NCT01802671

Efficacy Study of Cognitive Behavioural Treatment With Support on Communication and Information Technologies for the Management of Chronic Low Back Pain

Cognitive Behavioural Treatment With Support on Communication and Information Technologies for the Management of Chronic Low Back Pain: A Randomized Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana · Academic / Other
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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

Conditions

• Low Back Pain

Interventions

Type	Name	Description
OTHER	Rehabilitation treatment and information	Patients will receive the traditional rehabilitation treatment (back school). This treatment will consist of a 4-session group therapy every week, with each session lasting 45 minutes. The content of the first session will be educational (ergonomics, pain demystification) and the other three will include physical therapy focused on stabilisation training: lower extremity stretching; finding the neutral spine position; spine stabiliser activation (transversus abdominis and multifidus); abdominal, spinal extensor and lower extremity strengthening; and proprioceptive control (stabilisation kinesitherapy)
BEHAVIORAL	cognitive behavioural therapy (CBT)	Patients will receive the same treatment in physical therapy than the control group and additionally they will receive CBT. The aim of the CBT intervention is to produce changes in the beliefs and behaviors about physical activity and avoidance of activity. The treatment's components are: * Psychoeducation to counteract the misconceptions about low back pain and to point on the relevance of maintaining an adequate level of activity. * Cognitive restructuring techniques * Behavioural therapy and activity pacing * Training on self-management pain techniques (mindfulness and relaxation). It is a 6-session group therapy, with one session per week. Each group will be composed by 6-8 participants. It will be considered as a patient who receives the treatment when the patient attends to the assessment sessions and to at least 4 out of 6 CBT sessions.
BEHAVIORAL	cognitive behaviour therapy supported by ICT	The patients of this group will receive the same interventions that the CBT group but will receive a reinforcements of the sessions' content through two different ways, both based on ICTs: a web tool named TEO (Emotional Therapy Online) specially designed to practicing the therapeutic strategies at home; and SMS that will send to the patients' mobile phone with reminders and reinforcements. The content of sessions will be related to the therapeutic components including on the CBT. Patients will access TEO from their home using a personal password. Besides TEO, messages will be sent through SMS three times per week during the treatment and once a week during the follow-up. The messages will consist on reminders to do the homework along with reinforcements of the working and effort made to improve their health.

Timeline

• Start date: 2013-04-01
• Primary completion: 2015-10-01
• Completion: 2015-12-01
• First posted: 2013-03-01
• Last updated: 2013-03-01

Locations

1 site across 1 country: Spain