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
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
-
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.