Health TrialsbyHealthPanel

Osteopathy in Postpartum Lumbopelvic Pain

ConditionsPostpartum Lumbopelvic PainPostpartum Pelvic Girdle PainPostpartum Low Back Pain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorHalic University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Patient Education

    Behavioral

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

  • Osteopathic Manipulative Treatment

    Other intervention

    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 Treatment

    Other intervention

    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.

Treatment groups

45 Participants
are divided into 3 treatment groups
Group A: Education and Core Stabilization ExercisesActive comparator 2 interventions
Group B: Education and Core Stabilization Exercises + OMTExperimental treatment 3 interventions
Group C: Education and Core Stabilization Exercises + Sham OMTSham comparator 3 interventions

Trial outcomes

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.

Time frame
Baseline and Week 9

Secondary outcomes

1

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.

Time frame
Baseline and Week 9
2

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.

Time frame
Baseline and Week 9
3

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.

Time frame
Baseline and Week 9
4

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.

Time frame
Baseline and Week 9

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Halic University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: