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Effect of Global Postural Reeducation on Low Back Pain Patients With Lower Cross Syndrome

Primary Purpose

Low Back Pain, Postural

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Global postural reeducation
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain, Postural

Eligibility Criteria

25 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Damanhour teaching hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Global postural reeducation approach

Conventional treatment

Arm Description

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 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.

Outcomes

Primary Outcome Measures

anterior pelvic tilting
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.
lumbar lordosis
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.
flexibility of hip flexors muscle
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
pain severity
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
function disability
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

Secondary Outcome Measures

Full Information

First Posted
December 12, 2022
Last Updated
June 12, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05664022
Brief Title
Effect of Global Postural Reeducation on Low Back Pain Patients With Lower Cross Syndrome
Official Title
Effect of Global Postural Reeducation on Low Back Pain Patients With Lower Cross Syndrome. Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
June 10, 2023 (Actual)
Study Completion Date
June 10, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This study will be conducted toinvestigate the effect of Global Postural Re-education on low back pain patients with Lower cross syndrome
Detailed Description
Lower cross syndrome is common, with up to 85% of low back pain cases due to long-term postural faults (Lower crossed syndrome) and it has a negative result on our society. Global Postural Re-education (GPR) is an intervention that is used frequently for chronic low pain to improve pain and function. 50 low back pain patients with lower cross syndrome will be assigned randomly into 2 groups, Group A will receive a Global Postural Re-education approach and consists of 15 treatment sessions of Global Postural Re-education approach, performed 2times/week for 1 hour including patient education. Each treatment is individualized for every patient and for his/her pain-related limitation. Each session includes only 2-3 postures to increase the standardization of treatment. Group B 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Postural

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Global postural reeducation approach
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional treatment
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Global postural reeducation
Intervention Description
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.
Primary Outcome Measure Information:
Title
anterior pelvic tilting
Description
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.
Time Frame
up to twelve weeks
Title
lumbar lordosis
Description
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.
Time Frame
up to twelve weeks
Title
flexibility of hip flexors muscle
Description
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
Time Frame
up to twelve weeks
Title
pain severity
Description
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
Time Frame
up to twelve weeks
Title
function disability
Description
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
Time Frame
up to twelve weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Enas En Kandil
Organizational Affiliation
Damanhour Teaching Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Damanhour teaching hospital
City
Damanhūr
Country
Egypt

12. IPD Sharing Statement

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Effect of Global Postural Reeducation on Low Back Pain Patients With Lower Cross Syndrome

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