Chronic Low-back PainMyPNCT06186193
Mind Your Pain: Validating a Mindful Interoceptive Exposure Task for Patients With Chronic Low Back Pain
An observational study of Chronic Low-back Pain, run by University of California, San Francisco at 1 site in United States.
Trial summary
The usual coping mechanism with chronic pain is distraction, It is unclear whether the opposite, sensory monitoring, can benefit patients with chronic low back pain (cLBP). The study assesses the feasibility and acceptability of a 2-minute phone-based attention exercise, used several times a day over 8 weeks plus a… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Low-back Pain
- What is being tested?
- MyP
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 21 May 2021to 21 Jul 2023
- Phase
- Observational
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with chronic low back pain living in the Bay Area
Who may be able to join
- Chronic low back pain (cLBP) defined according to the NIH Research Task Force recommendation on Research Standards for cLBP: pain at least half the days in the past 6 months, by using 2 questions and a human figure drawing illustrating the region as the space between the lower posterior margin of the rib cage and the horizontal gluteal fold.
- Average pain in the last month at least 3 out of 10 on Numeric Rating Scale [range 0 - 10, for 0 signifying no pain and 10 signifying worst pain imaginable]. This level of pain allows comparability of the study results with the majority of cLBP studies. Pain rated less than 3 is too mild to detect improvement.
- Men and women aged 18-65 years old. We are not enrolling younger children as they are not part of the Intensive Pain Rehabilitation Therapy program. 65 is our upper limit for age due to changes in blood flow on the MRI.
- Eligibility will be assessed using the following questions: "(1) How long has back pain been an ongoing problem for you? and (2) How often has low-back pain been an ongoing problem for you over the past 6 months?" A response of greater than three months to question 1, and a response of "at least half the days in the past 6 months" to question 2 would meet the cLBP eligibility criterion.
- Ability to speak English. We do not have the capacity, given the resources available in this proposal, to translate all course material and conduct groups into another language. We have previously enrolled Hispanic participants into other studies who were fluent in English, and expect to do this in the proposed study.
- Low level of interoceptive awareness and habitual distraction as coping mechanism with pain. This is defined as:
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- MAIA summary score below the population mean score of 3.41. The value of 3.41 is the mean value of a sample of primary care patients at Kaiser Permanente in a prior study.
- the MAIA Non-Distraction score is below 2.91 [possible range 0-5]. The value of 2.91 is the mean value plus standard deviation in the same sample.4 This eligibility criterion was chosen to test the hypothesis that the MIET task will be able to increase interoceptive awareness in patients with chronic low back pain with below average interoceptive awareness and preference for distracting themselves from their pain experience.
- Owning a smart phone: the task is smart phone-based.
Who cannot join
- Unable to provide informed consent.
- A substance abuse, mental health, or medical condition that, in the opinion of investigators, will make it difficult for the potential participant to participate or that may need immediate changes in medical management that will affect study outcome measures. Such conditions may include cancer, liver failure, renal failure, pain conditions from inflammatory diseases (e.g. rheumatoid arthritis, ankylosing spondylitis, lupus), malignancies or abdominal aortic aneurysm, muscle weakness from radiculopathy. Radiculopathy or sciatic pain is NOT excluded as long as the condition is stable and does not lead to significant movement restrictions or <4/5 muscle weakness. Persons with significant substance abuse or mental health conditions that interfere with social functioning may be disruptive. Oher medical or mental health conditions that need immediate changes in management need to be addressed before starting the study so that more reliable baseline measurements can be made. Patients who may need assessment for potentially necessary surgical interventions may not be able to complete the study. Regular opioid prescription is not an exclusion if stabile over the past 3 months.
- Spine related current or history of spine infection, spine tumor, vertebral fracture, cauda equina syndrome. Colorblindness or left handedness. Conditions would increase heterogeneity of the sample.
- Blindness, severe vision problems, deafness, severe hearing problems, bipolar or manic depression and not taking medication, major depression, psychoses (major), a substance abuse condition, dementia, unable to get up and down from the floor. Condition might make it difficult to participate.
- Some other serious medical conditions that may alter key study outcomes, including untreated hypothyroidism, renal failure, and cirrhosis. Conditions that may alter key study outcomes.
- Involvement in a lawsuit related to their back. Complicated medico-legal issues that could lead to individuals having a financial incentive to not report improvement.
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- Involved in Worker's Compensation claim.
- Pregnant, breast-feeding, or planning to get pregnant in the next 12 months or less than 3 months post-partum. Particular back problems than may be associated with pregnancy and delivery may confound study outcomes.
- Lack of stable housing or plan to move out of the area within the next 6 months.
- MRI-related exclusion criteria: Cardiac pacemaker, metal fragments in eyes/skin/body (shrapnel), subjects who have ever been a metal worker/welder; history of eye surgery/eyes washed out because of metal, aortic aneurysm clips, prosthesis, by-pass surgery/coronary artery clips, hearing aid, heart valve replacement, subjects with an I.U.D, a shunt (ventricular or spinal), electrodes, metal plates/ pins/screws/wires, or neuro/bio-stimulators (TENS unit), vision problems uncorrectable with lenses, claustrophobia; inability to lie still on one's back for approximately 60 minutes; prior neurosurgery; older tattoos with metal dyes; unwillingness to remove nose, ear or face jewelry, braces or permanent dental retainers. Iron-containing metal parts in the body can potentially be dislocated by strong magnetic fields and preclude assessment with MRI.
- Received a steroid or botox injection in or near the spine in the last 3 months. This may alter key study outcomes.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco; Osher Center for Integrative Health
San Francisco, California, 94115
About this study
Official title: Mind Your Pain: Validating the Mindful Interoceptive Exposure Task (MIET) for Patients With Chronic Low Back Pain
The usual coping mechanism with chronic pain is distraction, It is unclear whether the opposite, sensory monitoring, can benefit patients with chronic low back pain (cLBP). The study assesses the feasibility and acceptability of a 2-minute phone-based attention exercise, used several times a day over 8 weeks plus a 1-hour introduction, in patients with cLBP. The attention exercise is based on mindfulness-based interoceptive exposure, a task that has been tested before in a mixed pain population in Australia.
Read the detailed description
Mind your Pain (MyP), also known as Mindfulness-based Interoceptive Exposure Therapy (MIET) is an innovative brief mindfulness-based task, developed within the frame of mindfulness-based cognitive therapy, and has been pilot tested in a small cohort of 15 patients with chronic musculoskeletal pain, the majority with cLBP, in Australia. It consists of an individual guided 1-hour introduction session and a 1 to 2-minute attention task subsequently performed several times per day over 12 weeks. The task will be provided by a smart phone app and be sent to participants as phone message reminders at up to 5 times per day: according to participant preference once in the morning and once at bedtime, as well as up to 3 additional times when participants are asked to use the app whenever they perceive the pain at its worst. The task is to focus on the most intense pain sensation in a detached and equanimous way and carefully observe potential changes in five aspects of that sensation: space (region/ borders/ immobile/ moving); sense of mass (heavy/ neutral/ light), temperature (cold/ warm/ hot/ neutral); density (dense/ solid/ loose/ constricted), and borders (diffuse/ sharp). This neutral sensory-descriptive interoceptive attention focus is aiming at preventing the learned aversive response to pain that entails ruminating thoughts, and negative affect rather than immediate sensory awareness. The pilot study in 15 chronic pain patients showed significant beneficial pre-post effects (Cohen's d, ES) of 0.96 for pain anxiety, 0.86 for pain duration and 1.37 for pain intensity, maintained at 2-month follow-up. The investigators offer the MyP-MIET to patients in the US with clearly defined chronic low back pain over 8 weeks, validate it with 30 participants for feasibility and acceptability and exploratory self-report key pain outcomes and objectively (using QST and fMRI), who fit a low interoceptive awareness phenotype. The investigators also use qualitative exit interviews.
- Conditions
- Chronic Low-back Pain
- Being tested
- MyP
- Keywords
- chronic low back pain, interoceptive exposure, attention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyPBehavioural
Also called Mind your Pain
see above: attention exercise based on phone app
| Study group | Role | What they receive |
|---|---|---|
| Mindful Interoceptive Exposure | Mindful Interoceptive Exposure Phone-based interoceptive exposure task as attention exercise with chronic low back pain Receives: Behavioral: MyP |
What is being measured
The primary outcome is the main question the study is designed to answer.
app usage
acceptability/feasibility: number of app uses
Measured: daily over 8 weeks
Pain, Enjoyment of life and General activity scale (PEG)
scale range is 0-30, higher scores are worse outcome. change in PEG scores for combined pain intensity and pain interference
Measured: pre-post 8 weeks
Numeric Rating Scale (NRS) for pain intensity in the past 7 days. Range 0-10, with 10 worst pain.
pain intensity
Measured: past 7 days
Secondary outcomes (4)
Quantitative Sensory Testing (QST), pain threshold to thermal stimulus
QST measures pain threshold with a heat stimulus in a pain physiology laboratory.
Measured: pre-post 8 weeks
resting state functional Magnetic Resonance Imaging (rsfMRI)
rsfMRI assesses the structural integrity of the brain and detects changes in grey cortical thickness in distinct brain areas. Reduced thickness indicates less neural density.
Measured: pre-post 8 weeks
fMRI connectivity
Using a thermal stimulus in the MRI scanner, changes from before to after the intervention in fMRI connectivity between distinct brain areas can be detected.
Measured: pre-post 8 weeks
Multidisciplinary Assessment of Interoceptive Awareness (MAIA)
This is an 8-scale instrument, each ranging 0-5, with higher scores indicating higher interoceptive awareness, in order to assess pre-post changes.
Measured: pre-post 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2023
- Study start21 May 2021
- Primary completion21 Jul 2023
- Study completion21 Jul 2023
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 Chronic Low-back PainStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Sponsor
- Investigators
- Wolf E Mehling, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06186193
- Sponsor's protocol ID
- 20-32001
- Other IDs
- U19AR076737
- Acronym
- MyP
- Status last verified
- Dec 2023
- First submitted
- 6 Dec 2023
- Last updated
- 29 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data Depository all IPD on which the main publication is based on
Publications
Mehling WE, Strigo IA, Goldman V, Hartogensis W, Adler SR, Lotz J, Hecht FM. Mind your pain: A single-arm feasibility study to assess a smartphone-based interoceptive attention training for patients with chronic low back pain. PLoS One. 2024 Oct 24;19(10):e0307690. doi: 10.1371/journal.pone.0307690. eCollection 2024.
PubMed 39446767
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mind Your Pain: Validating the Mindful Interoceptive Exposure Task (MIET) for Patients With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT06186193
- Acronym / sponsor ID
- MyP / 20-32001
- Conditions
- Chronic Low-back Pain
- Keywords
- chronic low back pain, interoceptive exposure, attention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- 21 May 2021 (actual)
- Primary completion
- 21 Jul 2023 (actual)
- Study completion
- 21 Jul 2023 (actual)
- First posted
- 29 Dec 2023 (actual)
- 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 usual coping mechanism with chronic pain is distraction, It is unclear whether the opposite, sensory monitoring, can benefit patients with chronic low back pain (cLBP). The study assesses the feasibility and acceptability of a 2-minute phone-based attention exercise, used several times a day over 8 weeks plus a 1-hour introduction, in patients with cLBP. The attention exercise is based on mindfulness-based interoceptive exposure, a task that has been tested before in a mixed pain population in Australia.
Detailed description
Mind your Pain (MyP), also known as Mindfulness-based Interoceptive Exposure Therapy (MIET) is an innovative brief mindfulness-based task, developed within the frame of mindfulness-based cognitive therapy, and has been pilot tested in a small cohort of 15 patients with chronic musculoskeletal pain, the majority with cLBP, in Australia. It consists of an individual guided 1-hour introduction session and a 1 to 2-minute attention task subsequently performed several times per day over 12 weeks. The task will be provided by a smart phone app and be sent to participants as phone message reminders at up to 5 times per day: according to participant preference once in the morning and once at bedtime, as well as up to 3 additional times when participants are asked to use the app whenever they perceive the pain at its worst. The task is to focus on the most intense pain sensation in a detached and equanimous way and carefully observe potential changes in five aspects of that sensation: space (region/ borders/ immobile/ moving); sense of mass (heavy/ neutral/ light), temperature (cold/ warm/ hot/ neutral); density (dense/ solid/ loose/ constricted), and borders (diffuse/ sharp). This neutral sensory-descriptive interoceptive attention focus is aiming at preventing the learned aversive response to pain that entails ruminating thoughts, and negative affect rather than immediate sensory awareness. The pilot study in 15 chronic pain patients showed significant beneficial pre-post effects (Cohen's d, ES) of 0.96 for pain anxiety, 0.86 for pain duration and 1.37 for pain intensity, maintained at 2-month follow-up. The investigators offer the MyP-MIET to patients in the US with clearly defined chronic low back pain over 8 weeks, validate it with 30 participants for feasibility and acceptability and exploratory self-report key pain outcomes and objectively (using QST and fMRI), who fit a low interoceptive awareness phenotype. The investigators also use qualitative exit interviews.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mindful Interoceptive Exposure | – | Behavioral: MyPMindful Interoceptive Exposure Phone-based interoceptive exposure task as attention exercise with chronic low back pain |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with chronic low back pain living in the Bay Area
Key inclusion criteria (9 listed)
- Chronic low back pain (cLBP) defined according to the NIH Research Task Force recommendation on Research Standards for cLBP: pain at least half the days in the past 6 months, by using 2 questions and a human figure drawing illustrating the region as the space between the lower posterior margin of the rib cage and the horizontal gluteal fold.
- Average pain in the last month at least 3 out of 10 on Numeric Rating Scale [range 0 - 10, for 0 signifying no pain and 10 signifying worst pain imaginable]. This level of pain allows comparability of the study results with the majority of cLBP studies. Pain rated less than 3 is too mild to detect improvement.
- Men and women aged 18-65 years old. We are not enrolling younger children as they are not part of the Intensive Pain Rehabilitation Therapy program. 65 is our upper limit for age due to changes in blood flow on the MRI.
- Eligibility will be assessed using the following questions: "(1) How long has back pain been an ongoing problem for you? and (2) How often has low-back pain been an ongoing problem for you over the past 6 months?" A response of greater than three months to question 1, and a response of "at least half the days in the past 6 months" to question 2 would meet the cLBP eligibility criterion.
- Ability to speak English. We do not have the capacity, given the resources available in this proposal, to translate all course material and conduct groups into another language. We have previously enrolled Hispanic participants into other studies who were fluent in English, and expect to do this in the proposed study.
Key exclusion criteria (11 listed)
- Unable to provide informed consent.
- A substance abuse, mental health, or medical condition that, in the opinion of investigators, will make it difficult for the potential participant to participate or that may need immediate changes in medical management that will affect study outcome measures. Such conditions may include cancer, liver failure, renal failure, pain conditions from inflammatory diseases (e.g. rheumatoid arthritis, ankylosing spondylitis, lupus), malignancies or abdominal aortic aneurysm, muscle weakness from radiculopathy. Radiculopathy or sciatic pain is NOT excluded as long as the condition is stable and does not lead to significant movement restrictions or <4/5 muscle weakness. Persons with significant substance abuse or mental health conditions that interfere with social functioning may be disruptive. Oher medical or mental health conditions that need immediate changes in management need to be addressed before starting the study so that more reliable baseline measurements can be made. Patients who may need assessment for potentially necessary surgical interventions may not be able to complete the study. Regular opioid prescription is not an exclusion if stabile over the past 3 months.
- Spine related current or history of spine infection, spine tumor, vertebral fracture, cauda equina syndrome. Colorblindness or left handedness. Conditions would increase heterogeneity of the sample.
- Blindness, severe vision problems, deafness, severe hearing problems, bipolar or manic depression and not taking medication, major depression, psychoses (major), a substance abuse condition, dementia, unable to get up and down from the floor. Condition might make it difficult to participate.
- Some other serious medical conditions that may alter key study outcomes, including untreated hypothyroidism, renal failure, and cirrhosis. Conditions that may alter key study outcomes.
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 |
|---|---|---|
| MyPAlso: Mind your Painsee above: attention exercise based on phone app | Behavioural | Mindful Interoceptive Exposure |
Primary outcome
app usage
Time frame: daily over 8 weeks
acceptability/feasibility: number of app uses
Pain, Enjoyment of life and General activity scale (PEG)
Time frame: pre-post 8 weeks
scale range is 0-30, higher scores are worse outcome. change in PEG scores for combined pain intensity and pain interference
Numeric Rating Scale (NRS) for pain intensity in the past 7 days. Range 0-10, with 10 worst pain.
Time frame: past 7 days
pain intensity
4 secondary outcomes
Quantitative Sensory Testing (QST), pain threshold to thermal stimulus
Time frame: pre-post 8 weeks
resting state functional Magnetic Resonance Imaging (rsfMRI)
Time frame: pre-post 8 weeks
fMRI connectivity
Time frame: pre-post 8 weeks
Multidisciplinary Assessment of Interoceptive Awareness (MAIA)
Time frame: pre-post 8 weeks
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 29 Dec 2023.
- Derived from this study: PubMed 39446767Mehling WE, Strigo IA, Goldman V, Hartogensis W, Adler SR, Lotz J, Hecht FM. Mind your pain: A single-arm feasibility study to assess a smartphone-based interoceptive attention training for patients with chronic low back pain. PLoS One. 2024 Oct 24;19(10):e0307690. doi: 10.1371/journal.pone.0307690. eCollection 2024.
- Individual participant dataSharing planned: Yes. Data Depository all IPD on which the main publication is based on
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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.
Wolf E Mehling, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Low-back Pain, run by University of California, San Francisco 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 9 inclusion and 11 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 29 Dec 2023. 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?
app usage (time frame: daily over 8 weeks). The study lists 3 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 NCT06186193, 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 29 Dec 2023.