Clinical course and prognostic indicators in patients presenting with back and leg pain in primary care
| ISRCTN | ISRCTN75555299 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN75555299 |
| Secondary identifying numbers | 16279 |
- Submission date
- 02/04/2014
- Registration date
- 06/05/2014
- Last edited
- 07/09/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
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
Contact information
Scientific
Arthritis Research UK Primary Care Centre
Primary Care Sciences
Keele University
Newcastle-Under-Lyme
ST5 5BG
United Kingdom
Study information
| Study design | Non-randomised; Observational; Design type: Cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| 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) |
| Study acronym | ATLAS follow-up study |
| Study objectives | 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(s) | MREC, 08/01/2014, 13/NS/0170 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 02/04/2014 |
| Completion date | 30/06/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned Sample Size: 300; UK Sample Size: 300 |
| Key inclusion criteria | 1. Previous participants in the ATLAS study 2. Target Gender: Male & Female |
| Key exclusion criteria | 1. Withdrawn or excluded from the ATLAS study 2. Declined further contact for research purposes at their 12-month follow-up questionnaire |
| Date of first enrolment | 02/04/2014 |
| Date of final enrolment | 30/06/2016 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
ST5 5BG
United Kingdom
Sponsor information
University/education
Keele
Newcastle
ST5 5BG
England
United Kingdom
| Website | http://www.keele.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/00340yn33 |
Funders
Funder type
Charity
Private sector organisation / Other non-profit organizations
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 20/01/2012 | 07/09/2020 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
07/09/2020: Publication reference added.
05/06/2017: The overall trial end date was changed from 30/06/2016 to 30/06/2018.
