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

F

Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

Status

Unknown

Conditions

Low Back Pain

Treatments

Behavioral: cognitive behavioural therapy (CBT)
Behavioral: cognitive behaviour therapy supported by ICT
Other: Rehabilitation treatment and information

Study type

Interventional

Funder types

Other

Identifiers

NCT01802671
FIS-PI12-02710

Details and patient eligibility

About

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

Full 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

Enrollment

180 estimated patients

Sex

All

Ages

20 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

180 participants in 3 patient groups

cognitive behaviour therapy supported by ICT
Experimental group
Description:
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: a web tool named TEO (Emotional Therapy Online) and SMS that will send to the patients' mobile phone with reminders and reinforcements.
Treatment:
Other: Rehabilitation treatment and information
Behavioral: cognitive behaviour therapy supported by ICT
Behavioral: cognitive behavioural therapy (CBT)
Rehabilitation treatment and information
Active Comparator group
Description:
Patients will receive the traditional rehabilitation treatment and information
Treatment:
Other: Rehabilitation treatment and information
cognitive behavioural therapy (CBT)
Experimental group
Description:
Patients will receive the same treatment in physical therapy than the control group and additionally they will receive CBT.
Treatment:
Other: Rehabilitation treatment and information
Behavioral: cognitive behavioural therapy (CBT)

Trial contacts and locations

1

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Central trial contact

Lourdes Peñalver, MD

Data sourced from clinicaltrials.gov

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