Pelvic Girdle PainNCT05181384
Pelvic Floor Muscles and Stabilization Integrated Training Improved Pregnancy-related Pelvic Girdle Pain
A study testing isolated pelvic floor muscles training, comprehensive stabilization exercise program and education of pelvic girdle in people with Pelvic Girdle Pain, run by YI-JU TSAI at 1 site in Taiwan.
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)… Read more about this study
- Who is it for?
- Ages 20 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Girdle Pain
- What is being tested?
- isolated pelvic floor muscles training, comprehensive stabilization exercise program and education of pelvic girdle
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Oct 2019to 31 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 9Show fewer
- lmental disorder
- lpregnancy
- lhave been trained in stable muscle strength in the past.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- isolated pelvic floor muscles training, comprehensive stabilization exercise program, education of pelvic girdle
- Keywords
- Pregnancy-related pelvic girdle pain, Postpartum women, Pelvic stabilization exercise, Pelvic floor muscles, Ultrasonography imaging, Biofeedback
- Medical subject headings
- Pelvic Girdle Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
isolated pelvic floor muscles trainingOther
isolated pelvic floor muscles training was emphasized, consisting of both quick and sustained contractions.
comprehensive stabilization exercise programOther
incorporated the contraction of PFMs with other spinal or extremity muscles
education of pelvic girdleOther
educational session includes pelvic anatomy, mechanism of and risk factors for PPGP, and proper posture or body mechanism
| Study group | Role | What they receive |
|---|---|---|
| Transabdominal Sonography-guided Biofeedback group | Experimental | pelvic floor muscle training with transabdominal sonography-guided Biofeedback Receives: Other: isolated pelvic floor muscles training; Other: comprehensive stabilization exercise program; Other: education of pelvic girdle |
| Exercise group | Active comparator | pelvic floor muscle training Receives: Other: isolated pelvic floor muscles training; Other: comprehensive stabilization exercise program; Other: education of pelvic girdle |
| Control group | Placebo comparator | pelvic girdle education Receives: Other: education of pelvic girdle |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: Change from baseline to 8 weeks
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2022
- Study start15 Oct 2019
- Primary completion30 Jun 2020
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Girdle PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- YI-JU TSAI
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, YI-JU TSAI, National Cheng Kung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05181384
- Sponsor's protocol ID
- NCKU_PPGP three group
- Status last verified
- Sep 2022
- First submitted
- 24 Nov 2021
- Last updated
- 16 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05181384
- Acronym / sponsor ID
- NCKU_PPGP three group
- Conditions
- Pelvic Girdle Pain
- Keywords
- Pregnancy-related pelvic girdle pain, Postpartum women, Pelvic stabilization exercise, Pelvic floor muscles, Ultrasonography imaging, Biofeedback
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- YI-JU TSAIUniversity, hospital or other
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 6 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Transabdominal Sonography-guided Biofeedback group | Experimental | Other: isolated pelvic floor muscles training, Other: comprehensive stabilization exercise program, Other: education of pelvic girdlepelvic floor muscle training with transabdominal sonography-guided Biofeedback |
| Exercise group | Active comparator | Other: isolated pelvic floor muscles training, Other: comprehensive stabilization exercise program, Other: education of pelvic girdlepelvic floor muscle training |
| Control group | Placebo comparator | Other: education of pelvic girdlepelvic girdle education |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| isolated pelvic floor muscles trainingisolated pelvic floor muscles training was emphasized, consisting of both quick and sustained contractions. | Other | Exercise group, Transabdominal Sonography-guided Biofeedback group |
| comprehensive stabilization exercise programincorporated the contraction of PFMs with other spinal or extremity muscles | Other | Exercise group, Transabdominal Sonography-guided Biofeedback group |
| education of pelvic girdleeducational session includes pelvic anatomy, mechanism of and risk factors for PPGP, and proper posture or body mechanism | Other | Control group, Exercise group, Transabdominal Sonography-guided Biofeedback group |
Primary outcome
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).
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).
5 secondary outcomes
functional performance of ASLR fatigue task
Time frame: Change from baseline to 8 weeks
functional performance of timed up and go test
Time frame: Change from baseline to 8 weeks
functional performance of 6m timed walk test (fast walking)
Time frame: Change from baseline to 8 weeks
Muscle function measures of abdominal muscle
Time frame: Change from baseline to 8 weeks
Muscle function measures of pelvic floor muscle control
Time frame: Change from baseline to 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing isolated pelvic floor muscles training, comprehensive stabilization exercise program and education of pelvic girdle in people with Pelvic Girdle Pain, run by YI-JU TSAI at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain intensity measure of Numeric Rating Scale (NRS) (time frame: Change from baseline to 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2022.