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Clinical Trials/NCT05181384
NCT05181384
Completed
Not Applicable

Pelvic Floor Muscles and Stabilization Integrated Training With Transabdominal Ultrasonography-guided Biofeedback Improved Pregnancy-related Pelvic Girdle Pain and Disability: A Randomized Controlled Trial

YI-JU TSAI1 site in 1 country53 target enrollmentOctober 15, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pelvic Girdle Pain
Sponsor
YI-JU TSAI
Enrollment
53
Locations
1
Primary Endpoint
pain intensity measure of pelvic girdle questionnaire(PGQ)
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 15, 2019
End Date
July 31, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
YI-JU TSAI
Responsible Party
Sponsor Investigator
Principal Investigator

YI-JU TSAI

professor

National Cheng Kung University

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.

Outcomes

Primary Outcomes

pain intensity 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).

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).

Secondary Outcomes

  • functional performance of ASLR fatigue task(Change from baseline to 8 weeks)
  • functional performance of timed up and go test(Change from baseline to 8 weeks)
  • functional performance of 6m timed walk test (fast walking)(Change from baseline to 8 weeks)
  • Muscle function measures of abdominal muscle(Change from baseline to 8 weeks)
  • Muscle function measures of pelvic floor muscle control(Change from baseline to 8 weeks)

Study Sites (1)

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