Condition category
Musculoskeletal Diseases
Date applied
25/04/2003
Date assigned
25/04/2003
Last edited
24/08/2009
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

Prof Martin Underwood

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 01/09/02

Study information

Scientific title

Are topical or oral ibuprofen equally effective for the treatment of chronic knee pain in older people?

Acronym

TOIB

Study hypothesis

1. 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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Knee pain

Intervention

The 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 type

Drug

Phase

Not Specified

Drug names

Ibuprofen

Primary outcome measures

The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire, which measures pain and disability in the preceding 48 hours.

Secondary outcome measures

1. 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 trial start date

01/07/2002

Overall trial end date

31/08/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. 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

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

283

Participant exclusion criteria

1. 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

Recruitment start date

01/07/2002

Recruitment end date

31/08/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
+44 (0)1132 545 843
Sheila.Greener@doh.gsi.gov.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/en/index.htm

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (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

2008 cost-effectiveness results in http://www.ncbi.nlm.nih.gov/pubmed/18511476
2008 HTA monograph at http://www.ncbi.nlm.nih.gov/pubmed/18505668
2008 main results publication at http://www.ncbi.nlm.nih.gov/pubmed/18056743
2005 protocol in http://www.ncbi.nlm.nih.gov/pubmed/16274477

Publication citations

  1. Protocol

    Cross PL, Ashby D, Harding G, Hennessy EM, Letley L, Parsons S, Spencer AE, Underwood M, , TOIB Study. Are topical or oral ibuprofen equally effective for the treatment of chronic knee pain presenting in primary care: a randomised controlled trial with patient preference study. [ISRCTN79353052]., BMC Musculoskelet Disord, 2005, 6, 55, doi: 10.1186/1471-2474-6-55.

  2. Castelnuovo E, Cross P, Mt-Isa S, Spencer A, Underwood M, , Cost-effectiveness of advising the use of topical or oral ibuprofen for knee pain; the TOIB study [ISRCTN: 79353052]., Rheumatology (Oxford), 2008, 47, 7, 1077-1081, doi: 10.1093/rheumatology/ken128.

  3. Underwood M, Ashby D, Carnes D, Castelnuovo E, Cross P, Harding G, Hennessy E, Letley L, Martin J, Mt-Isa S, Parsons S, Spencer A, Vickers M, Whyte K, Topical or oral ibuprofen for chronic knee pain in older people. The TOIB study., Health Technol Assess, 2008, 12, 22, iii-iv, ix-155.

  4. Underwood M, Ashby D, Cross P, Hennessy E, Letley L, Martin J, Mt-Isa S, Parsons S, Vickers M, Whyte K, , Advice to use topical or oral ibuprofen for chronic knee pain in older people: randomised controlled trial and patient preference study., BMJ, 2008, 336, 7636, 138-142, doi: 10.1136/bmj.39399.656331.25.

Additional files

Editorial Notes