Condition category
Injury, Occupational Diseases, Poisoning
Date applied
25/04/2013
Date assigned
03/12/2013
Last edited
15/08/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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?
In-patients are 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 their mouth for a couple of minutes. The saliva sample is analysed to see how much of a substance called cortisol they are producing. Cortisol is produced when people feel stressed. It takes about 35 minutes to answer the questionnaires and provide the saliva sample. Out-patients are asked to complete the same set of questionnaires and provide a saliva sample but only on one occasion. They are given the option of filling in paper questionnaires or of completing them online.

What are the possible benefits and risks of participating?
There may not be any direct benefits from taking part in this study. However, the information obtained will influence the design of a pain management programme, which spinal cord injured patients could benefit from. Taking part in the study will help to improve understanding of the nature of chronic pain experienced by people with a spinal cord injury. Because the questions ask participants to think about how they are feeling there is a chance they may find some of them upsetting. Participants can stop and have a break at any time or they can choose not to answer any questions they don'’t like. Participants can stop taking part in the study at any time without any consequences.

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?
June 2013 to June 2015

Who is funding the study?
The University of Buckingham (UK)

Who is the main contact?
Margaret Tilley
margaret.tilley@buckingham.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Margaret Tilley

ORCID ID

Contact details

Department of Psychology
University of Buckingham
Buckingham
MK18 1EG
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

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

Acronym

Study hypothesis

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

Ethics approval

1. School of Science and Medicine Ethical Approval Committee, University of Buckingham, 15/04/2013
2. Berkshire Research Ethics Committee, 09/10/2013, ref: 13/SC/0457
3. NRES Committee South Central – Oxford C, 09/10/2013, ref: 13/SC/0457
4. Buckinghamshire Healthcare NHS Trust Research and Development Office, 25/02/2014, ref: RXQ584

Study design

Longitudinal design using questionnaires and cortisol sampling with in-patients
Cross-sectional design using questionnaires and cortisol sampling with out-patients

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

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

Condition

Chronic pain in patients with a spinal cord injury

Intervention

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 3, 6 and 12 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

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Pain intensity, measured using the Multidimensional Pain Inventory - Spinal Cord Injury and the Leeds Assessment of Neuropathic Pain at 3, 6 and 12 months following injury for in-patients and on one occasion with out-patients

Secondary outcome measures

Measure at 3, 6 and 12 months after admission to the NSIC:
1. Catastrophising, measured using Pain Catastrophising Scale
2. Appraisals, measured using Appraisals of Disability: Primary and Secondary Scale
3. Pain acceptance, measured using Chronic Pain Acceptance Questionnaire
4. Cortisol concentration, analysed using salivary samples and enzyme-linked immunosorbent assay
5. Perceived stress, measured using Perceived Stress Scale
6. Mental defeat, measured by the Pain Self-Perception Scale
7. Anxiety and depression, measured using Hospital Anxiety and Depression Scale
8. Disability, measured using the Multidimensional Pain Inventory-SCI

Overall trial start date

01/06/2013

Overall trial end date

31/12/2017

Reason abandoned

Eligibility

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

Participant type

Patient

Age group

Adult

Gender

Both

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
2. Illiterate

Recruitment start date

01/05/2014

Recruitment end date

01/01/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

National Spinal Injuries Centre
Stoke Mandeville
HP21 8AL
United Kingdom

Sponsor information

Organisation

University of Buckingham (UK)

Sponsor details

c/o Dr Alan Martin
Head of Psychology
Department of Psychology
Buckingham
MK18 1EG
United Kingdom

Sponsor type

University/education

Website

http://www.buckingham.ac.uk/

Funders

Funder type

University/education

Funder name

University of Buckingham

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal towards the end of 2018.

IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/12/2018

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

15/08/2017: The following changes were made to the trial record: 1. Recruitment dates, publication and dissemination plan, and IPD sharing statement added. 2. The overall trial end date was changed from 30/06/2015 to 31/12/2017.