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

NCT04377516 | Withdrawn

• 1 other identifier: NCKU-TSAI
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Pelvic Girdle Pain

Outcome Measures

Primary Outcomes (9)

• 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

• 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

• 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

Secondary Outcomes (1)

• General health

  8 weeks

Study Arms (4)

Transabdominal Sonography-guided Biofeedback group

EXPERIMENTAL

pelvic floor muscle training with transabdominal sonography-guided Biofeedback

Other: pelvic floor muscle training; Other: pelvic floor muscle combined global muscle exercise training; Other: education of pelvic girdle

Exercise group

ACTIVE COMPARATOR

pelvic floor muscle training

Other: pelvic floor muscle training; Other: pelvic floor muscle combined global muscle exercise training; Other: education of pelvic girdle

Control group

PLACEBO COMPARATOR

pelvic girdle education

Other: education of pelvic girdle

Health group

PLACEBO COMPARATOR

pelvic girdle education

Other: education of pelvic girdle

Interventions

pelvic floor muscle training OTHER

pelvic floor muscle training

Exercise group; Transabdominal Sonography-guided Biofeedback group

pelvic floor muscle combined global muscle exercise training OTHER

pelvic floor muscle combined global muscle exercise training

Exercise group; Transabdominal Sonography-guided Biofeedback group

education of pelvic girdle OTHER

education of pelvic girdle

Control group; Exercise group; Health group; Transabdominal Sonography-guided Biofeedback group

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (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
• 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.

Sponsors & Collaborators

• YI-JU TSAI: lead

Study Sites (1)

National Cheng Kung University

Tainan, 701, Taiwan

Location

MeSH Terms

Conditions

Pelvic Girdle Pain

Condition Hierarchy (Ancestors)

Musculoskeletal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pelvic 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: April 28, 2020
• First Posted: May 6, 2020
• Study Start: October 15, 2019
• Primary Completion: June 30, 2020
• Study Completion: July 31, 2023
• Last Updated: November 22, 2024

Record last verified: 2024-11

Locations

TW (1)