Feasibility of n-of-1 Trials - a Pilot Study
Primary Purpose
Osteoarthritis
Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
diclofenac
paracetamol
heat retaining knee support
standard knee support
Sponsored by
About this trial
This is an interventional health services research trial for Osteoarthritis
Eligibility Criteria
Inclusion Criteria:
- Patients attending clinics in the North Bristol Health Care Trust, with confirmed OA of the knee (Kellgren-Lawrence radiographic score of 2-4 within the previous 12 months) and use-related pain.
Exclusion Criteria:
- Patients who had received corticosteroid injections or operations on their knee in the previous six months were excluded. Those with known contraindications to paracetamol or any NSAID, and those taking steroids, warfarin or aspirin for another medical condition were excluded from the drug trials.
Sites / Locations
- Southmead Hospital
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00371696
First Posted
September 1, 2006
Last Updated
September 1, 2006
Sponsor
University of Bristol
1. Study Identification
Unique Protocol Identification Number
NCT00371696
Brief Title
Feasibility of n-of-1 Trials - a Pilot Study
Official Title
Pilot Study of the Feasibility of n-of-1 Trials: the Individualisation of Treatments for Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2003
Overall Recruitment Status
Completed
Study Start Date
December 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2003 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Bristol
4. Oversight
5. Study Description
Brief Summary
The aim of this study was to provide essential pilot data on the feasibility of conducting n-of-1 trials within secondary care within the UK, notably to: test the process of recruitment and design aspects of such trials; assess the acceptability of this research method to patients, explore the experiences of patients involved; determine the most appropriate treatment for individual patients.
Detailed Description
Whilst the large scale randomised controlled trial (RCT) remains the scientific "gold standard" for evaluating therapies in clinical medicine, the assumption made, that the treatment effect demonstrated is generalisable and applicable to all patients, is unlikely to be true. There will inevitably be some patients who benefit from a particular treatment more than others. N-of-1 trials are a means of conducting RCTs in individual patients with the added opportunity to use patient generated outcome measures. Patients act as their own control and receive all treatments under comparison, more than once, in a random sequence. While n-of-1 trial methodology is reasonably well specified they remain under-exploited and little is known about the process aspects of conducting such trials or the experiences and views of those who participate in them. The time commitment by patients and health professionals is not inconsiderable and there may well be particular problems with recruitment and drop out. N-of-1 trials rely on co-operation between individual clinicians and patients, however, no work has been undertaken to explore the ways in which patient-practitioner relationships and their experiences and views influence the progress and outcome of n-of-1 trials.
Patients with confirmed osteoarthritis (OA) of the knee, selected for a mix of gender, age, weight, will be recruited to the n-of-1 trials to compare either, an NSAID (diclofenac) with simple analgesic (paracetamol) or a standard knee support with a heat retaining support. Patients will undergo a (1 hour) semi-structured interview before the trial commences and once the trial is completed or terminated. Patients treated with supports/drugs will receive each treatment for a period of one/two weeks respectively, for 3 cycles (order determined at random). Patients will complete daily diaries including standard patient questionnaires and a patient generated outcome measure. Qualitative interviews and observational methods will be employed to study practitioner/ patient relationships; decision to participate; expectations and experience; appropriateness and acceptability of research design and measures. Patients declining to take part will be approached to explore reasons for not participating.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
10 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
diclofenac
Intervention Type
Drug
Intervention Name(s)
paracetamol
Intervention Type
Device
Intervention Name(s)
heat retaining knee support
Intervention Type
Device
Intervention Name(s)
standard knee support
10. Eligibility
Sex
All
Minimum Age & Unit of Time
0 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients attending clinics in the North Bristol Health Care Trust, with confirmed OA of the knee (Kellgren-Lawrence radiographic score of 2-4 within the previous 12 months) and use-related pain.
Exclusion Criteria:
Patients who had received corticosteroid injections or operations on their knee in the previous six months were excluded. Those with known contraindications to paracetamol or any NSAID, and those taking steroids, warfarin or aspirin for another medical condition were excluded from the drug trials.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Dieppe
Organizational Affiliation
MRC Health Services Research Collaboration
Official's Role
Study Director
Facility Information:
Facility Name
Southmead Hospital
City
Bristol
ZIP/Postal Code
BS20 5NB
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Feasibility of n-of-1 Trials - a Pilot Study
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