Recruiting

Mind Body Therapy

Sponsor:

Beth Israel Deaconess Medical Center

Code:

NCT04689646

Conditions

Chronic Pain

Chronic Pain Syndrome

Eligibility Criteria

Sex: All

Age: 18 - 67

Healthy Volunteers: Not accepted

Interventions

Mind Body Intervention 1

Mind body intervention 2

Study Details

Brief summary:

The goal of this study is to determine if a mind-body intervention can help people suffering from chronic back pain. The study is a randomized, partially blinded trial examining the effectiveness of a mind body intervention in reducing disability from back pain and alleviating back pain in participants as compared to usual care and an active control (second mind body intervention). The investigators will secondarily investigate whether the intervention alleviates anxiety related to the pain and other quality of life parameters.

Conditions

Chronic Pain

Chronic Pain Syndrome

Study ID

NCT04689646

Start date

May 20, 2021

Status verified date

Mar, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 67

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Mind-Body Intervention 1

Participants will receive a mind body educational based intervention to learn the techniques comprising intervention 1.

active comparator: Mind-Body Intervention 2

Participants will receive a mind body educational based intervention to learn the techniques comprising intervention 2.

no intervention: Usual Care

Participants will continue their usual care for 26 weeks

Interventions

Mind Body Intervention 1

Mind body techniques for Intervention 1 will be taught in lectures and group discussion sessions.

Mind body intervention 2

Mind body techniques for Intervention 2 will be taught in lectures and group and/or individual sessions.

Primary outcome measure

  • Pain Disability [ Time Frame: 26 weeks ]

Central Contacts and Locations

Central contacts

Samuel Kukler, BA

617-754-2885skukler@bidmc.harvard.edu

Michael Donnino, MD

617-754-2885mdonnino@bidmc.harvard.edu

Locations

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

More Information

Sponsor

Beth Israel Deaconess Medical Center

Last update posted

Mar 17, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Beth Israel Deaconess Medical Center on 2026-03-17.