Low Back Pain, PosturalNCT05664022
Effect of Global Postural Reeducation on Low Back Pain Patients With Lower Cross Syndrome
A study testing Global postural reeducation in people with Low Back Pain, Postural, run by Cairo University at 1 site in Egypt.
Trial summary
This study will be conducted toinvestigate the effect of Global Postural Re-education on low back pain patients with Lower cross syndrome Read more about this study
- Who is it for?
- Ages 25 to 40 years
- Conditions the study is for
- Low Back Pain, Postural
- What is being tested?
- Global postural reeducation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 10 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Global Postural Reeducation on Low Back Pain Patients With Lower Cross Syndrome. Randomized Controlled Trial
This study will be conducted toinvestigate the effect of Global Postural Re-education on low back pain patients with Lower cross syndrome
Read the 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
- Conditions
- Low Back Pain, Postural
- Being tested
- Global postural reeducation
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Global postural reeducationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Global postural reeducation approach | Experimental | 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. Receives: Procedure: Global postural reeducation |
| Conventional treatment | Active comparator | 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. Receives: Procedure: Global postural reeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to twelve weeks
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.
Measured: up to twelve weeks
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
Measured: up to twelve weeks
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
Measured: up to twelve weeks
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
Measured: up to twelve weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2022
- Study start1 Jan 2023
- Primary completion10 Jun 2023
- Study completion10 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back Pain, PosturalStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Al Shaymaa Shaaban Abd El Azeim, Cairo University
- Investigators
- Enas En Kandil, Principal investigator, Damanhour Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05664022
- Sponsor's protocol ID
- p.t.REC/012/003923
- Status last verified
- Jun 2023
- First submitted
- 12 Dec 2022
- Last updated
- 15 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Global Postural Reeducation on Low Back Pain Patients With Lower Cross Syndrome. Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05664022
- Acronym / sponsor ID
- p.t.REC/012/003923
- Conditions
- Low Back Pain, Postural
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 10 Jun 2023 (actual)
- Study completion
- 10 Jun 2023 (actual)
- First posted
- 23 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Global postural reeducation approach | Experimental | Procedure: Global postural reeducationThe 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. |
| Conventional treatment | Active comparator | Procedure: Global postural reeducationThe 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. |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Global postural reeducationThe 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. | Procedure or surgery | Conventional treatment, Global postural reeducation approach |
Primary outcome
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.
lumbar lordosis
Time frame: up to twelve weeks
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
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
pain severity
Time frame: up to twelve weeks
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
Time frame: up to twelve weeks
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
Related trials for Low Back Pain, Postural
RecruitingObservational study
The Forgotten Role of Back Muscle Characteristics to Tailor Exercise Therapy for Recurrent Non-specific Low Back Pain
Low Back Pain, Back Pain Lower Back Chronic
Not yet recruiting
Dual-Task Neuromuscular Warm-Up Exercises in Chronic Low Back Pain
Low Back Pain
Enrolling by invitation
Egoscue and Core Stabilization for Chronic Low Back Pain
Chronic Low Back Pain (CLBP)
RecruitingObservational study
The Relationship Between Lost Extremity Percentage and Postural Control, Neck and Low Back Pain, Daily Living Activities, and Reaction Time in Individuals With Unilateral Upper Limb Amputation
Upper Limb Amputation, Postural Control
Not yet recruiting
Mirror Image Spine Correction Exercises Versus Conservative Physiotherapy for Lumbar Radiculopathy
Radiculopathy, Radiculopathy Lumbar
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Enas En Kandil principal investigator
Damanhour Teaching Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Global postural reeducation in people with Low Back Pain, Postural, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anterior pelvic tilting (time frame: up to twelve weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.