Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PSI C-17 (N0466011634)
Study information
Scientific title
Acronym
Study hypothesis
This study will develop a model of patient information for patients with low back pain, and its impact on the management of low back pain, including self-management:
1. To investigate the effect of giving targeted information to patients on the management of low back pain in primary care, including referral patterns and to describe what information patients currently have, including its source, appropriateness and use
2. To determine what patients perceive they need in terms of information, and how that fits into their existing information framework
3. To establish what information clinicians provide, the reasons for their choice and clinicians perceptions of patients information needs
4. To evaluate the impact of patient information on referral patterns (including self referral) and on patient perceptions of their back pain
Ethics approval
Not provided at time of registration
Study design
Interviews, randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Musculoskeletal diseases: Spinal conditions
Intervention
Patients are given targeted information on the management of low back pain
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Aberdeen back pain questionnaire
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/1999
Overall trial end date
01/07/2001
Reason abandoned
Eligibility
Participant inclusion criteria
1. Focus groups - practice record of low back pain consultation in the preceding 12 months selected from General Practitioner (GP) records; a random selection invited to participate
2. Clinician interviews - six GPs from each of three areas
3. Intervention study - patients consulting one of the 96 participating GPs for back pain during a specified 12-week period. Eligibility for the study decided by GP using uniform recognised criteria
4. Age range 25 - 64 years
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/1999
Recruitment end date
01/07/2001
Locations
Countries of recruitment
United Kingdom
Trial participating centre
School of Health and Related Research
Sheffield
S1 4DA
United Kingdom
Sponsor information
Organisation
Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Primary and Secondary Care Interface National Research and Development Programme (UK)
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