Effects of Soft Tissue Mobilization on Postsurgical Adhesions, Pain, Lumbopelvic Muscle Functions, Spinal Mobility, and Posture in Postpartum Women With Caesarean Section

July 1, 2026 updated by: YI-JU TSAI
Postpartum women with C-section receiving deep and superficial tissue mobilization would have better improvement on pain, lumbopelvic muscle functions, spinal mobility, and posture compare to the superficial tissue mobilization and control group

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Suspended

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Taiwan
    • Tainan
      • Tainan, Tainan, Taiwan, 701
        • National Cheng Kung University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

vaginal delivery

Inclusion Criteria:

  • Natural birth without C-section scar
  • Postpartum more than 6 months
  • Without any pain in the lumbopelvic region

C-section

Inclusion Criteria:

  • Healed C-section scar > six months
  • Scar with or without pain

Both mode of delivery

Exclusion Criteria:

  • Active infection or infectious disease in the pelvis or abdomen
  • Pain medications on days of measurements
  • Skin irritation and inflammation at the site of the scar
  • Currently pregnant or actively trying to get pregnant
  • History of radiation to the area
  • Any fracture around spine and pelvis
  • Any previous gynecologic and obstetric surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: deep and superficial tissue mobilization group
include deep and superficial tissue mobilization
Other: Myofascial abdominal diaphragm release
Myofascial abdominal diaphragm release
Other: Direct focused scar release technique
Direct focused scar release technique
Other: Direct manipulations to visceral structures
Direct manipulations to visceral structures
Other: pelvic anatomy education
pelvic anatomy education
Active Comparator: superficial tissue mobilization group
superficial tissue mobilization
Other: Myofascial abdominal diaphragm release
Myofascial abdominal diaphragm release
Other: Direct focused scar release technique
Direct focused scar release technique
Placebo Comparator: control group
Sham (very light hand touch on the same location as the other two groups but without any treatment intention)
Other: pelvic anatomy education
pelvic anatomy education
Other: sham
sham
Other: vaginal delivery group
education session
Other: pelvic anatomy education
pelvic anatomy education

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Scar Characteristic: Extensibility
Time Frame: 8 weeks
The extensibility of the scar will be measured using the modified adheremeter in each of 4 directions including superior, inferior, medial and lateral and then the area of mobility will be calculated.
8 weeks
Scar Characteristic: Viscoelasticity
Time Frame: 8 weeks
The biomechanical and viscoelastic properties of the scar tissue will be measured using a non-invasive myometer
8 weeks
Scar Characteristic: Irritability
Time Frame: 8 weeks
The irritability of the scar will be measured using the digital pressure algometer for two conditions: first, when the pressure turns from discomfort to pain and the participant asks to stop, and then when the maximal pressure or pain the participant can tolerate.
8 weeks
Muscle function measures of lumbopelvic muscles
Time Frame: 8 weeks
Ultrasonography image for muscle thickness of lumbopelvic muscles during rest and maximum contraction.
8 weeks
Muscle function measures of pelvic floor muscle control
Time Frame: 8 weeks
Ultrasonography image for muscle thickness of pelvic floor muscle control during rest, maximum contraction
8 weeks
Spinal Mobility
Time Frame: 8 weeks
Range of motion for cervical, thoracic, and lumbar spine in the sagittal, frontal, and transverse plane as well as pelvic tilt will be assessed using the wireless double inclinometers
8 weeks
Myofascial Flexibility
Time Frame: 8 weeks
Straight leg raise test and Thomas test will be used to examine the muscle flexibility of the major lower extremity muscles.
8 weeks
Spinal Alignment and Posture
Time Frame: 8 weeks
Radiographic measurement, posture will be assessed using the photographic measurement. Reflective markers will first be placed and attached on the canthus of the eye, tragus of the ear, the spinous processes of C2, C7, T1, T3, T11, T12, L1, L5, S1, S5, and bilateral anterior superior iliac spine and posterior superior iliac spine in standing. The participants will be instructed to maintain their gaze straight ahead at a target adjusted for body height. Two standing photographs will be taken, one in the usual standing posture and the other in the best standing posture. Following the other two photographs will be taken, one in maximal pelvic anterior tilt and the other in the maximal pelvic posterior tilt.
8 weeks
Pain intensity measure of Visual Analogue Scale
Time Frame: 8 weeks
Visual Analogue Scale is a self-reported instrument assessing average pain intensity in currently. Possible score range from 0 (no pain) to 10 (worst possible pain).
8 weeks
Pain intensity measure of pelvic girdle questionnaire
Time Frame: 8 weeks
pelvic girdle questionnaire is a self-reported instrument assessing pelvic girdle pain intensity in currently. Questionnaire consisting of 20 activity items and 5 symptom items on a 4-point response scale. Possible score range from 0 (no pain) to 100 (worst possible pain).
8 weeks
Pain intensity measure of Oswestry Low Back Pain Disability Questionnaire
Time Frame: 8 weeks
Oswestry Low Back Pain Disability Questionnaire is a self-reported instrument assessing patient's permanent functional disability in currently. For each section the total possible score is 5: if the first statement is marked the section score = 0; if the last statement is marked, it = 5. The higher the score, the greater the degree of disability.
8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Self-perceived Change Health Status: Global Rating of Change Scale (GROC)
Time Frame: 8 weeks
The GROC is a single-item instrument that provides a means of measuring self-perceived change in health status. The GROC uses the 15-point Likert scale to rate the perceived "overall change" on a continuum, with -7 (labeled "worse") on the left and +7 (labeled "better") on the right, and 0 in the middle (labeled "no change"), compared with the baseline
8 weeks
Patient and Observer Scar Assessment Scale (POSAS)
Time Frame: 8 weeks
The POSAS includes 2 numerical numeric scales: The Patient Scar Assessment Scale and the Observer Scar Assessment Scale. It objectively assesses vascularity, pigmentation, thickness, relief, pliability, and surface area, and incorporates patient subjective symptoms of pain, itching, color, stiffness, thickness, and relief.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
YI-JU TSAI

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 8, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 10, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 17, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NCKU_adhesion

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings