Condition category
Musculoskeletal Diseases
Date applied
23/08/2012
Date assigned
09/10/2012
Last edited
20/04/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 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

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

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

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

Publication citations

Additional files

Editorial Notes

20/04/2016: No publications found, verifying study status with principal investigator.