Markers of pain chronicity V1.0
Research type
Research Study
Full title
Markers of pain chronicity: A feasibility study
IRAS ID
297688
Contact name
Christopher Brown
Contact email
Sponsor organisation
University of Liverpool
Duration of Study in the UK
0 years, 5 months, 29 days
Research summary
Summary of Research
Chronic low back pain can significantly reduce quality of life, and sometimes may need to be treated with surgery. However, spinal surgery is an expensive and invasive treatment, which does not always achieve successful outcomes. Research suggests that the likely benefit from surgery depends on a range of individual characteristics. With this project, we plan to gather the evidence needed to design and refine a new battery of assessments for individuals with back pain who would be eligible for spinal surgery. These assessments include questionnaires as well as psychological and physiological tests that in combination are likely to predict how well patients will respond to surgery. Patients with chronic low back pain who are waiting for spine surgery will be recruited through the Walton Centre NHS foundation Trust (Liverpool). They will complete the assessments and an interview during one or two study visits taking place online at home and in person in a research room owned by the Pain Relief Foundation located on Aintree University Hospital campus. In this observational study, we want to find out what patients think and how they feel about our proposed assessments (acceptability) and if it is possible and practical to use them in the clinic (feasibility). We hope that in the future, this assessment battery will help to identify individuals at higher risk of poor outcomes from surgery, and allow to address modifiable risk factors before surgery to improve its outcomes.
Summary of Results
Our long-term aim is to develop a clinical system for predicting outcomes (especially pain relief) from spinal surgery by measuring hypothesised prognostic factors. To this end, in this current study we planned to recruit up to a maximum of 20 patients on the waiting list for spinal surgery to test the acceptability and feasibility of new clinical assessments that we will test (in future studies) as predictors of treatment outcome. Each patient had an opportunity to complete an online (home-based), a lab-based, or both study visits and take part in interviews to assess acceptability and attitudes towards a range of assessment methods. Our objective was to establish the feasibility and patient acceptability of the clinical use of sensory, cognitive, neurophysiological, and questionnaire-based methods.
The study recruited n=8 patients from whom we collected subsets of the above variables prior to their spinal surgery. We sought to recruit a larger number than this but identifying patients to participate proved to be more challenging than expected, largely due to the COVID-19 pandemic and its impact on NHS services. However, 8 patients was deemed sufficient to meet most of our objectives. Publication of the results is unlikely but will act as feasibility data for further research. Much of the data remains to be analysed, however we can report so far that we found:
1. Some patients (n=6) were able and willing to attend a laboratory for detailed sensory and EEG assessments, while others (n=2) elected to participate in online questionnaires and cognitive tasks, ecological momentary assessments (EMA) and accelerometry measurements only. However, some of the patient decisions may have been impacted by the COVID situation during the recruitment period.
2. We elected to use an Enobio wireless EEG-8 system (Neuroelectrics Barcelona SLU) which allows fast and comfortable EEG recording from patient populations. The system was well tolerated by most patients. Analysis of the reliability of the EEG signals from this dataset is ongoing.
3. We implemented a system for ecological momentary assessments (EMA) and accelerometry to assess patient behaviour. The EMA system used the Qualtrics platform which patients could access from their smartphone, allowing reporting of pain and other symptoms multiple times per day. We elected to use the Axivity 3-axis accelerometer also used in the UK Biobank study; this accelerometer data was collected from n=6 of these patients and processed according to standardised protocols. Both EMA and accelerometry methods were found to be feasible, and the study provided data such as adherence rates, and feedback from patients on how to improve the diary system (this data has yet to be written up in full). Patients reported especial benefits of smartphone calendar alerts and the convenience of using their mobile phone.
4. Online neuropsychological testing of working memory performance, using the Gorilla online platform, was found to be feasible in all patients.REC name
North West - Liverpool Central Research Ethics Committee
REC reference
21/NW/0117
Date of REC Opinion
12 Apr 2021
REC opinion
Favourable Opinion