ClinicalTrials.gg
CompletedNCT03030846Updated Jan 25, 2017

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

An interventional study of Stabilization exercise and Control group in Postpartum Lumbopelvic Pain, sponsored by Zahedan University of Medical Sciences. Completed at 1 site in Iran, Islamic Republic of. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-01-25.

Sponsored by Zahedan University of Medical Sciences · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Postpartum Lumbopelvic Pain

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Keywords

  • pregnancy
  • pelvic floor muscles
  • Lumbo-pelvic pain
  • Stabilization exercises
  • abdominal muscles thickness
  • Multifidus muscles thickness
  • Multifidus muscles cross section area
03

In context

Pain

10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.

This study's enrollment of 36 is below the median of 66 across 8,493 interventional studies indexed under Pain.

Browse Pain studies →

Lead sponsor

Zahedan University of Medical Sciences is the lead sponsor of 15 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • known chronic rheumatologic or Orthopedic disorders
  • systemic locomotor disease
  • history of fracture, neoplasm,intervertebral disk pathology or radiculopathy, spondylolysis or spondylolysthesis
  • of exercises, heart disease, diabetes, thrombophlebitis, uncontrolled epilepsy
  • ongoing pregnancy
  • treatment with specific stabilisation exercise during previous 3 months.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
36 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • OtherStabilization 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.

  • OtherControl group

    8 sessions during 6 consecutive weeks, three times per week, per session including: Twenty minutes for receiving hot pack and TENS

06

What researchers measure

Primary outcomes

  1. pain

    Visual Analog Scale(VAS) questionnaire

    Time frame: 6 weeks

  2. Disability

    Oswestry Disability Index(ODI) questionnaire

    Time frame: 6 weeks

  3. Pelvic Floor Muscle activity

    Transabdominal approach of Ultrasound imaging

    Time frame: 6 weeks

  4. Abdominal muscles(Transverse Abdominis,Internal Oblique,External Oblique) thickness

    Ultrasound imaging

    Time frame: 6 weeks

  5. Multifidus muscle thickness and crass section area(S1 level)

    Ultrasound imaging

    Time frame: 6 weeks

Other outcomes

  1. age

    with questionnaire

    Time frame: 6 weeks

  2. weight

    with questionnaire

    Time frame: 6 weeks

  3. height

    with questionnaire

    Time frame: 6 weeks

  4. Body Mass Index(BMI)

    with questionnaire

    Time frame: 6 weeks

07

Study locations

1 site
  • Zahra Teymuri
    Sistan and Bluchestan, Iran, Islamic Republic of
08

References and documents

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. PubMed 29979205 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2015, a primary completion of Mar 2016 and a completion of Apr 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 15, 2017
First posted
Jan 25, 2017
Start
Sep 2015
Primary completionActual
Mar 2016
CompletionActual
Apr 2016
Last update
Jan 25, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 25, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03030846
Lead sponsor
Zahedan University of Medical Sciences
Responsible party
Teymuri (zahra teymuri, Zahedan University of Medical Sciences) — Principal investigator
First posted
Jan 25, 2017
Start date
Sep 2015
Primary completion
Mar 2016
Completion
Apr 2016
Last update
Jan 25, 2017

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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