Fat to Lean Mass Ratio and Its Effect on Low Back Pain an... | NCT05749705

Studies
Fat to Lean Mass Ratio and Its Effect on Low Back Pain and Permanent Functional Disability.

NCT05749705

Sponsor

University of Jazan

Status

Completed

Last Update Posted

Mar 15, 2023Actual

Enrollment

500Actual

Phase

Not provided

Conditions

Low Back Pain, Mechanical

Interventions

Fat to Lean Mass Ratio

Countries

Saudi Arabia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 5, 2023Actual

Primary Completion Date

Mar 5, 2023Actual

Completion Date

Mar 12, 2023Actual

First Submitted Date

Feb 18, 2023

First Submission Date that Met QC Criteria

Feb 18, 2023

First Posted Date

Mar 1, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 12, 2023

Last Update Posted Date

Mar 15, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fat to Lean Mass Ratio	Other	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Fat to Lean mass ratio	Body composition analyzer will be used to measure the percentage of fat	Immediately after the admission

Secondary Outcomes

Measure	Description	Time Frame
Low Back Pain and disability	Oswestry disability index arabic version will be used.	Immediately after the admission

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Excess fat mass
Age must be over 18 years.

Exclusion Criteria:

People under the age of 18.
Low back pain not associated with increased fat mass.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

24 Years

Standard Ages

Adult

Study Population

People who suffer from excess fat mass and their age is over 18 years.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Jazan University		Jizan	Gizan	45142	Saudi Arabia

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D017116	Low Back Pain

Ancestor Terms

ID	Term
D001416	Back Pain
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided