Investigation the effect of stabilization exercises on pain, disability and pelvic floor muscles activity in patients with postpartum lumbopelvic pain: A Randomized Clinical Trial
Objectives: Investigation of the effect of stabilization exercises on pain, disability and pelvic floor muscles activity in patients with postpartum lumbopelvic pain
Design: In this randomized controlled trial (phase 2), 36 women with postpartum lumbopelvic pain were selected through nonprobability simple sampling and were assigned randomly to 2 groups by using consecutive assignment, Stabilization exercises(18 subjects) and Control group(18 subjects).
Setting: This randomized clinical trial was performed in Zahedan University of Medical Sciences, from September 2015 to February 2016.
Inclusion criteria: age more than 18 years old; pain located betweeen 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: history of fracture; neoplasm; intervertebral disk pathology or radiculopathy; spondylolysis or spondylolysthesis; ongoing pregnancy; treatment with specific stabilisation exercise during previous 3 months.
Sample size: 36 subjects(18 person in control group and 18 person in training group).
Intervention group: physical therapy with specific stabilization exercises in training group for 6 weeks (18 sessions every other day).
control group: physical therapy without stabilization exercises in control group for 6 weeks(18 sessions every other day).
Outcomes:Variables were include of pain, disability, pelvic floor muscle activity that measured one day before of the intervention and one day after the intervention.
the pain intensity is measured using Visual Analog Scale(VAS)
the disability is measured using Oswestry Disability Index(ODI)
The pelvic floor muscle activity is measured using Transabdominal approach of ultrasound imaging. in this approach bladder wall displacement was measured as a function of the pelvic floor muscles at rest and during maximal contraction.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2016053128186N1
Registration date:2016-08-18, 1395/05/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-08-18, 1395/05/28
Registrant information
Name
Mohammad Hosseinifar
Name of organization / entity
Zahedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 54 3329 1692
Email address
fardash_s@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Zahedan University of Medical Sciences research, Deputy of Research.
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2016-02-18, 1394/11/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation the effect of stabilization exercises on pain, disability and pelvic floor muscles activity in patients with postpartum lumbopelvic pain: A Randomized Clinical Trial
Public title
The effect of stabilization exercises in postpartum lumbopelvic pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age more than 18 years old; pain located betweeen 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.
Age
From 18 years old to 58 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this clinical trial (phase 2) patients by using consecutive assignment were assigned into two groups,Stabilization exercise(18 subjects) and Control group(18 subjects).
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Zahedan University of Medical Sciences
Street address
Deputy of Research, Zahedan University of Medical Sciences, Jannat Blvd., Dr. Hesabi Sq.
City
Zahedan
Postal code
9816743463
Approval date
2015-10-11, 1394/07/19
Ethics committee reference number
IR.ZAUMS.REC1394.280
Health conditions studied
1
Description of health condition studied
Postpartum Low Back Pain
ICD-10 code
M54.9
ICD-10 code description
Dorsalgia, unspecified
Primary outcomes
1
Description
pain
Timepoint
Before and after the period of the interventions
Method of measurement
Visual Analog Scale(VAS) questionnaire
2
Description
Disability
Timepoint
Before and after the period of the interventions
Method of measurement
Oswestru Disability Index(ODI) questionnaire
3
Description
Pelvic Floor Muscle activity
Timepoint
Before and after the period of the interventions
Method of measurement
transabdominal approach of Ultrasound imaging
Secondary outcomes
empty
Intervention groups
1
Description
control group:18 sessions during 6 consecutive weeks, three times per week, per session including: Twenty minutes for receiving hot pack and TENS
Category
Rehabilitation
2
Description
Stabilization exercise group: 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.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Razmjo Moghadam Physiotherapy Clinic
Full name of responsible person
Dr.Mohammad Hosseinifar
Street address
Dept. of Physiotherapy, School of Rehabilitation Sciences, Razmejo Moghadam Laboratory, Ayatoallah Kafami St.
City
zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Zahedan University of Medical Sciences
Full name of responsible person
Dr. Hoshang rafigdost
Street address
Deputy of Research, Zahedan University of Medical Sciences, Jannat Blvd., Dr. Hesabi Sq.
City
zahedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Zahedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Mohammad Hosseinifar
Position
Ph.D in Physiotherapy
Other areas of specialty/work
Street address
Dept. of Physiotherapy, School of Rehabilitation Sciences, Razmejo-Moghadam Laboratory, Ayatoallah Kafami St.
City
zahedan
Postal code
64855-98136
Phone
+98 54 3342 4675
Fax
+98 54 3342 4675
Email
fardash_s@yahoo.com; faedash_s@zaums.ac.ir
Web page address
www.zaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr.Mohammad Hosseinifar
Position
Ph.D in Physiotherapy
Other areas of specialty/work
Street address
Dept. of Physiotherapy, School of Rehabilitation Sciences, Razmejo-Moghadam Laboratory, Ayatoallah Kafami St.
City
zahedan
Postal code
64855-98136
Phone
+98 54 3342 4675
Fax
+98 54 3342 4675
Email
fardash_s@yahoo.com; fardash_s@zaums.ac.ir
Web page address
www.zaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr.Mohammad Hosseinifar
Position
Ph.D in Physiotherapy
Other areas of specialty/work
Street address
Dept. of Physiotherapy, School of Rehabilitation Sciences, Razmejo-Moghadam Laboratory, Ayatoallah Kafami St
City
zahedan
Postal code
Phone
+98 54 3342 4675
Fax
+98 54 3342 4675
Email
fardash-s@zaums.ac.ir; fardash-s@yahoo.com
Web page address
www.zaums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)