NCT05664022

Brief Summary

This study will be conducted toinvestigate the effect of Global Postural Re-education on low back pain patients with Lower cross syndrome

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 12, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 23, 2022

Completed
9 days until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2023

Completed
Last Updated

June 15, 2023

Status Verified

June 1, 2023

Enrollment Period

5 months

First QC Date

December 12, 2022

Last Update Submit

June 12, 2023

Conditions

Outcome Measures

Primary Outcomes (5)

  • 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.

    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.

    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

    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

    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

    up to twelve weeks

Study Arms (2)

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.

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.

Procedure: Global postural reeducation

Interventions

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.

Conventional treatmentGlobal postural reeducation approach

Eligibility Criteria

Age25 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Damanhour teaching hospital

Damanhūr, Egypt

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Enas En Kandil

    Damanhour Teaching Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

December 12, 2022

First Posted

December 23, 2022

Study Start

January 1, 2023

Primary Completion

June 10, 2023

Study Completion

June 10, 2023

Last Updated

June 15, 2023

Record last verified: 2023-06

Locations