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

Not Applicable

Recruiting

• Conditions: Postpartum; Pregnancy Related; Pelvic Girdle Pain
• Interventions: Other: Diaphragmatic breathing retraining; Other: Pelvic stabilization exercise; Other: pelvic anatomy education

• Registration Number: NCT06284278
• Lead Sponsor: YI-JU TSAI

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-19
• Study First Submitted QC: 2024-02-26
• Study First Posted: 2024-02-28
• Study Start: 2024-03-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-13
• Last Update Posted: 2024-11-15
• Primary Completion: 2026-05-31
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diaphragmatic breathing exercise group	Diaphragmatic breathing retraining	Diaphragmatic breathing exercise through telehealth
Diaphragmatic breathing exercise group	pelvic anatomy education	Diaphragmatic breathing exercise through telehealth
Pelvic stabilization exercise group	Pelvic stabilization exercise	Pelvic stabilization exercise through telehealth
Pelvic stabilization exercise group	pelvic anatomy education	Pelvic stabilization exercise through telehealth

Primary Outcome Measures

Name	Time	Method
Health-related Quality of Life: Short Form-36 (SF36)	Change from baseline to 8 weeks	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
Diaphragm thickness	Change from baseline to 8 weeks	Ultrasonography image for diaphragm thickness during maximum inspiration and expiration (B mode)
Self-Efficacy: Pain Self-efficacy Questionnaire	Change from baseline to 8 weeks	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
Fear Avoidance Belief: Tampa Scale of Kinesiophobia	Change from baseline to 8 weeks	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
Muscle function measures of lumbopelvic muscles	Change from baseline to 8 weeks	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
Diaphragm strength	Change from baseline to 8 weeks	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
Functional performance of ASLR fatigue task	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.
Functional performance of timed up and go test	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.
Functional performance of 6m timed walk test	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.
Diaphragm mobility	Change from baseline to 8 weeks	Ultrasonography image for mobility during maximum inspiration and expiration (M mode)
Mechanical Property of Thoracolumbar Fascia	Change from baseline to 8 weeks	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.
pain intensity measure of Numeric Rating Scale (NRS)	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).
Disability Level: measure of pelvic girdle questionnaire(PGQ)	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).
Parenting Stress Level: Parenting Stress Index-Short Form (PSI-SF)	Change from baseline to 8 weeks	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.
Self-perceived Change: Global Rating of Change Scale (GROC)	Change from baseline to 8 weeks	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.

Trial Locations

Locations (1)

National Cheng Kung University; 🇨🇳 Tainan, Taiwan