A comparative study of stabilization exercise focusing pelvic floor muscles training and routine physiotherapy on pain, disability and muscles thickness in females with low back pain following pregnancy
Objective: evaluation the effect of stabilization exercise with an emphasis on deep muscles of the pelvic floor and deep abdominal muscles in compare with routine physiotherapy on pain, disability and thickness of deep abdominal muscle and pelvic floor in women with back ache of pregnancy.
Study design: randomly, without placebo control, single central.
The study population: 60 persons of women with back ache after pregnancy period referred to Neuromuscular Rehabilitation research center for physiotherapy.
Inclusion criteria: age between 20 to 40 years; natural childbirth; first delivery; pain from T12 area to gluteus muscles; persons with L5-S1 terminal or lateral pain in gluteal area.
Exclusion criteria: acute inflammation or infectious disease, cerebral disorder and back ache of internal organ disorders, chronic back ache more than 3 months; history of fracture and neoplasms or spine, pelvic or femoral surgery; new pregnancy
Sample size, intervention, intervention time, outcome of study: sample size for this study is 60 persons in intervention (stabilization exercise) and control (routine exercise) group.
Intervention group: 30 persons in intervention group, 8 weeks exercise therapy with 3 sessions per week (each session 3 sets of 10 to 12 times) is performed. Muscle contraction will keep for 6 to 8 seconds then rest for a few seconds and then repeat. Each of stability exercises are doing for strengthen abdominal muscles.
Control group: 30 persons in control group, only receive routine exercise and they are only to compare the results with the intervention group.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017060125732N18
Registration date:2017-06-11, 1396/03/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-06-11, 1396/03/21
Registrant information
Name
Alireza Emadi
Name of organization / entity
Semnan University of Medical Sciences, Semnan, Iran
Country
Iran (Islamic Republic of)
Phone
+98 23 3345 1336
Email address
are20935@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Semnan University of Medical Sciences
Expected recruitment start date
2017-05-22, 1396/03/01
Expected recruitment end date
2017-08-21, 1396/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of stabilization exercise focusing pelvic floor muscles training and routine physiotherapy on pain, disability and muscles thickness in females with low back pain following pregnancy
Public title
A comparative study of stabilization exercise focusing pelvic floor muscles training and routine physiotherapy on pain, disability and muscles thickness in females with low back pain following pregnancy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: age between 20 to 40 years; pain from T12 area to gluteus muscles with or without pain to knees; People who have 2 or more than 2 pelvic pain are positive in stimulation test; pain during pregnancy or 3 weeks after delivery; persons with L5-S1 terminal or lateral pain in gluteal area; natural childbirth; first delivery.
Exclusion criteria: acute inflammation or infectious disease, cerebral disorder and backache of internal organ disorders; chronic back ache more than 3 months and pain to blew the knees, people who have a locomotor disorders, verified and identified the spinal cord problems in last 2 months; history of fracture and neoplasms or spine, pelvic or femoral surgery; treatment with stabilization exercises during the previous 3 months; new pregnancy.
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee, Deputy of research and technology, Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Postal code
3514799442
Approval date
2017-05-21, 1396/02/31
Ethics committee reference number
IR.SEMUMS.REC.1396.-----
Health conditions studied
1
Description of health condition studied
Low back pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain
Primary outcomes
1
Description
The thickness of the abdominal muscles
Timepoint
Before and after the intervention
Method of measurement
Ultrasonography HS-2100V
2
Description
Pain intensity
Timepoint
Before and after intervention
Method of measurement
VAS questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 30 persons in intervention group, 8 weeks exercise therapy with 3 sessions per week (each session 3 sets of 10 to 12 times) is performed. Muscle contraction will keep for 6 to 8 seconds then rest for a few seconds and then repeat. Each of stability exercises are doing for strengthen abdominal muscles.
Category
Rehabilitation
2
Description
Control group: 30 persons in control group, only receive routine exercise and they are only to compare the results with the intervention group.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Neuromuscular Rehabilitation Research Center
Full name of responsible person
Fatemeh Ehsani
Street address
Blvd Qods, Semnan
City
Semnan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences, Deputy of Research and Technology
Full name of responsible person
Mohammadreza Asgari
Street address
Semnan University of Medical Sciences, Deputy of Research and Technology, Basij Blvd, Semnan
City
Semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan University of Medical Sciences, Deputy of Research and Technology
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
Semnan University of Medical Sciences
Full name of responsible person
Fatemeh Ehsani
Position
physiotherapist
Other areas of specialty/work
Street address
Semnan University of Medical Sciences, Blvd Basij, Semnan
City
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Fax
+98 23 3344 8999
Email
are20935@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Fatemeh Ehsani
Position
physiotherapist
Other areas of specialty/work
Street address
Semnan University of Medical Sciences, Blvd Basij, Semnan
City
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Fax
+98 23 3344 8999
Email
are20935@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Fatemeh Ehsani
Position
physiotherapist
Other areas of specialty/work
Street address
Semnan University of Medical Sciences, Blvd Basij, Semnan
City
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Fax
+98 23 3344 8999
Email
are20935@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)