A Comparison of Two Self-management Programmes for Patients With Back Pain
A Comparison of Two Different Self-management Programmes for Patients With Back Pain: A Double-blind Randomised Controlled Trial.
1 other identifier
interventional
200
1 country
1
Brief Summary
This investigation is a mixed methods research proposal to answer the question: 'Does Using the Pain Toolkit Improve Outcomes for Patients accessing the North of England Regional Back Pain Pathway?'. The study is part of a 5 year professional doctorate programme at Teesside University. The aim of the study is to test whether with a double blind randomised controlled trial patients accessing the North of England Regional Back Pain Pathway experience reduced Oswestry Disability Index (ODI) when using the pain toolkit compared to a control group of patients offered the standard treatment. The study also contains a nested qualitative element which aims to explore the participants' experiences of using the Pain Toolkit. According to the British Pain Society (2017), chronic pain management is a significant burden to the National Health Service NHS. Back pain alone accounts for a significant disease burden and loss in productivity among working people (Al Mazroa 2013 and TUC 2008). Commissioners must justify their expenditure on health services to the local population and therefore for an area such as pain management where there is significant disease prevalence (WHO 2013) and significant costs, potential service developments should be considered. The development of the pain toolkit (Pain Toolkit 2017a) as a straightforward, easy to use self-management option offers a potentially cost effective support mechanism for patients but as yet there is no evidence to support its use in clinical practice. This study aims to fill that knowledge gap.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 21, 2018
CompletedFirst Posted
Study publicly available on registry
January 2, 2019
CompletedStudy Start
First participant enrolled
January 24, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedMay 7, 2019
May 1, 2019
2.2 years
November 21, 2018
May 5, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
a change in the Oswestry Disability Index
the ODI is a measure of functionality
baseline, 6 months and 1 year
Secondary Outcomes (3)
EQ-5D
baseline, 6 months and 1 year
Questionnaire relating to Healthcare Usage
baseline, 6 months and 1 year
Numerical pain score
baseline, 6 months and 1 year
Study Arms (2)
Pain Toolkit plus the Back Book
EXPERIMENTALParticipants who are being discharged from the regional back pain pathway who are allocated the 'Pain Toolkit' booklet along with the control intervention 'the Back Book'. They follow the interventions in the 'PainToolkit' for 12 months and are followed up 6 months and 1 year.
Back Book
ACTIVE COMPARATORParticipants who are being discharged from the regional back pain pathway who are allocated 'the Back Book'. They are followed up 6 months and 1 year. This is the control group.
Interventions
the Pain Toolkit is a leaflet that encourages self management techniques for patients with chronic pain
The Back Book is a patient information leaflet that offers information and advice about back pain
Eligibility Criteria
You may qualify if:
- : patients with back pain who have been referred to the North of England regional back pain service who consent to take part in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
County Durham and Darlington Nhs Foundation Trust
Durham, DH15TW, United Kingdom
Related Publications (1)
Findley G, Ryan C, Cartwright A, Martin D. Study protocol for an investigation of the effectiveness of the pain toolkit for people with low back pain: double-blind randomised controlled trial. BMJ Open. 2019 Nov 10;9(11):e031266. doi: 10.1136/bmjopen-2019-031266.
PMID: 31712337DERIVED
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- The investigator and the outcome assessor are blinded as to which intervention the participants have been allocated until after data collection and evaluation
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
November 21, 2018
First Posted
January 2, 2019
Study Start
January 24, 2019
Primary Completion
April 1, 2021
Study Completion
December 1, 2021
Last Updated
May 7, 2019
Record last verified: 2019-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- following publication of results
- Access Criteria
- reasonable request to the author
Data relating to the study will be published as a technical appendix to any paper and will be available upon reasonable request once the results have been published