Development and Feasibility of Mindfulness Based Pain Reduction

Completed · Not applicable

Conditions studied: Chronic Low-back Pain

In brief

This is a development study with clinical outcomes. The investigators aim to develop and test an 8-week MBPR (Mindfulness-Based Pain Reduction) program, which draws on intervention work and clinical experience in the investigative team to optimize a mindfulness-based intervention for individuals with chronic pain. The overall goal of this study is to ensure that the MBPR program has been carefully refined and manualized in an in-person setting before performing clinical trials comparing MBPR to MBSR (Mindfulness-Based Stress Reduction) to test whether it improves pain outcomes. This study includes a Pain Attention Task that separates insula activation during experimental heat application between different pain attention conditions.

Key facts

Study ID

NCT04980612

Run by

University of California, San Francisco

People needed

52

Starts

2021-12-14

Expected to finish

2025-05-01

Last updated by the study team

2026-07-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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 years old and older. The investigators are not enrolling younger children as they are not part of the Intensive Pain Rehabilitation Therapy program.
• 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. The investiagtors have previously enrolled Hispanic participants into other studies who were fluent in English, and expect to do this in the proposed study.
• Owning a smart phone

You may not qualify if…

• 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. Other 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 stable over the past 3 months.
• Spine related current or history of spine infection, spine tumor, vertebral fracture, cauda equina syndrome. Condition 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.
• 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.

Where it is running

• University of California San Francisco; Osher Center for Intgerative Medicine — San Francisco, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.