Effects of abdominal hypopressive exercise on pain intensity, functional disability, transversus abdominis muscle thickness and quality of life in Primiparous female with Sacroiliac hypermobility dysfunction
To find the effect of abdominal hypopressive exercise on pain intensity in primiparous female with sacroiliac hypermobility dysfunction
To assess the effects of abdominal hypopressive exercise on functional activities of primiparous female with sacroiliac hypermobility dysfunction.
To evaluate the effects of abdominal hypopressive exercise on sonographic change in transversus abdominus muscle thickness in primiparous female with sacroiliac hypermobility dysfunction
To find the change in quality of life in primiparous female with sacroiliac hypermobility dysfunction
Design
Randomized, single blinded, parallel group
Settings and conduct
The Physical therapy department, ULTH, The University of Lahore
It will be a single blinded trial in which the assessor will be kept blind.
Assessor will be senior physiotherapist who will take measurements after giving consent to participate in the study. He will be blind, not confirmed about the group of intervention
Participants/Inclusion and exclusion criteria
• Primiparous Female aged between 18-30 years
• Patient with vaginal delivery
• Within one year after post-partum
• Unilateral sacroiliac dysfunction
• Positive SI joint dysfunction test
Exclusion Criteria:
• Pregnancy
• History of Cardiopulmonary Disease
• History of Spondyloarthropathies
Intervention groups
Abdominal hypopressive exercise group
Conventional physical therapy
Effects of abdominal hypopressive exercise on pain intensity, functional disability, transversus abdominis muscle thickness and quality of life in Primiparous female with Sacroiliac hypermobility dysfunction
Public title
Effects of abdominal hypopressive exercise on pain intensity, functional disability, transversus abdominis muscle thickness and quality of life in Primiparous female with Sacroiliac hypermobility dysfunction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient with vaginal delivery
Within one year after post-partum
Unilateral sacroiliac dysfunction
Sacroiliac Forward Flexion Test ( = or more than 5mm difference will suggest sacral torsion)
Positive SI joint dysfunction test (= or more than 3 tests +ve)
The SIJ and posterior elements of the pelvic girdle can be examined using the P4 posterior pelvic pain provocation test, Patrick’s FABER (flexion, abduction, external rotation of the hip) test, active straight leg raise, palpation of the long dorsal sacroiliac ligament and Gaenslen’s test
VAS score equal or greater than 4
• Modified Oswetry disability index score equal or greater than 15
Exclusion criteria:
Pregnancy
History of Cardiopulmonary Disease
History of Spondyloarthropathies
History of Femoral acetabular impingement
History of Ischeofemoral impingement
History of Lumar disc herniation
History of Lumbar facet syndrome
History of traumatic injury to lumbar spine, sacroiliac joint or hip joint
Diagnosed by physician with any disease other than iliosacral dysfunction
Previous surgical history of back
Age
From 18 years old to 30 years old
Gender
Female
Phase
4
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
The patients having diagnosed Sacroiliac dysfunction will be recruited in the study by purposive sampling, and the patients who fulfill the inclusion and exclusion criteria will be selected, with similar baseline characteristics. The consent will be taken from the subjects to participate in the study. The subjects will be randomly assigned to one of two groups by using a table of random numbers generated the randomization sequence, using a restricted randomization scheme to assure equal numbers in each group. Random allocation to all groups will be ensured, from all study personnel and participants by entry of data into computer randomization program immediately. Group assignments will be sealed in opaque envelopes and opened sequentially by the investigators.
Blinding (investigator's opinion)
Single blinded
Blinding description
It will be a single blinded trial in which the assessor will be kept blind. Assessor will be senior physiotherapist who will take measurements after giving consent to participate in the study. He will be blind, not confirmed about the group of intervention.
Placebo
Not used
Assignment
Parallel
Other design features
single blinded, single setting
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics committee, Faculty of Allied Health Sciences, The University Of Lahore
Street address
1-km defence road, off bhoptian chowk, Lahore Pakistan
City
Lahore
Postal code
0544
Approval date
2023-12-20, 1402/09/29
Ethics committee reference number
REC-UOL-616-12-2023
Health conditions studied
1
Description of health condition studied
Sacroiliac hypermobility dysfunction
ICD-10 code
M53.2X
ICD-10 code description
Spinal instabilities
Primary outcomes
1
Description
Pain intensity
Timepoint
before intervention, 4 and 8 weeks after intervention
Method of measurement
Visual Analogue Scale
2
Description
Functional Disability
Timepoint
before intervention, 4 and 8 weeks after intervention
Method of measurement
Modified Oswestry disability index (MODI)
3
Description
thickness of transverses abdominus muscle
Timepoint
before and after the intervention
Method of measurement
Sonography
Secondary outcomes
1
Description
quality of life
Timepoint
before and after treatment
Method of measurement
SF-12 questionnaire
Intervention groups
1
Description
Intervention group:In abdominal hypopressive exercise group the participants will receive 3 sessions of exercises per week over the period of two months. Participants will learn the posture and breathing techniques in the first week. AHT involves 3 cycles of normal breathing followed by total air expiration and gradual contraction of the TrA and intercostal muscle with the rise of the hemi diaphragm and apnea. In 8 weeks the participant will learn performing abdominal hypopressive exercise in different postures in progressive manner. Postures will be repeated three times and apnea will be maintained for an average of 30 seconds. Conventional Physiotherapy which included US with a frequency of 1 MHz and intensity of 0.8 Wcm2 for 5 minutes followed by Corrective exercises.WEEKS EXERCISES Week 1: Standing posture and Tailor Sitting postureWeek 2: Semi-Sitting posture and Tailor Sitting posture Week 3: Supine position and Tailor Sitting posture Week 4: Kneeling posture, Quadruped posture and Genupectoral Sitting posture Week 5: Standing posture and Tailor Sitting posture Week 6: Kneeling posture and Quadruped posture Week 7: Semi-Sitting posture and Supine position Week 8: Tailor sitting posture and Genupectoral Sitting posture
Category
Rehabilitation
2
Description
Control group:Conventional Physiotherapy includes Ultra sound with a frequency of 1 MHz and intensity of 0.8 Wcm2 for 5 minutes followed by Corrective exercises. Corrective ExercisesThe following low back corrective exercises will be given:1. To stretch the tight lower back muscles- Seated Forward Bend- hold for 5 sec and repeat for 3 times, once a day2. To stretch the tight lower back muscles- Full Squat hold for 5 sec and repeat for 3 times, once a day3. To strengthen the weak lower abdomen- Draw inholding for 3 seconds, repeat 5 times, once a day4. To strengthen the weak lower abdomen- Reverse Crunch- holding for 2 sec, repeating 5 times, twice a day.5. To stretch the tight hip flexors: Standing Hip Flexor Stretch- hold for 10-15 seconds repeat 5 times on both legs, once a day.6. To strengthen the weak gluteus: Toed in Glutei Squeeze- hold for 3 sec, repeat 10 times, once a day.7. To strengthen the weak gluteus: Bridge both single and double leg- hold for 3 seconds, repeat 10 times, once a day8. To stretch the tight quadriceps: Standing Quadriceps Stretch- holdfor 3 seconds,Repeat 5 times on each side, once a day.9. To strengthen weak hamstrings: Kick Butts -hold for 2 sec, repeat 8 times, once a day, progression 2 times per day
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
The Physical therapy department, ULTH, The University of Lahore
Full name of responsible person
Asim Arif
Street address
1-km defence road, off bhoptian chowk, Lahore
City
lahore
Postal code
54000
Phone
+92 42 35322501
Email
asim.pt@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Lahore
Full name of responsible person
Ashfaq Ahmad
Street address
1-km defence road, off bhoptian chowk, Lahore
City
Lahore
Postal code
54000
Phone
+92 42 35322501
Email
ashfaq.ahmad@uipt.uol.edu.pk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Lahore
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
government college university, faisalabad
Full name of responsible person
Halima Shoukat
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
kotwali road, Gurunanakpura,
City
faisalabad
Province
punjab
Postal code
38000
Phone
+92 41 9200952
Email
halimashoukat92@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Government College University, Faisalabad
Full name of responsible person
Halima Shoukat
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
kotwali road, gurunanakpura
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 41 9200953
Email
Halimashoukat92@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
government college university, faisalabad
Full name of responsible person
Halima Shoukat
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
kotwali road, Gurunanakpura,
City
faisalabad
Province
punjab
Postal code
38000
Phone
+92 41 9200952
Email
halimashoukat92@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
all collected IPD for all outcome measures
When the data will become available and for how long
starting in February, 2025 6 months after publication
To whom data/document is available
persons in academic institutes and researchers
Under which criteria data/document could be used
it could be used on permission from investigator
From where data/document is obtainable
through email to investigator Halimashoukat92@gmail.com
What processes are involved for a request to access data/document
through email to investigator Halimashoukat92@gmail.com and Call Halima Shoukat 0923244257755