Chronic PainPhase 1/2NCT00796536
Using Functional MRI to Evaluate Cognitive Behavioral Therapy Treatment Response in Adults With Chronic Pain
A Phase 1/2 study testing Group cognitive behavioral therapy and Pain education in people with Chronic Pain, run by University of Vermont at 1 site in United States.
Trial summary
Chronic pain is a condition in which pain continues for 1 month or more beyond the usual recovery period for an injury or illness or persists for months or years due to a chronic condition. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Group cognitive behavioral therapy and Pain education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Jul 2011
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 6 months of musculoskeletal non-neuropathic pain confined to lumbar or thoracic back
- Meets study threshold for severity of typical pain of 4 or more on a 10-point scale adapted from the McGill Pain Questionnaire
- Has ongoing standard pain management from a physician
- Agrees to participate in this research study
Who cannot join
- Malignancy
- Reflex sympathetic dystrophy and/or naturopathic pain
- Opioid medication use
- Substance use disorder
- Neurological disorder, such as epilepsy, stroke, or other medical condition that could confound or interfere with the current study
- Major depression or/and dysthymia
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- Post traumatic stress disorder or panic disorder
- Left-handedness
- Pregnancy
- History of illicit drug use (cocaine, cannabis, heroin) that can result in altered cognition
- Exceeding the weight limit on the MRI scanner
- Suffering from claustrophobia
- Any of the following: cardiac pacemakers, auto defibrillators, neural stimulators, aneurysm clips, metallic prostheses, cochlear implants, any implanted devices (pumps, infusion devices, stents), permanent eye make-up, intrauterine devices, shrapnel injuries
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using fMRI to Evaluate CBT Treatment Response for Patients With Chronic Pain
Chronic pain is a condition in which pain continues for 1 month or more beyond the usual recovery period for an injury or illness or persists for months or years due to a chronic condition. A commonly used type of psychotherapy called cognitive behavioral therapy (CBT) has been found to be effective in treating people with chronic pain. The purpose of this study is to determine whether and how CBT geared specifically for treating chronic pain can change the way the brain responds to painful emotional and physical stimuli.
Read the detailed description
Many recent studies have suggested that there is an overlap between pain and emotion-related neurophysiological processes. Several modern pain theories also advocate that pain should be considered as a complex sensory and emotional experience, rather than as an isolated sensory event. In accordance with these theories, it is reasonable to expect that an intervention such as CBT, which teaches patients to understand and control both the emotional and sensory aspects of pain, could alter the brain's responses to both pain and emotionally provocative stimuli and, consequently, change the underlying neural circuitry.
To date, there are no published studies that explore the neurobiological effects of psychotherapeutic approaches, such as CBT, on chronic pain. A previous pilot study showed that the exaggerated amygdala response to negative emotional stimuli in chronic pain patients was normalized after 12 weeks of group CBT, suggesting that CBT may affect at least the emotional component of the pain process. Using functional magnetic resonance imaging (fMRI), which creates a three-dimensional picture of the brain, this study will determine the following: (1) whether CBT treatment changes the function of brain neural circuitry in response to acute noxious physical stimuli and to fearful emotional stimuli; and (2) how altered activation in brain areas associated with the attentional, affective, and sensory aspects of chronic pain relate to measurable improvement in someone's clinical response to group CBT. Directly measuring the effects of CBT on brain function could ultimately improve clinical decision making and contribute to the development of individualized treatment for patients with chronic pain.
Participants will be randomly assigned to receive 12 weeks of either CBT or pain education, which will act as an attention control condition. Each CBT session will last for 90 minutes and will teach participants specific skills to better cope with chronic pain. These skills will include breathing exercises, distraction, and relaxation techniques. Each weekly pain education session, also lasting 90 minutes, will be structured as a group discussion and led by a health care counselor. During the session, participants will receive information about the nature of chronic back pain, talk about treatment options, learn exercises and stretching techniques for maintaining strength and flexibility, and learn how to protect their backs. Every participant will undergo two fMRI examinations: one before treatment and one after treatment.
- Conditions
- Chronic Pain
- Being tested
- Group cognitive behavioral therapy, Pain education
- Keywords
- Acute Pain, Low Back Pain, Back Pain, Functional Magnetic Resonance Imaging (fMRI), Cognitive Behavioral Therapy, Pain Education
- Medical subject headings
- Chronic Pain, Acute Pain, Low Back Pain, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group cognitive behavioral therapyBehavioural
Each CBT session will last for 90 minutes and will teach participants specific skills to better cope with chronic pain. These skills will include breathing exercises, distraction, and relaxation techniques.
Pain educationBehavioural
Patients will receive mailed educational materials to their homes on a weekly basis. Weekly materials will contain information about the nature of chronic back pain, treatment options, exercises and stretching techniques for maintaining strength and flexibility, and proper protection for a healthy back. Pain education is the standard of care for most outpatient clinics.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will undergo 12 weeks of group cognitive behavioral therapy (CBT) and a pre- and post-intervention MRI brain scan. Receives: Behavioral: Group cognitive behavioral therapy |
| 2 | Active comparator | Participants will received 12 weeks of pain education and a pre- and post-intervention MRI brain scan. Receives: Behavioral: Pain education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thermal pain threshold, tolerance, perception of acute pain, ability to decrease pain, and brain reactivity
Measured: Measured before and after the 12-week intervention
Secondary outcomes (1)
Acute pain perception and brain activation correlated with improvement in clinical outcomes
Measured: Measured before and after the 12-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2008 (estimated)
- Study startJun 2009
- Primary completionJun 2010
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Principal investigator, Magdalena Naylor, MD, PhD, University of Vermont
- Investigators
- Magdalena R. Naylor, MD, PhD, Principal investigator, MindBody Medicine Clinic, Department of Psychiatry, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00796536
- Sponsor's protocol ID
- R21AR055716
- Other IDs
- R21AR055716
- Status last verified
- Feb 2013
- First submitted
- 21 Nov 2008
- Last updated
- 18 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using fMRI to Evaluate CBT Treatment Response for Patients With Chronic Pain
- ClinicalTrials.gov ID
- NCT00796536
- Acronym / sponsor ID
- R21AR055716
- Conditions
- Chronic Pain
- Keywords
- Acute Pain, Low Back Pain, Back Pain, Functional Magnetic Resonance Imaging (fMRI), Cognitive Behavioral Therapy, Pain Education
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- Jun 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 24 Nov 2008 (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.
Chronic pain is a condition in which pain continues for 1 month or more beyond the usual recovery period for an injury or illness or persists for months or years due to a chronic condition. A commonly used type of psychotherapy called cognitive behavioral therapy (CBT) has been found to be effective in treating people with chronic pain. The purpose of this study is to determine whether and how CBT geared specifically for treating chronic pain can change the way the brain responds to painful emotional and physical stimuli.
Detailed description
Many recent studies have suggested that there is an overlap between pain and emotion-related neurophysiological processes. Several modern pain theories also advocate that pain should be considered as a complex sensory and emotional experience, rather than as an isolated sensory event. In accordance with these theories, it is reasonable to expect that an intervention such as CBT, which teaches patients to understand and control both the emotional and sensory aspects of pain, could alter the brain's responses to both pain and emotionally provocative stimuli and, consequently, change the underlying neural circuitry.
To date, there are no published studies that explore the neurobiological effects of psychotherapeutic approaches, such as CBT, on chronic pain. A previous pilot study showed that the exaggerated amygdala response to negative emotional stimuli in chronic pain patients was normalized after 12 weeks of group CBT, suggesting that CBT may affect at least the emotional component of the pain process. Using functional magnetic resonance imaging (fMRI), which creates a three-dimensional picture of the brain, this study will determine the following: (1) whether CBT treatment changes the function of brain neural circuitry in response to acute noxious physical stimuli and to fearful emotional stimuli; and (2) how altered activation in brain areas associated with the attentional, affective, and sensory aspects of chronic pain relate to measurable improvement in someone's clinical response to group CBT. Directly measuring the effects of CBT on brain function could ultimately improve clinical decision making and contribute to the development of individualized treatment for patients with chronic pain.
Participants will be randomly assigned to receive 12 weeks of either CBT or pain education, which will act as an attention control condition. Each CBT session will last for 90 minutes and will teach participants specific skills to better cope with chronic pain. These skills will include breathing exercises, distraction, and relaxation techniques. Each weekly pain education session, also lasting 90 minutes, will be structured as a group discussion and led by a health care counselor. During the session, participants will receive information about the nature of chronic back pain, talk about treatment options, learn exercises and stretching techniques for maintaining strength and flexibility, and learn how to protect their backs. Every participant will undergo two fMRI examinations: one before treatment and one after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Group cognitive behavioral therapyParticipants will undergo 12 weeks of group cognitive behavioral therapy (CBT) and a pre- and post-intervention MRI brain scan. |
| 2 | Active comparator | Behavioral: Pain educationParticipants will received 12 weeks of pain education and a pre- and post-intervention MRI brain scan. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- At least 6 months of musculoskeletal non-neuropathic pain confined to lumbar or thoracic back
- Meets study threshold for severity of typical pain of 4 or more on a 10-point scale adapted from the McGill Pain Questionnaire
- Has ongoing standard pain management from a physician
- Agrees to participate in this research study
Key exclusion criteria (13 listed)
- Malignancy
- Reflex sympathetic dystrophy and/or naturopathic pain
- Opioid medication use
- Substance use disorder
- Neurological disorder, such as epilepsy, stroke, or other medical condition that could confound or interfere with the current study
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 |
|---|---|---|
| Group cognitive behavioral therapyEach CBT session will last for 90 minutes and will teach participants specific skills to better cope with chronic pain. These skills will include breathing exercises, distraction, and relaxation techniques. | Behavioural | 1 |
| Pain educationPatients will receive mailed educational materials to their homes on a weekly basis. Weekly materials will contain information about the nature of chronic back pain, treatment options, exercises and stretching techniques for maintaining strength and flexibility, and proper protection for a healthy back. Pain education is the standard of care for most outpatient clinics. | Behavioural | 2 |
Primary outcome
Thermal pain threshold, tolerance, perception of acute pain, ability to decrease pain, and brain reactivity
Time frame: Measured before and after the 12-week intervention
1 secondary outcome
Acute pain perception and brain activation correlated with improvement in clinical outcomes
Time frame: Measured before and after the 12-week intervention
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 18 Feb 2013.
- Click here for more information about this studyLink 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.
Magdalena R. Naylor, MD, PhD principal investigator
MindBody Medicine Clinic, Department of Psychiatry, University of Vermont
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Group cognitive behavioral therapy and Pain education in people with Chronic Pain, run by University of Vermont 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 4 inclusion and 13 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 18 Feb 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 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Thermal pain threshold, tolerance, perception of acute pain, ability to decrease pain, and brain reactivity (time frame: Measured before and after the 12-week intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Feb 2013.