Plain English Summary
Background and study aims:
The aim of this study is to try and identify whether chemicals in the blood called cytokines influence pain in people with sciatica. We will examine the blood samples and investigate the presence of such chemicals. We will also investigate whether the presence of any of these chemicals is related to higher pain levels. Through this study we hope to improve our understanding of sciatica and how it might be treated.
Who can participate?
This study takes place within a larger study (ATLAS) and patients for this study will be recruited from the ATLAS study. These participants will be adults aged 18 years and over who are attending an ATLAS clinic because they have consulted their GP with low back and leg pain of any duration and who consent and are eligible to take part in the ATLAS study.
What does the study involve?
Patients will attend a phlebotomy service, where a 10ml blood sample will be collected by an experienced hospital phlebotomist. Only one sample will be collected, on a single occasion.
What are the possible benefits and risks of participating?
There is not expected to be any benefit to patients who take part in the research study. The data generated from this study will help to extend our understanding of the role of inflammation in sciatica. This may ultimately have implications for improved treatment strategies and care in the future, although not necessarily for the participants of the study.
As a blood sample will be taken there is the potential risk of experiencing discomfort.
Where is the study run from?
The Arthritis Research UK Primary Care Centre at Keele University, UK
When is study starting and how long is it expected to run for?
The study started on 07 June 2012, and is expected to run for 10 months.
Who is funding the study?
Department of Health - Academic Training Programme for Nurses, Midwives and Allied Health Professionals
Who is the main contact?
Miss Zoe Lingard
z.l.lingard@keele.ac.uk
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
+44 1782 734857
j.gray@keele.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
12681
Study information
Scientific title
The Influence of cytokine biomarkers on sciatica: a nested study within the ATLAS cohort
Acronym
Study hypothesis
Sciatica describes the clinical syndrome of leg pain and or weakness, which is usually caused by irritation of the sciatic nerve. Studies show that patients with sciatica suffer more severe pain and disability, take longer to recover, and lose more time off work than those with back pain alone. Studies suggest inflammation may be a key cause of sciatica and specific medicines called cytokine inhibitors have been shown to give promising results for the treatment of sciatica. These therapies may represent a novel way of treating sciatica but are expensive. Data is required to effectively target these drugs at patients most likely to derive benefit. This study will compare blood levels of cytokines in patients with recent onset sciatica symptoms to patients with non specific low back pain. The study will also determine whether the levels are linked to clinical factors such as pain intensity, severity or disability. Patients will be recruited from clinics of an existing low back and leg pain cohort study (ATLAS study). Patients agreeing to take part will be asked to give a single blood sample for the research.
Ethics approval
NRES Comittee North West - Greater Manchester South, 10 April 2012, ref: 12/NW/0173
Study design
Non-randomised observational study
Primary study design
Observational
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Sciatica
Intervention
We aim to recruit 120 participants from patients attending ATLAS clinics. As part of the ATLAS clinic, the patients are assessed by a physiotherapist who will determine if they have a radiculopathy (sciatica due to disc herniation) or non specific low back and leg pain (NSLBLP). At the ATLAS study clinics we aim to recruit 80 patients with radiculopathy symptoms and 40 patients with NSLBLP. Following the results of the MRI scan we plan to subdivide the radiculopathy patients into those with and without disc herniation on MRI, which is expected to produce three groups
1. 40 patients with radiculopathy symptoms and disc herniation on MRI
2. 40 patients with radiculopathy symptoms and no disc herniation on MRI
3. 40 patients with nonspecific low back pain
Following collection the blood samples will be centrifuged and plasma will be separated from blood within an hour of collection and stored at 80°C at the Haywood Hospital. Plasma cytokine and MMP levels will be measured using commercial multiplex detection kits (BioRad & R&D Systems).
Simple comparisons between biomarker levels will be performed using MannWhitney U tests. Data will also be analysed using software designed for microarray analysis (e.g. GENESIS) using hierarchical clustering and principal component analysis.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Median cytokine levels compared across the 3 study groups measured at baseline
Secondary outcome measures
1. Comparing cytokine levels with baseline
2. Pain intensity, pain severity and pain duration measured at baseline
Overall trial start date
07/06/2012
Overall trial end date
29/03/2013
Reason abandoned
Eligibility
Participant inclusion criteria
This study is nested within a larger cohort study (ATLAS study) and patients for this study will be recruited from the ATLAS cohort.
Hence the principal inclusion criteria is:
1. Adults aged 18 years and over who are attending an ATLAS clinic because they have consulted their GP with low back
2. Leg pain of any duration and who consent and are eligible to take part in the ATLAS study
3. Male & female participants
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
UK Sample Size: 120
Participant exclusion criteria
Ineligibility and/or not consenting to take part in the ATLAS study. All participants for this study will be recruited from the ATLAS study hence the exclusion criteria to take part in this study are the same as the exclusion criteria for the ATLAS study:
1. Persons with signs and symptoms indicative of possible serious spinal pathology
2. Serious comorbidity 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 GPs 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
07/06/2012
Recruitment end date
29/03/2013
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 Road
Staffordshire
Newcastle-under-Lyme
ST5 5BG
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Department of Health (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