Effectiveness of a Pain Management Programme

NCT ID: NCT03152604

Last Updated: 2018-10-26

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 8 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-06-28
• Study Completion Date: 2019-03-08

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 One unpublished Australian study combined PNE with a pain management program and found significant beneficial effects.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.

Conditions

Chronic Pain

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Have capacity to give informed consent
• 18+ years of age
• Have had pain that has persisted for greater than six months
• Have been referred to the pain management programme at James Cook University Hospital.

Exclusion Criteria

• Pain arising from a non-musculoskeletal origin such as cancer pain, visceral pain or post stroke pain
• Have worsening neural signs
• Anyone being treated by or who has been treated by the researcher (JW)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

South Tees Hospitals NHS Foundation Trust

OTHER

Sponsor Role: collaborator

Teesside University

OTHER

Sponsor Role: lead

Responsible Party

James Watson

PhD Student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Teesside University

Middlesbrough, North Yorkshire, United Kingdom

The Pain Clinic, South Tees Hospitals NHS Foundation Trust

Middlesbrough, North Yorkshire, United Kingdom

Countries

United Kingdom

Other Identifiers

177/16

Identifier Type: -

Identifier Source: org_study_id