An interventional study of isolated pelvic floor muscles training and comprehensive stabilization exercise program in Pelvic Girdle Pain, sponsored by YI-JU TSAI. Completed at 1 site in Taiwan. Open to female participants aged 20 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-16.
Sponsored by YI-JU TSAI · Not applicable, Interventional, and Treatment
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.
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.
58 studies on the registry are indexed under Pelvic Girdle Pain; 12 are open to participants now.
This study's enrollment of 53 is close to the median of 57 across 41 interventional studies indexed under Pelvic Girdle Pain.
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pelvic floor muscle training with transabdominal sonography-guided Biofeedback
Other: isolated pelvic floor muscles training · Other: comprehensive stabilization exercise program · Other: education of pelvic girdle
pelvic floor muscle training
Other: isolated pelvic floor muscles training · Other: comprehensive stabilization exercise program · Other: education of pelvic girdle
pelvic girdle education
Other: education of pelvic girdle
isolated pelvic floor muscles training was emphasized, consisting of both quick and sustained contractions.
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
pain intensity measure of Numeric Rating Scale (NRS)
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).
Time frame: Change from baseline to 8 weeks
pain intensity measure of pelvic girdle questionnaire(PGQ)
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).
Time frame: Change from baseline to 8 weeks
functional performance of ASLR fatigue task
Participants 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.
Time frame: Change from baseline to 8 weeks
functional performance of timed up and go test
Test 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.
Time frame: Change from baseline to 8 weeks
functional performance of 6m timed walk test (fast walking)
Subjects 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.
Time frame: Change from baseline to 8 weeks
Muscle function measures of abdominal muscle
Untrasonography image for muscle thickness of abdominal muscle during rest and ASLR test.
Time frame: Change from baseline to 8 weeks
Muscle function measures of pelvic floor muscle control
Untrasonography image for muscle thickness of pelvic floor muscle control at maximum contraction.
Time frame: Change from baseline to 8 weeks
Ran from Oct 2019 to primary completion in Jun 2020, 8 months.
Of 29 interventional studies with no phase under Pelvic Girdle Pain, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 59. This study's 8 months is below that.
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This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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