Mind Body Syndrome Therapy for Chronic Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-67
SponsorBeth Israel Deaconess Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Mind Body Intervention 1
BehavioralMind body techniques for Intervention 1 will be taught in lectures and group discussion sessions.
Mind body intervention 2
BehavioralMind body techniques for Intervention 2 will be taught in lectures and group and/or individual sessions.
Treatment groups
150 Participants
are divided into 3 treatment groupsGroup A: Mind-Body Intervention 1Experimental treatment 1 intervention
Group B: Mind-Body Intervention 2Active comparator 1 intervention
Group C: Usual CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Pain Disability
Roland Morris Disability Index (Scale 0-24 with 24 being worst)
Time frame
26 weeksSecondary outcomes
1
Average pain
Average pain as determined in the Brief Pain Inventory Survey (Scale 0-10 with 10 being worst)
Time frame
Baseline, 4, 8, 13, and 26 weeks after initiation of the study.2
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
Time frame
Baseline, 4 weeks, 8 weeks, 13 weeks, 26 weeks3
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'
Time frame
Baseline, 4 weeks, 8 weeks, 13 weeks, 26 weeks4
Resolution of pain disability
Resolution of pain disability as measured by 0 or 1 on Roland Morris Disability (Scale 0-24 with 24 being worst)
Time frame
Baseline, 4 weeks, 8 weeks, 13 weeks, 26 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov