Condition category
Musculoskeletal Diseases
Date applied
03/01/2003
Date assigned
03/01/2003
Last edited
06/03/2007
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

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 measures

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

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

http://www.arc.org.uk

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

Results - basic reporting

Publication summary

Results on http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17056608

Publication citations

  1. 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.

Additional files

Editorial Notes