A Study Protocol for an Investigation of the effectiveness of the Pain Toolkit for people with low back pain: a double blind randomised controlled trial

Gillien Findley, Cormac Ryan, Amy Cartwright, Denis Martin

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Abstract

Introduction
The Pain Toolkit is a self-management tool for people with persistent pain. It is available for use worldwide in multiple formats. To date, no studies have investigated the effectiveness of this intervention. This study aims to investigate the effectiveness of the Pain Toolkit in comparison to a simple education control for people with low back pain.
Method and analysis
Participants who have been discharged from the North of England Regional Back Pain pathway will be randomised using sealed consecutively numbered opaque envelopes to receive either the Pain Toolkit and the Back Book (intervention group) or the Back Book only (control group). Both the therapist and the participant will be blind to group allocation. The primary outcome measure will be disability (Oswestry Disability Index (ODI)). Secondary outcome measures will be pain (0-10 numerical scale), healthcare utilisation (number of health care professional visits) and quality-of-life (EuroQol (EQ5D)). Outcome measures will be completed at baseline, 6 months and at 12 months. Data will be analysed using ANCOVA adjusting for baseline values. A change of 10 points in the ODI will be considered a clinically important change. Additionally, a subsample of participants from the intervention group will undergo semi-structured interviews to explore individuals’ experience of the Pain Toolkit. Participants will be asked questions about the ease of use and acceptability of the Pain Toolkit and also for how long they used the Toolkit. The qualitative data will be analysed using thematic analysis.
Ethics and dissemination
Approval for the study was given by the Health Research Authority and the North East Newcastle, North Tyneside 2 Regional Ethics Committee (reference 18/NE/0144) and Teesside University (reference 176/17). Findings will be disseminated through peer reviewed journals and presentation at relevant patient groups, local, national and international conferences. Protocol registration number NCT03791164, registered in December 2018.
Original languageEnglish
Number of pages5
JournalBMJ Open
Volume9
Issue number11
Publication statusPublished - 10 Nov 2019

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Low Back Pain
Randomized Controlled Trials
Pain
Outcome Assessment (Health Care)
Back Pain
Patient Acceptance of Health Care
Ethics Committees
Self Care
Ethics
England
Quality of Life
Interviews
Delivery of Health Care
Education
Control Groups
Health
Research

Cite this

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title = "A Study Protocol for an Investigation of the effectiveness of the Pain Toolkit for people with low back pain:: a double blind randomised controlled trial",
abstract = "IntroductionThe Pain Toolkit is a self-management tool for people with persistent pain. It is available for use worldwide in multiple formats. To date, no studies have investigated the effectiveness of this intervention. This study aims to investigate the effectiveness of the Pain Toolkit in comparison to a simple education control for people with low back pain.Method and analysisParticipants who have been discharged from the North of England Regional Back Pain pathway will be randomised using sealed consecutively numbered opaque envelopes to receive either the Pain Toolkit and the Back Book (intervention group) or the Back Book only (control group). Both the therapist and the participant will be blind to group allocation. The primary outcome measure will be disability (Oswestry Disability Index (ODI)). Secondary outcome measures will be pain (0-10 numerical scale), healthcare utilisation (number of health care professional visits) and quality-of-life (EuroQol (EQ5D)). Outcome measures will be completed at baseline, 6 months and at 12 months. Data will be analysed using ANCOVA adjusting for baseline values. A change of 10 points in the ODI will be considered a clinically important change. Additionally, a subsample of participants from the intervention group will undergo semi-structured interviews to explore individuals’ experience of the Pain Toolkit. Participants will be asked questions about the ease of use and acceptability of the Pain Toolkit and also for how long they used the Toolkit. The qualitative data will be analysed using thematic analysis.Ethics and disseminationApproval for the study was given by the Health Research Authority and the North East Newcastle, North Tyneside 2 Regional Ethics Committee (reference 18/NE/0144) and Teesside University (reference 176/17). Findings will be disseminated through peer reviewed journals and presentation at relevant patient groups, local, national and international conferences. Protocol registration number NCT03791164, registered in December 2018.",
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N2 - IntroductionThe Pain Toolkit is a self-management tool for people with persistent pain. It is available for use worldwide in multiple formats. To date, no studies have investigated the effectiveness of this intervention. This study aims to investigate the effectiveness of the Pain Toolkit in comparison to a simple education control for people with low back pain.Method and analysisParticipants who have been discharged from the North of England Regional Back Pain pathway will be randomised using sealed consecutively numbered opaque envelopes to receive either the Pain Toolkit and the Back Book (intervention group) or the Back Book only (control group). Both the therapist and the participant will be blind to group allocation. The primary outcome measure will be disability (Oswestry Disability Index (ODI)). Secondary outcome measures will be pain (0-10 numerical scale), healthcare utilisation (number of health care professional visits) and quality-of-life (EuroQol (EQ5D)). Outcome measures will be completed at baseline, 6 months and at 12 months. Data will be analysed using ANCOVA adjusting for baseline values. A change of 10 points in the ODI will be considered a clinically important change. Additionally, a subsample of participants from the intervention group will undergo semi-structured interviews to explore individuals’ experience of the Pain Toolkit. Participants will be asked questions about the ease of use and acceptability of the Pain Toolkit and also for how long they used the Toolkit. The qualitative data will be analysed using thematic analysis.Ethics and disseminationApproval for the study was given by the Health Research Authority and the North East Newcastle, North Tyneside 2 Regional Ethics Committee (reference 18/NE/0144) and Teesside University (reference 176/17). Findings will be disseminated through peer reviewed journals and presentation at relevant patient groups, local, national and international conferences. Protocol registration number NCT03791164, registered in December 2018.

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