Actively Recruiting

Phase Not Applicable
Age: 18Years - 67Years
All Genders
ID04689646

Mind Body Syndrome Therapy for the Treatment of Chronic Pain

Led by Beth Israel Deaconess Medical Center · Updated on 2026-03-17

150

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating whether mind-body interventions can help people with chronic back pain. This randomized, double-blinded trial compares two different mind-body educational programs against usual care to see if they reduce back pain disability and alleviate pain. The study also looks at whether these interventions lessen anxiety related to pain and improve quality of life. Participants are assigned to one of three groups: one group receives mind-body intervention 1 taught through lectures and group discussions, another group receives mind-body intervention 2 taught via lectures and group or individual sessions, and the last group continues with their usual care for 26 weeks. These interventions aim to teach techniques that may help manage pain. During the 26-week study, participants will be assessed at multiple points for pain disability, average pain levels, how bothersome the pain is, anxiety from pain, and the impact of pain on enjoyment of life. Assessments using surveys like the Brief Pain Inventory will be collected at baseline, 4, 8, 13, and 26 weeks. Researchers will monitor these outcomes to understand the effects of the interventions over time.

CONDITIONS

Brief Title

Mind Body Syndrome Therapy for Chronic Pain

Who Can Participate

Age: 18Years - 67Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patient 18 years or older
  • Chronic back pain
  • Pain persistent at least 3 days a week for the past 3 months prior to enrollment
  • Willingness to consider mind-body intervention
  • A score of 2 or more on the Roland Disability Questionnaire
  • A score of 3 or more on back pain bothersomeness
Not Eligible

You will not qualify if you...

  • Patients younger than 18 years
  • Patients older than 67 years
  • Diagnosed organic disease causing pain, such as malignancy, neurologic disorders (e.g., amyotrophic lateral sclerosis), or cauda equina syndrome (pain from disc disease is allowed unless neurological impairments are present)
  • Diagnosis of significant psychiatric conditions such as schizophrenia, dementia, or bipolar disorder

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - 26 weeks

Participants receive mind-body educational interventions through lectures and group or individual sessions to learn techniques aimed at reducing chronic back pain and associated disability. Participants in the control group continue their usual care.

Visits at baseline, 4, 8, 13, and 26 weeks

Trial Site Locations

Total: 1 location

1

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

Actively Recruiting

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Research Team

S

Samuel Kukler, BA

M

Michael Donnino, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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