## Protocol Section
### Identification Module
**NCT ID:** NCT04647279

**Acronym:** NMSSJ

**Brief Title:** New MRI Sequences in Spine and Joint

**Official Title:** Clinical Study of New MRI Sequences in Spine and Joint

#### Organization Study ID Info
**ID:** ZDWY.FSK.004
#### Organization
**Class:** OTHER
**Full Name:** Fifth Affiliated Hospital, Sun Yat-Sen University
### Status Module
#### Completion Date
**Date:** 2022-12-31

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2021-04-06

**Type:** ACTUAL

**Last Update Submit Date:** 2021-04-05

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2022-07-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2020-06-01

**Type:** ACTUAL

**Status Verified Date:** 2021-04

#### Study First Post Date
**Date:** 2020-11-30
**Type:** ACTUAL
**Study First Submit Date:** 2020-11-27
**Study First Submit QC Date:** 2020-11-27
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Fifth Affiliated Hospital, Sun Yat-Sen University

#### Responsible Party

**Investigator Affiliation:** Fifth Affiliated Hospital, Sun Yat-Sen University

**Investigator Full Name:** ShaoLin Li

**Investigator Title:** Director of Radiology Department

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** Low back pain and osteoarticular degeneration or injury is the leading worldwide cause of years lost to disability, accounting for 17 % of all patients with disabilities and its burden is growing alongside the increasing and aging population. The anatomical regions of the intervertebral disc include the central nucleus pulposus, the peripheral fibrocartilaginous annulus fibrosus, and the superior and inferior cartilaginous endplates (CEP). The CEP is a thin layer of hyaline cartilage located between the avascular intervertebral disc and the bony vertebral endplate. The endplate cartilage consists of chondrocytes interspersed throughout an extracellular matrix of proteoglycans, collagen (types I and II), and water. It plays an important role in the function and homeostasis. The CEP has been considered the pathway between the largely avascular disk tissues and the blood supply of the vertebral body and thus provides nutrition for disk cells. Many musculoskeletal tissues, including the CEP, cartilage-bone interface of articular joints, entheses, tendons, and ligaments, have components with very short T2 values (much less than 1 msec), which are orders of magnitude shorter than that of the nucleus of the disk (\~100 msec). In a conventional pulse sequence, such as proton density-weighted spin-echo (SE) or fast SE, with standard clinical section profile, the minimum echo time (TE) is typically 10 msec, which is much longer than that needed to capture the short-lived signal from these tissues. Recently, ultrashort echo sequence UTE technology has been introduced, and the TE time can be as low as 0.008ms. This range of TE is sufficient to capture signals from the cartilage endplate before it decays. With using new MRI technology, such as IR-UTE, UTE-MT, UTE-T2\*mapping, Maigc, DTI, and IVIM, which can quantitative tissues that have previously been "invisible" at conventional MR imaging, and provide imaging basis for early diagnosis of injury at molecular level. The purpose of this study was to investigate the clinical application value of different MRI sequences in spine and joint.

### Conditions Module

**Conditions:**

- Degeneration of Spine and Osteoarticular

**Keywords:**

- Magnetic resonance imaging

- Low back pain

- Disk degeneration

- Ultrashort echo time

- Osteoarticular degeneration

### Design Module

#### Design Info

**Observational Model:** OTHER

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 300

**Type:** ESTIMATED

**Patient Registry:** True

**Study Type:** OBSERVATIONAL

**Target Duration:** 2 Years

### Arms Interventions Module

#### Arm Group 1

**Description:** Diagnostic Test: Quantitative MRI imaging IR-UTE, UTE-MT, Maigc, Ideal IQ, DTI, and IVIM

**Intervention Names:**

- Diagnostic Test: Dual-emission X-ray Absorptiometry

**Label:** Normal control group

#### Arm Group 2

**Description:** Diagnostic Test: Quantitative MRI imaging IR-UTE, UTE-MT, Maigc, Ideal IQ, DTI, and IVIM

**Intervention Names:**

- Diagnostic Test: Dual-emission X-ray Absorptiometry

**Label:** Osteopenia

#### Arm Group 3

**Description:** Diagnostic Test: Quantitative MRI imaging IR-UTE, UTE-MT, Maigc, Ideal IQ, DTI, and IVIM

**Intervention Names:**

- Diagnostic Test: Dual-emission X-ray Absorptiometry

**Label:** Osteoporosis

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Normal control group

- Osteopenia

- Osteoporosis

**Description:** The recruiters were divided into osteoporosis, osteopenia and normal by dual emission X-ray absorptiometry.

**Name:** Dual-emission X-ray Absorptiometry

**Type:** DIAGNOSTIC_TEST

### Outcomes Module

#### Primary Outcomes

**Description:** Quantitative MRI imaging(such as IR-UTE, UTE-MT, UTE-T2\*mapping, Maigc, Ideal IQ, DTI, and IVIM) used to quantitative diagnosis of disk degeneration, osteoporosis, osteoarticular degeneration etc.

**Measure:** New MRI sequences in the diagnosis of spine and joint

**Time Frame:** 2 years

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 1.The patient had history and clinical symptoms of low back pain and joint sports injury 2.The patient had a history of osteoporosis; 3.There was no contraindication of MRI; 4.The patient who has clear lumbar intervertebral disc degeneration or herniation or osteoporosis or joint sports injury found by routine CT or MRI examination, and the clinical symptoms were consistent with the image.

Exclusion Criteria:

* 1. Patients with previous history of lumbar or joint surgery; 2. Patients with congenital bone deformity; 3. Patients with history of lumbar tumor and infection; 4. Cognitive function is limited or mental illness can not cooperate with imaging.

**Healthy Volunteers:** True

**Maximum Age:** 80 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** All suspected patients with osteoporosis and low back pain meet the inclusion criteria will include in this study. And patients who meet the criteria of the normal control group will include in this study.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** 602046738@qq.com

**Name:** Jin Liu, Master

**Phone:** 0086 756 2528321

**Role:** CONTACT

**Contact 2:**

**Email:** lishaolin1963@126.com

**Name:** Shaolin Li, Director

**Phone:** 0086 756 2528321

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Zhuhai

**Contacts:**

***Contact 1:***

- **Email:** 602046738@qq.com

- **Name:** Jin Liu, Master

- **Phone:** 0086 756 2528321

- **Role:** CONTACT

***Contact 2:***

- **Email:** lishaolin1963@126.com

- **Name:** Shaolin Li, Doctor

- **Phone:** 0086 756 2528321

- **Role:** CONTACT

**Country:** China

**Facility:** The Fifth Affiliated Hospital of Sun Yat-sen University

**State:** Guangdong

**Status:** RECRUITING

**Zip:** 519000

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** Kawakami M, Tamaki T, Hayashi N, Hashizume H, Nishi H. Possible mechanism of painful radiculopathy in lumbar disc herniation. Clin Orthop Relat Res. 1998 Jun;(351):241-51.

**PMID:** 9646768

**Citation:** Bae WC, Statum S, Zhang Z, Yamaguchi T, Wolfson T, Gamst AC, Du J, Bydder GM, Masuda K, Chung CB. Morphology of the cartilaginous endplates in human intervertebral disks with ultrashort echo time MR imaging. Radiology. 2013 Feb;266(2):564-74. doi: 10.1148/radiol.12121181. Epub 2012 Nov 28.

**PMID:** 23192776

**Citation:** Freburger JK, Holmes GM, Agans RP, Jackman AM, Darter JD, Wallace AS, Castel LD, Kalsbeek WD, Carey TS. The rising prevalence of chronic low back pain. Arch Intern Med. 2009 Feb 9;169(3):251-8. doi: 10.1001/archinternmed.2008.543.

**PMID:** 19204216

**Citation:** Lotz JC, Fields AJ, Liebenberg EC. The role of the vertebral end plate in low back pain. Global Spine J. 2013 Jun;3(3):153-64. doi: 10.1055/s-0033-1347298. Epub 2013 May 23.

**PMID:** 24436866

**Citation:** Gatehouse PD, Bydder GM. Magnetic resonance imaging of short T2 components in tissue. Clin Radiol. 2003 Jan;58(1):1-19. doi: 10.1053/crad.2003.1157.

**PMID:** 12565203

**Citation:** Bae WC, Dwek JR, Znamirowski R, Statum SM, Hermida JC, D'Lima DD, Sah RL, Du J, Chung CB. Ultrashort echo time MR imaging of osteochondral junction of the knee at 3 T: identification of anatomic structures contributing to signal intensity. Radiology. 2010 Mar;254(3):837-45. doi: 10.1148/radiol.09081743.

**PMID:** 20177096

**Citation:** Bae WC, Du J, Bydder GM, Chung CB. Conventional and ultrashort time-to-echo magnetic resonance imaging of articular cartilage, meniscus, and intervertebral disk. Top Magn Reson Imaging. 2010 Oct;21(5):275-89. doi: 10.1097/RMR.0b013e31823ccebc.

**PMID:** 22129641

**Citation:** Pfirrmann CW, Metzdorf A, Zanetti M, Hodler J, Boos N. Magnetic resonance classification of lumbar intervertebral disc degeneration. Spine (Phila Pa 1976). 2001 Sep 1;26(17):1873-8. doi: 10.1097/00007632-200109010-00011.

**PMID:** 11568697

**Citation:** GBD 2015 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 310 diseases and injuries, 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet. 2016 Oct 8;388(10053):1545-1602. doi: 10.1016/S0140-6736(16)31678-6. Erratum In: Lancet. 2017 Jan 7;389(10064):e1.

**PMID:** 27733282

**Citation:** Hoy D, Bain C, Williams G, March L, Brooks P, Blyth F, Woolf A, Vos T, Buchbinder R. A systematic review of the global prevalence of low back pain. Arthritis Rheum. 2012 Jun;64(6):2028-37. doi: 10.1002/art.34347. Epub 2012 Jan 9.

**PMID:** 22231424

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC05

- Name: Musculoskeletal Diseases

### Condition Browse Module - Browse Leaves

- ID: M4714

- Name: Back Pain

- Relevance: LOW

- As Found: Unknown

- ID: M19433

- Name: Low Back Pain

- Relevance: LOW

- As Found: Unknown

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M28405

- Name: Intervertebral Disc Degeneration

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
