Effects of Specific Pelvic Stabilization Exercise With Transabdominal Ultrasonography-guided Biofeedback in Postpartum Women Suffering From Pregnancy-related Pelvic Girdle Pain

Sponsor
YI-JU TSAI (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04377516
Collaborator
(none)
120
1
4
21.5
5.6

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Other: pelvic floor muscle training
  • Other: pelvic floor muscle combined global muscle exercise training
  • Other: education of pelvic girdle
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Effects of Specific Pelvic Stabilization Exercise With Transabdominal Ultrasonography-guided Biofeedback in Postpartum Women Suffering From Pregnancy-related Pelvic Girdle Pain
Actual Study Start Date :
Oct 15, 2019
Actual Primary Completion Date :
Jun 30, 2020
Anticipated Study Completion Date :
Jul 31, 2021

Arms and Interventions

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

Other: Health group

pelvic girdle education

Other: education of pelvic girdle
education of pelvic girdle

Outcome Measures

Primary Outcome Measures

  1. Muscle function measures of abdominal muscle [8 weeks]

    Untrasonography image for muscle thickness of abdominal muscle during rest and ASLR test.

  2. Muscle function measures of inter recti distance [8 weeks]

    Untrasonography image for muscle thickness of inter recti distance during rest, maximum contraction, and ASLR test.

  3. Muscle function measures of pelvic floor muscle control [8 weeks]

    Untrasonography image for muscle thickness of pelvic floor muscle control during rest, maximum contraction, and ASLR test.

  4. pain intensity measure of Visual Analogue Scale(VAS) [8 weeks]

    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).

  5. pain intensity measure of pelvic girdle questionnaire(PGQ) [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).

  6. pain intensity measure of Oswestry Low Back Pain Disability Questionnaire(ODI) [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.

  7. functional performance of ASLR fatigue task [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.

  8. functional performance of timed up and go test [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.

  9. functional performance of 6m timed walk test(fast walking) [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.

Secondary Outcome Measures

  1. General health [8 weeks]

    36-item Short-Form Survey(SF-36)

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Cheng Kung University Tainan Taiwan 701

Sponsors and Collaborators

  • YI-JU TSAI

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
YI-JU TSAI, professor, National Cheng Kung University
ClinicalTrials.gov Identifier:
NCT04377516
Other Study ID Numbers:
  • NCKU-TSAI
First Posted:
May 6, 2020
Last Update Posted:
Sep 10, 2020
Last Verified:
Sep 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 10, 2020