Clinical trial NCT03152604: Effectiveness of a Pain Management Programme
Official title: The Effectiveness of a Pain Management Programme for Patients With Persistent Pain
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Pain
Lead sponsor: Teesside University
Sponsor class: OTHER
Collaborators: name: South Tees Hospitals NHS Foundation Trust
First posted: 2017-05-15
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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 One unpublished Australian study combined PNE with a pain management program and found significant beneficial effects.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


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)

Primary outcomes:
measure: The Brief Pain Inventory (Short Form)
timeFrame: Change from pre intervention (week 0) to post intervention (week 9)
Secondary outcomes:
measure: Centre of pressure
timeFrame: Change from pre intervention (week 0) to post intervention (week 9)
measure: Fifty-foot walk at fastest speed
timeFrame: Change from pre intervention (week 0) to post intervention (week 9)
measure: Repeated sit-to-stand
timeFrame: Change from pre intervention (week 0) to post intervention (week 9)
measure: The Pain Catastrophising Scale
timeFrame: Change from pre intervention (week 0) to post intervention (week 9)
measure: Neurophysiology of Pain Questionnaire
timeFrame: Change from pre intervention (week 0) to post intervention (week 9)
measure: EQ-5D-5L
timeFrame: Change from pre intervention (week 0) to post intervention (week 9)
measure: EQ-VAS
timeFrame: Change from pre intervention (week 0) to post intervention (week 9)
measure: The Tampa Scale of Kinesiophobia
timeFrame: Change from pre intervention (week 0) to post intervention (week 9)
measure: Pain Self-Efficacy Questionnaire
timeFrame: Change from pre intervention (week 0) to post intervention (week 9)
measure: CORE-10
timeFrame: Collected at the start of every session of the 8 session pain management programme which runs over 9 weeks
measure: Stride Length
timeFrame: Change from pre intervention (week 0) to post intervention (week 9)
measure: Step Length
timeFrame: Change from pre intervention (week 0) to post intervention (week 9)
measure: H-H Base of Support or Base Width
timeFrame: Change from pre intervention (week 0) to post intervention (week 9)
measure: Toe In / Toe Out
timeFrame: Change from pre intervention (week 0) to post intervention (week 9)
measure: Step Width
timeFrame: Change from pre intervention (week 0) to post intervention (week 9)
measure: Stride width
timeFrame: Change from pre intervention (week 0) to post intervention (week 9)
measure: Step Time
timeFrame: Change from pre intervention (week 0) to post intervention (week 9)
measure: Stride Time
timeFrame: Change from pre intervention (week 0) to post intervention (week 9)
measure: Single Support
timeFrame: Change from pre intervention (week 0) to post intervention (week 9)
measure: % Single Support
timeFrame: Change from pre intervention (week 0) to post intervention (week 9)
measure: Total Double Support
timeFrame: Change from pre intervention (week 0) to post intervention (week 9)
measure: %Total Double Support
timeFrame: Change from pre intervention (week 0) to post intervention (week 9)
measure: Stance Time
timeFrame: Change from pre intervention (week 0) to post intervention (week 9)
measure: % Stance Time
timeFrame: Change from pre intervention (week 0) to post intervention (week 9)
measure: Swing Time
timeFrame: Change from pre intervention (week 0) to post intervention (week 9)
measure: %Swing Time
timeFrame: Change from pre intervention (week 0) to post intervention (week 9)
measure: Comfortable walking velocity
timeFrame: Change from pre intervention (week 0) to post intervention (week 9)
Other outcomes:
Locations:
city: Middlesbrough
country: United Kingdom
facility: Teesside University
state: North Yorkshire
city: Middlesbrough
country: United Kingdom
facility: The Pain Clinic, South Tees Hospitals NHS Foundation Trust
state: North Yorkshire
Study officials:
References: