Mind Body Therapy for the Treatment of Chronic Pain

• Sponsor: Beth Israel Deaconess Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT04039139
• Collaborator: (none)
• Enrollment: 35
• Location: 1
• Arms: 3
• Actual Duration (Months): 8.7
• Patients Per Site Per Month: 4

Study Details

Study Description

Brief Summary

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 interventions (treatment arms) in reducing disability from back pain and alleviating back pain in participants as compared to usual care (control arm ). The investigators will secondarily investigate whether mind body interventions improve participant quality of life and reduce the need for pain-related hospitalization.

Condition or Disease	Intervention/Treatment	Phase
Chronic Pain; Chronic Pain Syndrome	Behavioral: Mind Body Intervention 1; Behavioral: Mind Body Intervention 2	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 35 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Usual Care, InterventionUsual Care, Intervention
• Masking: Double (Participant, Outcomes Assessor)
• Masking Description: Participants will be partially blinded. Participants in the usual care arm will be blinded to the specifics of the interventions. Intervention participants will be blinded to the specifics of the intervention until after they have been randomized into that arm. Data analysis will be conducted by persons who are completely blinded.
• Primary Purpose: Treatment
• Official Title: Mind Body Therapy for the Treatment of Chronic Pain
• Actual Study Start Date: Jul 30, 2019
• Actual Primary Completion Date: Apr 20, 2020
• Actual Study Completion Date: Apr 20, 2020

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Usual Care Participants will continue their usual care for 26 weeks
Active Comparator: Mind Body Intervention 1 Participants will receive a mind body educational-based intervention to learn the techniques comprising intervention 1.	Behavioral: Mind Body Intervention 1; Mind body techniques for Intervention 1 will be taught in lectures and group discussion sessions.
Experimental: Mind Body Intervention 2 Participants will receive a mind-body educational-based intervention to learn the techniques comprising intervention 2.	Behavioral: Mind Body Intervention 2; Mind body techniques for Intervention 2 will be taught in lectures and group and/or individual sessions.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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)

2. 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)

3. 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)

4. Pain affecting enjoyment of life [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 [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 [26 weeks]

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

7. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215

Sponsors and Collaborators

• Beth Israel Deaconess Medical Center

Investigators

• Principal Investigator: Michael Donnino, MD, Beth Israel Deaconess Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Michael Donnino, Associate Professor of Emergency Medicine, Beth Israel Deaconess Medical Center
• ClinicalTrials.gov Identifier: NCT04039139
• Other Study ID Numbers: 2018P000578
• First Posted: Jul 31, 2019
• Last Update Posted: Dec 1, 2020
• Last Verified: Nov 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Chronic Pain

Study Results

No Results Posted as of Dec 1, 2020