NCT07193212 How Osteopathic Treatment Affects the Leg and Foot in People With Low Back Pain
| NCT ID | NCT07193212 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Edward Via Virginia College of Osteopathic Medicine |
| Condition | Chronic Low Back Pain (CLBP) |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-11-05 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2025-11-05 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Daniel Cawley, DC, MS, MSHS
PRINCIPAL INVESTIGATOR
VCOM
Frequently Asked Questions
Who can join the NCT07193212 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Chronic Low Back Pain (CLBP). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07193212 currently recruiting?
Yes, NCT07193212 is actively recruiting participants. Contact the research team at dcawley@vcom.edu for enrollment information.
Where is the NCT07193212 trial being conducted?
This trial is being conducted at Auburn, United States.
Who is sponsoring the NCT07193212 clinical trial?
NCT07193212 is sponsored by Edward Via Virginia College of Osteopathic Medicine. The principal investigator is Daniel Cawley, DC, MS, MSHS at VCOM. The trial plans to enroll 20 participants.