How Osteopathic Treatment Affects the Leg and Foot in People With Low Back Pain (NCT07193212) | Clinical Trial Compass
RecruitingNot Applicable
How Osteopathic Treatment Affects the Leg and Foot in People With Low Back Pain
United States20 participantsStarted 2025-11-05
Plain-language 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
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Stiffness of Low Back and Lower Extremity Muscles Assessed by Ultrasound Shear Wave Elastography
Timeframe: From baseline measures on Day 1 until the last OMT treatment, up to 6 weeks.
2
Body sway normalized path length, area, and velocity.
Timeframe: From baseline measures on Day 1 until the last OMT treatment, up to 6 weeks.
Trial details
NCT IDNCT07193212
SponsorEdward Via Virginia College of Osteopathic Medicine