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Clinical Trials/NCT03152604
NCT03152604
Unknown
N/A

The Effectiveness of a Pain Management Programme for Patients With Persistent Pain

Teesside University2 sites in 1 country8 target enrollmentJune 28, 2017
ConditionsChronic Pain

Overview

Phase
N/A
Intervention
Not specified
Conditions
Chronic Pain
Sponsor
Teesside University
Enrollment
8
Locations
2
Primary Endpoint
The Brief Pain Inventory (Short Form)
Last Updated
7 years ago

Overview

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 One unpublished Australian study combined PNE with a pain management program and found significant beneficial effects.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

Registry
clinicaltrials.gov
Start Date
June 28, 2017
End Date
March 8, 2019
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

James Watson

PhD Student

Teesside University

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)

Outcomes

Primary Outcomes

The Brief Pain Inventory (Short Form)

Time Frame: Change from pre intervention (week 0) to post intervention (week 9)

Secondary Outcomes

  • 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))
  • EQ-5D-5L(Change from pre intervention (week 0) to post intervention (week 9))
  • EQ-VAS(Change from pre intervention (week 0) to post intervention (week 9))
  • The Tampa Scale of Kinesiophobia(Change from pre intervention (week 0) to post intervention (week 9))
  • Pain Self-Efficacy Questionnaire(Change from pre intervention (week 0) to post intervention (week 9))
  • CORE-10(Collected at the start of every session of the 8 session pain management programme which runs over 9 weeks)
  • Stride Length(Change from pre intervention (week 0) to post intervention (week 9))
  • Step Length(Change from pre intervention (week 0) to post intervention (week 9))
  • H-H Base of Support or Base Width(Change from pre intervention (week 0) to post intervention (week 9))
  • Toe In / Toe Out(Change from pre intervention (week 0) to post intervention (week 9))
  • Step Width(Change from pre intervention (week 0) to post intervention (week 9))
  • Stride width(Change from pre intervention (week 0) to post intervention (week 9))
  • Step Time(Change from pre intervention (week 0) to post intervention (week 9))
  • Stride Time(Change from pre intervention (week 0) to post intervention (week 9))
  • Single Support(Change from pre intervention (week 0) to post intervention (week 9))
  • % Single Support(Change from pre intervention (week 0) to post intervention (week 9))
  • Total Double Support(Change from pre intervention (week 0) to post intervention (week 9))
  • %Total Double Support(Change from pre intervention (week 0) to post intervention (week 9))
  • Stance Time(Change from pre intervention (week 0) to post intervention (week 9))
  • % Stance Time(Change from pre intervention (week 0) to post intervention (week 9))
  • Swing Time(Change from pre intervention (week 0) to post intervention (week 9))
  • %Swing Time(Change from pre intervention (week 0) to post intervention (week 9))
  • Comfortable walking velocity(Change from pre intervention (week 0) to post intervention (week 9))

Study Sites (2)

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