NCT06907394

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable low-back-pain

Timeline
Completed

Started Apr 2025

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 2, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

1 year

First QC Date

March 26, 2025

Last Update Submit

April 25, 2026

Conditions

Keywords

Osteopathic ManipulationLow Back PainPost Cesarean Section AdhesionsVisual Analogue ScaleOswestry Low Back Disability QuestionnaireModified Schober Test

Outcome Measures

Primary Outcomes (1)

  • Visual analogue scale

    a self-reported pain measurement a widely utilized scale in rehabilitation. It has been shown to be valid and reliable, and its ratio scale properties make VAS the optional tool for describing pain intensity

    Pre-treatment, and Post-treatment of the the study treatment program afetr 4-weeks).

Secondary Outcomes (2)

  • Oswestry Low Back Disability Questionnaire

    Pre-treatment, and Post-treatment of the the study treatment program after 4-weeks).

  • Modified Schober Test

    Pre-treatment, and Post-treatment of the the study treatment program after4-weeks).

Study Arms (2)

Control Group

PLACEBO COMPARATOR

Fifteen Females will receive only analgesic drugs for four weeks.

Other: Control Group

Study Group

EXPERIMENTAL

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

Other: Osteopathic ManipulationsOther: Control Group

Interventions

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

Study Group

Paracetamol tablets

Control GroupStudy Group

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe study targeting post cesarean section adhesions (among women) on low back pain management.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mitghamer Hospital, Mitghamer city, Qalyubia Governate

Al Maţmar, Qalubyia, 35611, Egypt

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Khadija S Abdulaziz, PHD

    Professor of Physical Therapy for Woman's Health

    STUDY CHAIR
  • Mohamed A Abo Elainin, PHD

    Consultant of Obstetrics and Gynecology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized, Pre/Posttreatment, Controlled Trial.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecturer of Physical Therapy

Study Record Dates

First Submitted

March 26, 2025

First Posted

April 2, 2025

Study Start

April 1, 2025

Primary Completion

April 1, 2026

Study Completion

April 1, 2026

Last Updated

April 30, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations