Mind Body Syndrome Therapy for Chronic Pain
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04689646|
Recruitment Status : Recruiting
First Posted : December 30, 2020
Last Update Posted : December 8, 2021
|Condition or disease||Intervention/treatment||Phase|
|Chronic Pain Chronic Pain Syndrome||Behavioral: Mind Body Intervention 1 Behavioral: Mind body intervention 2||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Mind-Body Intervention 1, Mind-Body Intervention 2 and Usual Care|
|Masking:||Double (Participant, Outcomes Assessor)|
|Masking Description:||Double (Participant, Outcomes Assessor) Participants will be partially blinded. Participants in the usual care arm will be blinded to the specifics of the interventions. Participants in Mind-Body Intervention 2 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.|
|Official Title:||Mind Body Syndrome Therapy for the Treatment of Chronic Pain|
|Actual Study Start Date :||May 20, 2021|
|Estimated Primary Completion Date :||November 2023|
|Estimated Study Completion Date :||November 2024|
Experimental: 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.
Active Comparator: 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.
No Intervention: Usual Care
Participants will continue their usual care for 26 weeks
- Pain Disability [ Time Frame: 26 weeks ]Roland Morris Disability Index (Scale 0-24 with 24 being worst)
- Average pain [ Time Frame: 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 [ Time Frame: 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
- Pain bothersomeness: Brief Pain Inventory [ Time Frame: 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)
- Anxiety from pain [ Time Frame: 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'
- Self-reported hospital admissions [ Time Frame: Baseline, 26 weeks ]Self reported. Number of pain-related hospital admissions, including emergency room visits
- Complete resolution of pain disability [ Time Frame: 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 affecting enjoyment of life [ Time Frame: Baseline, 4 weeks, 8 weeks, 13 weeks, 26 weeks ]Scale 0-10 with 10 being worst from Brief Pain Inventory
- Complete resolution of back pain [ Time Frame: Baseline, 4 weeks, 8 weeks, 13 weeks, 26 weeks ]complete resolution of pain as measured on scale 0-10
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04689646
|Contact: Shivani Mehta, BAemail@example.com|
|Contact: Michael Donnino, MDfirstname.lastname@example.org|
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Michael Donnino, MD|
|Principal Investigator:||Michael Donnino, MD||Beth Israel Deaconess Medical Center|