Back to resultsEffects of Specific Pelvic Stabilization Exercise With Transabdominal Ultrasonography-guided Biofeedback in Postpartum Women Suffering From Pregnancy-related Pelvic Girdle Pain
Primary Purpose
Pelvic Girdle Pain
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
pelvic floor muscle training
pelvic floor muscle combined global muscle exercise training
education of pelvic girdle
Sponsored by
About this trial
This is an interventional treatment trial for Pelvic Girdle Pain
Eligibility Criteria
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
- 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
- mental disorder
- pregnancy
- have been trained in stable muscle strength in the past.
Sites / Locations
- National Cheng Kung University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Placebo Comparator
Other
Arm Label
Transabdominal Sonography-guided Biofeedback group
Exercise group
Control group
Health group
Arm Description
pelvic floor muscle training with transabdominal sonography-guided Biofeedback
pelvic floor muscle training
pelvic girdle education
pelvic girdle education
Outcomes
Primary Outcome Measures
Muscle function measures of abdominal muscle
Untrasonography image for muscle thickness of abdominal muscle during rest and ASLR test.
Muscle function measures of inter recti distance
Untrasonography image for muscle thickness of inter recti distance during rest, maximum contraction, and ASLR test.
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.
pain intensity measure of Visual Analogue Scale(VAS)
Visual Analogue Scale(VAS) 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)
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)
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
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
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)
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.
Secondary Outcome Measures
General health
36-item Short-Form Survey(SF-36)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04377516
Brief Title
Effects of Specific Pelvic Stabilization Exercise With Transabdominal Ultrasonography-guided Biofeedback in Postpartum Women Suffering From Pregnancy-related Pelvic Girdle Pain
Official Title
Effects of Specific Pelvic Stabilization Exercise With Transabdominal Ultrasonography-guided Biofeedback in Postpartum Women Suffering From Pregnancy-related Pelvic Girdle Pain
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 15, 2019 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
July 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
YI-JU TSAI
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Girdle Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Transabdominal Sonography-guided Biofeedback group
Arm Type
Experimental
Arm Description
pelvic floor muscle training with transabdominal sonography-guided Biofeedback
Arm Title
Exercise group
Arm Type
Active Comparator
Arm Description
pelvic floor muscle training
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
pelvic girdle education
Arm Title
Health group
Arm Type
Other
Arm Description
pelvic girdle education
Intervention Type
Other
Intervention Name(s)
pelvic floor muscle training
Intervention Description
pelvic floor muscle training
Intervention Type
Other
Intervention Name(s)
pelvic floor muscle combined global muscle exercise training
Intervention Description
pelvic floor muscle combined global muscle exercise training
Intervention Type
Other
Intervention Name(s)
education of pelvic girdle
Intervention Description
education of pelvic girdle
Primary Outcome Measure Information:
Title
Muscle function measures of abdominal muscle
Description
Untrasonography image for muscle thickness of abdominal muscle during rest and ASLR test.
Time Frame
8 weeks
Title
Muscle function measures of inter recti distance
Description
Untrasonography image for muscle thickness of inter recti distance during rest, maximum contraction, and ASLR test.
Time Frame
8 weeks
Title
Muscle function measures of pelvic floor muscle control
Description
Untrasonography image for muscle thickness of pelvic floor muscle control during rest, maximum contraction, and ASLR test.
Time Frame
8 weeks
Title
pain intensity measure of Visual Analogue Scale(VAS)
Description
Visual Analogue Scale(VAS) 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
8 weeks
Title
pain intensity measure of pelvic girdle questionnaire(PGQ)
Description
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
8 weeks
Title
pain intensity measure of Oswestry Low Back Pain Disability Questionnaire(ODI)
Description
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.
Time Frame
8 weeks
Title
functional performance of ASLR fatigue task
Description
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
8 weeks
Title
functional performance of timed up and go test
Description
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
8 weeks
Title
functional performance of 6m timed walk test(fast walking)
Description
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
8 weeks
Secondary Outcome Measure Information:
Title
General health
Description
36-item Short-Form Survey(SF-36)
Time Frame
8 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
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
mental disorder
pregnancy
have been trained in stable muscle strength in the past.
Facility Information:
Facility Name
National Cheng Kung University
City
Tainan
ZIP/Postal Code
701
Country
Taiwan
12. IPD Sharing Statement
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Effects of Specific Pelvic Stabilization Exercise With Transabdominal Ultrasonography-guided Biofeedback in Postpartum Women Suffering From Pregnancy-related Pelvic Girdle Pain
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