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NCT Number: NCT06284278

Telehealth: Diaphragmatic vs. Pelvic Exercise in Postpartum Pregnancy-related Pelvic Girdle Pain

The goal of this interventional study is to compare investigate the short-term and long-term effects of 8-week real-time telehealth-based diaphragmatic breathing exercise and pelvic stabilization exercise on pain, disability, and quality of life in postpartum women with pregnancy-related pelvic girdle pain.

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Key information

Age range

20 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

National Cheng Kung University

Tainan, Taiwan, 701

Location status: Recruiting

Location contact

Tsai Yi-Ju

CONTACT

[email protected]

06-2353535 ext. 5930

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 20-65 years
  • Postpartum ≥ 3 months
  • Pain located in sacroiliac joints (i.e., pain located between the posterior iliac crest and gluteal fold)
  • Pregnancy-related cause of pelvic pain that pain occurs during pregnancy or after delivery (i.e., not traumatic or degenerative cause)
  • At least 2 positive findings of 6 pain provocation tests for pelvic pain
  • Score of Active Straight Leg Rise (ASLR) test > 0

Exclusion criteria

  • being pregnant or actively trying to get pregnant
  • having known causes of pelvic girdle pain, such as fractures and rheumatism
  • having undergone lumbar, pelvic, gynecologic or obstetric surgery
  • having current neurological symptoms and signs in lower extremities such as lumbar radiculopathy and myelopathy
  • having cancer
  • having cardiovascular disease
  • being diagnosed as having a psychiatric disease
  • active infection or infectious disease in the pelvis or abdomen
  • having experience with structured and supervised core or trunk exercise training programs.

Treatment and study plan

Diaphragmatic breathing retraining

Other

8 weeks diaphragmatic breathing training

Pelvic stabilization exercise

Other

8 weeks pelvic stabilization exercise training

pelvic anatomy education

Other

pelvic anatomy education

Primary outcomes

  1. Muscle function measures of lumbopelvic muscles

    Time frame: Change from baseline to 8 weeks

    Ultrasonography image for muscle thickness of trunk and back muscles during rest and during active straight leg raise.

    Ultrasonography image for bladder displacement for pelvic floor muscles during rest,maximum contraction and during active straight leg raise

  2. Diaphragm thickness

    Time frame: Change from baseline to 8 weeks

    Ultrasonography image for diaphragm thickness during maximum inspiration and expiration (B mode)

  3. Diaphragm mobility

    Time frame: Change from baseline to 8 weeks

    Ultrasonography image for mobility during maximum inspiration and expiration (M mode)

  4. Diaphragm strength

    Time frame: Change from baseline to 8 weeks

    Ultrasonography image for diaphragm strength during maximal sniff and expiration (M mode). The slope achieved (mm/sec) during the diaphragmatic excursion is used to calculate the velocity of the diaphragmatic contraction

  5. Mechanical Property of Thoracolumbar Fascia

    Time frame: Change from baseline to 8 weeks

    The biomechanical and viscoelastic properties of the muscles will be measured using a non-invasive myometer. It automatically calculate and provide the biomechanical and viscoelastic properties of stiffness, frequency, decrement, and stress relaxation time that offer the information of tone, elasticity, stiffness and stress relaxation time of the tested tissue.

  6. Functional performance of ASLR fatigue task

    Time frame: Change from baseline to 8 weeks

    Participants lifted the heel of the test leg to 20 cm for as long as possible. Participants were required to maintain pressure in the cuff beneath their back as close to 40 mm Hg as possible. Visual feedback of cuff pressure was provided throughout the task, but no instruction was given on how to affect cuff pressure. Task failure was defi ned as an inability to maintain heel height 10 cm or more off the plinth and/or a change in cuff pressure of 20 mm Hg or more.

  7. Functional performance of timed up and go test

    Time frame: Change from baseline to 8 weeks

    Test instructions were given in Norwegian. Translated into English, the instructions were as follows: 'After "ready, set, go" stand up, walk as fast as you can until you cross the white line, turn around, and walk back to the chair and sit down again'. The white line was positioned 3m from the patient's starting position.

    'After "ready, set, go" stand up, walk as fast as you can until you cross the white line, turn around, and walk back to the chair and sit down again'. The white line was positioned 3m from the patient's starting position.

  8. Functional performance of 6m timed walk test

    Time frame: Change from baseline to 8 weeks

    Subjects commenced the test in standing with their toes up against the tape marker. Test instructions translated into English were as follows: 'After "ready, set, go", walk as fast as you can up to the last white line without stopping or speaking along the way'. Performances were timed (to the nearest 100th of a second) between the 2m and 8m markers and later converted into speed in metres per second.

  9. pain intensity measure of Numeric Rating Scale (NRS)

    Time frame: Change from baseline to 8 weeks

    Numeric Rating Scale (NRS) is a self-reported instrument assessing average pain intensity in currently. Possible score range from 0 (no pain) to 10 (worst possible pain).

  10. Disability Level: measure of pelvic girdle questionnaire(PGQ)

    Time frame: Change from baseline to 8 weeks

    pelvic girdle questionnaire(PGQ) 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).

  11. Health-related Quality of Life: Short Form-36 (SF36)

    Time frame: Change from baseline to 8 weeks

    SF-36 include 36 questions constructing into 8 domains (i.e., physical functioning, physical role, bodily pain, general health, vitality, social functioning, emotional role, and mental health). The scores of physical and mental components and total are ranged from 0 to 100, with higher scores representing better quality of life

  12. Fear Avoidance Belief: Tampa Scale of Kinesiophobia

    Time frame: Change from baseline to 8 weeks

    Fear of movement, fear of physical activity, and fear avoidance will be assessed using the Tampa scale of kinesiophobia (TSK). The TSK is 17-items questionnaire, where patients rate their agreement using 4-points scale. It consists of two subscales including activity avoidance to reflect the activity that may result in an increase in pain or cause injury, and somatic focus to reflect the beliefs and underlying serious conditions

  13. Self-Efficacy: Pain Self-efficacy Questionnaire

    Time frame: Change from baseline to 8 weeks

    The pain self-efficacy questionnaire (PSEQ) is a 10-item questionnaire, where patients rate their confidence from 0 points (not at all confident) to 6 points (completely confident). Total scores of the PSEQ is 60 points and a higher score indicates more self-efficacy

  14. Parenting Stress Level: Parenting Stress Index-Short Form (PSI-SF)

    Time frame: Change from baseline to 8 weeks

    The PSI-SF is a self-reported questionnaire that consists of 36 items to assess stress related to three aspects including parent-child relationship, parental distress, and difficulties in the parent-child interaction. The subscales for parental distress, parent-child dysfunctional interaction and difficult child, as well as the total stress scale are rated from 1 (strongly disagree) to 5 (strongly agree). The higher the score indicates the greater the stress.

  15. Self-perceived Change: Global Rating of Change Scale (GROC)

    Time frame: Change from baseline to 8 weeks

    The GROC rates perceived "overall change" on a 15-point Likert scale, with 7 (labeled "worse") on the left, +7 (labeled "better") on the right, and 0 in the middle (labeled "no change") compared to the baseline.

Sponsors and collaborators

Lead sponsor

YI-JU TSAI

Other

Registry information

Official study title

Comparison of Diaphragmatic Breathing Exercise and Pelvic Stabilization Exercise in Postpartum Women With Pregnancy-related Pelvic Girdle Pain: A Real-time Telehealth-based Intervention

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 28, 2024
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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