Plain English Summary
Background and study aims
It is estimated that there are 40,000 people living with a spinal cord injury (SCI) in the UK, with 1,200 being paralysed from a SCI every year. Of these, over 62% experience chronic pain. It is known that adaptation to the significant changes in health and lifestyle for SCI patients is limited by the experience of persistent pain and yet in the UK there is currently no tailored pain management programme available. This study aims to get more information about the different things that contribute to the chronic pain experienced by people with a spinal cord injury. It is known that psychological factors are involved. These include things such as the way we think about the pain, whether we believe we can do anything about it and how bad we think it is. Stress might also affect how bad the pain feels and even our social relationships may play a part. This research will investigate all of these areas to see which aspects are important on their own and which aspects combine with other things to affect the pain we feel. Additionally, the study will look at whether these things change over a nine month period. The information will be used to design a pain management programme specifically for people with a spinal cord injury and to increase our knowledge about this area.
Who can participate?
English speaking in-patients and out-patients of the National Spinal Injuries Centre (NSIC), Stoke Mandeville, aged 18 and over who are experiencing chronic pain. In-patients can participate three months after being admitted to hospital. Out-patients can participate if it has been a minimum of two years since they were discharged from hospital.
What does the study involve?
If you are an in-patient you will be asked to complete a set of 8 questionnaires at three, six and twelve months after admission to the NSIC and to provide saliva samples on each occasion. This is done by wiping a cotton bud around the inside of your mouth for a couple of minutes. The saliva sample will be analysed to see how much of a substance called cortisol you are producing. We produce cortisol when we are feeling stressed. It will take about 35 minutes to answer the questionnaires and provide the saliva sample. If you are an out-patient and were discharged from hospital a minimum of two years ago you will be asked to complete the same set of questionnaires and provide a saliva sample but only on one occasion. You will be given the option of filling in paper questionnaires or of completing them on-line.
What are the possible benefits and risks of participating?
Because the questions ask you to think about how you are feeling there is a chance you may find some of them upsetting. You can stop and have a break at any time or you can choose not to answer any questions you dont like. You can stop taking part in the study at any time without any consequences. There may not be any direct benefits to you from taking part in this study. However, the information obtained will influence the design of a pain management programme, which you and other spinal cord injured patients could benefit from. Taking part in the study will help us to better understand the nature of chronic pain experienced by people with a spinal cord injury.
Where is the study run from?
The National Spinal Injuries Centre, Stoke Mandeville Hospital, Aylesbury (UK).
When is the study starting and how long is it expected to run for?
It is expected that recruitment of participants will begin in June 2013 and that the last participants will leave the study by the end of June 2015.
Who is funding the study?
The University of Buckingham (UK)
Who is the main contact?
A longitudinal (in-patient) study and a cross-sectional (out-patient) study investigating the contribution of cortisol, psychological and social factors in the experience of chronic pain in spinal cord injured patients
1. Negative appraisals, mental defeat and pain catastrophising will individually and in combination increase pain intensity and disability.
2. Mental defeat will trigger catastrophising, which in turn will trigger further catastrophic thinking.
3. Higher levels of cortisol will negatively mediate pain intensity, disability and duration and will predict higher levels of depression and anxiety.
4. Greater acceptance of pain will predict lower psychological distress, less catastrophic thinking and mental defeat and lower cortisol levels.
5. Interpersonal factors will be associated with pain disability and pain behaviours.
1. School of Science and Medicine Ethical Approval Committee, University of Buckingham, 15/04/2013
2. Berkshire Research Ethics Committee, 09/10/2013, NRES ref: 13/SC/0457
3. NRES Committee South Central Oxford C, 09/10/2013, REC ref: 13/SC/0457
4. Buckinghamshire Healthcare NHS Trust Research and Development Office, 25/02/2014, ref: RXQ584
Longitudinal design using questionnaires and cortisol sampling with in-patients
Cross-sectional design using questionnaires and cortisol sampling with out-patients
Primary study design
Secondary study design
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Chronic pain in patients with a spinal cord injury
A longitudinal, multiple assessment-point design will be used with spinal cord injured in-patients at the National Spinal Injuries Centre (NSIC), Stoke Mandeville. Participants will be asked to complete a set of two pain assessment questionnaires and six psychological assessments at three, six and twelve months after admission to the NSIC and to provide salivary cortisol samples on each occasion. Additionally, a cross-sectional study, using the same questionnaires and cortisol sampling, will be undertaken with out-patients of the NSIC who have been out of hospital for a minimum of two years.
The following questionnaires will be used:
Multidimensional Pain Inventory - Spinal Cord Injury
Leeds Assessment of Neuropathic Symptoms and Signs
Pain Self-Perception Scale
Perceived Stress Scale
Hospital Anxiety and Depression Scale
Pain Catastrophising Scale
Appraisals of Disability: Primary and Secondary Scale
Chronic Pain Acceptance Questionnaire
Primary outcome measures
Pain intensity is the primary outcome measure and will be measured using the Multidimensional Pain Inventory - Spinal Cord Injury and the Leeds Assessment of Neuropathic Pain. This will be measured at 3, 6 and 12 months following injury for in-patients and on one occasion with out-patients.
Secondary outcome measures
Participants will be asked to complete a set of two pain assessment questionnaires and six psychological assessments at three, six and twelve months after admission to the NSIC and to provide salivary cortisol samples on each occasion. The salivary samples will be analysed using enzyme-linked immuno-sorbent assay.
Catastrophising measured using Pain Catastrophising Scale
Appraisals measured using Appraisals of Disability: Primary and Secondary Scale
Pain acceptance measured using Chronic Pain Acceptance Questionnaire
Cortisol concentration will be analysed using enzyme-linked immuno-sorbent assay
Perceived stress measured using Perceived Stress Scale
Mental defeat measured by the Pain Self-Perception Scale
Anxiety and depression measured using Hospital Anxiety and Depression Scale
Disability will be measured using the Multidimensional Pain Inventory-SCI
Overall trial start date
Overall trial end date
Participant inclusion criteria
1. Men and women with a spinal cord injury
2. English speaking
3. Experiencing chronic pain
4. Aged 18 years or over
5. Considered by health professionals/ward staff to be well enough to participate
Target number of participants
110 in-patients, 110 out-patients
Participant exclusion criteria
1. A significant head injury or communication disorder that would impair their ability to complete questionnaires
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Department of Psychology
University of Buckingham (UK)
c/o Dr Alan Martin
Head of Psychology
Department of Psychology
University of Buckingham (UK) - Department of Psychology
Funding Body Type
Funding Body Subtype
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