Postsurgical AdhesionNCT05008315
Effects of Soft Tissue Mobilization on Postsurgical Adhesions, Pain, Lumbopelvic Muscle Functions, Spinal Mobility, and Posture in Postpartum Women With Caesarean Section
A study testing Myofascial abdominal diaphragm release, Direct focused scar release technique and Direct manipulations to visceral structures in people with Postsurgical Adhesion, run by YI-JU TSAI at 1 site in Taiwan.
Trial 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 Read more about this study
- Who is it for?
- Ages 20 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postsurgical Adhesion
- What is being tested?
- Myofascial abdominal diaphragm release, Direct focused scar release technique and Direct manipulations to visceral structures
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 8 Apr 2023to Dec 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Myofascial abdominal diaphragm release, Direct focused scar release technique, Direct manipulations to visceral structures, pelvic anatomy education, sham
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myofascial abdominal diaphragm releaseOther
Myofascial abdominal diaphragm release
Direct focused scar release techniqueOther
Direct focused scar release technique
Direct manipulations to visceral structuresOther
Direct manipulations to visceral structures
pelvic anatomy educationOther
pelvic anatomy education
shamOther
sham
| Study group | Role | What they receive |
|---|---|---|
| deep and superficial tissue mobilization group | Experimental | include deep and superficial tissue mobilization Receives: 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 Receives: 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) Receives: Other: pelvic anatomy education; Other: sham |
| vaginal delivery group | Other | education session Receives: Other: pelvic anatomy education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Scar Characteristic: Viscoelasticity
The biomechanical and viscoelastic properties of the scar tissue will be measured using a non-invasive myometer
Measured: 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.
Measured: 8 weeks
Muscle function measures of lumbopelvic muscles
Ultrasonography image for muscle thickness of lumbopelvic muscles during rest and maximum contraction.
Measured: 8 weeks
Muscle function measures of pelvic floor muscle control
Ultrasonography image for muscle thickness of pelvic floor muscle control during rest, maximum contraction
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 8 weeks
Secondary outcomes (2)
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
Measured: 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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2021
- Study start8 Apr 2023
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Why it stopped: The clinical trial has been suspended due to a lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postsurgical AdhesionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- YI-JU TSAI
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, YI-JU TSAI, National Cheng Kung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05008315
- Sponsor's protocol ID
- NCKU_adhesion
- Status last verified
- Jul 2026
- First submitted
- 10 Aug 2021
- Last updated
- 6 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Soft Tissue Mobilization on Postsurgical Adhesions, Pain, Lumbopelvic Muscle Functions, Spinal Mobility, and Posture in Postpartum Women With Caesarean Section
- ClinicalTrials.gov ID
- NCT05008315
- Acronym / sponsor ID
- NCKU_adhesion
- Conditions
- Postsurgical Adhesion
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: The clinical trial has been suspended due to a lack of funding
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- YI-JU TSAIUniversity, hospital or other
- Study start
- 8 Apr 2023 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 17 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| deep and superficial tissue mobilization group | Experimental | Other: Myofascial abdominal diaphragm release, Other: Direct focused scar release technique, Other: Direct manipulations to visceral structures, Other: pelvic anatomy educationinclude deep and superficial tissue mobilization |
| superficial tissue mobilization group | Active comparator | Other: Myofascial abdominal diaphragm release, Other: Direct focused scar release techniquesuperficial tissue mobilization |
| control group | Placebo comparator | Other: pelvic anatomy education, Other: shamSham (very light hand touch on the same location as the other two groups but without any treatment intention) |
| vaginal delivery group | Other | Other: pelvic anatomy educationeducation session |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Myofascial abdominal diaphragm releaseMyofascial abdominal diaphragm release | Other | deep and superficial tissue mobilization group, superficial tissue mobilization group |
| Direct focused scar release techniqueDirect focused scar release technique | Other | deep and superficial tissue mobilization group, superficial tissue mobilization group |
| Direct manipulations to visceral structuresDirect manipulations to visceral structures | Other | deep and superficial tissue mobilization group |
| pelvic anatomy educationpelvic anatomy education | Other | control group, deep and superficial tissue mobilization group, vaginal delivery group |
| shamsham | Other | control group |
Primary outcome
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.
Scar Characteristic: Viscoelasticity
Time frame: 8 weeks
The biomechanical and viscoelastic properties of the scar tissue will be measured using a non-invasive myometer
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.
Muscle function measures of lumbopelvic muscles
Time frame: 8 weeks
Ultrasonography image for muscle thickness of lumbopelvic muscles during rest and maximum contraction.
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
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
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.
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.
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).
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).
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.
2 secondary outcomes
Self-perceived Change Health Status: Global Rating of Change Scale (GROC)
Time frame: 8 weeks
Patient and Observer Scar Assessment Scale (POSAS)
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myofascial abdominal diaphragm release, Direct focused scar release technique and Direct manipulations to visceral structures in people with Postsurgical Adhesion, run by YI-JU TSAI at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scar Characteristic: Extensibility (time frame: 8 weeks). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.