Postpartum Lumbopelvic PainNCT07631949
Osteopathy in Postpartum Lumbopelvic Pain
A study testing Core Stabilization Exercises, Patient Education and Osteopathic Manipulative Treatment in people with Postpartum Lumbopelvic Pain and Postpartum Pelvic Girdle Pain, run by Halic University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Postpartum Lumbopelvic Pain, Postpartum Pelvic Girdle Pain, Postpartum Low Back Pain
- What is being tested?
- Core Stabilization Exercises, Patient Education and Osteopathic Manipulative Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2026to 1 Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
ANTE SAĞLIK Op. Dr. Bilge Öğütçüoğlu Clinic
Kocaeli, İzmit, 41040
About this study
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
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.
Read more
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.
Read the 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.
- Being tested
- Core Stabilization Exercises, Patient Education, Osteopathic Manipulative Treatment, Sham Osteopathic Manipulative Treatment
- Keywords
- Postpartum Lumbopelvic Pain, Osteopathic Manipulative Treatment, Core Stabilization Exercise, Inflammatory Biomarkers, Cortisol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core Stabilization ExercisesBehavioural
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.
Patient EducationBehavioural
Participants will receive education regarding postpartum lumbopelvic pain, posture, activity modification, daily life recommendations, and self-management strategies.
Osteopathic Manipulative TreatmentOther
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.
Sham Osteopathic Manipulative TreatmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Core Stabilization Exercises; Behavioral: Patient Education; Other: Sham Osteopathic Manipulative Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Week 9
Secondary outcomes (21)
Change from Baseline in Pain Intensity at Rest Measured by Visual Analog Scale (VAS)
Change from baseline in pain intensity at rest measured using a 10-cm Visual Analog Scale (VAS). Higher scores indicate greater pain intensity.
Measured: Baseline and Week 9
Change from Baseline in Pain Intensity During Activity Measured by Visual Analog Scale (VAS)
Change from baseline in pain intensity during activity measured using a 10-cm Visual Analog Scale (VAS). Higher scores indicate greater pain intensity.
Measured: Baseline and Week 9
Change from Baseline in Night Pain Measured by Visual Analog Scale (VAS)
Change from baseline in night pain measured using a 10-cm Visual Analog Scale (VAS). Higher scores indicate greater pain intensity.
Measured: Baseline and Week 9
Change from Baseline in Pelvic Girdle Questionnaire (PGQ) Score
Change from baseline in pelvic girdle pain-related disability measured using the Pelvic Girdle Questionnaire. Higher scores indicate greater disability.
Measured: Baseline and Week 9
Change from Baseline in SF-12 Physical Component Score
Change from baseline in health-related quality of life measured using the SF-12 Physical Component Score. Higher scores indicate better physical health status.
Measured: Baseline and Week 9
Change from Baseline in SF-12 Mental Component Score
Change from baseline in health-related quality of life measured using the SF-12 Mental Component Score. Higher scores indicate better mental health status.
Measured: Baseline and Week 9
Change from Baseline in Edinburgh Postnatal Depression Scale (EPDS) Score
Change from baseline in depressive symptoms measured using the Edinburgh Postnatal Depression Scale. Higher scores indicate greater depressive symptom severity.
Measured: Baseline and Week 9
Change from Baseline in C-Reactive Protein (CRP) Level
Change from baseline in serum C-reactive protein concentration.
Measured: Baseline and Week 9
Change from Baseline in Interleukin-6 (IL-6) Level
Change from baseline in serum interleukin-6 concentration.
Measured: Baseline and Week 9
Change from Baseline in Interleukin-10 (IL-10) Level
Change from baseline in serum interleukin-10 concentration.
Measured: Baseline and Week 9
Change from Baseline in Tumor Necrosis Factor-Alpha (TNF-α) Level
Change from baseline in serum tumor necrosis factor-alpha concentration.
Measured: Baseline and Week 9
Change from Baseline in Serum Cortisol Level
Change from baseline in serum cortisol concentration.
Measured: Baseline and Week 9
Change from Baseline in Pressure Pain Threshold at the Lumbar Region Measured by Algometer
Change from baseline in lumbar pressure pain threshold measured using a digital algometer. Measurements are obtained bilaterally at points located 5 cm lateral to the L3 spinous process. Three measurements are recorded at each site and the mean value is used for analysis. Higher values indicate a higher pressure pain threshold and lower pain sensitivity.
Measured: Baseline and week 9
Change from Baseline in Gluteus Medius Pressure Pain Threshold
Change from baseline in pressure pain threshold of the gluteus medius muscle measured using a digital algometer. Three measurements are averaged for analysis.
Measured: Baseline and Week 9
Change from Baseline in Gluteus Maximus Pressure Pain Threshold
Change from baseline in pressure pain threshold of the gluteus maximus muscle measured using a digital algometer. Three measurements are averaged for analysis.
Measured: Baseline and Week 9
Change from Baseline in Piriformis Pressure Pain Threshold
Change from baseline in pressure pain threshold of the piriformis muscle measured using a digital algometer. Three measurements are averaged for analysis.
Measured: Baseline and Week 9
Change from Baseline in Trunk Flexor Endurance Time
Change from baseline in trunk flexor muscle endurance measured using the Trunk Flexor Endurance Test. Participants maintain a standardized seated trunk flexion position with the trunk supported at approximately 60 degrees and the support removed. Endurance time is recorded in seconds until the test position can no longer be maintained. Longer times indicate greater trunk flexor endurance.
Measured: Baseline and Week 9
Change from Baseline in Trunk Extensor Endurance Time
Change from baseline in trunk extensor muscle endurance measured using the Biering-Sørensen Test. Participants maintain the upper body unsupported in a horizontal prone position while the pelvis and lower extremities are stabilized. Endurance time is recorded in seconds until the position can no longer be maintained. Longer times indicate greater trunk extensor endurance.
Measured: Baseline and Week 9
Change from Baseline in Right Side Plank Endurance Time
Change from baseline in right lateral trunk muscle endurance measured using the Side Plank Test. Participants maintain a side plank position supported on the forearm and feet. Endurance time is recorded in seconds until loss of the test position. Longer times indicate greater lateral trunk muscle endurance.
Measured: Baseline and Week 9
Change from Baseline in Left Side Plank Endurance Time
Change from baseline in left lateral trunk muscle endurance measured using the Side Plank Test. Participants maintain a side plank position supported on the forearm and feet. Endurance time is recorded in seconds until loss of the test position. Longer times indicate greater lateral trunk muscle endurance.
Measured: Baseline and Week 9
Change from Baseline in Prone Plank Endurance Time
Change from baseline in trunk stabilization endurance measured using the Prone Plank Test. Participants maintain a prone plank position supported on the forearms and toes. Endurance time is recorded in seconds until loss of the test position. Longer times indicate greater trunk stabilization endurance.
Measured: Baseline and Week 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start1 Jun 2026
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Postpartum Lumbopelvic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Halic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seda Saka, Halic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07631949
- Sponsor's protocol ID
- AYO-Postpartum-2026-06
- Status last verified
- Sep 2026
- First submitted
- 2 Jun 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 37123793Licciardone 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.
PubMed 22984233Franke 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.
PubMed 29037623Yin 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.
PubMed 41930536