Clinical trial NCT05181384: Pelvic Floor Muscles and Stabilization Integrated Training Improved Pregnancy-related Pelvic Girdle Pain
Official title: Pelvic Floor Muscles and Stabilization Integrated Training With Transabdominal Ultrasonography-guided Biofeedback Improved Pregnancy-related Pelvic Girdle Pain and Disability: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Girdle Pain
Keywords: Pregnancy-related pelvic girdle pain
Postpartum women
Pelvic stabilization exercise
Pelvic floor muscles
Ultrasonography imaging
Biofeedback
Lead sponsor: National Cheng Kung University
Sponsor class: OTHER
First posted: 2022-01-06
Enrollment: 53
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pregnancy-related pelvic girdle pain (PPGP) is a common musculoskeletal problem for women during pregnancy and after delivery. The main purpose of this study was to investigate the effects of integrated training for pelvic floor muscles (PFMs) and stabilization with and without transabdominal ultrasonography (TAUS) imaging-guided biofeedback on pain, disability, and physical function, and muscle functions for the abdominal muscles and PFMs in postpartum women with PPGP.

Detailed description: Many women have pregnancy-related pelvic girdle pain (PPGP), and about 30% with PPGP women still complain of pain after 1-year postpartum. Both physical and mental functions of PPGP women are impaired. Pelvic stabilization exercise with pelvic floor muscle training is believed to be effective for reducing pain and improved pelvic stability. However, intervention studies on PPGP women is limited and current evidence are controversial. Incorrect pelvic floor muscle activations may be partly contributed to these results. One previous study has showed about 60% of women cannot activate pelvic floor muscles correctly. Transabdominal sonography-guided biofeedback by observing bladder movements is no-invasive and benefit learning correct muscle contraction. Therefore, the main purposes for this study are to investigate the effects of pelvic stabilization training using transabdominal sonography-guided biofeedback in postpartum women with PPGP. A total of 50 postpartum PPGP women will be randomized into one of the two groups: (1) biofeedback group, (2) exercise group, (3) control group, and (4) health group. Subjects in the biofeedback group and exercise group will perform the same exercise training for 8 weeks except the subjects in the biofeedback group will receive transabdominal sonography-guided biofeedback of bladder movement for the first 4 weeks. The outcome assessment will include the muscle thickness of abdominal muscle and pelvic floor muscle control, functional performance of ASLR fatigue task, timed up and go and fast walking, pelvic girdle questionnaire (PGQ), and numeric rating scale (NRS). It is anticipated that the biofeedback group will have more improvements that the exercise group.

Eligibility criteria: Inclusion Criteria:

* postpartum : ≥ 3 months
* pregnancy-related pelvic pain
* pain location is located between posterior iliac crest and gluteal fold
* Clinical screening test for pelvic pain: ASLR : positive and SI joint ≥ 2 (+ symphysis ≥ 1)

Exclusion Criteria:

* lumbar or pelvic surgery
* lother causes of pelvic pain (such as fractures)
* lRadiculopathy
* lother health problems, such as cancer, cardiovascular disease, rheumatism , etc
* ldaily activities limited , unable to complete the experiment
* lcommunication disorders
* lmental disorder
* lpregnancy
* lhave been trained in stable muscle strength in the past.

Primary outcomes:
measure: pain intensity measure of Numeric Rating Scale (NRS)
timeFrame: Change from baseline to 8 weeks
measure: pain intensity measure of pelvic girdle questionnaire(PGQ)
timeFrame: Change from baseline to 8 weeks
Secondary outcomes:
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 (fast walking)
timeFrame: Change from baseline to 8 weeks
measure: Muscle function measures of abdominal muscle
timeFrame: Change from baseline to 8 weeks
measure: Muscle function measures of pelvic floor muscle control
timeFrame: Change from baseline to 8 weeks
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University
Study officials:
References: