Chronic Low Back PainNCT02133976
Comparative Mechanisms of Psychosocial Chronic Pain Treatments
A study testing cognitive therapy, mindfulness training and behavioral therapy in people with Chronic Low Back Pain, run by Rush University Medical Center at 1 site in United States.
Trial summary
Psychosocial interventions are attractive options for treating chronic low back pain, and many approaches now have strong support for efficacy. However, few empirical data address whether psychosocial pain treatments work because of mechanisms specified by theory, and thus investigators know very little about HOW our… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- cognitive therapy, mindfulness training and behavioral therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 521 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Jul 2019
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- significant daily chronic pain intensity (at least 4 on a 10-point scale; see below) and interference in performing daily activities due to pain (at least 3 on a 6-point scale; see below) for at least 6 months
- musculoskeletal pain of the low back and/or leg pain that may be related to history of degenerative disk disease, spinal stenosis, or disk herniation (radiculopathy subcategory), or muscular or ligamentous strain (chronic myofascial pain subcategory)
- age between 18 and 75 years.
Who cannot join
- meet criteria for alcohol or substance abuse problems
- meet criteria for past or present psychotic or bipolar disorders
- inability to understand English well enough to complete questionnaires or to participate in therapy
- active suicidal ideation with intent
- pain is due to malignant conditions (eg, cancer, rheumatoid arthritis), migraine or tension headache, fibromyalgia or complex regional pain syndrome.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
Official title: Comparative Mechanisms (Mediators, Moderators) of Psychosocial Chronic Pain Treatments
Psychosocial interventions are attractive options for treating chronic low back pain, and many approaches now have strong support for efficacy. However, few empirical data address whether psychosocial pain treatments work because of mechanisms specified by theory, and thus investigators know very little about HOW our treatments work. It may be that different treatments work via distinct pathways that are specific to a given treatment (single effect model), or it may be that different treatments work to the extent they all operate via key mechanisms that they share (additive effects model). Examination of specific and/or shared effects on outcomes of mechanisms will provide theoretical and empirical rationale for enhancing procedures and techniques most closely linked to strong outcomes and incorporating them into future interventions, while limiting the use of others that may be revealed as inert.
- Conditions
- Chronic Low Back Pain
- Being tested
- cognitive therapy, mindfulness training, behavioral therapy, treatment as usual
- Keywords
- chronic low back pain, psychosocial interventions, mechanisms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive therapyBehavioural
mindfulness trainingBehavioural
behavioral therapyBehavioural
treatment as usualOther
| Study group | Role | What they receive |
|---|---|---|
| cognitive therapy | Active comparator | Cognitive therapy will be delivered to decrease pain interference Receives: Behavioral: cognitive therapy; Other: treatment as usual |
| mindfulness training | Active comparator | Mindfulness training will be delivered to decrease pain interference Receives: Behavioral: mindfulness training; Other: treatment as usual |
| behavior therapy | Active comparator | Behavior therapy will be delivered to decrease pain interference Receives: Behavioral: behavioral therapy; Other: treatment as usual |
| treatment as usual | Active comparator | Subjects will engage in their usual care for low back pain. Receives: Other: treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain interference
Pain interference will be assessed with Pain Interference Subscale items of the Multidimensional Pain Inventory
Measured: 12 months
Secondary outcomes (1)
Activity level
Activity level will be assessed with the General Activity subscale items of the Multidimensional Pain Inventory, and via actigraphy.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2014 (estimated)
- Study startJun 2014
- Primary completionSep 2018
- Study completionJul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- 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
- 521 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Duke University, University of Alabama, Tuscaloosa
- Responsible party
- Sponsor
- Investigators
- John W Burns, PhD, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02133976
- Sponsor's protocol ID
- 12101001
- Status last verified
- May 2024
- First submitted
- 5 May 2014
- Last updated
- 21 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Burns JW, Gerhart J, Jensen MP, Thorn B, Carmody J, Keefe F. Relationships among mechanisms in psychosocial treatments for chronic pain: mechanism to mechanism lagged effects and relationships with outcomes. Pain. 2026 Sep 1;167(9):2104-2116. doi: 10.1097/j.pain.0000000000004030. Epub 2026 Jun 8.
PubMed 42615503Gerhart J, Burns JW, Thorn B, Jensen M, Carmody J, Keefe F. Treatment mechanism and outcome decoupling effects in cognitive therapy, mindfulness-based stress reduction, and behavior therapy for chronic pain. Pain. 2025 Feb 1;166(2):408-419. doi: 10.1097/j.pain.0000000000003374. Epub 2024 Aug 30.
PubMed 39226076Burns JW, Jensen MP, Thorn BE, Lillis TA, Carmody J, Gerhart J, Keefe F. Cognitive Therapy, Mindfulness-Based Stress Reduction, and Behavior Therapy for the Treatment of Chronic Pain: Predictors and Moderators of Treatment Response. J Pain. 2024 Jun;25(6):104460. doi: 10.1016/j.jpain.2024.01.003. Epub 2024 Jan 8.
PubMed 38199593Burns JW, Jensen MP, Gerhart J, Thorn BE, Lillis TA, Carmody J, Keefe F. Cognitive therapy, mindfulness-based stress reduction, and behavior therapy for people with chronic low back pain: A comparative mechanisms study. J Consult Clin Psychol. 2023 Mar;91(3):171-187. doi: 10.1037/ccp0000801. Epub 2023 Feb 27.
PubMed 36848061Burns JW, Jensen MP, Thorn B, Lillis TA, Carmody J, Newman AK, Keefe F. Cognitive therapy, mindfulness-based stress reduction, and behavior therapy for the treatment of chronic pain: randomized controlled trial. Pain. 2022 Feb 1;163(2):376-389. doi: 10.1097/j.pain.0000000000002357.
PubMed 34074945
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Mechanisms (Mediators, Moderators) of Psychosocial Chronic Pain Treatments
- ClinicalTrials.gov ID
- NCT02133976
- Acronym / sponsor ID
- 12101001
- Conditions
- Chronic Low Back Pain
- Keywords
- chronic low back pain, psychosocial interventions, mechanisms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 521 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Collaborators
- Duke University, University of Alabama, Tuscaloosa
- Study start
- Jun 2014 (actual)
- Primary completion
- Sep 2018 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 8 May 2014 (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.
Psychosocial interventions are attractive options for treating chronic low back pain, and many approaches now have strong support for efficacy. However, few empirical data address whether psychosocial pain treatments work because of mechanisms specified by theory, and thus investigators know very little about HOW our treatments work. It may be that different treatments work via distinct pathways that are specific to a given treatment (single effect model), or it may be that different treatments work to the extent they all operate via key mechanisms that they share (additive effects model). Examination of specific and/or shared effects on outcomes of mechanisms will provide theoretical and empirical rationale for enhancing procedures and techniques most closely linked to strong outcomes and incorporating them into future interventions, while limiting the use of others that may be revealed as inert.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| cognitive therapy | Active comparator | Behavioral: cognitive therapy, Other: treatment as usualCognitive therapy will be delivered to decrease pain interference |
| mindfulness training | Active comparator | Behavioral: mindfulness training, Other: treatment as usualMindfulness training will be delivered to decrease pain interference |
| behavior therapy | Active comparator | Behavioral: behavioral therapy, Other: treatment as usualBehavior therapy will be delivered to decrease pain interference |
| treatment as usual | Active comparator | Other: treatment as usualSubjects will engage in their usual care for low back pain. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- significant daily chronic pain intensity (at least 4 on a 10-point scale; see below) and interference in performing daily activities due to pain (at least 3 on a 6-point scale; see below) for at least 6 months
- musculoskeletal pain of the low back and/or leg pain that may be related to history of degenerative disk disease, spinal stenosis, or disk herniation (radiculopathy subcategory), or muscular or ligamentous strain (chronic myofascial pain subcategory)
- age between 18 and 75 years.
Key exclusion criteria (5 listed)
- meet criteria for alcohol or substance abuse problems
- meet criteria for past or present psychotic or bipolar disorders
- inability to understand English well enough to complete questionnaires or to participate in therapy
- active suicidal ideation with intent
- pain is due to malignant conditions (eg, cancer, rheumatoid arthritis), migraine or tension headache, fibromyalgia or complex regional pain syndrome.
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 therapy | Behavioural | cognitive therapy |
| mindfulness training | Behavioural | mindfulness training |
| behavioral therapy | Behavioural | behavior therapy |
| treatment as usual | Other | behavior therapy, cognitive therapy, mindfulness training, treatment as usual |
Primary outcome
Pain interference
Time frame: 12 months
Pain interference will be assessed with Pain Interference Subscale items of the Multidimensional Pain Inventory
1 secondary outcome
Activity level
Time frame: 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 21 May 2024.
- Derived from this study: PubMed 42615503Burns JW, Gerhart J, Jensen MP, Thorn B, Carmody J, Keefe F. Relationships among mechanisms in psychosocial treatments for chronic pain: mechanism to mechanism lagged effects and relationships with outcomes. Pain. 2026 Sep 1;167(9):2104-2116. doi: 10.1097/j.pain.0000000000004030. Epub 2026 Jun 8.
- Derived from this study: PubMed 39226076Gerhart J, Burns JW, Thorn B, Jensen M, Carmody J, Keefe F. Treatment mechanism and outcome decoupling effects in cognitive therapy, mindfulness-based stress reduction, and behavior therapy for chronic pain. Pain. 2025 Feb 1;166(2):408-419. doi: 10.1097/j.pain.0000000000003374. Epub 2024 Aug 30.
- Derived from this study: PubMed 38199593Burns JW, Jensen MP, Thorn BE, Lillis TA, Carmody J, Gerhart J, Keefe F. Cognitive Therapy, Mindfulness-Based Stress Reduction, and Behavior Therapy for the Treatment of Chronic Pain: Predictors and Moderators of Treatment Response. J Pain. 2024 Jun;25(6):104460. doi: 10.1016/j.jpain.2024.01.003. Epub 2024 Jan 8.
- Derived from this study: PubMed 36848061Burns JW, Jensen MP, Gerhart J, Thorn BE, Lillis TA, Carmody J, Keefe F. Cognitive therapy, mindfulness-based stress reduction, and behavior therapy for people with chronic low back pain: A comparative mechanisms study. J Consult Clin Psychol. 2023 Mar;91(3):171-187. doi: 10.1037/ccp0000801. Epub 2023 Feb 27.
- Derived from this study: PubMed 34074945Burns JW, Jensen MP, Thorn B, Lillis TA, Carmody J, Newman AK, Keefe F. Cognitive therapy, mindfulness-based stress reduction, and behavior therapy for the treatment of chronic pain: randomized controlled trial. Pain. 2022 Feb 1;163(2):376-389. doi: 10.1097/j.pain.0000000000002357.
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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.
John W Burns, PhD principal investigator
Rush University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cognitive therapy, mindfulness training and behavioral therapy in people with Chronic Low Back Pain, run by Rush University Medical Center at 1 site in United States.
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 5 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 21 May 2024. 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 United States. 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?
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?
Pain interference (time frame: 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 NCT02133976, which also lists 5 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 21 May 2024.