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Investigation the Effects of Stabilization Exercises on Pain, Disability and Activity of Pelvic Floor Muscles in Patients With Postpartum Lumbopelvic Pain

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ClinicalTrials.gov Identifier: NCT03030846
Recruitment Status : Completed
First Posted : January 25, 2017
Last Update Posted : January 25, 2017
Sponsor:
Information provided by (Responsible Party):
Teymuri, Zahedan University of Medical Sciences

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Postpartum Lumbopelvic Pain Other: Stabilization exercise Other: Control group Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Zahra Teymuri, Zahedan University of Medical Sciences
Study Start Date : September 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: stabilization exercises
stabilization exercises for 6 weeks, 3 sessions per week and each session was 40 minutes for the training group.
Other: Stabilization exercise
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.

Experimental: control group
electrotherapy include of 20 minutes TENS conventional and Ultrasound pulse for 10 minutes without any exercises for the control group.
Other: Control group
8 sessions during 6 consecutive weeks, three times per week, per session including: Twenty minutes for receiving hot pack and TENS




Primary Outcome Measures :
  1. pain [ Time Frame: 6 weeks ]
    Visual Analog Scale(VAS) questionnaire

  2. Disability [ Time Frame: 6 weeks ]
    Oswestry Disability Index(ODI) questionnaire

  3. Pelvic Floor Muscle activity [ Time Frame: 6 weeks ]
    Transabdominal approach of Ultrasound imaging

  4. Abdominal muscles(Transverse Abdominis,Internal Oblique,External Oblique) thickness [ Time Frame: 6 weeks ]
    Ultrasound imaging

  5. Multifidus muscle thickness and crass section area(S1 level) [ Time Frame: 6 weeks ]
    Ultrasound imaging


Other Outcome Measures:
  1. age [ Time Frame: 6 weeks ]
    with questionnaire

  2. weight [ Time Frame: 6 weeks ]
    with questionnaire

  3. height [ Time Frame: 6 weeks ]
    with questionnaire

  4. Body Mass Index(BMI) [ Time Frame: 6 weeks ]
    with questionnaire



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03030846


Locations
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Iran, Islamic Republic of
Zahra Teymuri
Sistan and Bluchestan, Iran, Islamic Republic of
Sponsors and Collaborators
Zahedan University of Medical Sciences

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Teymuri, zahra teymuri, Zahedan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT03030846     History of Changes
Other Study ID Numbers: ZAUMS
First Posted: January 25, 2017    Key Record Dates
Last Update Posted: January 25, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Teymuri, Zahedan University of Medical Sciences:
pregnancy
pelvic floor muscles
Lumbo-pelvic pain
Stabilization exercises
abdominal muscles thickness
Multifidus muscles thickness
Multifidus muscles cross section area