- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06530589
Effects of Tupler's Technique on the Management of Diastasis Rectus Abdominis.
Effects of Tupler's Technique on the Management of Diastasis Rectus Abdominis in Post-Partum Females.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Literature suggest that during pregnancy due to hormonal changes such as increased in Relaxin, estrogen and progesterone level and also increased in the size of uterus affect the aponeurosis connection of abdominal muscles and due to these changes Diastasis Rectus Abdominis is common during pregnancy especially in third trimester and in the post-partum period. we can measure diastasis rectus abdominis by different methods such as palpatory, caliper and ultrasound. The condition can be mild (two fingers gap), moderate (two to three fingers gap) and severe (more than three fingers gap). The separation of greater than 2cm is considered as Diastasis Rectus Abdominis.
In this study effectiveness of Tupler's Technique will be assessed in post-partum diastasis rectus abdominis patients. Patients will have to wear diastasis rehab splints and then perform tupler's technique exercises. The mechanism behind this is when patients wear splint the splint will keep the connective tissues in narrow position for better healing and strengthening of muscles will be done by Tuper's Technique exercises and Diastasis of Rectus Abdominis willl be treated.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Punjab
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Faisalābad, Punjab, Pakistan, 38000
- Allied Hospital Faisalabad
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Faisalābad, Punjab, Pakistan, 38000
- Madinah Teaching Hospital Faisalabad
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Primiparous and multiparous females (Vaginal delivery).
- Greater than and equal to 12 weeks post-partum
- Age limit will be18-30 years
- BMI under or equa to 29kg/m2
- Visiting with the complain of low back pain
- Diastasis of rectus abdominis at the level of umbilicus with mild, moderate and severe condition.
Exclusion Criteria:
- Other musculoskeletal disease (disc prolapse and disc bulge)
- Trauma of bowel and bladder
- Heart and respiratory conditions including sneezing and excessive coughing
- Any pelvic floor, abdominal and spinal surgery
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Interventional Group
Tupler's Technique will be applied to this group.
This technique includes Tupler's technique exercises and patients will also wears diastasis rehab splints.
Patients will perform seated isometric exercises (elevator and contracting exercises) after wearing diastasis rehab splint.
Repetitions of exercises will be 100 and whole intervention will be provided for 6 weeks.
|
Patient will wear diastasis rehab splint and will follow Tupler's techniqe protocol for 6 weeks.
In the first 2 weeks both elevator and contracting exercises will be performed and after 2 weeks in the 3rd week only contracting exercises will be perform and for these exercises we divide abdomen into 6 floors and will patient have to contract her tummy towards the 3rd to 5th floor in first week, towards the 4th to 5th floor in 2nd week and from 5th to 6th floor in the 3rd week. in the wek 4 to week 6 head lifts will also be started along with contracting exercises from 5th to 6th floor.
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Active Comparator: Control Group
Traditional treatment protocol will be applied to this group that includes traditional exercises for diastasis rectus abdominis and this protocol will be followed 3 times per week for 6 weeks.
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The traditional treatment includes traditional abdominal exercises that patient will be perform for 6 weeks and three times per week with 15 repetitions of each exercise.
These exercises includes posterior pelvic tilt' static abdominal contractions', reverse sit up exercise, kegals, russian twist , trunk twist and reverse trunk twist.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Digital nylon caliper to measure inter-recti Distance
Time Frame: Before intervention, after 3 weeks and after 6 weeks.
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Digital nylon caliper is the valid and reliable instrument to measure the inter-recti distance and inter-recti distance will be measured at three levels.
at the level of umbilicus, 4.5cm above umbilicus and 4.5cm below umbilicus.
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Before intervention, after 3 weeks and after 6 weeks.
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Oswestry low bac pain disability Questionnaire
Time Frame: Before intervention, after 3 weeks and after 6 weeks.
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This is a valid tool to assess back pain and this questionnaire has 10 sections and we grade level of disability according to grading criteria.
0-4shows no disability, 5-14 shows mild disability, and 15-24 shows moderate disability, and 25-34 shows severe disability and grade 35-50 means completely disabled.
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Before intervention, after 3 weeks and after 6 weeks.
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Numeric Pain rating scale
Time Frame: Before intervention, after 3 weeks and after 6 weeks.
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By using this scale we will measure the intensity of back pain.
i scores pain from 0-10.
0 means no pain, 5 means moderate pain and 10 means severe pain.
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Before intervention, after 3 weeks and after 6 weeks.
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Maternal post-partum quality of life instrument (MPQOL-I)
Time Frame: Before intervention, after 3 weeks and after 6 weeks.
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This questionnaire has 5 domains.
psychological, reltion with family and friends, relation with spouse, socioeconomic and health related domain and we can assess every domain of female life.
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Before intervention, after 3 weeks and after 6 weeks.
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Huma Riaz, PhD, Riphah International University, Islamabad, Pakistan
- Principal Investigator: Aqsa Shahid, MSPT*, Riphah International University, Islamabad, Pakistan
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Aqsa Shahid
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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