Chronic Low Back PainPhase 2NCT00360802
Effectiveness of Cognitive Behavioral Treatment and Mindfulness Based Stress Reduction (MBSR) for Chronic Low Back Pain
A Phase 2 study testing Cognitive Behavioral Treatment and Mindfulness Based Stress Reduction in people with Chronic Low Back Pain, run by Kovacs Foundation at 1 site in Spain.
Trial summary
The primary purpose of this study is to determine the effectiveness of two psychological techniques in chronic low back pain patients treated in hospital pain clinics. The techniques are: cognitive behavioral treatment and mindfulness based stress reduction (MBSR). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Cognitive Behavioral Treatment and Mindfulness Based Stress Reduction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 1 siteSpain
- Study dates
- May 2006to May 2009
- Phase
- Phase 2
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic low back pain and failed back surgery patients
- With or without referred or radiated pain
- Who are between 18 and 70 years of age (inclusive)
Who cannot join
- Patients with red flags for systemic disease or criteria for surgery
- With intolerable intensity of pain despite 6 weeks or more of non-surgical treatment
- With pain that appears only on walking and disappears with sitting, persists after 6 months of conservative treatment, and is a possible spinal stenosis
- Under psychological or psychiatric treatment
- Unable to fill out the questionnaires
- Have received cognitive behavioral treatment in the past
- Have ongoing work litigation or are in the process of obtaining permanent disability.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Universidad Autónoma de Barcelona, Dept. Psicología Básica, Evolutiva y de la Educación
Bellaterra, Barcelona, Catalonia, 08193
About this study
Official title: The Effectiveness of Cognitive Behavioral Treatment and Mindfulness Based Stress Reduction for Chronic Low Back Pain Treated in Pain Clinics
The primary purpose of this study is to determine the effectiveness of two psychological techniques in chronic low back pain patients treated in hospital pain clinics. The techniques are: cognitive behavioral treatment and mindfulness based stress reduction (MBSR). This is a multiple site project in which patients come from 16 different pain clinics throughout Spain. The control group is formed by patients under usual medical treatment at pain clinics. The two intervention groups also receive usual medical treatment at pain clinics plus one psychological therapy treatment. The sample size is 330 subjects.
- Conditions
- Chronic Low Back Pain
- Being tested
- Cognitive Behavioral Treatment, Mindfulness Based Stress Reduction
- Keywords
- chronic low back pain, cognitive-behavioral therapy, Mindful Based Stress Reduction, pain clinics, anxiety, quality of life, chronic pain
- Medical subject headings
- Anxiety Disorders, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral TreatmentBehavioural
Behavioral treatment to reduce pain in chronic back pain patients
Mindfulness Based Stress ReductionBehavioural
Behavioral treatment to reduce pain in chronic back pain patients
| Study group | Role | What they receive |
|---|---|---|
| CBT | Active comparator | Cognitive Behavioral Treatment Receives: Behavioral: Cognitive Behavioral Treatment |
| MBSR | Active comparator | Mindfulness Based Stress Reduction Receives: Behavioral: Mindfulness Based Stress Reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of improvement in: anxiety, quality of life
Measured: immediately after therapy, at 3 months, and at 12 months
Secondary outcomes (1)
Degree of improvement in: pain, disability, catastrophizing, depression, anger, analgesic medication, satisfaction with treatment received
Measured: immediately after therapy, at 3 months, and at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2006 (estimated)
- Study startMay 2006
- Primary completionMar 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic 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 2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kovacs Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Spanish Back Pain Research Network (REIDE), Fondo de Investigacion Sanitaria, Universitat Autonoma de Barcelona
- Investigators
- Francisco M. Kovacs, MD, PhD, Study chair, Kovacs Foundation, Palma de Mallorca, 07012, SpainJenny Moix, PhD, Principal investigator, Departamento de Psicología Básica, Universidad Autónoma de Barcelona, Bellaterra, Barcelona 08193, SpainMaría José Martín, Study director, Hospital Mutua de Terrasa, Terrasa 08221, SpainMaría Angeles Pastor, Study director, Hospital General y Universitario de Alicante, Alicante 03010, SpainMaría Isabel Casado, PhD, Study director, Hospital 12 de Octubre, Madrid 28041, SoainCarlos Peña, PhD, Study director, Hospital Universitario Marqués de Valdecilla, Santander 39008, SpainAndrés Martín, BS, Study director, Hospital de Son Llatzer, Palma de Mallorca 07198, SpainGema Rodríguez, Study director, Hospital Severo Ochoa, Leganés, Madrid 28911, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00360802
- Sponsor's protocol ID
- FK-FIS-22
- Status last verified
- May 2009
- First submitted
- 4 Aug 2006
- Last updated
- 28 May 2009
- Results posted
- No
Publications
Deyo RA, Weinstein JN. Low back pain. N Engl J Med. 2001 Feb 1;344(5):363-70. doi: 10.1056/NEJM200102013440508. No abstract available.
PubMed 11172169van Tulder MW, Ostelo R, Vlaeyen JW, Linton SJ, Morley SJ, Assendelft WJ. Behavioral treatment for chronic low back pain: a systematic review within the framework of the Cochrane Back Review Group. Spine (Phila Pa 1976). 2000 Oct 15;25(20):2688-99. doi: 10.1097/00007632-200010150-00024.
PubMed 11034658Basler HD, Jakle C, Kroner-Herwig B. Incorporation of cognitive-behavioral treatment into the medical care of chronic low back patients: a controlled randomized study in German pain treatment centers. Patient Educ Couns. 1997 Jun;31(2):113-24. doi: 10.1016/s0738-3991(97)00996-8.
PubMed 9216352Moix J, Kovacs FM, Martin A, Plana MN, Royuela A; Spanish Back Pain Research Network. Catastrophizing, state anxiety, anger, and depressive symptoms do not correlate with disability when variations of trait anxiety are taken into account. a study of chronic low back pain patients treated in Spanish pain units [NCT00360802]. Pain Med. 2011 Jul;12(7):1008-17. doi: 10.1111/j.1526-4637.2011.01155.x. Epub 2011 Jun 13.
PubMed 21668743
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Cognitive Behavioral Treatment and Mindfulness Based Stress Reduction for Chronic Low Back Pain Treated in Pain Clinics
- ClinicalTrials.gov ID
- NCT00360802
- Acronym / sponsor ID
- FK-FIS-22
- Conditions
- Chronic Low Back Pain
- Keywords
- chronic low back pain, cognitive-behavioral therapy, Mindful Based Stress Reduction, pain clinics, anxiety, quality of life, chronic pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Kovacs FoundationUniversity, hospital or other
- Collaborators
- Spanish Back Pain Research Network (REIDE), Fondo de Investigacion Sanitaria, Universitat Autonoma de Barcelona
- Study start
- May 2006
- Primary completion
- Mar 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 7 Aug 2006 (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 primary purpose of this study is to determine the effectiveness of two psychological techniques in chronic low back pain patients treated in hospital pain clinics. The techniques are: cognitive behavioral treatment and mindfulness based stress reduction (MBSR). This is a multiple site project in which patients come from 16 different pain clinics throughout Spain. The control group is formed by patients under usual medical treatment at pain clinics. The two intervention groups also receive usual medical treatment at pain clinics plus one psychological therapy treatment. The sample size is 330 subjects.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT | Active comparator | Behavioral: Cognitive Behavioral TreatmentCognitive Behavioral Treatment |
| MBSR | Active comparator | Behavioral: Mindfulness Based Stress ReductionMindfulness Based Stress Reduction |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Chronic low back pain and failed back surgery patients
- With or without referred or radiated pain
- Who are between 18 and 70 years of age (inclusive)
Key exclusion criteria (7 listed)
- Patients with red flags for systemic disease or criteria for surgery
- With intolerable intensity of pain despite 6 weeks or more of non-surgical treatment
- With pain that appears only on walking and disappears with sitting, persists after 6 months of conservative treatment, and is a possible spinal stenosis
- Under psychological or psychiatric treatment
- Unable to fill out the questionnaires
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 |
|---|---|---|
| Cognitive Behavioral TreatmentBehavioral treatment to reduce pain in chronic back pain patients | Behavioural | CBT |
| Mindfulness Based Stress ReductionBehavioral treatment to reduce pain in chronic back pain patients | Behavioural | MBSR |
Primary outcome
Degree of improvement in: anxiety, quality of life
Time frame: immediately after therapy, at 3 months, and at 12 months
1 secondary outcome
Degree of improvement in: pain, disability, catastrophizing, depression, anger, analgesic medication, satisfaction with treatment received
Time frame: immediately after therapy, at 3 months, and at 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2009.
- Background: PubMed 11172169Deyo RA, Weinstein JN. Low back pain. N Engl J Med. 2001 Feb 1;344(5):363-70. doi: 10.1056/NEJM200102013440508. No abstract available.
- Background: PubMed 11034658van Tulder MW, Ostelo R, Vlaeyen JW, Linton SJ, Morley SJ, Assendelft WJ. Behavioral treatment for chronic low back pain: a systematic review within the framework of the Cochrane Back Review Group. Spine (Phila Pa 1976). 2000 Oct 15;25(20):2688-99. doi: 10.1097/00007632-200010150-00024.
- Background: PubMed 9216352Basler HD, Jakle C, Kroner-Herwig B. Incorporation of cognitive-behavioral treatment into the medical care of chronic low back patients: a controlled randomized study in German pain treatment centers. Patient Educ Couns. 1997 Jun;31(2):113-24. doi: 10.1016/s0738-3991(97)00996-8.
- Derived from this study: PubMed 21668743Moix J, Kovacs FM, Martin A, Plana MN, Royuela A; Spanish Back Pain Research Network. Catastrophizing, state anxiety, anger, and depressive symptoms do not correlate with disability when variations of trait anxiety are taken into account. a study of chronic low back pain patients treated in Spanish pain units [NCT00360802]. Pain Med. 2011 Jul;12(7):1008-17. doi: 10.1111/j.1526-4637.2011.01155.x. Epub 2011 Jun 13.
- Spanish Back Pain Research Network site that describes objectives and projects of its membersLink provided by the sponsor.
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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.
Francisco M. Kovacs, MD, PhD study chair
Kovacs Foundation, Palma de Mallorca, 07012, Spain
Jenny Moix, PhD principal investigator
Departamento de Psicología Básica, Universidad Autónoma de Barcelona, Bellaterra, Barcelona 08193, Spain
María José Martín study director
Hospital Mutua de Terrasa, Terrasa 08221, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cognitive Behavioral Treatment and Mindfulness Based Stress Reduction in people with Chronic Low Back Pain, run by Kovacs Foundation 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 3 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: finished, as of the sponsor's last update on 28 May 2009. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of improvement in: anxiety, quality of life (time frame: immediately after therapy, at 3 months, and at 12 months). 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 NCT00360802, which also lists 4 linked publications.
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 28 May 2009.