Contact information
Type
Scientific
Primary contact
Dr EM Hay
ORCID ID
Contact details
Primary Care Sciences Research Centre
Keele University
Keele
ST5 5BG
United Kingdom
+44 (0)1782 583908
e.m.hay@cphc.keele.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
S0646
Study information
Scientific title
Acronym
TOPIK (Treatment Options for Pain In the Knee)
Study hypothesis
The primary objective of this trial is to examine the clinical effectiveness, of two innovative interventions: enhanced pharmacy review and active physiotherapy, compared with a control group receiving an advice and information booklet reinforced with telephone support.
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
GP practices
Trial type
Treatment
Patient information sheet
Condition
Knee pain
Intervention
1. Pharmacy review of medication
2. Active physiotherapy management
3. Advice leaflet
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at 6 months.
Secondary outcome measures
Anxiety and Depression (HADS); Confidence in managing pain, function, and other symptoms associated with arthritis (Arthritis Self-Efficacy Scale); Overall health status (EuroQoL).
Overall trial start date
01/05/2001
Overall trial end date
31/03/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Male and female patients aged 55 years and above
2. Pain with or without stiffness in one or both knees
3. Considered suitable for primary care management by GP
4. Able to read English
5. Available for telephone contact
6. Able and willing to consent to participation
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
325
Participant exclusion criteria
1. Patients with potentially serious pathology (e.g. inflammatory arthritis, malignancy) on the basis of GP diagnosis or past medical history
2. Patients with severe disability: WOMAC Physical Function score ³ 40
3. Patients already on a surgical waiting list
4. Patients who have already had an exercise programme for their knee problem within the previous 3 months (normal recreational involvement in sport or exercise will not be an exclusion)
5. Patients who have received an intra-articular injection to the knee in the last 6 months
6. Patients who have a knee replacement
7. Patients unable or unwilling to receive the study interventions, or for whom the interventions are contraindicated
8. Patients with acute trauma
9. Knee pain due to malignancies
Recruitment start date
01/05/2001
Recruitment end date
31/03/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Primary Care Sciences Research Centre
Keele
ST5 5BG
United Kingdom
Sponsor information
Organisation
Arthritis Research Campaign (ARC) (UK)
Sponsor details
Copeman House
St Mary's Court
St Mary's Gate
Chesterfield
Derbyshire
S41 7TD
United Kingdom
-
info@arc.org.uk
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
Arthritis Research Campaign
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
Basic results (scientific)
Publication list
Publication citations
-
Results
Hay EM, Foster NE, Thomas E, Peat G, Phelan M, Yates HE, Blenkinsopp A, Sim J, Effectiveness of community physiotherapy and enhanced pharmacy review for knee pain in people aged over 55 presenting to primary care: pragmatic randomised trial., BMJ, 2006, 333, 7576, 995, doi: 10.1136/bmj.38977.590752.0B.