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

Not Applicable

Not yet recruiting

• Conditions: Chronic Low Back Pain (CLBP)

• Registration Number: NCT07193212
• Lead Sponsor: Edward Via Virginia College of Osteopathic Medicine

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study Start: 2025-09-01
• Study First Submitted: 2025-09-08
• Study First Submitted QC: 2025-09-18
• Last Update Submitted: 2025-09-18
• Study First Posted: 2025-09-25
• Last Update Posted: 2025-09-25
• Primary Completion: 2026-09
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Stiffness of Low Back and Lower Extremity Muscles Assessed by Ultrasound Shear Wave Elastography	From 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.

Secondary Outcome Measures

Name	Time	Method
Low back pain intensity and frequency.	From baseline measures on Day 1 until one week after the last OMT treatment, up to 7 weeks.	Low back and lower extremity pain intensity, and frequency measured by an NRS (intensity) and Likert scale (frequency).
Functional disability.	From baseline measures on Day 1 until one week after the last OMT treatment, up to 7 weeks.	The Roland-Morris Disability Questionnaire will be used to score functional disability.
Plantar Pressure Changes Assessed by EMED Pedobarographic Platform	From baseline measures on Day 1 until the last OMT treatment, up to 6 weeks.	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.
Pain self-efficacy score	From baseline measures on Day 1 until one week after the last OMT treatment, up to 7 weeks.	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.

Trial Locations

Locations (1)

Edward Via College of Osteopathic Medicine; 🇺🇸 Auburn, Alabama, United States