- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05664022
Effect of Global Postural Reeducation on Low Back Pain Patients With Lower Cross Syndrome
Effect of Global Postural Reeducation on Low Back Pain Patients With Lower Cross Syndrome. Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Damanhūr, Egypt
- Damanhour Teaching Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 50 patients.
- Both sexes will be included.
- Patients' age range will be 25 to 40 years old (Esakowitz., 2014).
- Participants will have to meet the criteria for lower crossed syndrome indicating tight hip flexors and erector spinae together with weak glutei and abdominals with low back pain will be presented three months or longer and level of pain intensity more than 3 on VAS.
Exclusion Criteria:
- On other forms of treatment that may interfere with the study including other physical therapy or medication specific to back pain.
- Enrolled in another interventional clinical research trial
- Pregnancy
- Nerve entrapment, bowel or bladder dysfunction and kidney disease.
- Surgery on the back, pelvis or sacrum is indicated or has previously occurred.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Global postural reeducation approach
The patient will receive 15 sessions of the Global Postural Re-education approach performed 2times/week for 1 hour including patient education.
Each treatment will be individualized for every patient and for his/her pain-related limitation.
Each session includes only 2-3 postures to increase the standardization of treatment.
|
The GPR involves a series of active gentle movements and postures aimed at realigning joints, stretching shortened muscles, and enhancing the contraction of antagonist's muscles, thus avoiding postural asymmetry. The GPR method includes eight therapeutic postures, lying, sitting or standing, to be held for 15/20 minutes each. Postures can be variously combined during sessions. Postures are chosen on the basis of some parameters, such as the amount of pain, load capacity and age of the patient, and muscle chains to be stretched. to increase the standardization of treatment, it will be proposed only 2 or 3 postures. |
|
Active Comparator: Conventional treatment
The patient will receive the conventional treatment in form of exercise program of(abdominal and pelvic floor strengthening)and (stretching exercise of back and hip flexor muscles)to improve pain and function in chronic low back pain patients.
|
The GPR involves a series of active gentle movements and postures aimed at realigning joints, stretching shortened muscles, and enhancing the contraction of antagonist's muscles, thus avoiding postural asymmetry. The GPR method includes eight therapeutic postures, lying, sitting or standing, to be held for 15/20 minutes each. Postures can be variously combined during sessions. Postures are chosen on the basis of some parameters, such as the amount of pain, load capacity and age of the patient, and muscle chains to be stretched. to increase the standardization of treatment, it will be proposed only 2 or 3 postures. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
anterior pelvic tilting
Time Frame: up to twelve weeks
|
Anterior pelvic tilt will be measured by software application (iHandy Soft, Inc., New York, USA).
This application has the capacity to convert the phone into an inclinometer using a built-in sensitive system.It is a tool for assessing angles of slope (or tilt) using all sides of the device plus the camera.
A smartphone with the iHandy app can be used in clinical practice and research as an easy and convenient alternative to an inclinometer.
|
up to twelve weeks
|
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lumbar lordosis
Time Frame: up to twelve weeks
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The lumbar lordosis will be measured by flexible ruler.
It is commonly used to measure the degree of spinal curvature of the lumbar lordosis in the sagittal plane.
Lumbar lateral X-ray radiography is considered as a golden standard method in lumbar lordosis measurement.
However, this method has a number of problems such as being time-consuming and expensive.
A flexible ruler is a safe, easy-to-use, and inexpensive tool.
Validity between lumbar lordosis measurement with the flexible ruler and the x-ray is 0.91 so the flexible ruler can be used effectively for lumbar lordosis measurements and is a valid, assured, portable and non-invasive tool with high reliability and validity.
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up to twelve weeks
|
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flexibility of hip flexors muscle
Time Frame: up to twelve weeks
|
Flexibility of hip flexors muscles will be measured by modified Thomas test.
This test is performed with the patient supine and the thigh is over the edge of the examining table.
The patient is told to grasp the thigh of the untested limb and pull it toward the chest.
Lumbar spine is flat on the plinth and the pelvis is in posterior rotation.
Length of iliopsoas is determined by measuring the angle of hip flexion.
Measurements will be taken pre and post treatment
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up to twelve weeks
|
|
pain severity
Time Frame: up to twelve weeks
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The pain severity level will be measured via the Visual Analogue Scale (VAS).
VAS is a pain rating scale, in which scores are based on self-reported measures of symptoms that are recorded with a single handwritten mark placed at one point along the length of a 10 cm line that represents a continuum between the two ends of the scale "no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm).
In this scale, zero represents the absence of pain, 1-3 shows mild pain, 4-6 denotes moderate pain, and 7-10 indicates severe pain
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up to twelve weeks
|
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function disability
Time Frame: up to twelve weeks
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The disability caused by low back pain will be measured via the The Arabic version of Oswestry Low Back Pain Disability Questionnaire.
The patient fills out the questionnaire in about 5 minutes and then the doctor scores it in about 1 minute.
The patient marks the most relevant answer for each question as accurately as they can.
Scoring is done on a scale of 0-5, starting with the first possible answer in the sequence being '0' and the last answer '5'.
The maximum possible score for each section is 5.
All the scores are added together and divided by the total number of possible points in order to calculate the total score
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up to twelve weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Enas En Kandil, Damanhour Teaching Hospital
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
- p.t.REC/012/003923
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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