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Completed

NCT Number: NCT04039139

Mind Body Therapy for the Treatment of Chronic Pain

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.

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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 and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

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 ≥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.

Treatment and study plan

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

Behavioral

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

Other names: MBST

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: Roland Morris Disability Index

    Time frame: change over 26 weeks

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

Secondary outcomes

  1. Average Pain: Brief Pain Inventory Survey

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

    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: 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. Pain Bothersomeness: Brief Pain Inventory Survey

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

    Whole-body pain bothersomeness as determined from modified Brief Pain Inventory Survey (Scale of 0-10 with 10 being the worst)

  4. Pain affecting enjoyment of life

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

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

  5. Anxiety from pain: Pain Anxiety Symptom Scale-20 survey

    Time frame: 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'

  6. Pain-related hospital admissions

    Time frame: 26 weeks

    Self reported. Number of pain-related hospital admissions, including emergency room visits

  7. Complete resolution of pain disability: Roland Morris Disability

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

    complete resolution of pain disability as measured by Roland Morris Disability (Scale 0-24 with 24 being worst)

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 31, 2019
Registry last updated
Jan 11, 2023

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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