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Mindfulness in a group setting may ease chronic back pain

NCT ID NCT04129450

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tested whether attending weekly group mindfulness sessions could improve function and reduce pain for people with chronic low back pain. Over 450 adults took part, comparing group mindfulness with usual one-on-one care. The goal was to see if this approach helps people feel better and move more easily.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
group mindfulness-based stress reduction sessions
What this could lead to
If it works, this could offer a non-drug option for managing chronic low back pain in primary care.
What could go wrong
This is a completed pragmatic trial, so results are available. However, mindfulness may not work for everyone, and benefits might be modest or short-lived.

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

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

451 people

The number who actually took part.

Started

May 2021

Finished

Nov 2024

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age ≥ 18 * Chronic low back pain, which is pain that persists for at least 3-months and has resulted in pain on at least half the days in the past 6 months * A score ≥ 3 on the Pain, Enjoyment of Life and General Activity (PEG) * Willing and able to provide online or telephone informed consent * Speak English as the intervention manual is currently written in English Exclusion Criteria: * Do not meet the above inclusion criteria * Red flags- recent (past month) worsening of pain, unexplained fever, unexplained weight loss * Pregnancy * Metastatic cancer * First-degree relatives (parents, siblings, child) of someone who has participated or is participating in the OPTIMUM study * Members of the same household * Not a patient at a participating clinic or persons not planning to continue as a patient at a participating clinic for 12 or more months

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Conditions

The condition(s) this trial relates to.

Back Pain Chronic Pain chronic pain syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Boston Medical Center

    Boston, Massachusetts, 02118, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.