NCT06660472

Brief Summary

The aim of the study is to investigate the relationship between core muscles endurance and Saliba Postural Classification System in patients with chronic mechanical low back pain.

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 all trials

Timeline
Completed

Started Nov 2023

Shorter than P25 for all trials

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

November 1, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 28, 2024

Completed
Last Updated

October 28, 2024

Status Verified

October 1, 2024

Enrollment Period

4 months

First QC Date

October 24, 2024

Last Update Submit

October 24, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • assessment of pain intensity using visual analogue scale

    The visual analog scale (VAS) is a unidimensional measure of pain intensity, consisting of a horizontal line 10 cm long. It is anchored by "no pain" (score 0) and "worst imaginable pain" (score 10), with higher scores indicating greater pain intensity.

    at baseline

Secondary Outcomes (7)

  • assessment of functional disability using cross-culturally adapted Arabic version of the Oswestry disability questionnaire

    at baseline

  • assessment of mechanical stress points using vertical stress test to confirm the Saliba Postural Classification System

    at baseline

  • assessment of proper timing of core and global muscles in response to an external load using Elbow flexion test

    at baseline

  • assessment of trunk endurance using Trunk flexion test

    at baseline

  • assessment of back extensors (the erector spinae and the multifidus) endurance using trunk extension test

    at baseline

  • +2 more secondary outcomes

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

This study was a cross sectional, Observational, and correlation analysis

You may qualify if:

  • Sixty male and female patients with CMLBP of more than 3 months duration
  • Patients with body mass between 18-25
  • Patients aged between 20-50 years old
  • Moderate level of pain (4-6 on visual analogue scale)
  • Minimal level of disability (0% to 20%) on Oswestry disability index as defined as "the patient can cope with most living activities. Usually, no treatment is indicated apart from advice on lifting, sitting, and exercise.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

out-patient clinic, faculty of physical therapy, Cairo university

Giza, Egypt

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

October 24, 2024

First Posted

October 28, 2024

Study Start

November 1, 2023

Primary Completion

March 1, 2024

Study Completion

July 1, 2024

Last Updated

October 28, 2024

Record last verified: 2024-10

Locations