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Mind Body Therapy for Chronic Pain
N/A
Recruiting
Led By Michael Donnino, MD
Research Sponsored by Beth Israel Deaconess Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adult patient 18 ≥ years old
Chronic back pain
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 4 weeks, 8 weeks, 13 weeks, 26 weeks
Awards & highlights
Summary
This trial is studying if a mind-body intervention can help people with chronic back pain by reducing disability and pain, and improving quality of life.
Who is the study for?
This trial is for adults over 18 with chronic back pain, who are open to mind-body interventions. They should have moderate disability and pain intensity from their condition, experiencing pain at least three days a week for the past three months. People with severe psychiatric conditions or organic diseases causing the pain are not eligible.
What is being tested?
The study tests two different mind-body interventions against usual care to see if they reduce disability and alleviate chronic back pain. It also looks at whether these methods can lessen anxiety related to the pain and improve overall quality of life.
What are the potential side effects?
Mind-body interventions typically have minimal side effects but may include temporary discomfort, emotional distress, or an increase in awareness of existing symptoms during initial practice.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I have long-term back pain.
Select...
I have had pain for at least 3 days a week for the last 3 months.
Select...
I am open to trying mind-body therapies.
Select...
My back pain affects my daily activities.
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My back pain is bothersome and scores 3 or more.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 4 weeks, 8 weeks, 13 weeks, 26 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 4 weeks, 8 weeks, 13 weeks, 26 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Pain Disability
Secondary study objectives
Anxiety from pain
Average pain
Complete resolution of back pain
+5 moreTrial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Mind-Body Intervention 1Experimental Treatment1 Intervention
Participants will receive a mind body educational based intervention to learn the techniques comprising intervention 1.
Group II: Mind-Body Intervention 2Active Control1 Intervention
Participants will receive a mind body educational based intervention to learn the techniques comprising intervention 2.
Group III: Usual CareActive Control1 Intervention
Participants will continue their usual care for 26 weeks
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Who is running the clinical trial?
Beth Israel Deaconess Medical CenterLead Sponsor
848 Previous Clinical Trials
12,929,954 Total Patients Enrolled
6 Trials studying Chronic Pain
616 Patients Enrolled for Chronic Pain
Michael Donnino, MDPrincipal InvestigatorBeth Israel Deaconess Medical Center
6 Previous Clinical Trials
462 Total Patients Enrolled
1 Trials studying Chronic Pain
35 Patients Enrolled for Chronic Pain
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.My pain is due to a diagnosed disease like cancer or ALS, not just disc disease.You have been diagnosed with serious mental health conditions such as schizophrenia, dementia, or bipolar disorder.I am open to trying mind-body therapies.I have long-term back pain.My back pain affects my daily activities.I have had pain for at least 3 days a week for the last 3 months.My back pain is bothersome and scores 3 or more.
Research Study Groups:
This trial has the following groups:- Group 1: Mind-Body Intervention 1
- Group 2: Mind-Body Intervention 2
- Group 3: Usual Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Chronic Pain Patient Testimony for trial: Trial Name: NCT04689646 — N/A
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