Effectiveness of a Pain Management Programme

NCT03152604 | Unknown

• 1 other identifier: 177/16
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 2

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 One unpublished Australian study combined PNE with a pain management program and found significant beneficial effects.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

Outcome Measures

Primary Outcomes (1)

• The Brief Pain Inventory (Short Form)

  Change from pre intervention (week 0) to post intervention (week 9)

Secondary Outcomes (27)

• Centre of pressure

  Change from pre intervention (week 0) to post intervention (week 9)

• Fifty-foot walk at fastest speed

  Change from pre intervention (week 0) to post intervention (week 9)

• Repeated sit-to-stand

  Change from pre intervention (week 0) to post intervention (week 9)

• The Pain Catastrophising Scale

  Change from pre intervention (week 0) to post intervention (week 9)

• Neurophysiology of Pain Questionnaire

  Change from pre intervention (week 0) to post intervention (week 9)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with persistent musculoskeletal pain of greater than six months duration who have been referred to the pain management programme at James Cook University Hospital.

You may qualify if:

• Have capacity to give informed consent
• + 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Teesside University: lead
• South Tees Hospitals NHS Foundation Trust: collaborator

Study Sites (2)

Teesside University

Middlesbrough, North Yorkshire, TS1 3BX, United Kingdom

Location

The Pain Clinic, South Tees Hospitals NHS Foundation Trust

Middlesbrough, North Yorkshire, TS4 3BW, United Kingdom

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

Study Record Dates

• First Submitted: May 3, 2017
• First Posted: May 15, 2017
• Study Start: June 28, 2017
• Primary Completion: March 8, 2019
• Study Completion: March 8, 2019
• Last Updated: October 26, 2018

Record last verified: 2018-10

Locations

GB (2)