NCT06296667

Brief Summary

This study is designed as a pre and post experimental study. The purposes of this study are to evaluate the effect of core muscles training in patients with chronic mechanical low back pain according to SALIBA'S postural classification system (SPCS) in terms of pain intensity, function, and core muscles endurance.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2023

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 6, 2024

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2024

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

August 3, 2025

Status Verified

July 1, 2025

Enrollment Period

11 months

First QC Date

February 27, 2024

Last Update Submit

July 30, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • pain intensity.

    Pain intensity will be assessed using the visual analog scale (VAS). The VAS is a unidimensional measure of pain intensity. It is a continuous scale comprises of a horizontal line 10 cm in length. The scale is anchored by "no pain" (score of 0) and "worst imaginable pain" (score of 10). A higher score indicates greater pain intensity

    one month

  • function disability

    Functional disability will be estimated using the cross-culturally adapted Arabic version of the Oswestry disability questionnaire.The score is calculated by the addition of the values assigned for each of the 10 individual questions and is used to categorize disability as: mild or no disability (0- 20%); moderate disability (21%-40%); severe disability (41% to 60%); incapacity (61% to 80%); restricted to bed (81% to 100%).

    one month

  • core muscles endurance

    The researcher will conduct a series of core stability tests before and after the core training program. The following core tests will be used: trunk flexion test (McGill's test) , Trunk extension (Sorenson Test, Right Side plank test,left side plank and prone plank test. We will record the time (in seconds) the patient can hold the isometric posture, with a normal range of 1-2 minutes

    one month

Other Outcomes (1)

  • participants gender will be male and females, their age in years,their height in meters,weight in kilograms.

    one month

Study Arms (6)

group1: vertical/ vertical

EXPERIMENTAL

participant posture: The thoracic block is vertically aligned over the pelvic block.The angle of the thoracic block is vertical in the sagittal plane allowing for the dome of the diaphragm to rest on top of the abdomen.Vertical force transfers through the musculoskeletal system through the mid-foot and into the standing surface causing no shifts in postural alignment.

Other: core muscles training exercises

group 2: vertical/ posterior

EXPERIMENTAL

participant posture: The thoracic block is vertically aligned over the pelvic block but is posteriorly tipped in the sagittal plane.Vertical force leads to an accentuated extension in the thoracolumbar and lumbar regions with decreased ability to sustain vertical forces.

Other: core muscles training exercises

group 3: posterior/ posterior

EXPERIMENTAL

participant posture: The thoracic block is aligned posterior to the pelvic block and is posteriorly tipped in the sagittal plane. Vertical force leads to an accentuated extension in the lower lumbar region with a forward shear of the pelvis and decreased ability to sustain vertical forces.

Other: core muscles training exercises

group 4: posterior/ anterior

EXPERIMENTAL

participant posture: The thoracic block is aligned posterior to the pelvic block and is anteriorly tipped in the sagittal plane. Vertical force leads to a slight flexion in the thoracic and lumbar regions with a forward shear of the pelvis and decreased ability to sustain vertical force.

Other: core muscles training exercises

group 5:anterior/ posterior

EXPERIMENTAL

participant posture: The thoracic block is aligned anterior to the pelvic block and is posteriorly tipped in the sagittal plane. Vertical force leads to extension in the mid and lower lumbar regions with a posterior shear of the pelvis and decreased ability to sustain vertical forces.

Other: core muscles training exercises

group 6: anterior/ anterior

EXPERIMENTAL

participant posture: The thoracic block is aligned anterior to the pelvic block and is anteriorly tipped in the sagittal plane. Vertical force leads to an overall flexion of the trunk and decreased ability to sustain vertical forces

Other: core muscles training exercises

Interventions

The sessions will be conducted three times per week for four weeks and each exercise will be performed two sets of 10 repetitions. For the static exercises, the final position will be held for 6 second. There will be a pause of 3 second between repetitions, and a 60 sec rest between each exercise. The exercise will be performed in three forms: abdominal bracing, dynamic stabilization, and advanced core strengthening.

group 2: vertical/ posteriorgroup 3: posterior/ posteriorgroup 4: posterior/ anteriorgroup 5:anterior/ posteriorgroup 6: anterior/ anteriorgroup1: vertical/ vertical

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients referred with a diagnosis of CMLBP of at least 3 months.
  • Age ranging from 20 to 55 years old.
  • Both genders will be included.
  • BMI(18.5-24.9).

You may not qualify if:

  • Lumbar canal stenosis.
  • History of vertebral fractures.
  • patients with neurological deficits such as altered sensation.
  • Spinal surgery or failed back surgery.
  • cardiovascular/ pulmonary disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University,Faculty of Physical Therapy

Giza, 11432, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
researcher

Study Record Dates

First Submitted

February 27, 2024

First Posted

March 6, 2024

Study Start

May 1, 2023

Primary Completion

March 15, 2024

Study Completion

April 1, 2024

Last Updated

August 3, 2025

Record last verified: 2025-07

Locations