Low Back PainPOETSNCT01802671
Efficacy Study of Cognitive Behavioural Treatment With Support on Communication and Information Technologies for the Management of Chronic Low Back Pain
A study testing Rehabilitation treatment and information, cognitive behavioural therapy (CBT) and cognitive behaviour therapy supported by ICT in people with Low Back Pain, run by Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana at 1 site in Spain.
Trial 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 Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Rehabilitation treatment and information, cognitive behavioural therapy (CBT) and cognitive behaviour therapy supported by ICT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2013to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Spain1 site
Hospital Arnau de Vilanova
Valencia, Valencia, 46015
Julio Domenech, MD PhD, 34 963868500, julio.domenech@uch.ceu.es
Lourdes Peñalver, MD, 34 963868500, lupeba65@gmail.com
About this study
Official title: Cognitive Behavioural Treatment With Support on Communication and Information Technologies for the Management of Chronic Low Back Pain: A Randomized Clinical Trial
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
Read the 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
- Being tested
- Rehabilitation treatment and information, cognitive behavioural therapy (CBT), cognitive behaviour therapy supported by ICT
- Keywords
- Low back pain, Cognitive behavioural treatment, internet, disability
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation treatment and informationOther
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)Behavioural
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 ICTBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| cognitive behaviour therapy supported by ICT | Experimental | 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. Receives: Other: Rehabilitation treatment and information; Behavioral: cognitive behavioural therapy (CBT); Behavioral: cognitive behaviour therapy supported by ICT |
| Rehabilitation treatment and information | Active comparator | Patients will receive the traditional rehabilitation treatment and information Receives: Other: Rehabilitation treatment and information |
| cognitive behavioural therapy (CBT) | Experimental | Patients will receive the same treatment in physical therapy than the control group and additionally they will receive CBT. Receives: Other: Rehabilitation treatment and information; Behavioral: cognitive behavioural therapy (CBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Pain coping strategies: The Coping Strategies Questionnaire (CSQ) assesses the frequency of several cognitive and behavioral strategies to cope with pain. Patients must select in a Likert-type scale how often they use each strategy. It comprises seven subscales, six for cognitive strategies (ignoring pain, reinterpretation of pain, diverting attention, coping self statements, catastrophizing, praying/hoping) and one subscale for behavioural strategies (activity level). This questionnaire has been validated in the Spanish population and has shown good psychometrics properties to the evaluation of patients with chronic musculoskeletal pain.
Measured: five assessment periods (pre-treatment, post-treatment, and three follow-ups at 3, 6 and 12 months).
Change in Anxiety and Depression
Levels of anxiety and depression will be assessed by using the HADS questionnaire (Hospital Anxiety and Depression Score). This questionnaire is widely used in clinical practice. The HADS is a fourteen item scale where seven of the items are related to anxiety and the others seven are related to depression. The Spanish version has shown good internal consistency and external validity, as well as an adequate sensitivity in order to identify clinically significant depression.
Measured: five assessment periods (pre-treatment, post-treatment, and three follow-ups at 3, 6 and 12 months).
Change in Fear-Avoidance Beliefs
The Fear-Avoidance Beliefs Questionnaire (FABQ) will be used to measure this domain. Is a scale composed by sixteen items developed to assess patients' beliefs and attitudes about the causes and consequences of their low back pain. Participants rate their agreement with each statement on a 7- point Likert scale (0 = completely disagree, 6 = completely agree). The FABQ consists of 2 subscales. The first sub-scale is the Physical Activity subscale (FABQpa), is composed by seven items, and assesses the effects of physical activities over pain. The second subscale is the Work subscale (FABQw) composed by four items, and it assesses the way that work activities can affect pain. The Spanish version has shown excellent psychometrics properties.
Measured: five assessment periods (pre-treatment, post-treatment, and three follow-ups at 3, 6 and 12 months).
Change in Catastrophizing
The Pain Catastrophizing Scale (PCS) assesses the tendency to consider pain as a threat with exaggerated negative consequence to the patient. It is a 13-item self-report scale, each item evaluate the pain experience, as an example: "I become afraid that the pain will get worse". Participants assess the frequency that these ideas appears, on a likert-type scale ranging from 0 to 4 being 0 "not at all" and 4 "all the time". The PCS yields a total score and three subscale scores assessing rumination, magnification and helplessness. A high score on the total PCS score indicates a high level of catastrophizing. The Spanish version of PCS has demonstrated adequate psychometrics properties.
Measured: 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
The SF-12 is the brief version of the 36-item Short Form Health Survey (SF-36). The SF-12 contains items that measure each of the eight concepts included in the SF-36, namely physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality (energy/fatigue), social functioning, role limitations due to emotional problems, and mental health (psychological distress and psychological well-being). The SF-12 contains six-point scales were patients evaluated the frequency and intensity of each statement during the past month.
Measured: five assessment periods (pre-treatment, post-treatment, and three follow-ups at 3, 6 and 12 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2013 (estimated)
- Study startApr 2013
- Primary completionOct 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julio Domenech, Md PhD, Orthopedic Surgery, Principal investigator, Hospital Arnau de Vilanova, Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01802671
- Sponsor's protocol ID
- FIS-PI12-02710
- Acronym
- POETS
- Status last verified
- Feb 2013
- First submitted
- 27 Feb 2013
- Last updated
- 1 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23607895
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioural Treatment With Support on Communication and Information Technologies for the Management of Chronic Low Back Pain: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01802671
- Acronym / sponsor ID
- POETS / FIS-PI12-02710
- Conditions
- Low Back Pain
- Keywords
- Low back pain, Cognitive behavioural treatment, internet, disability
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat ValencianaUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 1 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| cognitive behaviour therapy supported by ICT | Experimental | Other: Rehabilitation treatment and information, Behavioral: cognitive behavioural therapy (CBT), Behavioral: cognitive behaviour therapy supported by ICTThe 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 comparator | Other: Rehabilitation treatment and informationPatients will receive the traditional rehabilitation treatment and information |
| cognitive behavioural therapy (CBT) | Experimental | Other: Rehabilitation treatment and information, Behavioral: cognitive behavioural therapy (CBT)Patients will receive the same treatment in physical therapy than the control group and additionally they will receive CBT. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- mental retardation
- not proficient in Spanish
- neurogenic claudication or neurologic deficit
- history of vertebral fracture, previous lumbar surgery
- vertebral infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rehabilitation treatment and informationPatients 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) | Other | Rehabilitation treatment and information, cognitive behaviour therapy supported by ICT, cognitive behavioural therapy (CBT) |
| 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. | Behavioural | cognitive behaviour therapy supported by ICT, cognitive behavioural therapy (CBT) |
| cognitive behaviour therapy supported by ICTThe 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. | Behavioural | cognitive behaviour therapy supported by ICT |
Primary outcome
Change in Disability: Change in the Roland-Morris Questionnaire
Time frame: five assessment periods (pre-treatment, post-treatment, and three follow-ups at 3, 6 and 12 months).
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.
Change in Pain measured by Numerical Rating Scale (NRS)
Time frame: five assessment periods (pre-treatment, post-treatment, and three follow-ups at 3, 6 and 12 months).
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
5 secondary outcomes
Change in Pain coping strategies
Time frame: five assessment periods (pre-treatment, post-treatment, and three follow-ups at 3, 6 and 12 months).
Change in Anxiety and Depression
Time frame: five assessment periods (pre-treatment, post-treatment, and three follow-ups at 3, 6 and 12 months).
Change in Fear-Avoidance Beliefs
Time frame: five assessment periods (pre-treatment, post-treatment, and three follow-ups at 3, 6 and 12 months).
Change in Catastrophizing
Time frame: 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
Time frame: five assessment periods (pre-treatment, post-treatment, and three follow-ups at 3, 6 and 12 months).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2013.
- Derived from this study: PubMed 23607895Domenech 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julio Domenech, Md PhD, Orthopedic Surgery principal investigator
Hospital Arnau de Vilanova, Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation treatment and information, cognitive behavioural therapy (CBT) and cognitive behaviour therapy supported by ICT in people with Low Back Pain, run by Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lourdes Peñalver, MD (34 963868500, lupeba1965@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Disability: Change in the Roland-Morris Questionnaire (time frame: five assessment periods (pre-treatment, post-treatment, and three follow-ups at 3, 6 and 12 months).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01802671, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2013.