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Not yet recruiting NCT07631949

Osteopathy in Postpartum Lumbopelvic Pain

No phase Interventional Postpartum Lumbopelvic Pain Postpartum Pelvic Girdle Pain Postpartum Low Back Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Core Stabilization Exercises, Patient Education, Osteopathic Manipulative Treatment, Sham Osteopathic Manipulative Treatment.
Who it may be relevant to
Registry conditions: Postpartum Lumbopelvic Pain, Postpartum Pelvic Girdle Pain, Postpartum Low Back Pain. Basic parameters: 18 years — 50 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effects of Osteopathy on Pain, Function, Quality of Life, Stress Hormones and Inflammatory Biomarkers in Women With Postpartum Lumbopelvic Pain: A Randomized Controlled Trial

Overview

Postpartum lumbopelvic pain is a common condition after childbirth and may affect pain levels, physical function, daily activities, and quality of life. Conservative treatment options include patient education, exercise, and manual therapy. Although osteopathic manupilative treatment has been shown to improve pain and function in musculoskeletal disorders, limited evidence is available regarding its effects on stress hormone levels and inflammatory biomarkers in women with postpartum lumbopelvic pain. This randomized controlled trial aims to investigate the effects of osteopathic manupilative treatment on pain, physical function, quality of life, stress hormone levels, and inflammatory biomarkers among women with postpartum lumbopelvic pain. Participants will be randomly assigned to one of three groups: education and core stabilization exercises, education and core stabilization exercises combined with osteopathic manupilative treatment, or education and core stabilization exercises combined with sham osteopathic manupilative treatment. Outcome measures will be assessed before treatment and one week after the final treatment session.

Detailed description

Postpartum lumbopelvic pain is a common musculoskeletal condition experienced by women after childbirth. Pain may be localized in the lumbar spine, pelvic girdle, or both regions, and can persist for several months after delivery. This condition may affect physical function, mobility, daily activities, sleep quality, psychological well-being, and quality of life. Difficulties in caring for the newborn, reduced participation in social activities, and limitations in occupational and household tasks are frequently reported among women with postpartum lumbopelvic pain.

The etiology of postpartum lumbopelvic pain is considered multifactorial. Hormonal changes during pregnancy, altered biomechanics, increased ligamentous laxity, changes in muscle function, reduced trunk stability, and physical demands associated with pregnancy and childbirth may contribute to the development and persistence of symptoms. In addition, psychosocial factors and individual pain responses may influence symptom severity and recovery.

Conservative management is generally recommended as the first-line approach for postpartum lumbopelvic pain. Common treatment strategies include patient education, therapeutic exercise, stabilization programs, and manual therapy interventions. Exercise-based rehabilitation aims to improve trunk muscle function, enhance lumbopelvic stability, and reduce pain-related disability. Core stabilization exercises are frequently used to improve neuromuscular control and functional capacity in women with postpartum lumbopelvic pain.

Osteopathic Manipulative Treatment (OMT) is a manual therapy approach that utilizes a variety of hands-on techniques to address musculoskeletal dysfunctions, improve mobility, and optimize body function. Previous studies have reported beneficial effects of OMT on pain intensity, physical function, disability, and quality of life in different musculoskeletal conditions. OMT has also been investigated in women during pregnancy and the postpartum period, with findings suggesting potential improvements in pain and functional outcomes. However, the available evidence remains limited, and further high-quality randomized controlled trials are needed to clarify its effectiveness in postpartum lumbopelvic pain.

Exercise-based rehabilitation has been reported to influence inflammatory responses and is commonly used in the management of postpartum lumbopelvic pain. In addition to its clinical effects on pain and function, Osteopathic Manipulative Treatment may also influence inflammatory biomarkers and stress-related hormonal responses. However, evidence regarding the effects of Osteopathic Manipulative Treatment on inflammatory biomarkers and cortisol levels in women with postpartum lumbopelvic pain remains limited. Further research is needed to better understand both the clinical and biological effects of Osteopathic Manipulative Treatment in this population.

The primary aim of this randomized controlled trial is to investigate the effects of Osteopathic Manipulative Treatment on pain intensity in women with postpartum lumbopelvic pain. Secondary aims are to evaluate the effects of treatment on functional status, quality of life, inflammatory biomarkers, and stress-related hormone levels.

A total of 45 women with postpartum lumbopelvic pain will be recruited for this study. Participants will be randomly allocated to one of three groups: (1) education and core stabilization exercises, (2) education and core stabilization exercises combined with Osteopathic Manipulative Treatment, or (3) education and core stabilization exercises combined with sham Osteopathic Manipulative Treatment. Exercise interventions will be performed three times per week for six weeks, while Osteopathic Manipulative Treatment and sham Osteopathic Manipulative Treatment will be administered once every two weeks for a total of four sessions over eight weeks. Outcome measures will be assessed before treatment and one week after completion of the final treatment session.

Interventions

  • Behavioral Core Stabilization Exercises
    A supervised core stabilization exercise program performed three times per week for six weeks. The program aims to improve trunk muscle function, lumbopelvic stability, and functional capacity.
  • Behavioral Patient Education
    Participants will receive education regarding postpartum lumbopelvic pain, posture, activity modification, daily life recommendations, and self-management strategies.
  • Other Osteopathic Manipulative Treatment
    Osteopathic Manipulative Treatment will be administered once every two weeks for a total of four sessions over eight weeks. Treatment will consist of individualized osteopathic manual techniques based on the participant's clinical findings.
  • Other Sham Osteopathic Manipulative Treatment
    Sham Osteopathic Manipulative Treatment will be administered once every two weeks for a total of four sessions over eight weeks. Participants will receive a sham procedure designed to mimic treatment without delivering therapeutic osteopathic techniques.

Primary outcome measures

  • Change from Baseline in Oswestry Disability Index (ODI) [Time frame: Baseline and Week 9]
Secondary outcome measures (12)
  • Change from Baseline in Pain Intensity at Rest Measured by Visual Analog Scale (VAS) [Time frame: Baseline and Week 9]
  • Change from Baseline in Pain Intensity During Activity Measured by Visual Analog Scale (VAS) [Time frame: Baseline and Week 9]
  • Change from Baseline in Night Pain Measured by Visual Analog Scale (VAS) [Time frame: Baseline and Week 9]
  • Change from Baseline in Pelvic Girdle Questionnaire (PGQ) Score [Time frame: Baseline and Week 9]
  • Change from Baseline in SF-12 Physical Component Score [Time frame: Baseline and Week 9]
  • Change from Baseline in SF-12 Mental Component Score [Time frame: Baseline and Week 9]
  • Change from Baseline in Edinburgh Postnatal Depression Scale (EPDS) Score [Time frame: Baseline and Week 9]
  • Change from Baseline in C-Reactive Protein (CRP) Level [Time frame: Baseline and Week 9]
  • Change from Baseline in Interleukin-6 (IL-6) Level [Time frame: Baseline and Week 9]
  • Change from Baseline in Interleukin-10 (IL-10) Level [Time frame: Baseline and Week 9]
  • Change from Baseline in Tumor Necrosis Factor-Alpha (TNF-α) Level [Time frame: Baseline and Week 9]
  • Change from Baseline in Serum Cortisol Level [Time frame: Baseline and Week 9]

Eligibility criteria

Inclusion criteria

  • Female participants aged 18 to 50 years. History of childbirth within the previous 6 to 15 months. Diagnosis of postpartum lumbopelvic pain confirmed by an obstetrician-gynecologist.

Presence of low back pain and/or pelvic girdle pain for at least 3 months according to the European Guidelines for the Prevention of Low Back Pain and the European Guidelines for Pelvic Girdle Pain.

Pain intensity of at least 5/10 on the Visual Analog Scale (VAS). Willingness to participate and provide written informed consent.

Exclusion criteria

  • History of low back pain or pelvic girdle pain before pregnancy. Multiple pregnancy (twins or higher-order pregnancy). Receiving other physical therapy interventions or pain-related medication during the study period.

History of major trauma. Musculoskeletal injury or fracture. Myofascial pain syndrome. Fibromyalgia. Osteoarthritis. Neurological disorders (e.g., radiculopathy or myelopathy). Chronic inflammatory disease. History of cancer. Osteoporosis. Inability to comply with the study procedures.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • ANTE SAĞLIK Op. Dr. Bilge Öğütçüoğlu Clinic — Kocaeli

Publications

  • Thibaut D, Santarlas V, Hoppes J, Vasquez-Castillo A, Morrow A, Oviedo E, Toldi J. Osteopathic Manipulation as a Method of Cortisol Modification: A Systematic Review. Cureus. 2023 Mar 29;15(3):e36854. doi: 10.7759/cureus.36854. eCollection 2023 Mar. PMID 37123793
  • Licciardone JC, Kearns CM, Hodge LM, Bergamini MV. Associations of cytokine concentrations with key osteopathic lesions and clinical outcomes in patients with nonspecific chronic low back pain: results from the OSTEOPATHIC Trial. J Am Osteopath Assoc. 2012 Sep;112(9):596-605. doi: 10.7556/jaoa.2012.112.9.596. PMID 22984233
  • Franke H, Franke JD, Belz S, Fryer G. Osteopathic manipulative treatment for low back and pelvic girdle pain during and after pregnancy: A systematic review and meta-analysis. J Bodyw Mov Ther. 2017 Oct;21(4):752-762. doi: 10.1016/j.jbmt.2017.05.014. Epub 2017 May 31. PMID 29037623
  • Yin YT, Lin KY, Chen CY, Yeh CN, Li YT. The effects of core stabilizing exercise in postpartum women with lumbopelvic pain: A systematic review with meta-analysis. Braz J Phys Ther. 2026 May-Jun;30(3):101597. doi: 10.1016/j.bjpt.2026.101597. Epub 2026 Apr 1. PMID 41930536

Identifiers

NCT: NCT07631949 · AYO-Postpartum-2026-06

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗