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

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: Suspended
• Conditions: Postsurgical Adhesion
• Intervention / Treatment: Other: Myofascial abdominal diaphragm release; Other: Direct focused scar release technique; Other: Direct manipulations to visceral structures; Other: pelvic anatomy education; Other: sham

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Scar Characteristic: Extensibility	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	The biomechanical and viscoelastic properties of the scar tissue will be measured using a non-invasive myometer	8 weeks
Scar Characteristic: Irritability	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	Ultrasonography image for muscle thickness of lumbopelvic muscles during rest and maximum contraction.	8 weeks
Muscle function measures of pelvic floor muscle control	Ultrasonography image for muscle thickness of pelvic floor muscle control during rest, maximum contraction	8 weeks
Spinal Mobility	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	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	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	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	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	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

Outcome Measure	Measure Description	Time Frame
Self-perceived Change Health Status: Global Rating of Change Scale (GROC)	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)	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

• Sponsor: YI-JU TSAI

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2023
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: August 10, 2021
• First Submitted That Met QC Criteria: August 10, 2021
• First Posted (Actual): August 17, 2021

Study Record Updates

• Last Update Posted (Actual): May 23, 2025
• Last Update Submitted That Met QC Criteria: May 20, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cicatrix; Fibrosis; Tissue Adhesions
• Other Study ID 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