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

NCT06186193 | Completed

• 2 other identifiers: 20-32001U19AR076737
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Chronic Low-back Pain

Keywords

chronic low back pain; interoceptive exposure; attention

Outcome Measures

Primary Outcomes (3)

• app usage

  acceptability/feasibility: number of app uses

  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

  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

  past 7 days

Secondary Outcomes (4)

• Quantitative Sensory Testing (QST), pain threshold to thermal stimulus

  pre-post 8 weeks

• resting state functional Magnetic Resonance Imaging (rsfMRI)

  pre-post 8 weeks

• fMRI connectivity

  pre-post 8 weeks

• Multidisciplinary Assessment of Interoceptive Awareness (MAIA)

  pre-post 8 weeks

Study Arms (1)

Mindful Interoceptive Exposure

Mindful Interoceptive Exposure Phone-based interoceptive exposure task as attention exercise with chronic low back pain

Behavioral: MyP

Interventions

MyP BEHAVIORAL

see above: attention exercise based on phone app

Also known as: Mind your Pain

Mindful Interoceptive Exposure

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with chronic low back pain living in the Bay Area

You may qualify if:

• 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:
• 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.

You may not qualify if:

• Unable to provide informed consent.
• 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.
• 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.
• Received a steroid or botox injection in or near the spine in the last 3 months. This may alter key study outcomes.

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

University of California San Francisco; Osher Center for Integrative Health

San Francisco, California, 94115, United States

Location

Related Publications (1)

• 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.

  PMID: 39446767 DERIVED

Study Officials

• Wolf E Mehling, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2023
• First Posted: December 29, 2023
• Study Start: May 21, 2021
• Primary Completion: July 21, 2023
• Study Completion: July 21, 2023
• Last Updated: December 29, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: May 2024
• Access Criteria: To be determined

Locations

US (1)