NCT03030846

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 25, 2017

Completed
Last Updated

January 25, 2017

Status Verified

January 1, 2017

Enrollment Period

6 months

First QC Date

January 15, 2017

Last Update Submit

January 20, 2017

Conditions

Postpartum Lumbopelvic Pain

Keywords

pregnancypelvic floor musclesLumbo-pelvic painStabilization exercisesabdominal muscles thicknessMultifidus muscles thicknessMultifidus muscles cross section area

Outcome Measures

Primary Outcomes (5)

  • pain

    Visual Analog Scale(VAS) questionnaire

    6 weeks

  • Disability

    Oswestry Disability Index(ODI) questionnaire

    6 weeks

  • Pelvic Floor Muscle activity

    Transabdominal approach of Ultrasound imaging

    6 weeks

  • Abdominal muscles(Transverse Abdominis,Internal Oblique,External Oblique) thickness

    Ultrasound imaging

    6 weeks

  • Multifidus muscle thickness and crass section area(S1 level)

    Ultrasound imaging

    6 weeks

Other Outcomes (4)

  • age

    6 weeks

  • weight

    6 weeks

  • height

    6 weeks

  • +1 more other outcomes

Study Arms (2)

stabilization exercises

EXPERIMENTAL

stabilization exercises for 6 weeks, 3 sessions per week and each session was 40 minutes for the training group.

Other: Stabilization exercise

control group

EXPERIMENTAL

electrotherapy include of 20 minutes TENS conventional and Ultrasound pulse for 10 minutes without any exercises for the control group.

Other: Control group

Interventions

Stabilization exerciseOTHER

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.

stabilization exercises
Control groupOTHER

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

control group

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zahra Teymuri

Sistan and Bluchestan, Iran

Location

Related Publications (1)

  • 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.

    PMID: 29979205DERIVED

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
zahra teymuri

Study Record Dates

First Submitted

January 15, 2017

First Posted

January 25, 2017

Study Start

September 1, 2015

Primary Completion

March 1, 2016

Study Completion

April 1, 2016

Last Updated

January 25, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

IR(1)