<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03030846</url>
  </required_header>
  <id_info>
    <org_study_id>ZAUMS</org_study_id>
    <nct_id>NCT03030846</nct_id>
  </id_info>
  <brief_title>Investigation the Effects of Stabilization Exercises on Pain, Disability and Activity of Pelvic Floor Muscles in Patients With Postpartum Lumbopelvic Pain</brief_title>
  <official_title>Zahra Teymuri, Zahedan University of Medical Sciences</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zahedan University of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zahedan University of Medical Sciences</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study was to evaluate the effects of stabilization exercises on pain,&#xD;
      disability and pelvic floor muscles function in patients with lumbopelvic pain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pregnancy is a specific experience that leads to several physical changes in women's body and&#xD;
      influence most aspects of their lives. Pregnancy and delivery can cause serious complications&#xD;
      such as urinary incontinence, pelvic organ prolapse, fecal incontinence, and low back pain&#xD;
      (LBP) that have negative effects on women's sexual, physical, social and psychological&#xD;
      health.&#xD;
&#xD;
      Based on Wu et al. systematic review, prevalence of pregnancy related low back pain (PLBP)&#xD;
      during pregnancy and postpartum is 45% and 25% respectively.&#xD;
&#xD;
      LBP is one of the most current causes of disability and sick leave after delivery.Abnormal&#xD;
      load transfer in the lumbopelvic region has been considered as one possible explanation to&#xD;
      lumbopelvic pain.The local stabilizing muscles, i.e. the transversely oriented abdominal,&#xD;
      diaphragm, the lumbar MF and the PFM Play an important role in load transfer in the&#xD;
      lumbopelvic region.so, we considered that an exercise program that addresses muscular&#xD;
      dysfunction, such as lumbar stabilization exercise can improve motor pattern of local&#xD;
      stabilizing muscles and can use in management of postpartum lumbopelvic pain.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2015</start_date>
  <completion_date type="Actual">April 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>pain</measure>
    <time_frame>6 weeks</time_frame>
    <description>Visual Analog Scale(VAS) questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Disability</measure>
    <time_frame>6 weeks</time_frame>
    <description>Oswestry Disability Index(ODI) questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pelvic Floor Muscle activity</measure>
    <time_frame>6 weeks</time_frame>
    <description>Transabdominal approach of Ultrasound imaging</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Abdominal muscles(Transverse Abdominis,Internal Oblique,External Oblique) thickness</measure>
    <time_frame>6 weeks</time_frame>
    <description>Ultrasound imaging</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Multifidus muscle thickness and crass section area(S1 level)</measure>
    <time_frame>6 weeks</time_frame>
    <description>Ultrasound imaging</description>
  </primary_outcome>
  <other_outcome>
    <measure>age</measure>
    <time_frame>6 weeks</time_frame>
    <description>with questionnaire</description>
  </other_outcome>
  <other_outcome>
    <measure>weight</measure>
    <time_frame>6 weeks</time_frame>
    <description>with questionnaire</description>
  </other_outcome>
  <other_outcome>
    <measure>height</measure>
    <time_frame>6 weeks</time_frame>
    <description>with questionnaire</description>
  </other_outcome>
  <other_outcome>
    <measure>Body Mass Index(BMI)</measure>
    <time_frame>6 weeks</time_frame>
    <description>with questionnaire</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Postpartum Lumbopelvic Pain</condition>
  <arm_group>
    <arm_group_label>stabilization exercises</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>stabilization exercises for 6 weeks, 3 sessions per week and each session was 40 minutes for the training group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>electrotherapy include of 20 minutes TENS conventional and Ultrasound pulse for 10 minutes without any exercises for the control group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Stabilization exercise</intervention_name>
    <description>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.</description>
    <arm_group_label>stabilization exercises</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control group</intervention_name>
    <description>8 sessions during 6 consecutive weeks, three times per week, per session including: Twenty minutes for receiving hot pack and TENS</description>
    <arm_group_label>control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age more than 18 years old&#xD;
&#xD;
          -  pain located between costal margin to gluteal fold with or without radiation to lower&#xD;
             limbs&#xD;
&#xD;
          -  onset of pain during pregnancy or after delivery&#xD;
&#xD;
          -  history of delivery at least 3 months ago.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  known chronic rheumatologic or Orthopedic disorders&#xD;
&#xD;
          -  systemic locomotor disease&#xD;
&#xD;
          -  history of fracture, neoplasm,intervertebral disk pathology or radiculopathy,&#xD;
             spondylolysis or spondylolysthesis&#xD;
&#xD;
          -  contraindication of exercises, heart disease, diabetes, thrombophlebitis, uncontrolled&#xD;
             epilepsy&#xD;
&#xD;
          -  ongoing pregnancy&#xD;
&#xD;
          -  treatment with specific stabilisation exercise during previous 3 months.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Zahra Teymuri</name>
      <address>
        <city>Sistan and Bluchestan</city>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Iran, Islamic Republic of</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 15, 2017</study_first_submitted>
  <study_first_submitted_qc>January 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 25, 2017</study_first_posted>
  <last_update_submitted>January 20, 2017</last_update_submitted>
  <last_update_submitted_qc>January 20, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Zahedan University of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Teymuri</investigator_full_name>
    <investigator_title>zahra teymuri</investigator_title>
  </responsible_party>
  <keyword>pregnancy</keyword>
  <keyword>pelvic floor muscles</keyword>
  <keyword>Lumbo-pelvic pain</keyword>
  <keyword>Stabilization exercises</keyword>
  <keyword>abdominal muscles thickness</keyword>
  <keyword>Multifidus muscles thickness</keyword>
  <keyword>Multifidus muscles cross section area</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03030846
org study id: ZAUMS
nct id: NCT03030846
lead sponsor: 
has dmc: No
The purpose of this study was to evaluate the effects of stabilization exercises on pain,
      disability and pelvic floor muscles function in patients with lumbopelvic pain.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: pain
time frame: 6 weeks
description: Visual Analog Scale(VAS) questionnaire
measure: Disability
time frame: 6 weeks
description: Oswestry Disability Index(ODI) questionnaire
measure: Pelvic Floor Muscle activity
time frame: 6 weeks
description: Transabdominal approach of Ultrasound imaging
measure: Abdominal muscles(Transverse Abdominis,Internal Oblique,External Oblique) thickness
time frame: 6 weeks
description: Ultrasound imaging
measure: Multifidus muscle thickness and crass section area(S1 level)
time frame: 6 weeks
description: Ultrasound imaging
measure: age
time frame: 6 weeks
description: with questionnaire
measure: weight
time frame: 6 weeks
description: with questionnaire
measure: height
time frame: 6 weeks
description: with questionnaire
measure: Body Mass Index(BMI)
time frame: 6 weeks
description: with questionnaire
arm group label: stabilization exercises
arm group type: Experimental
description: stabilization exercises for 6 weeks, 3 sessions per week and each session was 40 minutes for the training group.
arm group label: control group
arm group type: Experimental
description: electrotherapy include of 20 minutes TENS conventional and Ultrasound pulse for 10 minutes without any exercises for the control group.
intervention type: Other
intervention name: Stabilization exercise
description: 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.
arm group label: stabilization exercises
intervention type: Other
intervention name: Control group
description: 8 sessions during 6 consecutive weeks, three times per week, per session including: Twenty minutes for receiving hot pack and TENS
arm group label: control group
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Iran, Islamic Republic of
responsible party type: Principal Investigator
investigator affiliation: Zahedan University of Medical Sciences
investigator full name: Teymuri
investigator title: zahra teymuri
sharing ipd: No