Efficacy Study of Cognitive Behavioural Treatment With Support on Communication and Information Technologies for the Management of Chronic Low Back Pain
NCT ID: NCT01802671
Last Updated: 2013-03-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
180 participants
INTERVENTIONAL
2013-04-30
2015-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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: 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
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)
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.
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.
Rehabilitation treatment and information
Patients will receive the traditional rehabilitation treatment and information
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)
cognitive behavioural therapy (CBT)
Patients will receive the same treatment in physical therapy than the control group and additionally they will receive CBT.
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)
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.
Interventions
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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)
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
20 Years
65 Years
ALL
No
Sponsors
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Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
OTHER
Responsible Party
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Principal Investigators
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Julio Domenech, Md PhD, Orthopedic Surgery
Role: PRINCIPAL_INVESTIGATOR
Hospital Arnau de Vilanova, Valencia
Locations
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Hospital Arnau de Vilanova
Valencia, Valencia, Spain
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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FIS-PI12-02710
Identifier Type: -
Identifier Source: org_study_id
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