Clinical Trial TitleStudy that looks at the effectiveness of mindfulness therapy or spinal manipulation therapy on participants with chronic low back pain.
Clinical Trial Protocol Description:
This study will compare the degree to which mindfulness training (MT) and spinal manipulation therapy (SMT) activate specific and non-specific mechanisms, and the degree to which these mechanisms affect pain-related outcomes. Comparing the activation and effects of mechanisms in these 2 interventions in a single trial will allow us to test the degree to which effects of certain mechanisms are shared across treatments or are unique to a given treatment. 240 people will be randomly assigned to MT or SMT at RUMC and Vanderbilt University Medical Center and RUMC aims to complete 120 participant trials. The two therapy treatments will be assigned randomly.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Have significant daily chronic pain intensity (≥4 on a 10-point scale) and interference in performing daily activities due to pain (≥3 on a 10-point scale) for at least 3 months.
- Are 18-75 years of age.
- Are not using opioid analgesics on a daily basis or within 3 days of each laboratory session (confirmed via urine drug screen).
You will be excluded from the study if any of the following criteria apply to you:
- Meet criteria for alcohol or substance abuse problems.
- Meet criteria for past or present psychotic or bipolar disorders.
- Are not able to understand English well enough to complete questionnaires or participate in therapy.
- Have pain due to malignant conditions, rheumatoid arthritis, migraine or tension headache, complex regional pain syndrome, or fibromyalgia syndrome.
- Have had umbar surgery within past 6 months.
- Are pregnant.
- Have signs of nerve root compression (i.e., positive straight-leg raise <45○).
- Have liver disease such as hepatitis or cirrhosis.
- Have bone demineralization such as osteoporosis or osteopenia.
- Have active suicidal ideation with intent.
- Have opioid-dependency.
- Are not able to hold breath for 15 seconds.
- Have acute trauma to spine.
- Have long term use of corticosteroids.
This is a partial list of inclusion and exclusion criteria.
Clinical Trial Investigator
RUSH University Medical Center
1620 W Harrison St
Chicago, IL 60612