Effects of Specific Pelvic Stabilization Exercise in Postpartum Pregnancy-related Pelvic Girdle Pain Women

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

Study Overview

• Status: Withdrawn
• Conditions: Pelvic Girdle Pain
• Intervention / Treatment: Other: pelvic floor muscle training; Other: pelvic floor muscle combined global muscle exercise training; Other: education of pelvic girdle

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Tainan, Taiwan, 701
    • National Cheng Kung University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transabdominal Sonography-guided Biofeedback group; pelvic floor muscle training with transabdominal sonography-guided Biofeedback	Other: pelvic floor muscle training; pelvic floor muscle training; Other: pelvic floor muscle combined global muscle exercise training; pelvic floor muscle combined global muscle exercise training; Other: education of pelvic girdle; education of pelvic girdle
Active Comparator: Exercise group; pelvic floor muscle training	Other: pelvic floor muscle training; pelvic floor muscle training; Other: pelvic floor muscle combined global muscle exercise training; pelvic floor muscle combined global muscle exercise training; Other: education of pelvic girdle; education of pelvic girdle
Placebo Comparator: Control group; pelvic girdle education	Other: education of pelvic girdle; education of pelvic girdle
Placebo Comparator: Health group; pelvic girdle education	Other: education of pelvic girdle; education of pelvic girdle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle function measures of abdominal muscle	Untrasonography image for muscle thickness of abdominal muscle during rest and ASLR test.	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.	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.	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.	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.	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.	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).	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).	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.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
General health	36-item Short-Form Survey(SF-36)	8 weeks

Collaborators and Investigators

• Sponsor: YI-JU TSAI

Study record dates

Study Major Dates

• Study Start (Estimated): October 15, 2019
• Primary Completion (Estimated): June 30, 2020
• Study Completion (Estimated): July 31, 2023

Study Registration Dates

• First Submitted: April 28, 2020
• First Submitted That Met QC Criteria: May 5, 2020
• First Posted (Actual): May 6, 2020

Study Record Updates

• Last Update Posted (Actual): March 27, 2024
• Last Update Submitted That Met QC Criteria: March 25, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Pain; Pelvic Pain; Pelvic Girdle Pain
• Other Study ID Numbers: NCKU-TSAI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No