Collecting COMPACT data for CRPS clinical studies 1.0
Research type
Research Study
Full title
A multi-centre study to explore the feasibility and acceptability of collecting data for Complex Regional Pain Syndrome clinical studies using a core measurement set.
IRAS ID
242650
Contact name
Candy McCabe
Contact email
Sponsor organisation
Royal United Hospitals Bath NHS Foundation Trust, Bath, UK
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
This is a multi-centre international study to test how practical it is to collect research data from patients with Complex Regional Pain Syndrome (CRPS), using a core set of questionnaires (COMPACT©). COMPACT is the acronym for Core Outcome Measurement set for complex regional PAin syndrome Clinical sTudies. We also wish to test an electronic data capture system (ALEA) which will be used to collect and manage the COMPACT data.
CRPS is a persistent pain condition that remains incompletely understood and challenging to treat. Currently, it is difficult to bring research findings from many different studies together because researchers may not always use the same questionnaires. We therefore have limited evidence on the causes, course and optimum management of CRPS. In our previous work, an international group of patients, clinicians, researchers and industry representatives agreed a minimum set of questionnaires (COMPACT) for use in future CRPS clinical studies in adults. It is the process of data collection, via these questionnaires, that we will test.
Eight international sites will recruit adults with CRPS at any point in their treatment pathway. Patients will be asked to complete the set of COMPACT questionnaires on two occasions; (1) on paper at baseline and (2) on paper, or using an online version, at six months. Patients will be invited to a focus group in their local area, to give us feedback on their experience of completing COMPACT. Clinicians will use an electronic questionnaire to feedback their experience of data collection.
The results of this study will inform the final version of COMPACT and the data collection process, which we will recommend for use in future CRPS studies. Using COMPACT in the future will make it easier to compare data across studies. This has long term importance for the advancement of our understanding and treatment of CRPS.
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
18/SC/0322
Date of REC Opinion
24 Aug 2018
REC opinion
Further Information Favourable Opinion