Recruiting

Osteopathic Manipulative Treatment

Sponsor:

Edward Via Virginia College of Osteopathic Medicine

Code:

NCT07193212

Conditions

Chronic Low Back Pain (CLBP)

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Osteopathic Manipulative Treatment

Study Details

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

Conditions

Chronic Low Back Pain (CLBP)

Study ID

NCT07193212

Start date

Nov 5, 2025

Status verified date

Nov, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: OMT Treatment Group

Interventions

Osteopathic Manipulative Treatment

Osteopathic Manipulative Treatment (OMT) is a hands-on approach where a trained physician uses techniques such as gentle pressure, stretching, and guided movements to improve mobility, reduce pain, and support the body's natural healing. It focuses on the interconnectedness of muscles, joints, and fascia to restore balance and function.

Primary outcome measure

  • Stiffness of Low Back and Lower Extremity Muscles Assessed by Ultrasound Shear Wave Elastography [ Time Frame: From baseline measures on Day 1 until the last OMT treatment, up to 6 weeks. ]
  • Body sway normalized path length, area, and velocity. [ Time Frame: From baseline measures on Day 1 until the last OMT treatment, up to 6 weeks. ]

Central Contacts and Locations

Central contacts

Daniel Cawley, DC, MS, MSHS

334-442-4105dcawley@vcom.edu

Locations

Edward Via College of Osteopathic Medicine

Recruiting

Auburn, Alabama, United States, 36832

Contacts

Daniel Cawley, DC, MS, MSHS

334-442-4105dcawley@vcom.edu

More Information

Sponsor

Edward Via Virginia College of Osteopathic Medicine

Last update posted

May 14, 2026

Last verified

Nov, 2025

Keywords

  • chronic low back pain
  • myofascial systems
  • omt

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Edward Via Virginia College of Osteopathic Medicine on 2026-05-14.