Osteopathy of Post Cesarean Section Adhesions

NCT ID: NCT06907394

Last Updated: 2025-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-01

Study Completion Date

2025-09-01

Brief Summary

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Chronic low back pain post cesarean section adhesions represents a restricting dysfunction, mainly influences abdominal fascia that leads to major welfare and economic restrictions. Osteopathic manipulation is a drug-free non-invasive is the therapeutic application of manually guided forces to improve physiologic function and support homeostasis. The purpose of the current study is to determine the effect of osteopathic manipulations of post cesarean section adhesions on low back pain

Detailed Description

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Chronic low back pain is a common musculoskeletal disorder affects adults with 84% prevalence. It influences lower back, and lasts at least 12 weeks. Where increased annual cesarean section rates up to 19.1% associated with scar, pelvic, abdominal and low back pain disorders (Chia et al., 2016). From the fascial point of view, abdominal muscles are in continuity with the thoracolumbar fascia and the pelvic floor. It has been demonstrated that they work with great synergy and guaranteed by fascial continuity (Fan et al., 2018).

Osteopathic manipulative technique consists of a range of direct, indirect, combined, fluid and reflex-based manual techniques that are applied specifically to a joint or non-specifically to a body area. Direct techniques apply thrust, impulse, muscle contraction, fascial loading or passive range of motion (Fan et al., 2018).The purpose of the current study is to determine the effect of osteopathic manipulations of post cesarean section adhesions on low back pain. Up on that 30 post cesarean women suffering from low back pain at least for 6 months from the Outpatient Clinic of Mitghamer Hospital, El-Daqahlia. Their age range 20-35 years old, BMI range≤ 25 kg /m2. They will be allocated into control group will receive analgesics. Study group will receive four weeks of analgesics, plus osteopathic manipulations once per week.

Conditions

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Low Back Pain Cesarean Section Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, Pre/Posttreatment, Controlled Trial.
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
The whole participants, care provider, investigator and the outcome assessor will not be aware of each participant allocation within the current study groups; Based on a third person will be assigned for randomization.

Study Groups

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Control Group

Fifteen Females will receive only analgesic drugs for four weeks.

Group Type PLACEBO_COMPARATOR

Control Group

Intervention Type OTHER

Paracetamol tablets

Study Group

Fifteen females will receive osteopathic manipulations once weekly along four weeks, plus analgesic drugs for four weeks.

Group Type EXPERIMENTAL

Osteopathic Manipulations

Intervention Type OTHER

Osteopathic Manipulations (a. Myofascial release technique: Direct scar release+ Indirect scar release 'Fascial unwinding'; b. Grand Maneuver; Visceral manipulations of uterus

Control Group

Intervention Type OTHER

Paracetamol tablets

Interventions

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Osteopathic Manipulations

Osteopathic Manipulations (a. Myofascial release technique: Direct scar release+ Indirect scar release 'Fascial unwinding'; b. Grand Maneuver; Visceral manipulations of uterus

Intervention Type OTHER

Control Group

Paracetamol tablets

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* They suffered from low back pain and undergoes cesarean section at least 6 months before entry into study.
* Their body mass index (BMI) will be ≤ 25 kg /m2.
* Their age will range from 20 to 35 years.
* They would not use any other analgesic drugs during the study period.

Exclusion Criteria

* Pregnancy or suspected pregnancy.
* Recent abdominal surgery
* Patients with severe spinal pathology (cauda equine syndrome, spinal canal stenosis, fracture of spine, discitis, infectious disease of spine).
* Cancer.
* Abdominal and pelvic infection, open wound, burn and skin irritation.
Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Adly A Adam

OTHER

Sponsor Role lead

Responsible Party

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Adly A Adam

Lecturer of Physical Therapy

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Khadija S Abdulaziz, PHD

Role: STUDY_CHAIR

Professor of Physical Therapy for Woman's Health

Mohamed A Abo Elainin, PHD

Role: STUDY_DIRECTOR

Consultant of Obstetrics and Gynecology

Locations

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Mitghamer Hospital, Mitghamer city, Qalyubia Governate

Al Maţmar, Qalubyia, Egypt

Site Status

Countries

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Egypt

Central Contacts

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Radwa H Fayiad, B.Sc

Role: CONTACT

+2035676103 ext. 105

Elham S Hassan, PHD

Role: CONTACT

+2035676103 ext. 103

Facility Contacts

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Radwa H Fayiad, B.Sc

Role: primary

+2035676103 ext. 105

Elham S Hassan, PHD

Role: backup

+2035676103 ext. 103

Other Identifiers

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P.T.REC/012/003148

Identifier Type: -

Identifier Source: org_study_id

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