NCT05181384

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 24, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 6, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2022

Completed
Last Updated

September 16, 2022

Status Verified

September 1, 2022

Enrollment Period

9 months

First QC Date

November 24, 2021

Last Update Submit

September 15, 2022

Conditions

Pelvic Girdle Pain

Keywords

Pregnancy-related pelvic girdle painPostpartum womenPelvic stabilization exercisePelvic floor musclesUltrasonography imagingBiofeedback

Outcome Measures

Primary Outcomes (2)

  • 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).

    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).

    Change from baseline to 8 weeks

Secondary Outcomes (5)

  • functional performance of ASLR fatigue task

    Change from baseline to 8 weeks

  • functional performance of timed up and go test

    Change from baseline to 8 weeks

  • functional performance of 6m timed walk test (fast walking)

    Change from baseline to 8 weeks

  • Muscle function measures of abdominal muscle

    Change from baseline to 8 weeks

  • Muscle function measures of pelvic floor muscle control

    Change from baseline to 8 weeks

Study Arms (3)

Transabdominal Sonography-guided Biofeedback group

EXPERIMENTAL

pelvic floor muscle training with transabdominal sonography-guided Biofeedback

Other: isolated pelvic floor muscles trainingOther: comprehensive stabilization exercise programOther: education of pelvic girdle

Exercise group

ACTIVE COMPARATOR

pelvic floor muscle training

Other: isolated pelvic floor muscles trainingOther: comprehensive stabilization exercise programOther: education of pelvic girdle

Control group

PLACEBO COMPARATOR

pelvic girdle education

Other: education of pelvic girdle

Interventions

isolated pelvic floor muscles trainingOTHER

isolated pelvic floor muscles training was emphasized, consisting of both quick and sustained contractions.

Exercise groupTransabdominal Sonography-guided Biofeedback group
comprehensive stabilization exercise programOTHER

incorporated the contraction of PFMs with other spinal or extremity muscles

Exercise groupTransabdominal Sonography-guided Biofeedback group
education of pelvic girdleOTHER

educational session includes pelvic anatomy, mechanism of and risk factors for PPGP, and proper posture or body mechanism

Control groupExercise groupTransabdominal Sonography-guided Biofeedback group

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cheng Kung University

Tainan, Taiwan

Location

MeSH Terms

Conditions

Pelvic Girdle Pain

Condition Hierarchy (Ancestors)

Musculoskeletal PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPelvic Pain

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

November 24, 2021

First Posted

January 6, 2022

Study Start

October 15, 2019

Primary Completion

June 30, 2020

Study Completion

July 31, 2022

Last Updated

September 16, 2022

Record last verified: 2022-09

Locations

TW(1)