Mind Body Therapy for the Treatment of Chronic Pain

Chronic Pain Clinical Trial

Official title:

Mind Body Therapy for the Treatment of Chronic Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04039139
• Other study ID #: 2018P000578
• Status: Completed
• Phase: N/A
• Start date: July 30, 2019
• Est. completion date: April 20, 2020

Study information

• Verified date: January 2023
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: April 20, 2020
• Est. primary completion date: April 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain
• Chronic Pain Syndrome

Intervention

Behavioral:
• Mind Body Intervention 1: Mind-Body-Syndrome-Therapy (MBST)
Mind body techniques for Intervention 1 will be taught in lectures and group discussion sessions.
• Mind Body Intervention 2
Mind body techniques for Intervention 2 will be taught in lectures and group and/or individual sessions.

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Disability: Roland Morris Disability Index	Change in the Roland Morris Disability Index (Scale 0-24 with 24 being worst)	change over 26 weeks
Secondary	Average Pain: Brief Pain Inventory Survey	Average pain as determined in the Brief Pain Inventory Survey (Scale 0-10 with 10 being worst)	4 weeks, 8 weeks, 13, weeks, 26 weeks
Secondary	Pain Bothersomeness (Back Specific): Brief Pain Inventory Survey	Back pain bothersomeness as determined from modified Brief Pain Inventory Survey. (Scale 0-10 with 10 being the worst)	4 weeks, 8 weeks, 13 weeks, 26 weeks
Secondary	Pain Bothersomeness: Brief Pain Inventory Survey	Whole-body pain bothersomeness as determined from modified Brief Pain Inventory Survey (Scale of 0-10 with 10 being the worst)	4 weeks, 8 weeks, 13 weeks, 26 weeks
Secondary	Pain affecting enjoyment of life	Scale 0-10 with 10 being worst from Brief Pain Inventory	4 weeks, 8 weeks, 13 weeks, 26 weeks
Secondary	Anxiety from pain: Pain Anxiety Symptom Scale-20 survey	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 weeks, 8 weeks, 13 weeks, 26 weeks
Secondary	Pain-related hospital admissions	Self reported. Number of pain-related hospital admissions, including emergency room visits	26 weeks
Secondary	Complete resolution of pain disability: Roland Morris Disability	complete resolution of pain disability as measured by Roland Morris Disability (Scale 0-24 with 24 being worst)	4 weeks, 8 weeks, 13 weeks, 26 weeks