Osteopathy in Postpartum Lumbopelvic Pain

NCT07631949 | Not Yet Recruiting

• 1 other identifier: AYO-Postpartum-2026-06
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postpartum Lumbopelvic Pain; Postpartum Pelvic Girdle Pain; Postpartum Low Back Pain

Keywords

Postpartum Lumbopelvic Pain; Osteopathic Manipulative Treatment; Core Stabilization Exercise; Inflammatory Biomarkers; Cortisol

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Oswestry Disability Index (ODI)

  Change from baseline in disability measured using the Oswestry Disability Index (ODI). Higher scores indicate greater disability.

  Baseline and Week 9

Secondary Outcomes (21)

• Change from Baseline in Pain Intensity at Rest Measured by Visual Analog Scale (VAS)

  Baseline and Week 9

• Change from Baseline in Pain Intensity During Activity Measured by Visual Analog Scale (VAS)

  Baseline and Week 9

• Change from Baseline in Night Pain Measured by Visual Analog Scale (VAS)

  Baseline and Week 9

• Change from Baseline in Pelvic Girdle Questionnaire (PGQ) Score

  Baseline and Week 9

• Change from Baseline in SF-12 Physical Component Score

  Baseline and Week 9

Study Arms (3)

Education and Core Stabilization Exercises

ACTIVE COMPARATOR

Participants will receive patient education and a supervised core stabilization exercise program. Exercises will be performed three times per week for six weeks.

Behavioral: Core Stabilization Exercises; Behavioral: Patient Education

Education and Core Stabilization Exercises + OMT

EXPERIMENTAL

Participants will receive patient education, a supervised core stabilization exercise program, and Osteopathic Manipulative Treatment. Exercises will be performed three times per week for six weeks. Osteopathic Manipulative Treatment will be administered once every two weeks for a total of four sessions over eight weeks.

Behavioral: Core Stabilization Exercises; Behavioral: Patient Education; Other: Osteopathic Manipulative Treatment

Education and Core Stabilization Exercises + Sham OMT

SHAM COMPARATOR

Participants will receive patient education, a supervised core stabilization exercise program, and sham Osteopathic Manipulative Treatment. Exercises will be performed three times per week for six weeks. Sham Osteopathic Manipulative Treatment will be administered once every two weeks for a total of four sessions over eight weeks.

Behavioral: Core Stabilization Exercises; Behavioral: Patient Education; Other: Sham Osteopathic Manipulative Treatment

Interventions

Core Stabilization Exercises BEHAVIORAL

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.

Education and Core Stabilization Exercises; Education and Core Stabilization Exercises + OMT; Education and Core Stabilization Exercises + Sham OMT

Patient Education BEHAVIORAL

Participants will receive education regarding postpartum lumbopelvic pain, posture, activity modification, daily life recommendations, and self-management strategies.

Education and Core Stabilization Exercises; Education and Core Stabilization Exercises + OMT; Education and Core Stabilization Exercises + Sham OMT

Osteopathic Manipulative Treatment OTHER

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.

Education and Core Stabilization Exercises + OMT

Sham Osteopathic Manipulative Treatment OTHER

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.

Education and Core Stabilization Exercises + Sham OMT

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Halic University: lead

Study Sites (1)

ANTE SAĞLIK Op. Dr. Bilge Öğütçüoğlu Clinic

Kocaeli, İzmit, 41040, Turkey (Türkiye)

Location

Related Publications (4)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Interventions

Patient Education as Topic; Manipulation, Osteopathic

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Central Study Contacts

Seda Saka, Associate Professor

CONTACT

+90 544 780 34 17; sedasaka@halic.edu.tr

Abdullah Yahya Okur, PT

CONTACT

+90 534 957 31 47; fzt.abdullahokur@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be blinded to group allocation between Osteopathic Manipulative Treatment and sham Osteopathic Manipulative Treatment. Due to the nature of the interventions, the therapist providing the treatments and the investigator conducting the outcome assessments cannot be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Physiotherapy and Rehabilitation, Haliç University

Model Details: Participants will be randomly assigned to one of three parallel groups: education and core stabilization exercises, education and core stabilization exercises combined with Osteopathic Manipulative Treatment, or education and core stabilization exercises combined with sham Osteopathic Manipulative Treatment.

Study Record Dates

• First Submitted: June 2, 2026
• First Posted: June 8, 2026
• Study Start: June 1, 2026
• Primary Completion: August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)