Low Back Pain Clinical Trial
Official title:
Cognitive Behavioural Treatment With Support on Communication and Information Technologies for the Management of Chronic Low Back Pain: A Randomized Clinical Trial
The objective of this study is to investigate the short- and long-term efficacy of a Cognitive Behavioural Treatment program for chronic low back pain supported by information and communication technologies
Background: Psychological treatments have been successful in the treatment of chronic low
back pain (CLBP). However the effect sizes are still modest and there is room for
improvement. A way to progress in this line is enhancing treatment adherence and
self-management by means of information and communication technologies (ICT). The objective
of this study is to investigate the short- and long-term efficacy of a Cognitive Behavioural
Treatment (CBT) group program for CLBP supported versus non-supported by ICTs. A secondary
objective is to evaluate the influence of relevant variables in treatment response. Possible
barriers in the implementation of CBT with and without ICT will be also investigated.
Methods: A randomized controlled trail with 180 CLBP patients recruited in specialized care
will be conducted. Participants will be randomly assigned to three conditions: Control group
(CG), Cognitive Behavioural program (CBT), and CBT supported by ICTs (CBT + ICT).
Participants belonging to the three conditions will receive a conventional rehabilitation
program (back school). The CBT group program will last six sessions. The CBT + ICT will use
the Internet and SMS in order to practice the therapeutic strategies between sessions and in
the follow-ups in their homes. Primary outcome variables are self-reported disability and
pain intensity. Assessment will be carried out by blinded assessors in five moments:
pre-treatment, post-treatment and 3-, 6-, and 12-month follow-up. The influence of
catastrophizing, fear-avoidance beliefs, anxiety and depression in response to treatment in
the primary outcomes will be also analysed.
Discussion This study will show data of the possible benefits of the use of ICTs in the
improvement of CBT for the treatment of CLBP
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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