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A pragmatic randomised controlled trial in primary care to determine the effectiveness of active physiotherapy treatment and enhanced pharmacy review for knee pain
ISRCTN ISRCTN55376150
DOI 10.1186/ISRCTN55376150
ClinicalTrials.gov identifier
EudraCT number
Public title A pragmatic randomised controlled trial in primary care to determine the effectiveness of active physiotherapy treatment and enhanced pharmacy review for knee pain
Scientific title
Acronym TOPIK (Treatment Options for Pain In the Knee)
Serial number at source S0646
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.
Lay summary
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Knee pain
Participants - 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
Participants - 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
Anticipated start date 01/05/2001
Anticipated end date 31/03/2005
Status of trial Completed
Patient information material
Target number of participants 325
Interventions 1. Pharmacy review of medication
2. Active physiotherapy management
3. Advice leaflet
Primary outcome measure(s) Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at 6 months.
Secondary outcome measure(s) Anxiety and Depression (HADS); Confidence in managing pain, function, and other symptoms associated with arthritis (Arthritis Self-Efficacy Scale); Overall health status (EuroQoL).
Sources of funding Arthritis Research Campaign
Trial website
Publications Results on http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17056608
Contact name Dr  EM  Hay
  Address Primary Care Sciences Research Centre
Keele University
  City/town Keele
  Zip/Postcode ST5 5BG
  Country United Kingdom
  Tel +44 (0)1782 583908
  Email e.m.hay@cphc.keele.ac.uk
Sponsor Arthritis Research Campaign (ARC) (UK)
  Address Copeman House
St Mary's Court
St Mary's Gate
Chesterfield
  City/town Derbyshire
  Zip/Postcode S41 7TD
  Country United Kingdom
  Email info@arc.org.uk
  Sponsor website: http://www.arc.org.uk
Date applied 03/01/2003
Last edited 06/03/2007
Date ISRCTN assigned 03/01/2003
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