To compare the effects of pelvic strengthening excercises with and without lumbopelvic belt on postpartum females with pelvic girdle pain.
Design
Randomize clinical trial, not blind trial, 2 group.
Settings and conduct
MEDLANE MEDICAL COMPLEX GULBERG 3 LAHORE. The study was conducted within 6 months after the approval of synopsis.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: •Age 25-35 •Diagnosed cases of pelvic girdle pain. •Willing to participate in the research •First post partum period.
Exclusion Criteria: •History of previous pelvic surgery •History of pelvis fracture •Any neurological problem •Patients using the pain killers •Patients with depression •Uncontrolled thyroid disorder
Intervention groups
Group A: patients were treated with conventional physical therapy treatment and pelvic strengthening exercises with lumbopelvic belt. Group B: patients were treated with conventional physical therapy treatment and pelvic strengthening exercises. Pre interventional readings will be taken at baseline & post interventional readings at 4 weeks
Main outcome variables
pain intensity (VAS) and low back pain (ODI)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210108049966N3
Registration date:2022-08-15, 1401/05/24
Registration timing:retrospective
Last update:2022-08-15, 1401/05/24
Update count:0
Registration date
2022-08-15, 1401/05/24
Registrant information
Name
Shanza Tanveer
Name of organization / entity
Riphah International University
Country
Pakistan
Phone
+92 48 3215215
Email address
cheematanvir666@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-14, 1400/10/24
Expected recruitment end date
2022-02-21, 1400/12/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of pelvic strengthening exercises with and without lumbopelvic belt on postpartum females with pelvic girdle pain.
Public title
Effects of pelvic strengthening exercises with and without lumbopelvic belt on postpartum females with pelvic girdle pain.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 25-35
Diagnosed cases of pelvic girdle pain
First post partum period
Willing to participate in the research
Exclusion criteria:
History of previous pelvic surgery
History of pelvis fracture
Any neurological problem
Patients using the pain killers
Patients with depression
Uncontrolled thyroid disorder
Age
From 25 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
16
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was done through sealed envelope method on sample size of 16 females selected on inclusion & exclusion criteria in order to minimize biasness. Written informed consent will be taken. Lottary method will be used for allocation. Number of chits will be equal to total sample size, odd numbers for Group A allocation and even numbers for group B allocation.Each patient will be requested to draw a chit from the box.
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
Riphah International University
Street address
28- M Quaid e Azam Industrial Estate, Kot Lakhpat, Lahore.
City
Lahore
Postal code
54000
Approval date
2022-01-14, 1400/10/24
Ethics committee reference number
RCR/RCR & AHS/20/021
Health conditions studied
1
Description of health condition studied
Pelvic girdle pain (PGP): PGP is pain in the front and/or the back of your pelvis that can also affect other areas such as the hips or thighs.
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain intensity
Timepoint
Before treatment and after treatment (4th week).
Method of measurement
Visual analogue scale
2
Description
Low back pain
Timepoint
Before treatment and after treatment (4th week).
Method of measurement
Modified Oswestry Low Back Pain Disability Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: patients were treated with conventional physical therapy treatment and pelvic strengthening exercises with lumbopelvic belt in which include the pelvic floor training as well as kegel exercises such as bird dog, dead bug(try to maintain the table top position , assisted heel drops bridges, bridges with core ball and foam rolls. Lumbo pelvic belt for the support up to 4 week and almost 12 hours a day. pre treatment reading were taken as baseline and post treatment reading at 4th week.
Category
Treatment - Other
2
Description
Intervention group: patients were treated with conventional physical therapy treatment with pelvic strengthening exercises in which include the bird dog ,dead bugs , assisted heel drops bridges, bridges with core balls and foam rolls without lumbopelvic belt. Treatment time was 30 to 40 minutes on the daily basis up to four weeks pre treatment reading were taken as baseline and post treatment reading at 4th week.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
MEDLANE MEDICAL COMPLEX GULBERG 3 LAHORE
Full name of responsible person
Mehar un nisa
Street address
GULBERG 3 LAHORE
City
Lahore
Postal code
54660
Phone
+92 48 3215215
Email
cheematanvir666@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Riphah International University Lahore, Pakistan
Full name of responsible person
Mehar un nisa
Street address
Gullberg lll Lahore
City
Lahore
Postal code
54660
Phone
+92 48 3215215
Email
cheematanvir666@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Riphah International University Lahore, Pakistan
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Riphah International University Lahore, Pakistan
Full name of responsible person
Mehar un nisa
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
House no.1 block A muhafiz town, Sargodha.
City
Sargodha
Province
Punjab
Postal code
40100
Phone
+92 48 3215215
Email
cheematanvir666@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Riphah College of Rehabilitation Sciences (RCRS)
Full name of responsible person
Mehar un nisa
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
House no.1 block A muhafiz town, Sargodha.
City
Sargodha
Province
Punjab
Postal code
40100
Phone
+92 48 3215215
Email
cheematanvir666@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Riphah College of Rehabilitation Sciences (RCRS)
Full name of responsible person
Mehar un nisa
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
House no.1 block A muhafiz town, Sargodha.
City
sargodha
Province
Punjab
Postal code
40100
Phone
+92 48 3215215
Email
cheematanvir666@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further decision & information is decided yet.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available