Telehealth: Diaphragmatic vs. Pelvic Exercise in Postpartum Pregnancy-related Pelvic Girdle Pain

Pregnancy Related Clinical Trial

Official title:

Comparison of Diaphragmatic Breathing Exercise and Pelvic Stabilization Exercise in Postpartum Women With Pregnancy-related Pelvic Girdle Pain: A Real-time Telehealth-based Intervention

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06284278
• Other study ID #: NCKU_PPGP_diaphragm
• Status: Recruiting
• Phase: N/A
• Start date: October 20, 2023
• Est. completion date: July 31, 2024

Study information

• Verified date: February 2024
• Source: National Cheng Kung University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this interventional study is to compare investigate the short-term and long-term effects of 8-week real-time telehealth-based diaphragmatic breathing exercise and pelvic stabilization exercise on pain, disability, and quality of life in postpartum women with pregnancy-related pelvic girdle pain.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age between 20-65 years
• Postpartum = 3 months
• Pain located in sacroiliac joints (i.e., pain located between the posterior iliac crest and gluteal fold)
• Pregnancy-related cause of pelvic pain that pain occurs during pregnancy or after delivery (i.e., not traumatic or degenerative cause)
• At least 2 positive findings of 6 pain provocation tests for pelvic pain
• Score of Active Straight Leg Rise (ASLR) test > 0

Exclusion Criteria:

• being pregnant or actively trying to get pregnant
• having known causes of pelvic girdle pain, such as fractures and rheumatism
• having undergone lumbar, pelvic, gynecologic or obstetric surgery
• having current neurological symptoms and signs in lower extremities such as lumbar radiculopathy and myelopathy
• having cancer
• having cardiovascular disease
• being diagnosed as having a psychiatric disease
• active infection or infectious disease in the pelvis or abdomen
• having experience with structured and supervised core or trunk exercise training programs.

Related Conditions & MeSH terms

• Pelvic Girdle Pain
• Postpartum
• Pregnancy Related

Intervention

Other:
• Diaphragmatic breathing retraining
8 weeks diaphragmatic breathing training
• Pelvic stabilization exercise
8 weeks pelvic stabilization exercise training
• pelvic anatomy education
pelvic anatomy education

Locations

Country	Name	City	State
Taiwan	National Cheng Kung University	Tainan

Sponsors (1)

Lead Sponsor	Collaborator
YI-JU TSAI

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle function measures of lumbopelvic muscles	Ultrasonography image for muscle thickness of trunk and back muscles during rest and during active straight leg raise.; Ultrasonography image for bladder displacement for pelvic floor muscles during rest,maximum contraction and during active straight leg raise	Change from baseline to 8 weeks
Primary	Diaphragm thickness	Ultrasonography image for diaphragm thickness during maximum inspiration and expiration (B mode)	Change from baseline to 8 weeks
Primary	Diaphragm mobility	Ultrasonography image for mobility during maximum inspiration and expiration (M mode)	Change from baseline to 8 weeks
Primary	Diaphragm strength	Ultrasonography image for diaphragm strength during maximal sniff and expiration (M mode). The slope achieved (mm/sec) during the diaphragmatic excursion is used to calculate the velocity of the diaphragmatic contraction	Change from baseline to 8 weeks
Primary	Mechanical Property of Thoracolumbar Fascia	The biomechanical and viscoelastic properties of the muscles will be measured using a non-invasive myometer. It automatically calculate and provide the biomechanical and viscoelastic properties of stiffness, frequency, decrement, and stress relaxation time that offer the information of tone, elasticity, stiffness and stress relaxation time of the tested tissue.	Change from baseline to 8 weeks
Primary	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.	Change from baseline to 8 weeks
Primary	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.	Change from baseline to 8 weeks
Primary	Functional performance of 6m timed walk test	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.	Change from baseline to 8 weeks
Primary	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
Primary	Disability Level: 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
Primary	Health-related Quality of Life: Short Form-36 (SF36)	SF-36 include 36 questions constructing into 8 domains (i.e., physical functioning, physical role, bodily pain, general health, vitality, social functioning, emotional role, and mental health). The scores of physical and mental components and total are ranged from 0 to 100, with higher scores representing better quality of life	Change from baseline to 8 weeks
Primary	Fear Avoidance Belief: Tampa Scale of Kinesiophobia	Fear of movement, fear of physical activity, and fear avoidance will be assessed using the Tampa scale of kinesiophobia (TSK). The TSK is 17-items questionnaire, where patients rate their agreement using 4-points scale. It consists of two subscales including activity avoidance to reflect the activity that may result in an increase in pain or cause injury, and somatic focus to reflect the beliefs and underlying serious conditions	Change from baseline to 8 weeks
Primary	Self-Efficacy: Pain Self-efficacy Questionnaire	The pain self-efficacy questionnaire (PSEQ) is a 10-item questionnaire, where patients rate their confidence from 0 points (not at all confident) to 6 points (completely confident). Total scores of the PSEQ is 60 points and a higher score indicates more self-efficacy	Change from baseline to 8 weeks
Primary	Parenting Stress Level: Parenting Stress Index-Short Form (PSI-SF)	The PSI-SF is a self-reported questionnaire that consists of 36 items to assess stress related to three aspects including parent-child relationship, parental distress, and difficulties in the parent-child interaction. The subscales for parental distress, parent-child dysfunctional interaction and difficult child, as well as the total stress scale are rated from 1 (strongly disagree) to 5 (strongly agree). The higher the score indicates the greater the stress.	Change from baseline to 8 weeks
Primary	Self-perceived Change: Global Rating of Change Scale (GROC)	The GROC rates perceived "overall change" on a 15-point Likert scale, with 7 (labeled "worse") on the left, +7 (labeled "better") on the right, and 0 in the middle (labeled "no change") compared to the baseline.	Change from baseline to 8 weeks