Supporting self-management of low back pain with an internet intervention in primary care: A randomised controlled trial of clinical and cost-effectiveness.
A Phase III randomised control trial investigating self-management of low back pain with an internet intervention in primary care patients with a current episode of low back pain (LBP).
Primary Objective: To determine the clinical effectiveness of the SupportBack intervention on LBP-related physical disability delivered with and without telephone Physiotherapist support in addition to usual care, compared to usual care alone.
Secondary Objective:
Randomised Controlled Trial (RCT)
Open for recruitment
The study aim to recruit 806 primary care patients with a current episode of low back pain (LBP).
This trial is funded by an NIHR Health Technology Assessment (HTA) grant (award reference no. NIHR16/111/78)
Fran Webley
Lorraine Durcan
Alannah Morgan
Clinical Trial Coordinator:
Alannah Morgan
Alex Allen
Email: SupportBack2@soton.ac.uk
Email: ctu@soton.ac.uk
Current Protocol
SupportBack 2 Protocol v8 14-Dec-2020
ISF Documents
SupportBack2-Study Contacts and Information Page (V9)
SupportBack2-Master Patient List (V1)
SupportBack2-Reporting Procedures and Guidance for SAE’s (V1)
SupportBack2-Blank SAE Report Form (V1)
SupportBack2-Summary of SupportBack2 for Practices (V1)
SupportBack2-Overview of Intervention
SupportBack2-Generic iMedidata Contact Sheet (V1)
Regulatory Documents
SupportBack2- IRAS Form (10 August 2018)
SupportBack2- Initial HRA Approval (06 September 2018)
Supportback2- Research Ethics Committee-Initial Favourable Opinion (17 August 2018)
Amendment 1 (Substantial)
SupportBack2- HRA Approval Amendment 1 (05 December 2018)
SupportBack2- Research Ethics Committee Amendment 1 Favourable Opinion (19 November 2018)
Amendment 2 (Substantial)
SupportBack2- HRA Approval Amendment 2 (12 February 2019)
SupportBack2- Research Ethics Committee Amendment 2 Favourable Opinion (11 February 2019)
Amendment 3 (non-Substantial)
SupportBack2- HRA Approval Amendment 3 (22 March 2019)
Amendment 4 (non-Substantial)
SupportBack2- HRA Approval Amendment 4 (29 October 2019)
Amendment 5 (Substantial)
SupportBack2- HRA Approval Amendment 5 (05 Feb 2020).pdf
Site Initiation
SupportBack2 PIC Recruitment Presentation (V5)
Adam W A Geraghty, et al. Supporting self-management of low back pain with an internet intervention in primary care: a protocol for a randomised controlled trial of clinical and cost-effectiveness (SupportBack 2) BMJ Open, vol 10, issue 8, Aug 2020 .