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

NCT05008315 | Suspended

• 1 other identifier: NCKU_adhesion
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Postsurgical Adhesion

Outcome Measures

Primary Outcomes (11)

• 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 Outcomes (2)

• Self-perceived Change Health Status: Global Rating of Change Scale (GROC)

  8 weeks

• Patient and Observer Scar Assessment Scale (POSAS)

  8 weeks

Study Arms (4)

deep and superficial tissue mobilization group

EXPERIMENTAL

include deep and superficial tissue mobilization

Other: Myofascial abdominal diaphragm release; Other: Direct focused scar release technique; Other: Direct manipulations to visceral structures; Other: pelvic anatomy education

superficial tissue mobilization group

ACTIVE COMPARATOR

superficial tissue mobilization

Other: Myofascial abdominal diaphragm release; Other: Direct focused scar release technique

control group

PLACEBO COMPARATOR

Sham (very light hand touch on the same location as the other two groups but without any treatment intention)

Other: pelvic anatomy education; Other: sham

vaginal delivery group

OTHER

education session

Other: pelvic anatomy education

Interventions

Myofascial abdominal diaphragm release OTHER

Myofascial abdominal diaphragm release

deep and superficial tissue mobilization group; superficial tissue mobilization group

Direct focused scar release technique OTHER

Direct focused scar release technique

deep and superficial tissue mobilization group; superficial tissue mobilization group

Direct manipulations to visceral structures OTHER

Direct manipulations to visceral structures

deep and superficial tissue mobilization group

pelvic anatomy education OTHER

pelvic anatomy education

control group; deep and superficial tissue mobilization group; vaginal delivery group

sham OTHER

sham

control group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Natural birth without C-section scar
• Postpartum more than 6 months
• Without any pain in the lumbopelvic region
• C-section
• Healed C-section scar \> six months
• Scar with or without pain
• Both mode of delivery

You may not qualify if:

• 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

Sponsors & Collaborators

• YI-JU TSAI: lead

Study Sites (1)

National Cheng Kung University

Tainan, Tainan, 701, Taiwan

Location

MeSH Terms

Interventions

salicylhydroxamic acid

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: August 10, 2021
• First Posted: August 17, 2021
• Study Start: April 8, 2023
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 23, 2025

Record last verified: 2025-05

Locations

TW (1)