Clinical trial NCT01802671: Efficacy Study of Cognitive Behavioural Treatment With Support on Communication and Information Technologies for the Management of Chronic Low Back Pain
Official title: Cognitive Behavioural Treatment With Support on Communication and Information Technologies for the Management of Chronic Low Back Pain: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain
Keywords: Low back pain
Cognitive behavioural treatment
internet
disability
Lead sponsor: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Sponsor class: OTHER
First posted: 2013-03-01
Enrollment: 180
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Eligibility criteria: Inclusion Criteria:

* age between 20 and 65 years
* suffering low back pain for at least 6 months
* availability of mobile phone in order to get SMS
* access to computer with Internet connection in order to be able to use the CBT program supported by ICT

Exclusion Criteria:

* mental retardation
* not proficient in Spanish
* neurogenic claudication or neurologic deficit
* history of vertebral fracture, previous lumbar surgery
* vertebral infection
* spinal or nerve tumor
* severe mental disorder or substance abuse or dependence.

Primary outcomes:
measure: Change in Disability: Change in the Roland-Morris Questionnaire
timeFrame: five assessment periods (pre-treatment, post-treatment, and three follow-ups at 3, 6 and 12 months).
measure: Change in Pain measured by Numerical Rating Scale (NRS)
timeFrame: five assessment periods (pre-treatment, post-treatment, and three follow-ups at 3, 6 and 12 months).
Secondary outcomes:
measure: Change in Pain coping strategies
timeFrame: five assessment periods (pre-treatment, post-treatment, and three follow-ups at 3, 6 and 12 months).
measure: Change in Anxiety and Depression
timeFrame: five assessment periods (pre-treatment, post-treatment, and three follow-ups at 3, 6 and 12 months).
measure: Change in Fear-Avoidance Beliefs
timeFrame: five assessment periods (pre-treatment, post-treatment, and three follow-ups at 3, 6 and 12 months).
measure: Change in Catastrophizing
timeFrame: five assessment periods (pre-treatment, post-treatment, and three follow-ups at 3, 6 and 12 months).
measure: Change in Quality of life assessed by the SF-12 questionnaire
timeFrame: five assessment periods (pre-treatment, post-treatment, and three follow-ups at 3, 6 and 12 months).
Other outcomes:
measure: Satisfaction with the treatment: The Spanish adaptation of Borkovec and Nau questionnaire
timeFrame: 12 months
measure: Analysis of the barriers for the use of cognitive behavioral therapy and communication and information technologies in chronic low back pain treatment:
timeFrame: 12 months
Locations:
city: Valencia
country: Spain
facility: Hospital Arnau de Vilanova
Study officials:
affiliation: Hospital Arnau de Vilanova, Valencia
name: Julio Domenech, Md PhD, Orthopedic Surgery
role: PRINCIPAL_INVESTIGATOR
References:
citation: Domenech J, Banos R, Penalver L, Garcia-Palacios A, Herrero R, Ezzedine A, Martinez-Diaz M, Ballester J, Horta J, Botella C. Design considerations of a randomized clinical trial on a cognitive behavioural intervention using communication and information technologies for managing chronic low back pain. BMC Musculoskelet Disord. 2013 Apr 22;14:142. doi: 10.1186/1471-2474-14-142.