Mind Body Syndrome Therapy for Chronic Pain

Chronic Pain Clinical Trial

Official title:

Mind Body Syndrome Therapy for the Treatment of Chronic Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04689646
• Other study ID #: 2020P000147
• Status: Recruiting
• Phase: N/A
• Start date: May 20, 2021
• Est. completion date: November 2024

Study information

• Verified date: January 2023
• Source: Beth Israel Deaconess Medical Center
• Contact: Shivani Mehta, BA
• Phone: 617-754-2885
• Email: smehta3[@]bidmc.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: November 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 67 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Chronic Pain Syndrome
• Syndrome

Intervention

Behavioral:
• Mind Body Intervention 1
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 (Scale 0-24 with 24 being worst)	26 weeks
Secondary	Average pain	Average pain as determined in the Brief Pain Inventory Survey (Scale 0-10 with 10 being worst)	Baseline, 4, 8, 13, and 26 weeks after initiation of the study.
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	Baseline, 4 weeks, 8 weeks, 13 weeks, 26 weeks
Secondary	Pain bothersomeness: Brief Pain Inventory	Whole-body pain bothersomeness as determined from modified Brief Pain Inventory Survey (Scale of 0-10 with 10 being the worst)	Baseline, 4 weeks, 8 weeks, 13 weeks, 26 weeks
Secondary	Anxiety from pain	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'	Baseline, 4 weeks, 8 weeks, 13 weeks, 26 weeks
Secondary	Self-reported hospital admissions	Self reported. Number of pain-related hospital admissions, including emergency room visits	Baseline, 26 weeks
Secondary	Complete resolution of pain disability	complete resolution of pain disability as measured by Roland Morris Disability (Scale 0-24 with 24 being worst)	Baseline, 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	Baseline, 4 weeks, 8 weeks, 13 weeks, 26 weeks
Secondary	Complete resolution of back pain	complete resolution of pain as measured on scale 0-10	Baseline, 4 weeks, 8 weeks, 13 weeks, 26 weeks