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Completed

NCT Number: NCT05181384

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

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.

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Key information

Conditions

Pelvic Girdle Pain Musculoskeletal Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Pelvic Pain Signs and Symptoms

Age range

20 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

National Cheng Kung University

Tainan, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

isolated pelvic floor muscles training

Other

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

comprehensive stabilization exercise program

Other

incorporated the contraction of PFMs with other spinal or extremity muscles

education of pelvic girdle

Other

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

Primary outcomes

  1. pain intensity measure of Numeric Rating Scale (NRS)

    Time frame: Change from baseline to 8 weeks

    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).

  2. pain intensity measure of pelvic girdle questionnaire(PGQ)

    Time frame: Change from baseline to 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).

Secondary outcomes

  1. functional performance of ASLR fatigue task

    Time frame: Change from baseline to 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.

  2. functional performance of timed up and go test

    Time frame: Change from baseline to 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.

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

    Time frame: Change from baseline to 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.

  4. Muscle function measures of abdominal muscle

    Time frame: Change from baseline to 8 weeks

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

  5. Muscle function measures of pelvic floor muscle control

    Time frame: Change from baseline to 8 weeks

    Untrasonography image for muscle thickness of pelvic floor muscle control at maximum contraction.

Sponsors and collaborators

Lead sponsor

YI-JU TSAI

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2022
First posted
Jan 6, 2022
Registry last updated
Sep 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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