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

Edward Via Virginia College of Osteopathic Medicine

Status: Not yet enrolling

Conditions: Chronic Low Back Pain (CLBP)

Treatments: Other: Osteopathic Manipulative Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT07193212

2024-206

Details and patient eligibility

About

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

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

OMT Treatment Group

Experimental group

Treatment:

Other: Osteopathic Manipulative Treatment