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

Primary Purpose

Postsurgical Adhesion

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Myofascial abdominal diaphragm release
Direct focused scar release technique
Direct manipulations to visceral structures
pelvic anatomy education
sham
Sponsored by
YI-JU TSAI
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postsurgical Adhesion

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • National Cheng Kung UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Placebo Comparator

Other

Arm Label

deep and superficial tissue mobilization group

superficial tissue mobilization group

control group

vaginal delivery group

Arm Description

include deep and superficial tissue mobilization

superficial tissue mobilization

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

education session

Outcomes

Primary Outcome Measures

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.
Scar Characteristic: Viscoelasticity
The biomechanical and viscoelastic properties of the scar tissue will be measured using a non-invasive myometer
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.
Muscle function measures of lumbopelvic muscles
Ultrasonography image for muscle thickness of lumbopelvic muscles during rest and maximum contraction.
Muscle function measures of pelvic floor muscle control
Ultrasonography image for muscle thickness of pelvic floor muscle control during rest, maximum contraction
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
Myofascial Flexibility
Straight leg raise test and Thomas test will be used to examine the muscle flexibility of the major lower extremity muscles.
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.
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).
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).
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.

Secondary Outcome Measures

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
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.

Full Information

First Posted
August 10, 2021
Last Updated
September 19, 2023
Sponsor
YI-JU TSAI
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1. Study Identification

Unique Protocol Identification Number
NCT05008315
Brief Title
Effects of Soft Tissue Mobilization on Postsurgical Adhesions, Pain, Lumbopelvic Muscle Functions, Spinal Mobility, and Posture in Postpartum Women With Caesarean Section
Official Title
Effects of Soft Tissue Mobilization on Postsurgical Adhesions, Pain, Lumbopelvic Muscle Functions, Spinal Mobility, and Posture in Postpartum Women With Caesarean Section
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 8, 2023 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
YI-JU TSAI

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postsurgical Adhesion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
deep and superficial tissue mobilization group
Arm Type
Experimental
Arm Description
include deep and superficial tissue mobilization
Arm Title
superficial tissue mobilization group
Arm Type
Active Comparator
Arm Description
superficial tissue mobilization
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
Sham (very light hand touch on the same location as the other two groups but without any treatment intention)
Arm Title
vaginal delivery group
Arm Type
Other
Arm Description
education session
Intervention Type
Other
Intervention Name(s)
Myofascial abdominal diaphragm release
Intervention Description
Myofascial abdominal diaphragm release
Intervention Type
Other
Intervention Name(s)
Direct focused scar release technique
Intervention Description
Direct focused scar release technique
Intervention Type
Other
Intervention Name(s)
Direct manipulations to visceral structures
Intervention Description
Direct manipulations to visceral structures
Intervention Type
Other
Intervention Name(s)
pelvic anatomy education
Intervention Description
pelvic anatomy education
Intervention Type
Other
Intervention Name(s)
sham
Intervention Description
sham
Primary Outcome Measure Information:
Title
Scar Characteristic: Extensibility
Description
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.
Time Frame
8 weeks
Title
Scar Characteristic: Viscoelasticity
Description
The biomechanical and viscoelastic properties of the scar tissue will be measured using a non-invasive myometer
Time Frame
8 weeks
Title
Scar Characteristic: Irritability
Description
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.
Time Frame
8 weeks
Title
Muscle function measures of lumbopelvic muscles
Description
Ultrasonography image for muscle thickness of lumbopelvic muscles during rest and maximum contraction.
Time Frame
8 weeks
Title
Muscle function measures of pelvic floor muscle control
Description
Ultrasonography image for muscle thickness of pelvic floor muscle control during rest, maximum contraction
Time Frame
8 weeks
Title
Spinal Mobility
Description
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
Time Frame
8 weeks
Title
Myofascial Flexibility
Description
Straight leg raise test and Thomas test will be used to examine the muscle flexibility of the major lower extremity muscles.
Time Frame
8 weeks
Title
Spinal Alignment and Posture
Description
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.
Time Frame
8 weeks
Title
Pain intensity measure of Visual Analogue Scale
Description
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).
Time Frame
8 weeks
Title
Pain intensity measure of pelvic girdle questionnaire
Description
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).
Time Frame
8 weeks
Title
Pain intensity measure of Oswestry Low Back Pain Disability Questionnaire
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Self-perceived Change Health Status: Global Rating of Change Scale (GROC)
Description
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
Time Frame
8 weeks
Title
Patient and Observer Scar Assessment Scale (POSAS)
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tsai Yi-Ju
Phone
06-2353535
Ext
5930
Email
lulilutsai@gmail.com
Facility Information:
Facility Name
National Cheng Kung University
City
Tainan
ZIP/Postal Code
701
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi-Ju Tsai

12. IPD Sharing Statement

Learn more about this trial

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

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