Low Back Pain, MechanicalNCT05749705
Fat to Lean Mass Ratio and Its Effect on Low Back Pain and Permanent Functional Disability.
An observational study of Low Back Pain, Mechanical, run by University of Jazan at 1 site in Saudi Arabia.
Trial summary
The study was conducted for people who suffer from excess fat mass and their age is over 18 years will be calculated with G*power will be used body composition analyzer to calculate the percentage of fat. Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain, Mechanical
- What is being tested?
- Fat to Lean Mass Ratio
- How many people
- 500 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 5 Feb 2023to 12 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: People who suffer from excess fat mass and their age is over 18 years.
Who may be able to join
- Excess fat mass
- Age must be over 18 years.
Who cannot join
- People under the age of 18.
- Low back pain not associated with increased fat mass.
Trial locations and contacts
1 site in 1 country.
About this study
The study was conducted for people who suffer from excess fat mass and their age is over 18 years will be calculated with G*power will be used body composition analyzer to calculate the percentage of fat.
Read the detailed description
Cross-sectional study was applied. Data was collected through a questionnaire (oswestry disability index arabic version). Fat percentage was taken by Body composition analyzer.
- Conditions
- Low Back Pain, Mechanical
- Being tested
- Fat to Lean Mass Ratio
- 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.
Fat to Lean Mass RatioOther
The study will be conducted for people who suffer from excess fat mass and their age is over 18 years.
years will be calculated with G power
What is being measured
The primary outcome is the main question the study is designed to answer.
Fat to Lean mass ratio
Body composition analyzer will be used to measure the percentage of fat
Measured: Immediately after the admission
Secondary outcomes (1)
Low Back Pain and disability
Oswestry disability index arabic version will be used.
Measured: Immediately after the admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start5 Feb 2023
- Primary completion5 Mar 2023
- Study completion12 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back Pain, MechanicalStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jazan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mohamed Moustafa Mohamed Ahmed, University of Jazan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05749705
- Sponsor's protocol ID
- 94177
- Status last verified
- Mar 2023
- First submitted
- 18 Feb 2023
- Last updated
- 15 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fat to Lean Mass Ratio and Its Effect on Low Back Pain and Permanent Functional Disability.
- ClinicalTrials.gov ID
- NCT05749705
- Acronym / sponsor ID
- 94177
- Conditions
- Low Back Pain, Mechanical
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- University of JazanOther government
- Study start
- 5 Feb 2023 (actual)
- Primary completion
- 5 Mar 2023 (actual)
- Study completion
- 12 Mar 2023 (actual)
- First posted
- 1 Mar 2023 (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.
The study was conducted for people who suffer from excess fat mass and their age is over 18 years will be calculated with G*power will be used body composition analyzer to calculate the percentage of fat.
Detailed description
Cross-sectional study was applied. Data was collected through a questionnaire (oswestry disability index arabic version). Fat percentage was taken by Body composition analyzer.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- People who suffer from excess fat mass and their age is over 18 years.
Key inclusion criteria (2 listed)
- Excess fat mass
- Age must be over 18 years.
Key exclusion criteria (2 listed)
- People under the age of 18.
- Low back pain not associated with increased fat mass.
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 |
|---|---|---|
| Fat to Lean Mass RatioThe study will be conducted for people who suffer from excess fat mass and their age is over 18 years. years will be calculated with G power | Other | – |
Primary outcome
Fat to Lean mass ratio
Time frame: Immediately after the admission
Body composition analyzer will be used to measure the percentage of fat
1 secondary outcome
Low Back Pain and disability
Time frame: Immediately after the admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
- Individual participant dataSharing planned: No
Related trials for Low Back Pain, Mechanical
Not yet recruiting
Effect of Dry Needling Plus Vibration on Myofascial Trigger Points in Individuals With Nonspecific Low Back Pain
Low Back Pain, Dry Needling
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability by Numerical Pain Rating Scale and Modified Oswestry Disability Index Respectively.
Chronic Non Specific Mechanical Low Back Pain
Recruiting
Fusion or Not - a Study on Low Back Pain
Low Back Pain, Mechanical, Degenerative Disc Disease Lumbar
Recruiting
Effects of Post-Isometric Relaxation and Myofascial Release on Low Back Pain With Lower Cross Syndrome
Low Back Pain, Mechanical, Lower Cross Syndrome
RecruitingPhase 1
Adia Med of Winter Park LLC Lower Back Pain Research Study
Chronic Mechanical Lower Back Pain, Lower Back Pain
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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, Mechanical, run by University of Jazan at 1 site in Saudi Arabia.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 15 Mar 2023. 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 Saudi Arabia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fat to Lean mass ratio (time frame: Immediately after the admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Mar 2023.