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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

Tracking Information
First Submitted Date  ICMJE January 15, 2017
First Posted Date  ICMJE January 25, 2017
Last Update Posted Date January 25, 2017
Study Start Date  ICMJE September 2015
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 20, 2017)
  • pain [ Time Frame: 6 weeks ]
    Visual Analog Scale(VAS) questionnaire
  • Disability [ Time Frame: 6 weeks ]
    Oswestry Disability Index(ODI) questionnaire
  • Pelvic Floor Muscle activity [ Time Frame: 6 weeks ]
    Transabdominal approach of Ultrasound imaging
  • Abdominal muscles(Transverse Abdominis,Internal Oblique,External Oblique) thickness [ Time Frame: 6 weeks ]
    Ultrasound imaging
  • Multifidus muscle thickness and crass section area(S1 level) [ Time Frame: 6 weeks ]
    Ultrasound imaging
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: January 20, 2017)
  • age [ Time Frame: 6 weeks ]
    with questionnaire
  • weight [ Time Frame: 6 weeks ]
    with questionnaire
  • height [ Time Frame: 6 weeks ]
    with questionnaire
  • Body Mass Index(BMI) [ Time Frame: 6 weeks ]
    with questionnaire
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Investigation the Effects of Stabilization Exercises on Pain, Disability and Activity of Pelvic Floor Muscles in Patients With Postpartum Lumbopelvic Pain
Official Title  ICMJE Zahra 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Postpartum Lumbopelvic Pain
Intervention  ICMJE
  • 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.
  • Other: Control group
    8 sessions during 6 consecutive weeks, three times per week, per session including: Twenty minutes for receiving hot pack and TENS
Study Arms  ICMJE
  • Experimental: stabilization exercises
    stabilization exercises for 6 weeks, 3 sessions per week and each session was 40 minutes for the training group.
    Intervention: Other: Stabilization exercise
  • Experimental: control group
    electrotherapy include of 20 minutes TENS conventional and Ultrasound pulse for 10 minutes without any exercises for the control group.
    Intervention: Other: Control group
Publications * Teymuri Z, Hosseinifar M, Sirousi M. The Effect of Stabilization Exercises on Pain, Disability, and Pelvic Floor Muscle Function in Postpartum Lumbopelvic Pain: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2018 Dec;97(12):885-891. doi: 10.1097/PHM.0000000000000993.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 20, 2017)
36
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03030846
Other Study ID Numbers  ICMJE ZAUMS
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Teymuri, Zahedan University of Medical Sciences
Study Sponsor  ICMJE Zahedan University of Medical Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Zahedan University of Medical Sciences
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP