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

NCT07193212 | Not Yet Recruiting

• 1 other identifier: 2024-206
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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)

Keywords

chronic low back pain; myofascial systems; omt

Outcome Measures

Primary Outcomes (2)

• Stiffness of Low Back and Lower Extremity Muscles Assessed by Ultrasound Shear Wave Elastography

  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.

  From baseline measures on Day 1 until the last OMT treatment, up to 6 weeks.

• Body sway normalized path length, area, and velocity.

  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.

  From baseline measures on Day 1 until the last OMT treatment, up to 6 weeks.

Secondary Outcomes (4)

• Low back pain intensity and frequency.

  From baseline measures on Day 1 until one week after the last OMT treatment, up to 7 weeks.

• Functional disability.

  From baseline measures on Day 1 until one week after the last OMT treatment, up to 7 weeks.

• Plantar Pressure Changes Assessed by EMED Pedobarographic Platform

  From baseline measures on Day 1 until the last OMT treatment, up to 6 weeks.

• Pain self-efficacy score

  From baseline measures on Day 1 until one week after the last OMT treatment, up to 7 weeks.

Other Outcomes (4)

• Depression Assessed by Depression Anxiety Stress Scale-21 (DASS-21)

  From baseline measures on Day 1 until one week after the last OMT treatment, up to 7 weeks.

• Anxiety Assessed by Depression Anxiety Stress Scale-21 (DASS-21)

  From baseline measures on Day 1 until one week after the last OMT treatment, up to 7 weeks.

• Stress Assessed by Depression Anxiety Stress Scale-21 (DASS-21)

  From baseline measures on Day 1 until one week after the last OMT treatment, up to 7 weeks.

Study Arms (1)

OMT Treatment Group

EXPERIMENTAL

Other: Osteopathic Manipulative Treatment

Interventions

Osteopathic Manipulative Treatment OTHER

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.

OMT Treatment Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Edward Via Virginia College of Osteopathic Medicine: lead

Study Sites (1)

Edward Via College of Osteopathic Medicine

Auburn, Alabama, 36832, United States

Location

Related Publications (15)

• Berenshteyn Y, Gibson K, Hackett GC, Trem AB, Wilhelm M. Is standing balance altered in individuals with chronic low back pain? A systematic review. Disabil Rehabil. 2019 Jun;41(13):1514-1523. doi: 10.1080/09638288.2018.1433240. Epub 2018 Jan 30.

  PMID: 29382241 BACKGROUND

• Wang H, Zheng J, Fan Z, Luo Z, Wu Y, Cheng X, Yang J, Zhang S, Yu Q, Lo WLA, Wang C. Impaired static postural control correlates to the contraction ability of trunk muscle in young adults with chronic non-specific low back pain: A cross-sectional study. Gait Posture. 2022 Feb;92:44-50. doi: 10.1016/j.gaitpost.2021.11.021. Epub 2021 Nov 19.

  PMID: 34823100 BACKGROUND

• Park J, Nguyen VQ, Ho RLM, Coombes SA. The effect of chronic low back pain on postural control during quiet standing: A meta-analysis. Sci Rep. 2023 May 16;13(1):7928. doi: 10.1038/s41598-023-34692-w.

  PMID: 37193730 BACKGROUND

• Ruhe A, Fejer R, Walker B. Is there a relationship between pain intensity and postural sway in patients with non-specific low back pain? BMC Musculoskelet Disord. 2011 Jul 15;12:162. doi: 10.1186/1471-2474-12-162.

  PMID: 21762484 BACKGROUND

• Ryum T, Stiles TC. Changes in pain catastrophizing, fear-avoidance beliefs, and pain self-efficacy mediate changes in pain intensity on disability in the treatment of chronic low back pain. Pain Rep. 2023 Sep 13;8(5):e1092. doi: 10.1097/PR9.0000000000001092. eCollection 2023 Sep.

  PMID: 37719924 BACKGROUND

• Ogunlana MO, Odole AC, Adejumo A, Odunaiya N. Catastrophising, pain, and disability in patients with nonspecific low back pain. Hong Kong Physiother J. 2015 Dec;33(2):73-79. doi: 10.1016/j.hkpj.2015.03.001. Epub 2015 Apr 16.

  PMID: 30930571 BACKGROUND

• Xu C, Fu Z, Wang J, Wu B, Wang XQ. Differences and Correlations of Anxiety, Sleep Quality, and Pressure-Pain Threshold between Patients with Chronic Low Back Pain and Asymptomatic People. Pain Res Manag. 2022 May 17;2022:8648584. doi: 10.1155/2022/8648584. eCollection 2022.

  PMID: 35619991 BACKGROUND

• Nguyen C, Boutron I, Zegarra-Parodi R, Baron G, Alami S, Sanchez K, Daste C, Boisson M, Fabre L, Krief P, Krief G, Lefevre-Colau MM, Rannou F. Effect of Osteopathic Manipulative Treatment vs Sham Treatment on Activity Limitations in Patients With Nonspecific Subacute and Chronic Low Back Pain: A Randomized Clinical Trial. JAMA Intern Med. 2021 May 1;181(5):620-630. doi: 10.1001/jamainternmed.2021.0005.

  PMID: 33720272 BACKGROUND

• Murillo C, Falla D, Rushton A, Sanderson A, Heneghan NR. Shear wave elastography investigation of multifidus stiffness in individuals with low back pain. J Electromyogr Kinesiol. 2019 Aug;47:19-24. doi: 10.1016/j.jelekin.2019.05.004. Epub 2019 May 3.

  PMID: 31077992 BACKGROUND

• Menz HB, Dufour AB, Riskowski JL, Hillstrom HJ, Hannan MT. Foot posture, foot function and low back pain: the Framingham Foot Study. Rheumatology (Oxford). 2013 Dec;52(12):2275-82. doi: 10.1093/rheumatology/ket298. Epub 2013 Sep 17.

  PMID: 24049103 BACKGROUND

• McClinton S, Weber CF, Heiderscheit B. Low back pain and disability in individuals with plantar heel pain. Foot (Edinb). 2018 Mar;34:18-22. doi: 10.1016/j.foot.2017.09.003. Epub 2017 Sep 28.

  PMID: 29202429 BACKGROUND

• Loffler M, Schneider P, Schuh-Hofer S, Kamping S, Usai K, Treede RD, Nees F, Flor H. Stress-induced hyperalgesia instead of analgesia in patients with chronic musculoskeletal pain. Neurobiol Pain. 2022 Dec 6;13:100110. doi: 10.1016/j.ynpai.2022.100110. eCollection 2023 Jan-Jul.

  PMID: 36561877 BACKGROUND

• Licciardone JC, Gatchel RJ, Aryal S. Recovery From Chronic Low Back Pain After Osteopathic Manipulative Treatment: A Randomized Controlled Trial. J Am Osteopath Assoc. 2016 Mar;116(3):144-55. doi: 10.7556/jaoa.2016.031.

  PMID: 26927908 BACKGROUND

• Anukoolkarn K, Vongsirinavarat M, Bovonsunthonchai S, Vachalathiti R. Plantar Pressure Distribution Pattern during Mid-Stance Phase of the Gait in Patients with Chronic Non-Specific Low Back Pain. J Med Assoc Thai. 2015 Sep;98(9):896-901.

  PMID: 26591401 BACKGROUND

• Alsaadi SM, McAuley JH, Hush JM, Maher CG. Prevalence of sleep disturbance in patients with low back pain. Eur Spine J. 2011 May;20(5):737-43. doi: 10.1007/s00586-010-1661-x. Epub 2010 Dec 29.

  PMID: 21190045 BACKGROUND

MeSH Terms

Interventions

Manipulation, Osteopathic

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Daniel Cawley, DC, MS, MSHS

  VCOM

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Cawley, DC, MS, MSHS

CONTACT

334-442-4105; dcawley@vcom.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2025
• First Posted: September 25, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)