The goal of this clinical trial is to learn if adding Osteopathic Manipulative Therapy (OMT) to the usual medical care provided at the VA (usual VA care) improves treatment outcomes in individuals with chronic low back pain (CLBP). OMT is a set of hands-on techniques a doctor uses to move a patient's muscles and joints which include stretching, gentle pressure, resistance and applying forces to specific areas of the body. This feasibility clinical trial aims to learn about the treatment effects (e.g., effect sizes) of adding OMT to the usual medical care provided at the VA (Usual VA Care) in individuals with LBP.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
The usual treatment provided by PM\&R clinicians for CLBP
Between your first visit (baseline) and 12 weeks, participants will receive up to 4 usual care visits plus OMT.
Edward Hines, Jr. VA Hospital, PM&R Clinic
Hines, Illinois, United States
RECRUITINGLow-Back Pain Specific Pain Intensity
A numeric pain rating scale (NPRS) question adapted by the BACPAC to obtain pain rating for over last 7 days.
Time frame: Baseline, 12 weeks, and 24 weeks
Pain, Enjoyment, General Activity Scale (PEG)
A 3-item measure to assess and to monitor different aspects of chronic pain. Originally intended to be used in a primary care setting, this instrument has been used as an outcome measure and recommended by NIH HEAL core outcome set.
Time frame: Baseline, 12 weeks, and 24 weeks
Brief Pain Inventory (BPI)
A 32-item questionnaire to assess pain history, interference, pain relief, pain quality, and perceived cause of pain.
Time frame: Baseline, 12 weeks, and 24 weeks
Patient-Reported Outcomes Measurement Information System (PROMIS)
PROMIS Depression Short Form 4a (4 item) , PROMIS Short Form Anxiety 4a (4 item), PROMIS Physical Functioning 6b (6 item), PROMIS Sleep Disturbance 6a (6 item), PROMIS Fatigue 4a (4 item)
Time frame: Baseline, 12 weeks, and 24 weeks
Patient Health Questionnaire (PHQ-2)
2-item questionnaire to screen for depression symptoms (frequency of depressed mood and anhedonia) during the past 2 weeks.
Time frame: Baseline, 12 weeks, and 24 weeks
Generalized Anxiety Disorder 2-item (GAD-2)
A 2-item questionnaire to screen for generalized anxiety disorder, panic disorder, social anxiety disorder, and post-traumatic stress disorder.
Time frame: Baseline, 12 weeks, and 24 weeks
Pain Catastrophizing Scale - Short Form 6 (PCS-6)
A 6-item measure to assess catastrophizing of pain.
Time frame: Baseline, 12 weeks, and 24 weeks
Sleep Duration
A measure of duration to quantify the amount of sleep participants report, which is in addition to PROMIS Sleep Disturbance 6a.
Time frame: Baseline, 12 weeks, and 24 weeks
Healthcare utilization cost
The number of treatment visits and medication use during study enrollment
Time frame: Baseline, 12 weeks, and 24 weeks
Patients' Global Impression of Change (PGIC)
A 1-item questionnaire that measures perception of patients beliefs about the effectiveness of treatment.
Time frame: Baseline, 12 weeks, and 24 weeks
Radicular Pain Questions
A 2-item measure adapted from NIH Research Task Force to capture radicular symptoms below the knee and/or thigh.
Time frame: Baseline, 12 weeks, and 24 weeks
Abbreviated Pain Somatization
A 2-item measure that captures somatization of back pain as stomach pain and headaches.
Time frame: Baseline, 12 weeks, and 24 weeks
Widespread Pain Inventory
A 1-item question to document areas of pain other than the low back.
Time frame: Baseline, 12 weeks, and 24 weeks
Low Back Pain Duration and Frequency
A 2-item measure to document CLBP as defined by NIH Task Force (back pain lasting greater than or equal to 3 months and having LBP at least half the days in the past 6 months).
Time frame: Baseline, 12 weeks, and 24 weeks
The Tobacco, Alcohol, Prescription medications, and other Substance Part 1 (TAPS1)
A 5- item questionnaire to identify unhealthy substance.
Time frame: Baseline, 12 weeks, and 24 weeks
Alcohol Use Disorders Identification Test (AUDIT-C)
A 3-item alcohol screen that can help identify persons who are hazardous drinkers or have active alcohol use disorders.
Time frame: Baseline, 12 weeks, and 24 weeks
Healing Encounters and Attitudes Lists (HEAL)
A 39-item questionnaire to capture Patient-Provider Connection, Healthcare Environment, Treatment Expectancy, Positive Outlook, Spirituality, and Attitudes toward Complementary and Alternative Medicine (CAM)/CIH approaches.
Time frame: Baseline, 12 weeks, and 24 weeks
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