Article Text
Abstract
Objective To determine the feasibility of a randomised controlled trial of an internet intervention for low back pain (LBP) using three arms: (1) usual care, (2) usual care plus an internet intervention or (3) usual care plus an internet intervention with additional physiotherapist telephone support.
Design and setting A three-armed randomised controlled feasibility trial conducted in 12 general practices in England.
Participants Primary care patients aged over 18 years, with current LBP, access to the internet and without indicators of serious spinal pathology or systemic illness.
Interventions The ‘SupportBack’ internet intervention delivers a 6-week, tailored programme, focused on graded goal setting, self-monitoring and provision of tailored feedback to encourage physical activity. Additional physiotherapist telephone support consisted of three brief telephone calls over a 4-week period, to address any concerns and provide reassurance.
Outcomes The primary outcomes were the feasibility of the trial design including recruitment, adherence and retention at follow-up. Secondary descriptive and exploratory analyses were conducted on clinical outcomes including LBP-related disability at 3 months follow-up.
Results Primary outcomes: 87 patients with LBP were recruited (target 60–90) over 6 months, and there were 3 withdrawals. Adherence to the intervention was higher in the physiotherapist-supported arm, compared with the stand-alone internet intervention. Trial physiotherapists adhered to the support protocol. Overall follow-up rate on key clinical outcomes at 3 months follow-up was 84%.
Conclusions This study demonstrated the feasibility of a future definitive randomised controlled trial to determine the clinical and cost-effectiveness of the SupportBack intervention in primary care patients with LBP.
Trial registration number ISRCTN31034004; Results.
- low back pain
- internet intervention
- self-management
- primary care
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Footnotes
Contributors LY, AWAG and PL conceived the idea for the study. AWAG, LY, PL, LCR, NEF, EMH and JCH designed the trial and secured funding. RS and AWAG developed the internet intervention with LY and LR, with further input from NEF, JCH, EMH, PL and LL. LY, AG, LCR, JCH, NEF, developed the physiotherapy telephone support package. RS managed the trial on a day-to-day basis with oversight from AG, PL, LCR, LY and input from NEF, JCH, EMH and LL. BS, DT, WM planned and carried out the statistical and health economic analysis. AWAG drafted the manuscript with input from all authors, AWAG is the guarantor for the data.
Funding This article presents independent research funded by the National Institute for Health Research (NIHR) Research for Patient Benefit programme (RfPB PB-PG- 1111-26080). NEF and JCH are funded by an NIHR Research Professorship awarded to NEF (NIHR-RP-011-015) and LR is funded by an HEFCE/NIHR Senior Clinical Lectureship (round 3). NEF, EMH and PL are NIHR Senior Investigators.
Competing interests None declared.
Patient consent Not required.
Ethics approval NHS Ethics Committee REC Reference 13/SC/020.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement The datasets generated during the current study are available from the corresponding author on reasonable request.