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

NCT ID: NCT07193212

Last Updated: 2025-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-30

Study Completion Date

2026-12-31

Brief Summary

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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

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Conditions

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Chronic Low Back Pain (CLBP)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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OMT Treatment Group

Group Type EXPERIMENTAL

Osteopathic Manipulative Treatment

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Edward Via Virginia College of Osteopathic Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniel Cawley, DC, MS, MSHS

Role: PRINCIPAL_INVESTIGATOR

VCOM

Locations

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Edward Via College of Osteopathic Medicine

Auburn, Alabama, United States

Site Status

Countries

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United States

Central Contacts

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Daniel Cawley, DC, MS, MSHS

Role: CONTACT

334-442-4105

Facility Contacts

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Daniel Cawley, DC, MS, MSHS

Role: primary

334-442-4105

References

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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.

Reference Type BACKGROUND
PMID: 29382241 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34823100 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37193730 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21762484 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37719924 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30930571 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35619991 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33720272 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31077992 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24049103 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29202429 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36561877 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26927908 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26591401 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21190045 (View on PubMed)

Other Identifiers

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2024-206

Identifier Type: -

Identifier Source: org_study_id

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