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	https://doi.org/10.1186/ISRCTN55376150
Secondary identifying numbers	S0646

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr EM Hay
Scientific

Primary Care Sciences Research Centre
Keele University
Keele
ST5 5BG
United Kingdom

Phone	+44 (0)1782 583908
Email	e.m.hay@cphc.keele.ac.uk

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	GP practice
Study type	Treatment
Scientific title
Study acronym	TOPIK (Treatment Options for Pain In the Knee)
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Knee pain
Intervention	1. Pharmacy review of medication 2. Active physiotherapy management 3. Advice leaflet
Intervention type	Other
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 study start date	01/05/2001
Completion date	31/03/2005

Participant type(s)	Patient
Age group	Senior
Sex	Both
Target number of participants	325
Key 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
Key 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
Date of first enrolment	01/05/2001
Date of final enrolment	31/03/2005

Primary Care Sciences Research Centre

Keele
ST5 5BG
United Kingdom

Arthritis Research Campaign (ARC) (UK)
Charity

Copeman House
St Mary's Court
St Mary's Gate
Chesterfield
Derbyshire
S41 7TD
United Kingdom

Charity

Arthritis Research Campaign

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	11/11/2006		Yes	No