Mind Your Pain: Validating a Mindful Interoceptive Exposure Task for Patients With Chronic Low Back Pain (MyP)

December 15, 2023 updated by: University of California, San Francisco

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
31

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94115
        • University of California San Francisco; Osher Center for Integrative Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

patients with chronic low back pain living in the Bay Area

Description

Inclusion Criteria:

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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.

  6. Low level of interoceptive awareness and habitual distraction as coping mechanism with pain. This is defined as:

    1. 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.
    2. 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.
  7. Owning a smart phone: the task is smart phone-based.

Exclusion Criteria:

  1. Unable to provide informed consent.
  2. 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.
  3. 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.
  4. 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.
  5. 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.
  6. 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.
  7. Involved in Worker's Compensation claim.
  8. 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.
  9. Lack of stable housing or plan to move out of the area within the next 6 months.
  10. 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.
  11. Received a steroid or botox injection in or near the spine in the last 3 months. This may alter key study outcomes.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Mindful Interoceptive Exposure
Mindful Interoceptive Exposure Phone-based interoceptive exposure task as attention exercise with chronic low back pain
Behavioral: MyP
see above: attention exercise based on phone app
Other Names:
  • Mind your Pain

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
app usage
Time Frame: daily over 8 weeks
acceptability/feasibility: number of app uses
daily over 8 weeks
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
pre-post 8 weeks
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
past 7 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Quantitative Sensory Testing (QST), pain threshold to thermal stimulus
Time Frame: pre-post 8 weeks
QST measures pain threshold with a heat stimulus in a pain physiology laboratory.
pre-post 8 weeks
resting state functional Magnetic Resonance Imaging (rsfMRI)
Time Frame: pre-post 8 weeks
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.
pre-post 8 weeks
fMRI connectivity
Time Frame: pre-post 8 weeks
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.
pre-post 8 weeks
Multidisciplinary Assessment of Interoceptive Awareness (MAIA)
Time Frame: pre-post 8 weeks
This is an 8-scale instrument, each ranging 0-5, with higher scores indicating higher interoceptive awareness, in order to assess pre-post changes.
pre-post 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, San Francisco

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Wolf E Mehling, MD, University of California, San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 21, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 21, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 21, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 6, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 15, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 29, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 29, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 15, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20-32001
  • U19AR076737 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data Depository all IPD on which the main publication is based on

IPD Sharing Time Frame

May 2024

IPD Sharing Access Criteria

To be determined

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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