How Osteopathic Treatment Affects the Leg and Foot in People With Low Back Pain

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.

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.

Low back and lower extremity pain intensity, and frequency measured by an NRS (intensity) and Likert scale (frequency).

The Roland-Morris Disability Questionnaire will be used to score functional disability.

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.

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.

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.

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.

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.

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.