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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05181384
Enrollment
53
Registered
2022-01-06
Start date
2019-10-15
Completion date
2022-07-31
Last updated
2022-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Girdle Pain

Keywords

Pregnancy-related pelvic girdle pain, Postpartum women, Pelvic stabilization exercise, Pelvic floor muscles, Ultrasonography imaging, Biofeedback

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.

Interventions

OTHERisolated pelvic floor muscles training

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

OTHERcomprehensive stabilization exercise program

incorporated the contraction of PFMs with other spinal or extremity muscles

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

Sponsors

YI-JU TSAI
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
pain intensity measure of Numeric Rating Scale (NRS)Change from baseline to 8 weeksNumeric 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).
pain intensity measure of pelvic girdle questionnaire(PGQ)Change from baseline to 8 weekspelvic 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).

Secondary

MeasureTime frameDescription
functional performance of 6m timed walk test (fast walking)Change from baseline to 8 weeksSubjects 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.
functional performance of ASLR fatigue taskChange from baseline to 8 weeksParticipants 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.
Muscle function measures of pelvic floor muscle controlChange from baseline to 8 weeksUntrasonography image for muscle thickness of pelvic floor muscle control at maximum contraction.
Muscle function measures of abdominal muscleChange from baseline to 8 weeksUntrasonography image for muscle thickness of abdominal muscle during rest and ASLR test.
functional performance of timed up and go testChange from baseline to 8 weeksTest 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.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026