Pelvic Girdle PainNCT04377516
Effects of Specific Pelvic Stabilization Exercise in Postpartum Pregnancy-related Pelvic Girdle Pain Women
A study testing pelvic floor muscle training, pelvic floor muscle combined global muscle exercise training and education of pelvic girdle in people with Pelvic Girdle Pain, run by YI-JU TSAI at 1 site in Taiwan.
Trial summary
Postpartum women with PPGP receiving specific pelvic stabilization exercise training with transabdominal sonography-guided Biofeedback would have better improvements on muscle functions, physical functions, pain, and disability compared to the regular pelvic stabilization exercise group 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?
- pelvic floor muscle training, pelvic floor muscle combined global muscle exercise training and education of pelvic girdle
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Oct 2019to 31 Jul 2023
- 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
- other causes of pelvic pain (such as fractures)
- Radiculopathy
- other health problems, such as cancer, cardiovascular disease, rheumatism , etc
- daily activities limited , unable to complete the experiment
- communication disorders
Show all 9Show fewer
- mental disorder
- pregnancy
- have been trained in stable muscle strength in the past.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Specific Pelvic Stabilization Exercise With Transabdominal Ultrasonography-guided Biofeedback in Postpartum Women Suffering From Pregnancy-related Pelvic Girdle Pain
Postpartum women with PPGP receiving specific pelvic stabilization exercise training with transabdominal sonography-guided Biofeedback would have better improvements on muscle functions, physical functions, pain, and disability compared to the regular pelvic stabilization exercise group
- Conditions
- Pelvic Girdle Pain
- Being tested
- pelvic floor muscle training, pelvic floor muscle combined global muscle exercise training, education of pelvic girdle
- 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.
pelvic floor muscle trainingOther
pelvic floor muscle training
pelvic floor muscle combined global muscle exercise trainingOther
pelvic floor muscle combined global muscle exercise training
education of pelvic girdleOther
education of pelvic girdle
| Study group | Role | What they receive |
|---|---|---|
| Transabdominal Sonography-guided Biofeedback group | Experimental | pelvic floor muscle training with transabdominal sonography-guided Biofeedback Receives: Other: pelvic floor muscle training; Other: pelvic floor muscle combined global muscle exercise training; Other: education of pelvic girdle |
| Exercise group | Active comparator | pelvic floor muscle training Receives: Other: pelvic floor muscle training; Other: pelvic floor muscle combined global muscle exercise training; Other: education of pelvic girdle |
| Control group | Placebo comparator | pelvic girdle education Receives: Other: education of pelvic girdle |
| Health 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.
Muscle function measures of abdominal muscle
Untrasonography image for muscle thickness of abdominal muscle during rest and ASLR test.
Measured: 8 weeks
Muscle function measures of inter recti distance
Untrasonography image for muscle thickness of inter recti distance during rest, maximum contraction, and ASLR test.
Measured: 8 weeks
Muscle function measures of pelvic floor muscle control
Untrasonography image for muscle thickness of pelvic floor muscle control during rest, maximum contraction, and ASLR test.
Measured: 8 weeks
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: 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: 8 weeks
pain intensity measure of Oswestry Low Back Pain Disability Questionnaire (ODI)
Oswestry Low Back Pain Disability Questionnaire(ODI) is a self-reported instrument assessing patient's permanent functional disability in currently. For each section the total possible score is 5: if the first statement is marked the section score = 0; if the last statement is marked, it = 5. The higher the score, the greater the degree of disability.
Measured: 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.
Measured: 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: 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: 8 weeks
Secondary outcomes (1)
General health
36-item Short-Form Survey(SF-36)
Measured: 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 May 2020
- Study start15 Oct 2019
- Primary completion30 Jun 2020 (estimated)
- Study completion31 Jul 2023 (estimated)
Why it stopped: Duplicated with another clinical trial registration.
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
- 0 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
- NCT04377516
- Sponsor's protocol ID
- NCKU-TSAI
- Status last verified
- Nov 2024
- First submitted
- 28 Apr 2020
- Last updated
- 22 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Specific Pelvic Stabilization Exercise With Transabdominal Ultrasonography-guided Biofeedback in Postpartum Women Suffering From Pregnancy-related Pelvic Girdle Pain
- ClinicalTrials.gov ID
- NCT04377516
- Acronym / sponsor ID
- NCKU-TSAI
- Conditions
- Pelvic Girdle Pain
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Duplicated with another clinical trial registration.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- YI-JU TSAIUniversity, hospital or other
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 6 May 2020 (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.
Postpartum women with PPGP receiving specific pelvic stabilization exercise training with transabdominal sonography-guided Biofeedback would have better improvements on muscle functions, physical functions, pain, and disability compared to the regular pelvic stabilization exercise group
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Transabdominal Sonography-guided Biofeedback group | Experimental | Other: pelvic floor muscle training, Other: pelvic floor muscle combined global muscle exercise training, Other: education of pelvic girdlepelvic floor muscle training with transabdominal sonography-guided Biofeedback |
| Exercise group | Active comparator | Other: pelvic floor muscle training, Other: pelvic floor muscle combined global muscle exercise training, Other: education of pelvic girdlepelvic floor muscle training |
| Control group | Placebo comparator | Other: education of pelvic girdlepelvic girdle education |
| Health 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 (5 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
- other causes of pelvic pain (such as fractures)
- Radiculopathy
- other health problems, such as cancer, cardiovascular disease, rheumatism , etc
- daily 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 |
|---|---|---|
| pelvic floor muscle trainingpelvic floor muscle training | Other | Exercise group, Transabdominal Sonography-guided Biofeedback group |
| pelvic floor muscle combined global muscle exercise trainingpelvic floor muscle combined global muscle exercise training | Other | Exercise group, Transabdominal Sonography-guided Biofeedback group |
| education of pelvic girdleeducation of pelvic girdle | Other | Control group, Exercise group, Health group, Transabdominal Sonography-guided Biofeedback group |
Primary outcome
Muscle function measures of abdominal muscle
Time frame: 8 weeks
Untrasonography image for muscle thickness of abdominal muscle during rest and ASLR test.
Muscle function measures of inter recti distance
Time frame: 8 weeks
Untrasonography image for muscle thickness of inter recti distance during rest, maximum contraction, and ASLR test.
Muscle function measures of pelvic floor muscle control
Time frame: 8 weeks
Untrasonography image for muscle thickness of pelvic floor muscle control during rest, maximum contraction, and ASLR test.
pain intensity measure of Numeric Rating Scale (NRS)
Time frame: 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: 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).
pain intensity measure of Oswestry Low Back Pain Disability Questionnaire (ODI)
Time frame: 8 weeks
Oswestry Low Back Pain Disability Questionnaire(ODI) is a self-reported instrument assessing patient's permanent functional disability in currently. For each section the total possible score is 5: if the first statement is marked the section score = 0; if the last statement is marked, it = 5. The higher the score, the greater the degree of disability.
functional performance of ASLR fatigue task
Time frame: 8 weeks
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.
functional performance of timed up and go test
Time frame: 8 weeks
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.
functional performance of 6m timed walk test(fast walking)
Time frame: 8 weeks
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.
1 secondary outcome
General health
Time frame: 8 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
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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 pelvic floor muscle training, pelvic floor muscle combined global muscle exercise training 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 5 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: withdrawn, as of the sponsor's last update on 22 Nov 2024. 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 was withdrawn before enrolling participants, so there are no results.
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?
Muscle function measures of abdominal muscle (time frame: 8 weeks). The study lists 9 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 22 Nov 2024.