Effects of Soft Tissue Mobilization on Postsurgical Adhesions, Pain, Lumbopelvic Muscle Functions, Spinal Mobility, and Posture in Postpartum Women With Caesarean Section
- Conditions
- Postsurgical Adhesion
- Interventions
- Other: Myofascial abdominal diaphragm releaseOther: shamOther: Direct focused scar release techniqueOther: Direct manipulations to visceral structuresOther: pelvic anatomy education
- Registration Number
- NCT05008315
- Lead Sponsor
- YI-JU TSAI
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- Female
- Target Recruitment
- 120
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description deep and superficial tissue mobilization group Myofascial abdominal diaphragm release include deep and superficial tissue mobilization control group sham Sham (very light hand touch on the same location as the other two groups but without any treatment intention) deep and superficial tissue mobilization group Direct focused scar release technique include deep and superficial tissue mobilization deep and superficial tissue mobilization group pelvic anatomy education include deep and superficial tissue mobilization vaginal delivery group pelvic anatomy education education session superficial tissue mobilization group Myofascial abdominal diaphragm release superficial tissue mobilization superficial tissue mobilization group Direct focused scar release technique superficial tissue mobilization deep and superficial tissue mobilization group Direct manipulations to visceral structures include deep and superficial tissue mobilization control group pelvic anatomy education Sham (very light hand touch on the same location as the other two groups but without any treatment intention)
- Primary Outcome Measures
Name Time Method Scar Characteristic: Extensibility 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.
Muscle function measures of lumbopelvic muscles 8 weeks Ultrasonography image for muscle thickness of lumbopelvic muscles during rest and maximum contraction.
Muscle function measures of pelvic floor muscle control 8 weeks Ultrasonography image for muscle thickness of pelvic floor muscle control during rest, maximum contraction
Myofascial Flexibility 8 weeks Straight leg raise test and Thomas test will be used to examine the muscle flexibility of the major lower extremity muscles.
Pain intensity measure of Visual Analogue Scale 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 Oswestry Low Back Pain Disability Questionnaire 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.
Scar Characteristic: Irritability 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.
Spinal Alignment and Posture 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.
Scar Characteristic: Viscoelasticity 8 weeks The biomechanical and viscoelastic properties of the scar tissue will be measured using a non-invasive myometer
Pain intensity measure of pelvic girdle questionnaire 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).
Spinal Mobility 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
- Secondary Outcome Measures
Name Time Method Self-perceived Change Health Status: Global Rating of Change Scale (GROC) 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
Patient and Observer Scar Assessment Scale (POSAS) 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.
Trial Locations
- Locations (1)
National Cheng Kung University
🇨🇳Tainan, Taiwan