Chronic Pain, Chronic Pain Syndrome
Conditions
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.
Interventions
BEHAVIORALMind Body Intervention 1
Mind body techniques for Intervention 1 will be taught in lectures and group discussion sessions.
BEHAVIORALMind body intervention 2
Mind body techniques for Intervention 2 will be taught in lectures and group and/or individual sessions.
Sponsors
Beth Israel Deaconess Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, 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.
Intervention model description
Mind-Body Intervention 1, Mind-Body Intervention 2 and Usual Care
Eligibility
Sex/Gender
ALL
Age
18 Years to 67 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Disability | 26 weeks | Roland Morris Disability Index (Scale 0-24 with 24 being worst) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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' |
| Resolution of pain disability | Baseline, 4 weeks, 8 weeks, 13 weeks, 26 weeks | Resolution of pain disability as measured by 0 or 1 on Roland Morris Disability (Scale 0-24 with 24 being 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 |
| Resolution of back pain bothersomeness | Baseline, 4 weeks, 8 weeks, 13 weeks, 26 weeks | Resolution of back pain bothersomeness as measured as 0-1 on scale 0-10 |
Countries
United States
Contacts
CONTACTSamuel Kukler, BA
CONTACTMichael Donnino, MD
PRINCIPAL_INVESTIGATORMichael Donnino, MD
Beth Israel Deaconess Medical Center
Outcome results
None listed