An interventional study of Osteopathic Manipulative Treatment in Chronic Low Back Pain (CLBP), sponsored by Edward Via Virginia College of Osteopathic Medicine. Recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-05-14.
Sponsored by Edward Via Virginia College of Osteopathic Medicine · Not applicable, Interventional, and Treatment
This pilot study will examine whether osteopathic manipulative treatment (OMT) can improve both physical and psychological aspects of chronic low back pain by focusing on the interconnected myofascial system of the back, legs, and feet. Twenty adults with chronic low back pain will receive four OMT sessions over 5-7 weeks. Before and after treatment, the investigators will measure muscle stiffness with ultrasound, plantar pressure during walking with a pressure plate, and patient-reported outcomes on pain, disability, sleep quality, stress, anxiety, depression, pain catastrophizing, and pain self-efficacy using surveys. By linking these objective and subjective measures, the study aims to provide early evidence of how OMT may influence musculoskeletal function, daily activity, and overall well-being, helping to guide future larger studies on treatment strategies for low back pain
2,922 studies on the registry are indexed under Low Back Pain; 580 are open to participants now.
This study's planned enrollment of 20 is below the median of 60 across 2,364 interventional studies indexed under Low Back Pain.
Browse Low Back Pain studies →Edward Via Virginia College of Osteopathic Medicine is the lead sponsor of 24 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Other: Osteopathic Manipulative Treatment
Osteopathic Manipulative Treatment (OMT) is a hands-on approach where a trained physician uses techniques such as gentle pressure, stretching, and guided movements to improve mobility, reduce pain, and support the body's natural healing. It focuses on the interconnectedness of muscles, joints, and fascia to restore balance and function.
Stiffness of Low Back and Lower Extremity Muscles Assessed by Ultrasound Shear Wave Elastography
Stiffness in the muscles of the low back and lower extremity will be quantitatively assessed using ultrasound shear wave elastography (SWE). SWE provides a non-invasive, reliable measure of tissue stiffness by calculating the shear wave speed (in meters/second) and corresponding elasticity modulus (in kilopascals). Regions of interest will be placed within target muscles and tissues (e.g., lumbar multifidus, thoracolumbar aponeurosis, hamstrings, gastrocnemius) and standardized acquisition protocols will be used to ensure reproducibility. This method allows for objective measurement of muscle stiffness rather than relying on subjective evaluation, thereby enhancing the validity of the outcome measure.
Time frame: From baseline measures on Day 1 until the last OMT treatment, up to 6 weeks.
Body sway normalized path length, area, and velocity.
A triaxial accelerometer will be used to measure postural control. The sensor will be secured over the lower trunk and measurements will occur under six conditions: feet together eyes open, feet together eyes closed, single-leg stance on the right and left with eyes opened and eyes closed. An average of 3 trials per condition will be used for each stance with 1 minute rest between trials. Double leg stance trials will be performed for 30 seconds while single leg stance trials will be performed for 15 seconds. Normalized path length (NPL) of acceleration in the anteroposterior (AP) and mediolateral (ML) directions, and sway excursion area, and velocity will be determined.
Time frame: From baseline measures on Day 1 until the last OMT treatment, up to 6 weeks.
Low back pain intensity and frequency.
Low back and lower extremity pain intensity, and frequency measured by an NRS (intensity) and Likert scale (frequency).
Time frame: From baseline measures on Day 1 until one week after the last OMT treatment, up to 7 weeks.
Functional disability.
The Roland-Morris Disability Questionnaire will be used to score functional disability.
Time frame: From baseline measures on Day 1 until one week after the last OMT treatment, up to 7 weeks.
Plantar Pressure Changes Assessed by EMED Pedobarographic Platform
Plantar pressure distribution will be assessed using a validated EMED pedobarographic platform (Novel), which records dynamic foot pressures during gait. Outcome parameters will include peak pressure (kPa), pressure-time integrals, and center of pressure trajectory. Participants will walk barefoot at a self-selected pace across the platform, and standardized protocols will be used to ensure reproducibility. An average of 5 measures from each foot will be obtained.
Time frame: From baseline measures on Day 1 until the last OMT treatment, up to 6 weeks.
Pain self-efficacy score
The pain self-efficacy questionnaire will be used to assess participants confidence in their ability to perform various activities and achieve goals despite experiencing pain, and its relationship to clinical response to treatment.
Time frame: From baseline measures on Day 1 until one week after the last OMT treatment, up to 7 weeks.
Depression Assessed by Depression Anxiety Stress Scale-21 (DASS-21)
Depression will be assessed using the Depression Anxiety Stress Scale-21 (DASS-21), a validated 21-item self-report questionnaire. The Depression subscale consists of 7 items, each scored on a 4-point Likert scale (0 = did not apply to me at all; 3 = applied to me very much, or most of the time). Scores are summed and multiplied by two to yield a final subscale score ranging from 0 to 42, with higher scores reflecting greater depressive symptoms.
Time frame: From baseline measures on Day 1 until one week after the last OMT treatment, up to 7 weeks.
Anxiety Assessed by Depression Anxiety Stress Scale-21 (DASS-21)
Anxiety will be assessed using the DASS-21 questionnaire. The Anxiety subscale includes 7 items scored on a 4-point Likert scale (0-3). Subscale scores are summed and multiplied by two, yielding a final score from 0 to 42, with higher scores reflecting greater anxiety symptoms.
Time frame: From baseline measures on Day 1 until one week after the last OMT treatment, up to 7 weeks.
Stress Assessed by Depression Anxiety Stress Scale-21 (DASS-21)
Stress will be assessed using the DASS-21 questionnaire. The Stress subscale consists of 7 items scored on a 4-point Likert scale (0-3). Subscale scores are summed and multiplied by two, yielding a final score from 0 to 42, with higher scores reflecting greater stress symptoms.
Time frame: From baseline measures on Day 1 until one week after the last OMT treatment, up to 7 weeks.
Impact of sleep quality on daily function
The PROMIS Sleep-Related Impairment Short Form (8-item) will be used to assess changes in self-reported perceptions of daytime sleepiness, tiredness, and functional impairments related to poor sleep.
Time frame: From baseline measures on Day 1 until one week after the last OMT treatment, up to 7 weeks.
Plan to share: No
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Edward Via Virginia College of Osteopathic Medicine