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

Официальное название

Osteopathic Manipulation Treatment Effect on the Leg and Foot Myofascial System in Adults With Chronic Low Back Pain - Pilot Study

Обзор

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

Вмешательства

• Другое 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.

Первичные конечные точки

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

Вторичные конечные точки (4)

• Low back pain intensity and frequency. [Срок оценки: From baseline measures on Day 1 until one week after the last OMT treatment, up to 7 weeks.]
• Functional disability. [Срок оценки: 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 [Срок оценки: From baseline measures on Day 1 until the last OMT treatment, up to 6 weeks.]
• Pain self-efficacy score [Срок оценки: From baseline measures on Day 1 until one week after the last OMT treatment, up to 7 weeks.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Edward Via College of Osteopathic Medicine — Auburn

Публикации

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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. PMID 33720272

Идентификаторы

NCT: NCT07193212 · 2024-206

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗