Modification of chronic oral nonsteroidal anti-inflammatory drug (NSAID) requirement; feasibility, patient benefit and cost-effectiveness.

ISRCTN	ISRCTN14558398
DOI	https://doi.org/10.1186/ISRCTN14558398
Protocol serial number	95XX2
Sponsor	NHS R&D Regional Programme Register - Department of Health (UK)
Funder	NHS Executive Trent (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr M Doherty
Scientific

Rheumatology Unit
Nottingham City Hospital NHS Trust
Hucknall Road
Nottingham
NG5 1PB
United Kingdom

Phone	+44 (0)115 8404 733
Email	michael.doherty@nottingham.ac.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Received from local medical ethics committee
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/03/1997

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	260
Key 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
Key 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)
Date of first enrolment	01/10/1995
Date of final enrolment	31/03/1997

Rheumatology Unit

Nottingham
NG5 1PB
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2002		Yes	No