NCT06766240

Brief Summary

This study aims to evaluate the role of MRI to diagnose different causes of low back pain among middle aged females at Sohag university hospital.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 12, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 29, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 9, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2025

Completed
Last Updated

January 9, 2025

Status Verified

December 1, 2024

Enrollment Period

7 months

First QC Date

December 29, 2024

Last Update Submit

January 3, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Magnetic Resonance Imaging (MRI) for diagnosis of low back pain in middle aged females

    disc degeneration

    6 months postmenopausal

Study Arms (1)

femles with low back pain

middle aged female patients aged from 40 to 60 years with complaint of low back pain who were referred to the department of radiology of sohag university hospital for Lumbosacral spine MRI. MRI imaging using Philips Achieva1.5T MRI device (Philips Achieva, Netherlands) or Siemens Magnetom Altea1.5T MRI device (Siemens Healthineers, Germany). the sequences used are Axial T2W; Sagittal T1W, T2W, Sagittal STIR, Coronal STIR and post gadolinium if needed.

Device: MRI on lumbosacral spine

Interventions

MRI imaging on lumbosacral spine using Philips Achieva1.5T MRI device (Philips Achieva, Netherlands) or Siemens Magnetom Altea1.5T MRI device (Siemens Healthineers, Germany). the sequences used are Axial T2W; Sagittal T1W, T2W, Sagittal STIR, Coronal STIR and post gadolinium if needed.

femles with low back pain

Eligibility Criteria

Age40 Years - 60 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

middle aged females complaining of low back pain in Sohag.

You may qualify if:

  • \- middle aged female patients aged from 40 to 60 years with complaints of low back pain who were referred to the department of radiology of sohag university hospital for Lumbosacral spine MRI.

You may not qualify if:

  • Male patients.
  • female patients aged less than 40 years or more than 60 years.
  • Contraindication to magnetic resonance imaging including cochlear implant, pacemaker, claustrophobia.
  • Non-cooperative sick patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag university Hospital

Sohag, Egypt

RECRUITING

Related Publications (3)

  • Bailey A. Risk factors for low back pain in women: still more questions to be answered. Menopause. 2009 Jan-Feb;16(1):3-4. doi: 10.1097/gme.0b013e31818e10a7. No abstract available.

    PMID: 19002014BACKGROUND
  • Chou R, Fu R, Carrino JA, Deyo RA. Imaging strategies for low-back pain: systematic review and meta-analysis. Lancet. 2009 Feb 7;373(9662):463-72. doi: 10.1016/S0140-6736(09)60172-0.

    PMID: 19200918BACKGROUND
  • Cousins JP, Haughton VM. Magnetic resonance imaging of the spine. J Am Acad Orthop Surg. 2009 Jan;17(1):22-30. doi: 10.5435/00124635-200901000-00004.

    PMID: 19136424BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Safia R Mohammed Abdellah, Resident

CONTACT

Mohamed T Mahmoud solyman, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident, Diagnostic and Interventional Radiology department, Sohag University Hospital, Sohag University.

Study Record Dates

First Submitted

December 29, 2024

First Posted

January 9, 2025

Study Start

November 12, 2024

Primary Completion

June 12, 2025

Study Completion

June 12, 2025

Last Updated

January 9, 2025

Record last verified: 2024-12

Locations