Condition category
Musculoskeletal Diseases
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
12/12/2013
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

Miss Aileen McIntosh

ORCID ID

Contact details

School of Health and Related Research
The University of Sheffield
Regent Court
30 Regent Street
Sheffield
S1 4DA
United Kingdom
+44 (0)114 222 0811

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

http://www.doh.gov.uk

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

Publication citations

Additional files

Editorial Notes