ISRCTN ISRCTN79353052
DOI https://doi.org/10.1186/ISRCTN79353052
Secondary identifying numbers HTA 01/09/02
Submission date
25/04/2003
Registration date
25/04/2003
Last edited
24/08/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Martin Underwood
Scientific

Queen Mary's School of Medicine & Dentistry
Barts & The London
Centre for Health Sciences
Abernethy Building
2 Newark Street
Whitechapel
London
E1 2AT
United Kingdom

Phone +44 (0)207 882 2511
Email m.underwood@qmul.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleAre topical or oral ibuprofen equally effective for the treatment of chronic knee pain in older people?
Study acronymTOIB
Study objectives1. To ascertain, for older people with knee pain, if oral and topical ibuprofen are equally effective at reducing pain and disability in a randomised controlled trial
2. To compare the incidence of adverse effects from oral and topical ibuprofen used to treat older people with knee pain
3. To compare the cost effectiveness of oral and topical ibuprofen used for treatment of older people with knee pain
4. To compare expected and actual satisfaction with treatment, with effectiveness of oral and topical ibuprofen for older people with knee pain
5. To explore how older people's expressed preferences for, and previous use of, oral or topical medication for chronic knee pain influences treatment effectiveness
6. To explore older people's beliefs about and expectations of treatments for chronic knee pain
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedKnee pain
InterventionThe two interventions being compared are the GP's recommendation (either a prescription or advice to get an over-the-counter preparation) to use either topical or oral ibuprofen. For those whose chosen/allocated treatment is oral ibuprofen, practices are asked to use no more than 1.2 g per day. Treatments for knee pain other than NSAIDs may be used as each patient's doctor thinks appropriate.

Participants are sent postal questionnaires three, six, 12 and 24 months after randomisation. One year and two years after randomisation participants are asked to visit the practice to have their blood pressure and respiratory function measured and blood taken for full blood count, serum ferritin, creatinine and liver function tests. The medical records are examined one year after randomisation to identify unplanned hospital admissions, and after two years (or at the end of the study) to collect health service activity data and confirm reported changes in medication and adverse effects.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Ibuprofen
Primary outcome measureThe Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire, which measures pain and disability in the preceding 48 hours.
Secondary outcome measures1. The postal version of the Chronic Pain Grade, which measures pain and disability over the preceding six months
2. The Euro Quality of Life questionnaire (EQ-5D), a measure of health-related quality of life
3. The 36-item Short Form health survey (SF-36) version 2, a different measure of health related quality of life
4. A question assessing satisfaction with treatment
Overall study start date01/07/2002
Completion date31/08/2006

Eligibility

Participant type(s)Patient
Age groupSenior
SexBoth
Target number of participants283
Key inclusion criteria1. Aged 50 or over
2. Have ever had pain in or around the knee on most days for at least a month and have experienced knee pain for more than three months out of the preceding year
3. General Practitioner (GP) consultation, or treatment, for knee pain in the preceding three years
4. Informed consent
5. Agreement to use chosen or allocated treatment
6. GP agreement to prescribe oral/topical ibuprofen
7. Ability to complete postal questionnaires
Key exclusion criteria1. Peptic ulceration (past or current)
2. Current moderate or severe indigestion
3. Previous severe adverse reaction to Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
4. Hypertension (systolic Blood Pressure [BP] of 155 mmHg or more or a diastolic BP of 105 mmHg or more)
5. Uncontrolled heart failure
6. Creatinine greater than 140 mmol/L
7. Abnormal liver function sufficient to contraindicate use of NSAIDs (as liver function tests performed and reference ranges vary between different laboratories, this decision is at the discretion of the participant's GP)
8. GP request not to include
9. Serious psychological or psychiatric disorders (including dementia)
10. Previous knee replacement/s or awaiting knee surgery
11. Inflammatory arthropathy
12. Pain referred from hip or back
13. Serious injury within six months
14. Currently on anticoagulants or oral steroids
15. Anaemia (Haemoglobin [Hb] less than 12.4 g/L for men or less than 11.8 g/L for women)
16. Disseminated malignancy

To meet the American College of Rheumatologists (ACR) clinical criteria for osteoarthritis of the knee, patients need to have knee pain, as defined for this study, and meet three out of the following six criteria:
1. Aged over fifty
2. Less than 30 minutes morning stiffness
3. Crepitus
4. Bony tenderness
5. Bony enlargement
6. No palpable warmth
Date of first enrolment01/07/2002
Date of final enrolment31/08/2006

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Queen Mary's School of Medicine & Dentistry
London
E1 2AT
United Kingdom

Sponsor information

Department of Health (UK)
Government

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom

Phone +44 (0)1132 545 843
Email Sheila.Greener@doh.gsi.gov.uk
Website http://www.dh.gov.uk/en/index.htm
ROR logo "ROR" https://ror.org/03sbpja79

Funders

Funder type

Government

NIHR Health Technology Assessment Programme - HTA (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 07/11/2005 Yes No
Results article main results publication at 19/01/2008 Yes No
Other publications HTA monograph at 01/05/2008 Yes No
Results article cost-effectiveness results 01/07/2008 Yes No