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| ID | Type | Description | Link |
|---|---|---|---|
| Department of Defense | Other Grant/Funding Number | CP230185 |
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| Name | Class |
|---|---|
| Michigan State University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual VA Care Group | Active Comparator | All study participants will receive usual VA care that will be provided by a physiatrist at the Hines VA. After taking their medical history, they will perform a physical exam to assess their conditions. Based on the physical exam, the physicians may recommend more testing and/or treatment procedures. |
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| Usual VA Care + OMT Group | Experimental | Participants in this group will receive your usual VA care plus OMT. The addition of OMT is the research portion of the treatment. During the physician prescribed usual care visits, participants will receive the OMT treatment. During OMT (the research portion), a physician may move participants muscles and joints using hands-on techniques including stretching, gentle pressure and resistance, as well as applying forces to specific areas of the body. While receiving OMT, participants may be asked to change positions such as standing, sitting, or lying on your back, stomach or side. This treatment will be provided by the VA physicians involved in this study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Usual VA Care | Procedure | The usual treatment provided by PM&R clinicians for CLBP |
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| Measure | Description | Time Frame |
|---|---|---|
| Low-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. | Baseline, 12 weeks, and 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 12 weeks, and 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Contact | 708-202-2282 | TBD@va.gov |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Edward Hines, Jr. VA Hospital, PM&R Clinic | Recruiting | Hines | Illinois | 60141 | United States |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D026301 | Manipulation, Osteopathic |
| ID | Term |
|---|---|
| D026201 | Musculoskeletal Manipulations |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
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| Osteopathic manipulative treatment | Procedure | Between your first visit (baseline) and 12 weeks, participants will receive up to 4 usual care visits plus OMT. |
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| Brief Pain Inventory (BPI) |
A 32-item questionnaire to assess pain history, interference, pain relief, pain quality, and perceived cause of pain. |
| 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) | 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. | 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. | Baseline, 12 weeks, and 24 weeks |
| Pain Catastrophizing Scale - Short Form 6 (PCS-6) | A 6-item measure to assess catastrophizing of pain. | 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. | Baseline, 12 weeks, and 24 weeks |
| Healthcare utilization cost | The number of treatment visits and medication use during study enrollment | 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. | 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. | Baseline, 12 weeks, and 24 weeks |
| Abbreviated Pain Somatization | A 2-item measure that captures somatization of back pain as stomach pain and headaches. | Baseline, 12 weeks, and 24 weeks |
| Widespread Pain Inventory | A 1-item question to document areas of pain other than the low back. | 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). | 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. | 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. | 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. | Baseline, 12 weeks, and 24 weeks |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D012046 | Rehabilitation |