Mind Body Therapy for the Treatment of Chronic Pain

Not Applicable

Completed

• Conditions: Chronic Pain Syndrome; Chronic Pain

• Registration Number: NCT04039139
• Lead Sponsor: Beth Israel Deaconess Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-29
• Study Start: 2019-07-30
• Study First Submitted QC: 2019-07-30
• Study First Posted: 2019-07-31
• Primary Completion: 2020-04-20
• Study Completion: 2020-04-20
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-10
• Last Update Posted: 2023-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain Disability: Roland Morris Disability Index	change over 26 weeks	Change in the Roland Morris Disability Index (Scale 0-24 with 24 being worst)

Secondary Outcome Measures

Name	Time	Method
Pain-related hospital admissions	26 weeks	Self reported. Number of pain-related hospital admissions, including emergency room visits
Pain Bothersomeness: Brief Pain Inventory Survey	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)
Pain affecting enjoyment of life	4 weeks, 8 weeks, 13 weeks, 26 weeks	Scale 0-10 with 10 being worst from Brief Pain Inventory
Average Pain: Brief Pain Inventory Survey	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)
Pain Bothersomeness (Back Specific): Brief Pain Inventory Survey	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)
Anxiety from pain: Pain Anxiety Symptom Scale-20 survey	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'
Complete resolution of pain disability: Roland Morris Disability	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)

Trial Locations

Locations (1)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States