.g. rheumatoid arthritis, ankylosin spondylitis, gout), bone malignancy or non-locomotor pain as reason for prescription (obtained from GP records)

Recruitment start date

01/10/1995

Recruitment end date

31/03/1997

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Rheumatology Unit
Nottingham
NG5 1PB
United Kingdom

Sponsor information

Organisation

NHS R&D Regional Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive Trent (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

2002 results in http://www.ncbi.nlm.nih.gov/pubmed/11792874

Publication citations

  1. Results

    Jones AC, Coulson L, Muir K, Tolley K, Lophatananon A, Everitt L, Pringle M, Doherty M, A nurse-delivered advice intervention can reduce chronic non-steroidal anti-inflammatory drug use in general practice: a randomized controlled trial., Rheumatology (Oxford), 2002, 41, 1, 14-21.

Additional files

Editorial Notes