Pelvic Floor Muscles and Stabilization Integrated Training Improved Pregnancy-related Pelvic Girdle Pain

NCT ID: NCT05181384

Last Updated: 2022-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-15
• Study Completion Date: 2022-07-31

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.

Conditions

Pelvic Girdle Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Transabdominal Sonography-guided Biofeedback group

pelvic floor muscle training with transabdominal sonography-guided Biofeedback

Group Type: EXPERIMENTAL

isolated pelvic floor muscles training

Intervention Type: OTHER

isolated pelvic floor muscles training was emphasized, consisting of both quick and sustained contractions.

comprehensive stabilization exercise program

Intervention Type: OTHER

incorporated the contraction of PFMs with other spinal or extremity muscles

education of pelvic girdle

Intervention Type: OTHER

educational session includes pelvic anatomy, mechanism of and risk factors for PPGP, and proper posture or body mechanism

Exercise group

pelvic floor muscle training

Group Type: ACTIVE_COMPARATOR

isolated pelvic floor muscles training

Intervention Type: OTHER

isolated pelvic floor muscles training was emphasized, consisting of both quick and sustained contractions.

comprehensive stabilization exercise program

Intervention Type: OTHER

incorporated the contraction of PFMs with other spinal or extremity muscles

education of pelvic girdle

Intervention Type: OTHER

educational session includes pelvic anatomy, mechanism of and risk factors for PPGP, and proper posture or body mechanism

Control group

pelvic girdle education

Group Type: PLACEBO_COMPARATOR

education of pelvic girdle

Intervention Type: OTHER

educational session includes pelvic anatomy, mechanism of and risk factors for PPGP, and proper posture or body mechanism

Interventions

isolated pelvic floor muscles training

isolated pelvic floor muscles training was emphasized, consisting of both quick and sustained contractions.

Intervention Type: OTHER

comprehensive stabilization exercise program

incorporated the contraction of PFMs with other spinal or extremity muscles

Intervention Type: OTHER

education of pelvic girdle

educational session includes pelvic anatomy, mechanism of and risk factors for PPGP, and proper posture or body mechanism

Intervention Type: OTHER

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

YI-JU TSAI

OTHER

Sponsor Role: lead

Responsible Party

YI-JU TSAI

professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

National Cheng Kung University

Tainan City, , Taiwan

Countries

Taiwan

Other Identifiers

NCKU_PPGP three group

Identifier Type: -

Identifier Source: org_study_id