Clinical trial NCT06284278: Telehealth: Diaphragmatic vs. Pelvic Exercise in Postpartum Pregnancy-related Pelvic Girdle Pain
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postpartum
Pregnancy Related
Pelvic Girdle Pain
Lead sponsor: National Cheng Kung University
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Muscle function measures of lumbopelvic muscles
timeFrame: Change from baseline to 8 weeks
measure: Diaphragm thickness
timeFrame: Change from baseline to 8 weeks
measure: Diaphragm mobility
timeFrame: Change from baseline to 8 weeks
measure: Diaphragm strength
timeFrame: Change from baseline to 8 weeks
measure: Mechanical Property of Thoracolumbar Fascia
timeFrame: Change from baseline to 8 weeks
measure: Functional performance of ASLR fatigue task
timeFrame: Change from baseline to 8 weeks
measure: Functional performance of timed up and go test
timeFrame: Change from baseline to 8 weeks
measure: Functional performance of 6m timed walk test
timeFrame: Change from baseline to 8 weeks
measure: pain intensity measure of Numeric Rating Scale (NRS)
timeFrame: Change from baseline to 8 weeks
measure: Disability Level: measure of pelvic girdle questionnaire(PGQ)
timeFrame: Change from baseline to 8 weeks
measure: Health-related Quality of Life: Short Form-36 (SF36)
timeFrame: Change from baseline to 8 weeks
measure: Fear Avoidance Belief: Tampa Scale of Kinesiophobia
timeFrame: Change from baseline to 8 weeks
measure: Self-Efficacy: Pain Self-efficacy Questionnaire
timeFrame: Change from baseline to 8 weeks
measure: Parenting Stress Level: Parenting Stress Index-Short Form (PSI-SF)
timeFrame: Change from baseline to 8 weeks
measure: Self-perceived Change: Global Rating of Change Scale (GROC)
timeFrame: Change from baseline to 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University
Study officials:
References: