Can a custom mindfulness program ease chronic back pain?
NCT ID NCT04980612
First seen Jul 16, 2026 · Last updated Jul 17, 2026 · Updated 1 time
Summary
This study develops and tests an 8-week mindfulness program called Mindfulness-Based Pain Reduction (MBPR) specifically designed for people with chronic low back pain. About 50 participants will either take the new MBPR program or a standard mindfulness stress reduction course. The goal is to see if the tailored program is feasible and helps reduce pain intensity and interference.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a behavioral intervention: an optimized mindfulness program called Mindfulness-Based Pain Reduction (MBPR)
- What this could lead to
- If successful, this could lead to a more effective, non-drug treatment option for chronic low back pain.
- What could go wrong
- This is an early feasibility study with a small number of participants, so results may not be generalizable. The new program may not prove better than existing mindfulness approaches.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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52 people
The number who actually took part.
- Started
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Dec 2021
- Finished
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May 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 years old and older. The investigators are not enrolling younger children as they are not part of the Intensive Pain Rehabilitation Therapy program. 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. The investiagtors have previously enrolled Hispanic participants into other studies who were fluent in English, and expect to do this in the proposed study. 6. Owning a smart phone 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. 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. 3. Spine related current or history of spine infection, spine tumor, vertebral fracture, cauda equina syndrome. Condition 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of California San Francisco; Osher Center for Intgerative Medicine
San Francisco, California, 94115, United States
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Other studies related to the condition(s) this trial covers.
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