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NCT Number: NCT04689646

Mind Body Syndrome Therapy for Chronic Pain

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.

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Key information

Conditions

Chronic Pain Chronic Pain Syndrome Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–67 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location status: Recruiting

Location contact

Michael Donnino, MD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mind Body Intervention 1

Behavioral

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

Mind body intervention 2

Behavioral

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

Primary outcomes

  1. Pain Disability

    Time frame: 26 weeks

    Roland Morris Disability Index (Scale 0-24 with 24 being worst)

Secondary outcomes

  1. Average pain

    Time frame: Baseline, 4, 8, 13, and 26 weeks after initiation of the study.

    Average pain as determined in the Brief Pain Inventory Survey (Scale 0-10 with 10 being worst)

  2. Pain Bothersomeness (Back Specific): Brief Pain Inventory Survey

    Time frame: Baseline, 4 weeks, 8 weeks, 13 weeks, 26 weeks

    Back pain bothersomeness as determined from modified Brief Pain Inventory Survey. (Scale 0-10 with 10 being the worst

  3. Anxiety from pain

    Time frame: Baseline, 4 weeks, 8 weeks, 13 weeks, 26 weeks

    Anxiety from pain as determined from the Pain Anxiety Symptom Scale-20 survey (20 questions with scale of 0-5 with 5 being 'always' and 0 being 'never'

  4. Resolution of pain disability

    Time frame: Baseline, 4 weeks, 8 weeks, 13 weeks, 26 weeks

    Resolution of pain disability as measured by 0 or 1 on Roland Morris Disability (Scale 0-24 with 24 being worst)

  5. Pain affecting enjoyment of life

    Time frame: Baseline, 4 weeks, 8 weeks, 13 weeks, 26 weeks

    Scale 0-10 with 10 being worst from Brief Pain Inventory

  6. Resolution of back pain bothersomeness

    Time frame: Baseline, 4 weeks, 8 weeks, 13 weeks, 26 weeks

    Resolution of back pain bothersomeness as measured as 0-1 on scale 0-10

Study contacts

Contact information is provided by the study sponsor or research team.

Michael Donnino, MD

CONTACT

[email protected]

617-754-2885

Samuel Kukler, BA

CONTACT

[email protected]

617-754-2885

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Registry information

Official study title

Mind Body Syndrome Therapy for the Treatment of Chronic Pain

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Dec 30, 2020
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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