Mind Body Syndrome Therapy for Chronic Pain

Not Applicable

Recruiting

• Conditions: Chronic Pain; Chronic Pain Syndrome
• Interventions: Behavioral: Mind Body Intervention 1; Behavioral: Mind body intervention 2

• Registration Number: NCT04689646
• Lead Sponsor: Beth Israel Deaconess Medical Center

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2020-12-27
• Study First Submitted QC: 2020-12-29
• Study First Posted: 2020-12-30
• Study Start: 2021-05-20
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-09
• Last Update Posted: 2024-08-12
• Primary Completion: 2025-12
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mind-Body Intervention 1	Mind Body Intervention 1	Participants will receive a mind body educational based intervention to learn the techniques comprising intervention 1.
Mind-Body Intervention 2	Mind body intervention 2	Participants will receive a mind body educational based intervention to learn the techniques comprising intervention 2.

Primary Outcome Measures

Name	Time	Method
Pain Disability	26 weeks	Roland Morris Disability Index (Scale 0-24 with 24 being worst)

Secondary Outcome Measures

Name	Time	Method
Anxiety from pain	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'
Average pain	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)
Pain Bothersomeness (Back Specific): Brief Pain Inventory Survey	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
Complete resolution of back pain	Baseline, 4 weeks, 8 weeks, 13 weeks, 26 weeks	complete resolution of pain as measured on scale 0-10
Complete resolution of pain disability	Baseline, 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)
Pain bothersomeness: Brief Pain Inventory	Baseline, 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	Baseline, 4 weeks, 8 weeks, 13 weeks, 26 weeks	Scale 0-10 with 10 being worst from Brief Pain Inventory
Self-reported hospital admissions	Baseline, 26 weeks	Self reported. Number of pain-related hospital admissions, including emergency room visits

Trial Locations

Locations (1)

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