Condition category
Musculoskeletal Diseases
Date applied
02/04/2014
Date assigned
06/05/2014
Last edited
05/06/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Patients with back pain may or may not experience pain which spreads to their legs. Previous research has found that patients who have back and leg pain suffer more severe pain and disability, take longer to recover, and lose more time off work than those with back pain alone. However, it is not known if this is because of the leg pain or some other related factors. One type of leg pain, called ‘Nerve Root Pain’, often spreads below the knee and means there is a problem with the nerves in the spine. Doctors think it is important to distinguish between patients who have back pain alone, those with back and leg pain, and those with back pain and nerve root pain. This is so that these groups can be assessed and treated appropriately. The ATLAS cohort study aimed to describe over one year the clinical course, characteristics and factors that predict the outcome for patients with back and leg pain including sciatica. The aim of this study is to conduct longer term follow-ups (at 3, 4 and 5 years) of this established group in order to describe over a longer time frame the clinical course, characteristics, factors that predict outcome and healthcare use over time, including direct and indirect healthcare costs. Similarities and/or differences of those factors are also investigated at the different time points to find out what predicts short-term and long-term outcomes. This knowledge will inform better targeting of treatment to improve outcomes in patients with back and leg pain, which will be tested in future studies.

Who can participate?
Patients who took part in the ATLAS study

What does the study involve?
ATLAS participants (apart from those who withdrew from the study or declined further contact for research purposes at their 12-month questionnaire) are sent a letter introducing the new longer term follow-up study 2 weeks before the third anniversary of their first ATLAS assessment visit, followed by further information and the study questionnaire 2 weeks later. Participants who respond to this questionnaire are then sent two further questionnaires at 4 and 5 years, respectively. Participants are also asked to give permission for the researchers to review their medical records to assess GP visits, medication and hospital visits in order to measure their healthcare use.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
University of Keele (UK)

When is the study starting and how long is it expected to run for?
April 2014 to June 2018

Who is funding the study?
Arthritis Research UK (UK)

Who is the main contact?
Ms Jacqueline Gray

Trial website

Contact information

Type

Scientific

Primary contact

Ms Jacqueline Gray

ORCID ID

Contact details

Arthritis Research UK Primary Care Centre
Primary Care Sciences
Keele University
Newcastle-Under-Lyme
ST5 5BG
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

16279

Study information

Scientific title

Clinical course and prognostic indicators in patients presenting with back and leg pain in primary care: 3, 4 and 5 year prospective study (ATLAS study cohort)

Acronym

ATLAS follow-up study

Study hypothesis

Patients with back pain may or may not experience pain which spreads to their legs. Previous research has found that patients who have back and leg pain suffer more severe pain and disability, take longer to recover, and lose more time off work than those with back pain alone. However, it is not known if this is because of the leg pain or some other related factors. One type of leg pain, called ‘Nerve Root Pain’, often spreads below the knee and means there is a problem with the nerves in the spine. Doctors think it is important to distinguish between patients who have back pain alone, those with back and leg pain, and those with back pain and nerve root pain. This is so that these groups can be assessed and treated appropriately. The ATLAS cohort observational study aims to describe over one year the clinical course, characteristics and factors that predict outcome in patients consulting in primary care with back and leg pain including sciatica. The aim is to conduct longer term follow-ups (at 3, 4 and 5 years) of this established cohort in order to describe over a longer time frame the clinical course, characteristics, factors that predict outcome and health care utilisation over time, including direct and indirect health care costs. Similarities and/or differences of those factors will also investigated at the different time points to characterise better what predicts short-term and long-term outcomes. This knowledge will inform better targeting of treatment to improve outcomes in patients with back and leg pain, which will be tested in future trials.

Ethics approval

MREC, 08/01/2014, 13/NS/0170

Study design

Non-randomised; Observational; Design type: Cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Musculoskeletal disease

Intervention

The ATLAS study looked at how people who visit their GP with back and leg pain do over time. This follow-up study aims to follow the same group of people at 3, 4 and 5 years after their initial participation in the ATLAS study to understand why some people take longer periods of time to recover than others. This information will be used to develop ways to improve the care of people with back and leg pain.

The aim is to conduct longer term follow-ups (at 3, 4 and 5 years) of the established ATLAS cohort in order to describe over a longer timeframe the clinical course, characteristics, prognostic indicators and health care utilisation over time, including direct and indirect health care costs. Similarities and/or differences of prognostic indicators will also investigated at the different time points.

At baseline ATLAS (REC reference: 10/H1207/82) participants attended an initial assessment clinic visit followed by treatment as appropriate, and were then followed up by questionnaire for 12 months. In this proposed study of longer term follow-up of the ATLAS cohort, ATLAS participants (with the exception of those who withdrew from the study or declined further contact for research purposes at their 12-month questionnaire) will be approached. Potential participants will be sent a letter introducing the new longer term follow-up study 2 weeks before the third anniversary of their baseline ATLAS assessment visit, followed by further information and the study questionnaire 2 weeks later. Participants who respond to this questionnaire will then be sent two further questionnaires at 4 and 5 years, respectively. Participants will also be asked to give permission for medical record review to capture GP visits and medication for the same problem and secondary care/hospital visits (inpatient and outpatient) in order to describe health care used over time by this cohort.

Study Entry: Registration only

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Improvement in the RMDQ (Roland and Morris Disability Questionnaire using the leg pain version): defined as a change of at least 30% improvement in an individual’s RMDQ score (Jordan et al., 2006). This will be measured at 3, 4 and 5 years.

Secondary outcome measures

N/A

Overall trial start date

02/04/2014

Overall trial end date

30/06/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Previous participants in the ATLAS study
2. Target Gender: Male & Female

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 300; UK Sample Size: 300

Participant exclusion criteria

1. Withdrawn or excluded from the ATLAS study
2. Declined further contact for research purposes at their 12-month follow-up questionnaire

Recruitment start date

02/04/2014

Recruitment end date

30/06/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Keele University
Newcastle-Under-Lyme
ST5 5BG
United Kingdom

Sponsor information

Organisation

University of Keele (UK)

Sponsor details

Keele
Newcastle
ST5 5BG
United Kingdom

Sponsor type

University/education

Website

http://www.keele.ac.uk/

Funders

Funder type

Charity

Funder name

Arthritis Research UK (UK)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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

05/06/2017: The overall trial end date was changed from 30/06/2016 to 30/06/2018.