Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2025-12-25 @ 7:06 PM
Study NCT ID:
NCT03152604
Status:
UNKNOWN
Last Update Posted:
2018-10-26
First Post:
2017-05-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of a Pain Management Programme
Sponsor:
Teesside University
Organization:
Study Overview
Official Title:
The Effectiveness of a Pain Management Programme for Patients With Persistent Pain
Status:
UNKNOWN
Status Verified Date:
2018-10
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Persistent pain (PP) affects many people worldwide. Patient Education is central to good management. Pain neurophysiology education (PNE) is a new form of education. It aims to help patients 'reconceptualise' their understanding of pain away from the perception that PP is an indicator of tissue damage, to PP is due to a sensitised nervous system. This perception is considered a less threatening and more conducive to rehabilitation. There is a growing body of evidence supporting its effectiveness. One unpublished Australian study combined PNE with a pain management program and found significant beneficial effects. However, there is a need to test this intervention rigorously under randomised controlled trial conditions to inform clinical practice. The Medical Research Council state that during the development and evaluation of a complex intervention (in this case a PNE informed PMP), it is important to undertake feasibility work, to investigate the components of randomised controlled trial (RCT) methodology prior to a full scale trial. The overarching aim of this mixed-methods study is to develop a feasible research protocol for a RCT investigating the efficacy of a pain neurophysiology education informed pain management programme. In this feasibility study, participants with PP will be assessed before and after a PNE informed pain management program that they are due to receive as part of their usual care. In the week before the programme participants will attend Teesside University (TU) where they will complete a battery of outcome measures. A subsample of participants will also undergo a semi-structured interview. In the week following completion of their usual care PMP participants will once again attend TU where they will complete the same outcome measures and the same subsample of participants will undergo a second semi-structured interview. At this point participants will have completed the study.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: