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Mind Body Syndrome Therapy for Chronic Pain

Beth Israel Lahey Health logo

Beth Israel Lahey Health

Status

Enrolling

Conditions

Chronic Pain Syndrome
Chronic Pain

Treatments

Behavioral: Mind Body Intervention 1
Behavioral: Mind body intervention 2

Study type

Interventional

Funder types

Other

Identifiers

NCT04689646
2020P000147

Details and patient eligibility

About

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.

Full description

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 (control arm) and an active control arm. The investigators will secondarily investigate whether the intervention alleviates anxiety related to the pain and other quality of life parameters.

Enrollment

150 estimated patients

Sex

All

Ages

18 to 67 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

150 participants in 3 patient groups

Mind-Body Intervention 1
Experimental group
Description:
Participants will receive a mind body educational based intervention to learn the techniques comprising intervention 1.
Treatment:
Behavioral: Mind Body Intervention 1
Mind-Body Intervention 2
Active Comparator group
Description:
Participants will receive a mind body educational based intervention to learn the techniques comprising intervention 2.
Treatment:
Behavioral: Mind body intervention 2
Usual Care
No Intervention group
Description:
Participants will continue their usual care for 26 weeks

Trial contacts and locations

1

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Central trial contact

Michael Donnino, MD; Samuel Kukler, BA

Data sourced from clinicaltrials.gov

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