- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07292051
Effect of Blood Flow Restriction Technique on Postpartum Pelvic Girdle Pain
Purpose of the study :
The purpose of the current study is investigating the effect of Blood Flow Restriction Training technique on postpartum pelvic girdle pain.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study is a randomized controlled trial. To fulfill its purpose, we have two groups; control group (A) and experimental group (B) are two matched postpartum pelvic girdle pain groups. While group (A) will receive a core stability exercise program, group (B) will receive core stability exercise program with blood flow restriction technique.
The primary outcome measure will be pelvic girdle pain intensity, while the secondary outcomes will include pelvic girdle-related disability, health-related quality of life, Kinesiophobia , global improvement and ASLR-RE angle.
Treatment duration will be eight weeks.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: jilan Adel, lecturer
- Phone Number: +20 01007519909
- Email: gelan_youssif@pt.kfs.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Patients will be eligible for the study if they met all the following criteria:
- Are between 3 and 12 months postpartum.
- Are aged between 20 and 35 years.
- Have a body mass index (BMI) < 30 kg/m².
- Reported experiencing pelvic girdle pain-defined as pain localized between the posterior iliac crest and the gluteal fold, particularly in the vicinity of the sacroiliac joints-that either began during pregnancy or persisted after delivery .
- Presented with a positive Active Straight Leg Raise (ASLR) test.
Showed positive findings in at least two of the following six pelvic pain provocation tests:
- Posterior Pelvic Pain Provocation (P4/Thigh Thrust) Test
- Patrick's (FABER) Test
- Long Dorsal Sacral Ligament Test
- Pelvic Compression Test
- Pelvic Distraction (Separation) Test
- Sacral Thrust Test
Exclusion Criteria:
-Patients will be excluded if they have any of the following:
- If they were Pregnant
- Known causes of pelvic girdle pain, such as fractures and rheumatism
- Undergone lumbar or pelvic surgery in the past
- Current neurological symptoms and signs in lower extremities such as lumbar radiculopathy and myelopathy
- Cancer
- Cardiovascular disease
- Experience with structured and supervised core or trunk exercise training programs
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group (A)
Group (A) will receive a core stability exercise program.
|
Patients will receive specific core stabilizing exercises, focusing on Pelvic floor muscles ,Gluteus maximus, Gluteus Medius, specific abdominal muscles , the lumbar multifidus, and Erector spinae.
|
|
Experimental: Group (B)
Group (B) will receive core stability exercise program with blood flow restriction technique.
|
Patients will receive specific core stabilizing exercises, focusing on Pelvic floor muscles ,Gluteus maximus, Gluteus Medius, specific abdominal muscles , the lumbar multifidus, and Erector spinae.
Patients will receive the same core stability exercise added to Blood Flow Restriction Technique
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
pelvic girdle pain intensity ( pain index )
Time Frame: Baseline , 8 weeks and 16 weeks
|
In this study, pain severity will be measured using the mean of three 11-point NRS questionnaires for least, usual, and current pain over the previous 2 weeks.
|
Baseline , 8 weeks and 16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
pelvic girdle-related disability
Time Frame: Baseline , 8 weeks and 16 weeks
|
pelvic girdle-related disability, measured by pelvic girdle questionnaire (PGQ)
|
Baseline , 8 weeks and 16 weeks
|
|
Health-related quality of life
Time Frame: Baseline , 8 weeks and 16 weeks
|
Health-related quality of life, measured by the Arabic version of European quality of life-Five-Dimension Five-Level Instrument (EQ-5d-5L)
|
Baseline , 8 weeks and 16 weeks
|
|
Kinesiophobia
Time Frame: Baseline , 8 weeks and 16 weeks
|
Kinesiophobia measured by an Arabic Tampa scale
|
Baseline , 8 weeks and 16 weeks
|
|
Global improvement
Time Frame: Baseline , 8 weeks and 16 weeks
|
Global improvement measured by global rating of change (GROC) scale
|
Baseline , 8 weeks and 16 weeks
|
|
Active straight leg raises repositioning error (ASLR-RE)
Time Frame: Baseline , 8 weeks and 16 weeks
|
ASLR-RE angle, measured by Image J
|
Baseline , 8 weeks and 16 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- KFSIRB200-813
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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