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The University of Southampton
Southampton Clinical Trials Unit

supportback2

Title

Supporting self-management of low back pain with an internet intervention in primary care: A randomised controlled trial of clinical and cost-effectiveness.

Description

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). 

Objectives

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: 

  1. To determine cost-effectiveness of the SupportBack intervention with and without telephone Physiotherapist support, compared to usual care.
  2. To determine the effect of the interventions on secondary outcomes including pain intensity, risk of persistent disability, fear of movement, catastrophizing, and pain self-efficacy.
  3. To understand the results from the randomised controlled trial (RCT) by conducting a mixed methods process evaluation exploring implementation, mechanisms of action, and context

Trial Design

Randomised Controlled Trial (RCT) 

Trial Status

Open for recruitment

Population

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)

Trial Team:

Senior Trial Manager:

Fran Webley

Trial Managers:

Lorraine Durcan

Alannah Morgan

Clinical Trial Coordinator: 

Alannah Morgan

Clinical Data Coordinator:

Alex Allen

Contact information:

Email:  SupportBack2@soton.ac.uk 

 

SAE Reporting:

Email: ctu@soton.ac.uk

 

 

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.

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