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Osteopathy in Postpartum Lumbopelvic Pain

2026년 6월 2일 업데이트: Seda Saka, Halic University

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.

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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

45

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

  • 이름: Seda Saka, Associate Professor
  • 전화번호: +90 544 780 34 17
  • 이메일: sedasaka@halic.edu.tr

연구 연락처 백업

연구 장소

  • 터키 (Türkiye)
    • İzmit
      • Kocaeli, İzmit, 터키 (Türkiye), 41040
        • ANTE SAĞLIK Op. Dr. Bilge Öğütçüoğlu Clinic
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: Education and Core Stabilization Exercises
Participants will receive patient education and a supervised core stabilization exercise program. Exercises will be performed three times per week for six weeks.
행동: 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.
행동: Patient Education
Participants will receive education regarding postpartum lumbopelvic pain, posture, activity modification, daily life recommendations, and self-management strategies.
실험적: Education and Core Stabilization Exercises + OMT
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.
행동: 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.
행동: Patient Education
Participants will receive education regarding postpartum lumbopelvic pain, posture, activity modification, daily life recommendations, and self-management strategies.
다른: 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.
가짜 비교기: Education and Core Stabilization Exercises + Sham OMT
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.
행동: 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.
행동: Patient Education
Participants will receive education regarding postpartum lumbopelvic pain, posture, activity modification, daily life recommendations, and self-management strategies.
다른: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change from Baseline in Oswestry Disability Index (ODI)
기간: Baseline and Week 9
Change from baseline in disability measured using the Oswestry Disability Index (ODI). Higher scores indicate greater disability.
Baseline and Week 9

2차 결과 측정

결과 측정
측정값 설명
기간
Change from Baseline in Pain Intensity at Rest Measured by Visual Analog Scale (VAS)
기간: Baseline and Week 9
Change from baseline in pain intensity at rest measured using a 10-cm Visual Analog Scale (VAS). Higher scores indicate greater pain intensity.
Baseline and Week 9
Change from Baseline in Pain Intensity During Activity Measured by Visual Analog Scale (VAS)
기간: Baseline and Week 9
Change from baseline in pain intensity during activity measured using a 10-cm Visual Analog Scale (VAS). Higher scores indicate greater pain intensity.
Baseline and Week 9
Change from Baseline in Night Pain Measured by Visual Analog Scale (VAS)
기간: Baseline and Week 9
Change from baseline in night pain measured using a 10-cm Visual Analog Scale (VAS). Higher scores indicate greater pain intensity.
Baseline and Week 9
Change from Baseline in Pelvic Girdle Questionnaire (PGQ) Score
기간: Baseline and Week 9
Change from baseline in pelvic girdle pain-related disability measured using the Pelvic Girdle Questionnaire. Higher scores indicate greater disability.
Baseline and Week 9
Change from Baseline in SF-12 Physical Component Score
기간: Baseline and Week 9
Change from baseline in health-related quality of life measured using the SF-12 Physical Component Score. Higher scores indicate better physical health status.
Baseline and Week 9
Change from Baseline in SF-12 Mental Component Score
기간: Baseline and Week 9
Change from baseline in health-related quality of life measured using the SF-12 Mental Component Score. Higher scores indicate better mental health status.
Baseline and Week 9
Change from Baseline in Edinburgh Postnatal Depression Scale (EPDS) Score
기간: Baseline and Week 9
Change from baseline in depressive symptoms measured using the Edinburgh Postnatal Depression Scale. Higher scores indicate greater depressive symptom severity.
Baseline and Week 9
Change from Baseline in C-Reactive Protein (CRP) Level
기간: Baseline and Week 9
Change from baseline in serum C-reactive protein concentration.
Baseline and Week 9
Change from Baseline in Interleukin-6 (IL-6) Level
기간: Baseline and Week 9
Change from baseline in serum interleukin-6 concentration.
Baseline and Week 9
Change from Baseline in Interleukin-10 (IL-10) Level
기간: Baseline and Week 9
Change from baseline in serum interleukin-10 concentration.
Baseline and Week 9
Change from Baseline in Tumor Necrosis Factor-Alpha (TNF-α) Level
기간: Baseline and Week 9
Change from baseline in serum tumor necrosis factor-alpha concentration.
Baseline and Week 9
Change from Baseline in Serum Cortisol Level
기간: Baseline and Week 9
Change from baseline in serum cortisol concentration.
Baseline and Week 9
Change from Baseline in Pressure Pain Threshold at the Lumbar Region Measured by Algometer
기간: Baseline and week 9
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.
Baseline and week 9
Change from Baseline in Gluteus Medius Pressure Pain Threshold
기간: Baseline and Week 9
Change from baseline in pressure pain threshold of the gluteus medius muscle measured using a digital algometer. Three measurements are averaged for analysis.
Baseline and Week 9
Change from Baseline in Gluteus Maximus Pressure Pain Threshold
기간: Baseline and Week 9
Change from baseline in pressure pain threshold of the gluteus maximus muscle measured using a digital algometer. Three measurements are averaged for analysis.
Baseline and Week 9
Change from Baseline in Piriformis Pressure Pain Threshold
기간: Baseline and Week 9
Change from baseline in pressure pain threshold of the piriformis muscle measured using a digital algometer. Three measurements are averaged for analysis.
Baseline and Week 9
Change from Baseline in Trunk Flexor Endurance Time
기간: Baseline and Week 9
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.
Baseline and Week 9
Change from Baseline in Trunk Extensor Endurance Time
기간: Baseline and Week 9
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.
Baseline and Week 9
Change from Baseline in Right Side Plank Endurance Time
기간: Baseline and Week 9
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.
Baseline and Week 9
Change from Baseline in Left Side Plank Endurance Time
기간: Baseline and Week 9
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.
Baseline and Week 9
Change from Baseline in Prone Plank Endurance Time
기간: Baseline and Week 9
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.
Baseline and Week 9

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Halic University

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 6월 1일

기본 완료 (추정된)

2026년 8월 1일

연구 완료 (추정된)

2026년 12월 1일

연구 등록 날짜

최초 제출

2026년 6월 2일

QC 기준을 충족하는 최초 제출

2026년 6월 2일

처음 게시됨 (실제)

2026년 6월 8일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 8일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 2일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • AYO-Postpartum-2026-06

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

산후 요골반 통증에 대한 임상 시험

Core Stabilization Exercises에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Uzbekistan

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다