Protocol summary
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Study aim
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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
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Design
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Randomized, single blinded, parallel group
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Settings and conduct
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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
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Participants/Inclusion and exclusion criteria
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• 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
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Intervention groups
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Abdominal hypopressive exercise group
Conventional physical therapy
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Main outcome variables
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Pain Intensity
functional disability
Muscle thickness changes
General information
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Reason for update
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The trial has been completed so, the dates need to be added and the data needs to be updated
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Acronym
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AHE
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IRCT registration information
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IRCT registration number:
IRCT20241222064127N1
Registration date:
2025-02-24, 1403/12/06
Registration timing:
prospective
Last update:
2026-08-27, 1405/06/05
Update count:
1
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Registration date
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2025-02-24, 1403/12/06
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2025-02-20, 1403/12/02
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Expected recruitment end date
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2025-08-20, 1404/05/29
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Actual recruitment start date
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2025-02-25, 1403/12/07
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Actual recruitment end date
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2026-09-01, 1405/06/10
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Trial completion date
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2026-09-01, 1405/06/10
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Scientific title
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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
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Public title
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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
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 30 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
84
Actual sample size reached:
84
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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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.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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single blinded, single setting
Ethics committees
1
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Ethics committee
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Approval date
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2023-12-20, 1402/09/29
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Ethics committee reference number
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REC-UOL-616-12-2023
Health conditions studied
1
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Description of health condition studied
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Sacroiliac hypermobility dysfunction
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ICD-10 code
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M53.2X
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ICD-10 code description
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Spinal instabilities
Primary outcomes
1
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Description
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Pain intensity
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Timepoint
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before intervention, 4 and 8 weeks after intervention
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Method of measurement
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Visual Analogue Scale
2
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Description
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Functional Disability
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Timepoint
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before intervention, 4 and 8 weeks after intervention
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Method of measurement
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Modified Oswestry disability index (MODI)
3
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Description
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thickness of transverses abdominus muscle (both at resting and contracted)
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Timepoint
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before and after intervention
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Method of measurement
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Sonography
Secondary outcomes
1
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Description
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quality of life
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Timepoint
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before and after intervention
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Method of measurement
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SF-12 questionnaire
Intervention groups
1
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Description
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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
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Category
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Rehabilitation
2
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Description
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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
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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The University of Lahore
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Proportion provided by this source
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100
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Not applicable
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Analytic Code
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Not applicable
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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all collected IPD for all outcome measures
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When the data will become available and for how long
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starting in February, 2025 6 months after publication
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To whom data/document is available
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persons in academic institutes and researchers
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Under which criteria data/document could be used
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it could be used on permission from investigator
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From where data/document is obtainable
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through email to investigator Halimashoukat92@gmail.com
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What processes are involved for a request to access data/document
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through email to investigator Halimashoukat92@gmail.com and Call Halima Shoukat 0923244257755
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Comments
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Data will be provided on request