Condition category
Musculoskeletal Diseases
Date applied
22/06/2011
Date assigned
13/09/2011
Last edited
18/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
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 factor(s).
One type of leg pain, called ‘Nerve Root Pain’, often spreads below the knee and means there is a problem with the nerves. 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 study aims to answer the following research questions: what are the characteristics and costs of patients with back and leg pain at the time they consult their GP and over the following 12 months, and which factors are associated with a worse outcome? Do patients with nerve root pain differ from those with no nerve root pain?

Who can participate?
Patients with lower leg and back pain.

What does the study involve?
Patients who consult their GP for back and leg pain will be referred to a community clinic for assessment by a physiotherapist and treatment according to their symptoms. Five hundred patients will be recruited to the study. Information about the characteristics (pain, disability, psychological factors, employment, other health conditions, health care use) of these patients will be collected on postal questionnaires at baseline (when they are enrolled in the study), and each month for the following year. Participants will also have a Magnetic Resonance Imaging (MRI) scan at baseline.

What are the possible benefits and risks of participating?
This study will inform better targeting of treatment to improve outcomes in patients with back and leg pain, which will be tested in future trials.
There are no risks to participants from taking part in this study.

Where is the study run from?
The study is taking place in North Staffordshire and Stoke-on-Trent (UK).

When is the study starting and how long is it expected to run for?
The study started in March 2011 and is expected to complete in December 2013.

Who is funding the study?
The National Institute for Health Research (NIHR), UK.

Who is the main contact?
Dr Kika Konstantinou (Principal Investigator)

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
Staffordshire
Newcastle Under Lyme
ST5 5BG
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

9961

Study information

Scientific title

Clinical course, characteristics and prognostic indicators in patients presenting with back and leg pain in primary care

Acronym

ATLAS

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. 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.

Research questions:
1. What are the characteristics and costs of patients with back and leg pain at the time they consult their GP and over the following 12 months, and which factors are associated with a worse outcome?
2. Do patients with nerve root pain differ from those with no nerve root pain?
3. Patients who consult their GP for back and leg pain will be referred to a community clinic for assessment by a physiotherapist and treatment according to their symptoms.

Five hundred patients will be recruited to the study. Information about the characteristics (pain, disability, psychological factors, employment, other health conditions, health care use) of these patients will be collected on postal questionnaires at baseline, and during one year of followup. Participants will also have an MRI scan at baseline. This study 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

South Birmingham Research Ethics Comittee, 19/10/2009, ref: 10/H1207/82

Study design

Non-randomised observational cohort study

Primary study design

Observational

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

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

Condition

Musculoskeletal diseases

Intervention

1. Patients receive a standardised physiotherapy assessment for back and leg pain and are treated by a study physiotherapist according to need
2. Clinical management will follow agreed care pathways, based on current best clinical evidence, practice guidelines and local services and resources
3. Allocation to one of 3 care pathways will take into account the patient’s diagnosis, severity of symptoms, response to previous treatment, and patient preferences

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Disability - Roland and Morris Disability Questionnaire (RMDQ, leg pain version) measured at baseline, 4 month and 12 months

Secondary outcome measures

1. Co-morbidity measured at baseline
2. Employment status, work absence, sick certification and difficulties at work measured at baseline, 4 months and 12 months
3. Episode Duration - current episode for each back and leg pain, plus time since ‘pain free month’ measured at baseline and 12 months
4. General Health (SF1 and EQ5D) measured at baseline, 4 month and 12 month
5. Global assessment of change 0-10 numerical rating scale measured at 4 months and 12 months
6. Health care utilisation measured at 4 months and 12 months
7. Height and Weight measured at baseline
8. Hospital Anxiety and Depression Scale (HADS) measured at baseline and 12 months
9. Illness Perceptions (Musculoskeletal IPQ-R Short Form) measured at baseline, 4 months and 12 months
10. Neuropathic pain (S-LANSS) measured at baseline, 4 month and 12 months
11. Pain intensity (current, average and 'least' pain in the last 2 weeks for both back and leg pain measured at baseline, 4 months and 12 months
12. Pain Location measured at baseline and 12 months
13. Pain Self Efficacy Questionnaire (PSEQ) measured at baseline, 4 months and 12 months
14. Pain trajectory measured at baseline and 12 months
15. Productivity - Performance at work – single numerical rating scale measured at baseline, 4 months and 12 months
16. Risk of poor outcome (STarT Back tool) measured at baseline, 4 months and 12 months
17. Satisfaction with care measured at 4 months
18. Sciatica Bothersomeness Index (SBI) measured at baseline, 4 months and 12 months
19. Smoking measured at baseline
20. Work Load measured at baseline

Overall trial start date

01/01/2011

Overall trial end date

01/01/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adults aged 18 years and over consulting their GP with LBP and radiating leg pain of any duration
2. Male or female
3. Lower Age Limit 18, no upper age limit

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

UK Sample Size: 500

Participant exclusion criteria

1. Persons with “red flags” indicative of possible serious spinal pathology
2. Serious co-morbidity which stop patients from being able to undergo the assessment
3. Patients with serious mental health problems who are vulnerable and for whom participation in the study would be detrimental (at the GP’s discretion)
4. Previous spinal surgery
5. Pregnancy
6. Currently receiving physiotherapy (or osteopathy, chiropractic) or under a secondary care consultant for the same problem
7. Not able to read and speak English

Recruitment start date

01/01/2011

Recruitment end date

01/01/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Arthritis Research UK Primary Care Centre
Newcastle Under Lyme
ST5 5BG
United Kingdom

Sponsor information

Organisation

Keele University (UK)

Sponsor details

Keele
Staffordshire
Newcastle Under Lyme
ST5 5BG
United Kingdom

Sponsor type

Research organisation

Website

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

Funders

Funder type

Government

Funder name

National Institute for Health Research ref: RP-PG-0707-10131

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

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

2012 protocol in http://www.ncbi.nlm.nih.gov/pubmed/22264273

Publication citations

Additional files

Editorial Notes

18/03/2016: Publication reference added