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

Primary Purpose

Pelvic Girdle Pain

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
isolated pelvic floor muscles training
comprehensive stabilization exercise program
education of pelvic girdle
Sponsored by
YI-JU TSAI
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Girdle Pain focused on measuring Pregnancy-related pelvic girdle pain, Postpartum women, Pelvic stabilization exercise, Pelvic floor muscles, Ultrasonography imaging, Biofeedback

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • National Cheng Kung University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Transabdominal Sonography-guided Biofeedback group

Exercise group

Control group

Arm Description

pelvic floor muscle training with transabdominal sonography-guided Biofeedback

pelvic floor muscle training

pelvic girdle education

Outcomes

Primary Outcome Measures

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).
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).

Secondary Outcome Measures

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.
Muscle function measures of abdominal muscle
Untrasonography image for muscle thickness of abdominal muscle during rest and ASLR test.
Muscle function measures of pelvic floor muscle control
Untrasonography image for muscle thickness of pelvic floor muscle control at maximum contraction.

Full Information

First Posted
November 24, 2021
Last Updated
September 15, 2022
Sponsor
YI-JU TSAI
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1. Study Identification

Unique Protocol Identification Number
NCT05181384
Brief Title
Pelvic Floor Muscles and Stabilization Integrated Training Improved Pregnancy-related Pelvic Girdle Pain
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
October 15, 2019 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
July 31, 2022 (Actual)

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
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Girdle Pain
Keywords
Pregnancy-related pelvic girdle pain, Postpartum women, Pelvic stabilization exercise, Pelvic floor muscles, Ultrasonography imaging, Biofeedback

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
53 (Actual)

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
Intervention Type
Other
Intervention Name(s)
isolated pelvic floor muscles training
Intervention Description
isolated pelvic floor muscles training was emphasized, consisting of both quick and sustained contractions.
Intervention Type
Other
Intervention Name(s)
comprehensive stabilization exercise program
Intervention Description
incorporated the contraction of PFMs with other spinal or extremity muscles
Intervention Type
Other
Intervention Name(s)
education of pelvic girdle
Intervention Description
educational session includes pelvic anatomy, mechanism of and risk factors for PPGP, and proper posture or body mechanism
Primary Outcome Measure Information:
Title
pain intensity measure of Numeric Rating Scale (NRS)
Description
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
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
Change from baseline to 8 weeks
Secondary Outcome Measure Information:
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
Change from baseline to 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
Change from baseline to 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
Change from baseline to 8 weeks
Title
Muscle function measures of abdominal muscle
Description
Untrasonography image for muscle thickness of abdominal muscle during rest and ASLR test.
Time Frame
Change from baseline to 8 weeks
Title
Muscle function measures of pelvic floor muscle control
Description
Untrasonography image for muscle thickness of pelvic floor muscle control at maximum contraction.
Time Frame
Change from baseline to 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 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.
Facility Information:
Facility Name
National Cheng Kung University
City
Tainan
Country
Taiwan

12. IPD Sharing Statement

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

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