Efficacy Study of Cognitive Behavioural Treatment With Support on Communication and Information Technologies for the Management of Chronic Low Back Pain
POETS
Cognitive Behavioural Treatment With Support on Communication and Information Technologies for the Management of Chronic Low Back Pain: A Randomized Clinical Trial
1 other identifier
interventional
180
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable low-back-pain
Started Apr 2013
Longer than P75 for not_applicable low-back-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 27, 2013
CompletedFirst Posted
Study publicly available on registry
March 1, 2013
CompletedStudy Start
First participant enrolled
April 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedMarch 1, 2013
February 1, 2013
2.5 years
February 27, 2013
February 28, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in Disability: Change in the Roland-Morris Questionnaire
The Roland-Morris Questionnaire is one of the most widely used measures to assess disability in patients with low back pain, and it has shown good psychometrics properties (reliability and validity). The Spanish version of the RM will be completed by the patients. This questionnaire was designed to evaluate low back pain, with 24 statements that describe different daily activities that can be affected by low back pain. The participant has to select those statements that describe the limitations produced by low back pain.
five assessment periods (pre-treatment, post-treatment, and three follow-ups at 3, 6 and 12 months).
Change in Pain measured by Numerical Rating Scale (NRS)
Pain: IMMPACT recommends the use of Numerical Rating Scales (NRS) as a core outcome measure of efficacy in clinical trials of chronic pain treatments. The scale is composed of 11 numbers ranging from 0 to 10 with 0 meaning 'No pain' and '10' meaning 'Pain as bad as you can imagine'. Two different scales will be used, one to assess low back pain and the other one to assess sciatica pain
five assessment periods (pre-treatment, post-treatment, and three follow-ups at 3, 6 and 12 months).
Secondary Outcomes (5)
Change in Pain coping strategies
five assessment periods (pre-treatment, post-treatment, and three follow-ups at 3, 6 and 12 months).
Change in Anxiety and Depression
five assessment periods (pre-treatment, post-treatment, and three follow-ups at 3, 6 and 12 months).
Change in Fear-Avoidance Beliefs
five assessment periods (pre-treatment, post-treatment, and three follow-ups at 3, 6 and 12 months).
Change in Catastrophizing
five assessment periods (pre-treatment, post-treatment, and three follow-ups at 3, 6 and 12 months).
Change in Quality of life assessed by the SF-12 questionnaire
five assessment periods (pre-treatment, post-treatment, and three follow-ups at 3, 6 and 12 months).
Other Outcomes (2)
Satisfaction with the treatment: The Spanish adaptation of Borkovec and Nau questionnaire
12 months
Analysis of the barriers for the use of cognitive behavioral therapy and communication and information technologies in chronic low back pain treatment:
12 months
Study Arms (3)
cognitive behaviour therapy supported by ICT
EXPERIMENTALThe 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.
Rehabilitation treatment and information
ACTIVE COMPARATORPatients will receive the traditional rehabilitation treatment and information
cognitive behavioural therapy (CBT)
EXPERIMENTALPatients will receive the same treatment in physical therapy than the control group and additionally they will receive CBT.
Interventions
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)
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Arnau de Vilanova
Valencia, Valencia, 46015, Spain
Related Publications (1)
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.
PMID: 23607895DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Julio Domenech, Md PhD, Orthopedic Surgery
Hospital Arnau de Vilanova, Valencia
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 27, 2013
First Posted
March 1, 2013
Study Start
April 1, 2013
Primary Completion
October 1, 2015
Study Completion
December 1, 2015
Last Updated
March 1, 2013
Record last verified: 2013-02