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

Pelvic Girdle Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05181384
• Other study ID #: NCKU_PPGP three group
• Status: Completed
• Phase: N/A
• Start date: October 15, 2019
• Est. completion date: July 31, 2022

Study information

• Verified date: September 2022
• Source: National Cheng Kung University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: July 31, 2022
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pelvic Girdle Pain

Intervention

Other:
• isolated pelvic floor muscles training
isolated pelvic floor muscles training was emphasized, consisting of both quick and sustained contractions.
• comprehensive stabilization exercise program
incorporated the contraction of PFMs with other spinal or extremity muscles
• education of pelvic girdle
educational session includes pelvic anatomy, mechanism of and risk factors for PPGP, and proper posture or body mechanism

Locations

Country	Name	City	State
Taiwan	National Cheng Kung University	Tainan

Sponsors (1)

Lead Sponsor	Collaborator
YI-JU TSAI

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Change from baseline to 8 weeks
Primary	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).	Change from baseline to 8 weeks
Secondary	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.	Change from baseline to 8 weeks
Secondary	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.	Change from baseline to 8 weeks
Secondary	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.	Change from baseline to 8 weeks
Secondary	Muscle function measures of abdominal muscle	Untrasonography image for muscle thickness of abdominal muscle during rest and ASLR test.	Change from baseline to 8 weeks
Secondary	Muscle function measures of pelvic floor muscle control	Untrasonography image for muscle thickness of pelvic floor muscle control at maximum contraction.	Change from baseline to 8 weeks