Mind-body therapy for chronic back pain
Mind Body Syndrome Therapy for the Treatment of Chronic Pain
NA · Beth Israel Deaconess Medical Center · NCT04689646
This study is testing a mind-body therapy to see if it can help adults with chronic back pain feel better and improve their daily life compared to regular treatment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 67 Years |
| Sex | All |
| Sponsor | Beth Israel Deaconess Medical Center (other) |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT04689646 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of a mind-body intervention in reducing disability and alleviating chronic back pain in adults. It is a randomized, partially blinded trial comparing the mind-body intervention to usual care and another active mind-body intervention. Additionally, the study will assess the impact of the intervention on anxiety related to pain and overall quality of life. Participants will be monitored for changes in pain levels and disability scores over the course of the trial.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 67 who experience chronic back pain at least three days a week for the past three months.
Not a fit: Patients with significant psychiatric co-morbidities or diagnosed organic diseases causing their pain may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this intervention could provide a non-pharmacological approach to managing chronic back pain and improving patients' quality of life.
How similar studies have performed: Other studies have shown promise with mind-body interventions for chronic pain, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patient 18 ≥ years old * Chronic back pain * Pain persistent for a minimum of 3 days a week for the past three months prior to enrollment * Willingness to consider mind-body intervention * At least score of 2 or more on Roland Disability Questionnaire * At least score of 3 or more back pain bothersomeness Exclusion Criteria: * Patients \< 18 years of age * Patients \> 67 years of age * Diagnosed organic disease as cause of pain, such as (but not limited) to malignancy, neurologic disorder (i.e., amyotrophic lateral sclerosis), cauda equina syndrome (note that pain related to disc disease is not an exclusion unless there are neurological impairments) * Patients with a diagnosis of significant psychiatric co-morbidities such as schizophrenia, dementia, and bipolar disorder
Where this trial is running
Boston, Massachusetts
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (RECRUITING)
Study contacts
- Principal investigator: Michael Donnino, MD — Beth Israel Deaconess Medical Center
- Study coordinator: Samuel Kukler, BA
- Email: skukler@bidmc.harvard.edu
- Phone: 617-754-2885
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Chronic Pain, Chronic Pain Syndrome