Low Back PainNCT06766240
the Role of MRI in Evaluation of Low Back Pain
An observational study of Low Back Pain, run by Sohag University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women only
- Conditions the study is for
- Low Back Pain
- What is being tested?
- MRI on lumbosacral spine
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Nov 2024to 12 Jun 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 40 to 60 years
- Women only
- No healthy volunteers
- Adult
Study population: middle aged females complaining of low back pain in Sohag.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mohamed T Mahmoud solyman, Professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag university Hospital
Sohag
Magdy M Amin, Professor, 01090801900
About this study
Official title: the Role of MRI in Evaluation of Low Back Pain in Middle Aged Females
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.
- Conditions
- Low Back Pain
- Being tested
- MRI on lumbosacral spine
- 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.
MRI on lumbosacral spineDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: MRI on lumbosacral spine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Magnetic Resonance Imaging (MRI) for diagnosis of low back pain in middle aged females
disc degeneration
Measured: 6 months postmenopausal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start12 Nov 2024
- Primary completion12 Jun 2025 (estimated)
- Study completion12 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Safia Rafaat Mohamed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06766240
- Sponsor's protocol ID
- Soh-Med-24-11-08MS
- Status last verified
- Dec 2024
- First submitted
- 29 Dec 2024
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 19002014Chou 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.
PubMed 19200918Cousins 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.
PubMed 19136424
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Role of MRI in Evaluation of Low Back Pain in Middle Aged Females
- ClinicalTrials.gov ID
- NCT06766240
- Acronym / sponsor ID
- Soh-Med-24-11-08MS
- Conditions
- Low Back Pain
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 12 Nov 2024 (actual)
- Primary completion
- 12 Jun 2025 (estimated)
- Study completion
- 12 Jun 2025 (estimated)
- First posted
- 9 Jan 2025 (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 aims to evaluate the role of MRI to diagnose different causes of low back pain among middle aged females at Sohag university hospital.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| femles with low back pain | – | Device: MRI on lumbosacral spinemiddle 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. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- middle aged females complaining of low back pain in Sohag.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| MRI on lumbosacral spineMRI 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. | Device | femles with low back pain |
Primary outcome
Magnetic Resonance Imaging (MRI) for diagnosis of low back pain in middle aged females
Time frame: 6 months postmenopausal
disc degeneration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
- Background: PubMed 19002014Bailey 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.
- Background: PubMed 19200918Chou 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.
- Background: PubMed 19136424Cousins 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.
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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.
Mohamed T Mahmoud solyman, Professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain, run by Sohag 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 1 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 9 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Safia R Mohammed Abdellah, Resident (01067976948, safeyah.rafat@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Magnetic Resonance Imaging (MRI) for diagnosis of low back pain in middle aged females (time frame: 6 months postmenopausal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06766240, which also lists 3 linked publications.
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 9 Jan 2025.