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

Lead sponsor

YI-JU TSAI is the lead sponsor of 4 studies on the registry; 2 are open to participants now.

Eligibility criteria

Study arms

• Experimental
  deep and superficial tissue mobilization group

  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

• Active comparator
  superficial tissue mobilization group

  superficial tissue mobilization

  Other: Myofascial abdominal diaphragm release · Other: 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 · Other: sham

• Other
  vaginal delivery group

  education session

  Other: pelvic anatomy education

Interventions

• OtherMyofascial abdominal diaphragm release

  Myofascial abdominal diaphragm release

• OtherDirect focused scar release technique

  Direct focused scar release technique

• OtherDirect manipulations to visceral structures

  Direct manipulations to visceral structures

• Otherpelvic anatomy education

  pelvic anatomy education

• Othersham

  sham

Primary outcomes

1. 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.

   Time frame: 8 weeks

2. Scar Characteristic: Viscoelasticity

   The biomechanical and viscoelastic properties of the scar tissue will be measured using a non-invasive myometer

   Time frame: 8 weeks

3. 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.

   Time frame: 8 weeks

4. Muscle function measures of lumbopelvic muscles

   Ultrasonography image for muscle thickness of lumbopelvic muscles during rest and maximum contraction.

   Time frame: 8 weeks

5. Muscle function measures of pelvic floor muscle control

   Ultrasonography image for muscle thickness of pelvic floor muscle control during rest, maximum contraction

   Time frame: 8 weeks

6. 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

   Time frame: 8 weeks

7. Myofascial Flexibility

   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

8. 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.

   Time frame: 8 weeks

9. 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).

   Time frame: 8 weeks

10. 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).

    Time frame: 8 weeks

11. 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.

    Time frame: 8 weeks

Secondary outcomes

1. 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

   Time frame: 8 weeks

2. 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.

   Time frame: 8 weeks