Mind Body Therapy for the Treatment of Chronic Pain

Beth Israel Lahey Health

Status: Completed

Conditions: Chronic Pain Syndrome; Chronic Pain

Treatments: Behavioral: Mind Body Intervention 2; Behavioral: Mind Body Intervention 1: Mind-Body-Syndrome-Therapy (MBST)

Study type: Interventional

Funder types: Other

Identifiers

NCT04039139

2018P000578

Details and patient eligibility

About

Chronic pain syndromes without identified organic etiology remain a challenge for physicians. Many syndromes, including back pain, are believed to have potential underlying psychological etiology; however, the exact link remains elusive. The goal of this study is to determine if mind body therapies can help people suffering from chronic back pain. The study is a randomized, partially blinded trial examining the effectiveness of Mind Body Syndrome Therapy (MBST) in reducing disability from back pain and alleviating back pain. The investigators will secondarily investigate whether MBST can improve participant quality of life and reduce the need for pain-related hospitalization. The design of the this study consists of 3 arms with one being the intervention (MBST), one being usual care, and one being a second mind-body intervention (active control). This education program consists of a series of personal interviews and group and/or individualized lectures/sessions. Participants will also be provided reading material to study during the intervention period, and asked to continue their usual care while going through the MBST program.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patient 18 > years old
• Chronic back pain
• Pain persistent for ≥3 days/week for the past 3 months prior to enrollment
• Willingness to consider mind-body intervention

Exclusion criteria

• Patients < 18 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. 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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35 participants in 3 patient groups

Usual Care

No Intervention group

Description:

Participants will continue their usual care for 26 weeks

Mind Body Intervention 1: Mind-Body-Syndrome-Therapy (MBST)

Experimental group

Description:

Participants will receive a mind body educational-based intervention to learn the techniques comprising intervention 1. Further details are not provided for blinding purposes.

Treatment:

Behavioral: Mind Body Intervention 1: Mind-Body-Syndrome-Therapy (MBST)

Mind Body Intervention 2

Active Comparator group

Description:

Participants will receive a mind-body educational-based intervention to learn the techniques comprising intervention 2. Further details are not provided for blinding purposes.

Treatment:

Behavioral: Mind Body Intervention 2