- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03030846
Investigation the Effects of Stabilization Exercises on Pain, Disability and Activity of Pelvic Floor Muscles in Patients With Postpartum Lumbopelvic Pain
Zahra Teymuri, Zahedan University of Medical Sciences
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Pregnancy is a specific experience that leads to several physical changes in women's body and influence most aspects of their lives. Pregnancy and delivery can cause serious complications such as urinary incontinence, pelvic organ prolapse, fecal incontinence, and low back pain (LBP) that have negative effects on women's sexual, physical, social and psychological health.
Based on Wu et al. systematic review, prevalence of pregnancy related low back pain (PLBP) during pregnancy and postpartum is 45% and 25% respectively.
LBP is one of the most current causes of disability and sick leave after delivery.Abnormal load transfer in the lumbopelvic region has been considered as one possible explanation to lumbopelvic pain.The local stabilizing muscles, i.e. the transversely oriented abdominal, diaphragm, the lumbar MF and the PFM Play an important role in load transfer in the lumbopelvic region.so, we considered that an exercise program that addresses muscular dysfunction, such as lumbar stabilization exercise can improve motor pattern of local stabilizing muscles and can use in management of postpartum lumbopelvic pain.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Sistan and Bluchestan, Iran, Islamic Republic of
- Zahra Teymuri
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- age more than 18 years old
- pain located between costal margin to gluteal fold with or without radiation to lower limbs
- onset of pain during pregnancy or after delivery
- history of delivery at least 3 months ago.
Exclusion Criteria:
- known chronic rheumatologic or Orthopedic disorders
- systemic locomotor disease
- history of fracture, neoplasm,intervertebral disk pathology or radiculopathy, spondylolysis or spondylolysthesis
- contraindication of exercises, heart disease, diabetes, thrombophlebitis, uncontrolled epilepsy
- ongoing pregnancy
- treatment with specific stabilisation exercise during previous 3 months.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: stabilization exercises
stabilization exercises for 6 weeks, 3 sessions per week and each session was 40 minutes for the training group.
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18 sessions during 6 consecutive weeks, three times per week, 30 or 40 minutes per session including: Twenty minutes for receiving hot pack and TENS and 10 or 20 minutes for training the exercises in 7 level : 1.Train the specific contraction of the deep abdominal muscles, multifidus and pelvic floor muscles(PFM).
2.Train the specific contraction of deep abdominal muscles with coactivation of multifidus and PFM in supine, prone, sitting, standing and quadruped position.
3. Segmental control exercises in close kinematic chain.
4. Segmental control exercises in open kinematic chain with limb loading, emphasis on abdominal muscles.
5. Segmental control exercises in open kinematic chain with limb loading, emphasis on back extensor muscles.
6. Progress exercises to functional task.
7. Coactivation of abdominal and multifidus muscles with limb loading in aerobic tasks.
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Experimental: control group
electrotherapy include of 20 minutes TENS conventional and Ultrasound pulse for 10 minutes without any exercises for the control group.
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8 sessions during 6 consecutive weeks, three times per week, per session including: Twenty minutes for receiving hot pack and TENS
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
pain
Time Frame: 6 weeks
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Visual Analog Scale(VAS) questionnaire
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6 weeks
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Disability
Time Frame: 6 weeks
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Oswestry Disability Index(ODI) questionnaire
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6 weeks
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Pelvic Floor Muscle activity
Time Frame: 6 weeks
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Transabdominal approach of Ultrasound imaging
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6 weeks
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Abdominal muscles(Transverse Abdominis,Internal Oblique,External Oblique) thickness
Time Frame: 6 weeks
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Ultrasound imaging
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6 weeks
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Multifidus muscle thickness and crass section area(S1 level)
Time Frame: 6 weeks
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Ultrasound imaging
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6 weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
age
Time Frame: 6 weeks
|
with questionnaire
|
6 weeks
|
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weight
Time Frame: 6 weeks
|
with questionnaire
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6 weeks
|
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height
Time Frame: 6 weeks
|
with questionnaire
|
6 weeks
|
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Body Mass Index(BMI)
Time Frame: 6 weeks
|
with questionnaire
|
6 weeks
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Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ZAUMS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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