- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06785363
The Study Focuses on the Release of the Iliolumbar Ligament Using a Pumped Technique, Addressing Its Tightness Caused by Excessive Anterior Pelvic Tilt During Pregnancy. This Condition Often Results in Low Back Pain and Mechanical Dysfunction of the Lumbar and Sacroiliac Regions.
Effect of Pumped Technique for Ilio-lumber Ligament Release on Postnatal Low Back Pain
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Group A (Control group) It will be consisted of postnatal women and will be treated by hot packs for 20 minutes three times per week for 8 weeks.
Group B (study group) the participant will treated by hot packs for 20 min in additional to pumping technique for iliolumbar ligament release for 30 min. 3 times per week for 8 weeks.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Cairo, Egypt
- Cairo University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
1- the women are delivery within 3 months. 3- Their BMI must be less than 30 Kg\m 2 . 4- Its included primipara or multipara. 5- Its included be normal vaginal labor delivery or caesarian section.
Exclusion Criteria:
- Clinical diagnosis by Lumbar disc prolapse.
- Clinical diagnosis by Lumbar spondylolysis and spondlysis.
- Clinical diagnosis by back trauma or fracture.
- Clinical diagnosis by Lumbar canal stenosis.
- Clinical diagnosis by Rheumatoid arthritis.
- Clinical diagnosis by Malignancy.
- Clinical diagnosis by any deformity for low limb.
- Clinical diagnosis by Scoliosis.
- Taking analgesic drugs.
- Clinical diagnosis by Deep vein thrombosis
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: Pumped technique for iliolumbar ligament release
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Patient position: the patient lying supine or side lying Therapist position: standing on one side of patient.
Hand grip: one hand placed on posterior region of iliac crest (close to attachment of ilio-lumbar ligament) while other hand stabilize the medial part of thigh.
Therapist force: therapist pulling patient's thigh posteriorly.
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Active Comparator: Hot packs
postnatal women will be treated by hot packs for 20 minutes three times per week for 8 weeks.
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postnatal women will be treated by hot packs for 20 minutes three times per week for 8 weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual analog scale (VAS):
Time Frame: 8 weeks
|
It will be used to assess the severity of low back pain in women from both groups A and B before and after treatment.
The scoring ranges from 1, indicating the least pain and discomfort, to 10, representing the most severe pain and discomfort.
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8 weeks
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Goniometer
Time Frame: 8 weeks
|
It will be used to assess lumbar flexion range of motion for each woman in both groups A and B before and after treatment.
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8 weeks
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Inclinometer
Time Frame: 8 weeks
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It will be used to assess lumbar curvature for each woman in both groups A and B before and after treatment.
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8 weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
- P.T.Rec/012/005571
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
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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