Osteopathic Treatment for Chronic Low Back Pain

This study is looking at how Osteopathic Manipulative Treatment (OMT) might help people with chronic low back pain. OMT is a hands-on approach where a trained physician uses gentle pressure and movements to improve mobility and reduce pain. Researchers want to see if OMT can improve both physical symptoms, like muscle stiffness in your back, legs, and feet, and how you feel emotionally, such as your stress or anxiety levels. They are looking for 20 adults, aged 18 to 65, who have had low back pain for at least three months. Success will be measured by changes in muscle stiffness (using ultrasound) and how your body sways, along with your reports on pain, disability, and mood over about 6 weeks. The study status is currently unclear.

Study design
This is a pilot study that will involve 20 participants. It is an interventional study, meaning participants will receive a specific treatment.
What's involved
You would receive four Osteopathic Manipulative Treatment (OMT) sessions over 5-7 weeks. Before and after treatment, researchers will measure muscle stiffness with ultrasound, plantar pressure during walking, and you will complete surveys about your pain and well-being.
Compensation
Not stated in the trial record.
Follow-up
Measurements will be taken from the start of the study until the last OMT treatment, which is up to 6 weeks.

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NCT07193212

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

Recruiting
NAAges 18–65InterventionalTreatment
Edward Via Virginia College of Osteopathic Medicine
~20 participants
Updated 2026-05-14 on ClinicalTrials.gov
What's tested:Osteopathic Manipulative Treatment

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Stiffness of Low Back and Lower Extremity Muscles Assessed by Ultrasound Shear Wave Elastography
Measured over From baseline measures on Day 1 until the last OMT treatment, up to 6 weeks.
+1 more outcome measured
Chronic Low Back Pain (CLBP)
1 sites across 1 states
Alabama1
  • Daniel Cawley, DC, MS, MSHS · PRINCIPAL_INVESTIGATOR · VCOM

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Eligibility criteria

Inclusion

male and female subjects 18-65 years old
presence of chronic low back \> 3 months duration or pain present \> 50% of the time within the previous 12 months

Exclusion

prior surgery of the thoracic, lumbar or sacral spine, pelvis
diagnosis lumbar radiculopathy or pinched nerve in the neck
diagnosis of foot condition that alters gait
diagnosis of connective tissue or muscle disorders
diagnosis of cancer
previous spinal cord injury inflammatory arthritis and fibromyalgia
pregnancy
tobacco use
known diabetes or prediabetes
allergy to ultrasound gel (propylene glycol)
history of manual therapy treatment within the past 2 weeks
injection for pain within the past 1 month
currently taking muscle relaxers
  • Stiffness of Low Back and Lower Extremity Muscles Assessed by Ultrasound Shear Wave ElastographyFrom baseline measures on Day 1 until the last OMT treatment, up to 6 weeks.

    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.

  • Body sway normalized path length, area, and velocity.From baseline measures on Day 1 until the last OMT treatment, up to 6 weeks.

    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.