Paraspinal Muscle Degeneration, Bone Mass and Clinical Outcomes in Patients With Lumbar Degenerative Diseases

NCT05190289 | Unknown

• 1 other identifier: M2021134
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

This study was a retrospective study. The investigators intended to review the preoperative paraspinal muscle imaging data of patients with lumbar spinal stenosis and degenerative scoliosis treated in hospital, and follow up the symptoms, quality of life and surgical complications at 1 year and at the last follow-up. The aims were: (1) to explore the correlation between paraspinal muscle imaging parameters and clinical outcomes; (2) based on the postoperative functional scores and the presence of complications, to explore the best combination of imaging parameters for predictive value of prognosis; (3) to evaluate the consistency between different measurement methods, and improve the standardized paraspinal muscle imaging assessment; (4) Combining the characteristics of individual bone mass and paravertebral muscle (functional and imaging assessment), to explore the correlation between bone loss and paravertebral muscle degeneration; (5) to explore a muscle-bone mass assessment system that could reflect the prognosis of patients.

Conditions

Degenerative Lumbar Spinal Stenosis; Degenerative Scoliosis

Keywords

Degenerative Lumbar Disease; Clinical Outcome; Complication; Paraspinal Muscle; Bone Mass

Outcome Measures

Primary Outcomes (8)

• Disability

  The Oswestry Disability Index (ODI) (0-100, high score indicates severer disability) is used to assess disability.

  12 months; through study completion, an average of 3 years

• Low Back pain

  The Visual Analog Scale (VAS) (0-10, high score indicates more pain) is used to evaluate leg pain.

  12 months; through study completion, an average of 3 years

• Leg pain

  The Visual Analog Scale (VAS) (0-10, high score indicates more pain) is used to evaluate leg pain.

  12 months; through study completion, an average of 3 years

• Sagittal balance

  Sagittal balance is evaluated by anteroposterior and lateral X-ray of the whole spine at the standing position.

  12 months; through study completion, an average of 3 years

• Bone nonunion

  Bone nonunion was evaluated by dynamic X-ray. Bone nonunion was defined as 1) there was no continued bone fusion mass at any fusion segment; 2) any motion (greater than 3 mm or 3°) on flexion/ extension plain radiographs.

  12 months; through study completion, an average of 3 years

• Screw loosening

  Screw loosening was evaluated on spine radiograph or CT. Screw loosening was defined when a 1mm or wider circumferential radiolucent line around the pedicle screw was confirmed.

  12 months; through study completion, an average of 3 years

• Proximal junctional kyphosis

  Proximal junctional angle (PJA) was determined by the sagittal angle subtended by the inferior endplate of the uppermost instrumented vertebra (UIV) and the superior end plate of the vertebrae two levels above the UIV (UIV + 2). The definition of proximal junctional kyphosis (PJK) was PJA 10 or greater and at least 10 greater than the corresponding preoperative measurement.

  12 months; through study completion, an average of 3 years

• Proximal scoliosis progression

  The proximal scoliosis progression (PSP) was defined as the disc wedging increased 10 degrees from postoperative to two-year follow up on the AP radiograph.

  12 months; through study completion, an average of 3 years

Study Arms (2)

Compared Group

Patients without inferior clinical outcomes

Other: Pre-existing degenerative factors of paraspinal muscles and bone mass

Case Group

Patients with inferior clinical outcomes

Other: Pre-existing degenerative factors of paraspinal muscles and bone mass

Interventions

Pre-existing degenerative factors of paraspinal muscles and bone mass OTHER

Pre-existing degenerative factors of paraspinal muscles, including muscle atrophy and fat infiltration; bone mass

Case Group; Compared Group

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

In the orthopaedic department of Peking University Third Hospital, patients with a clear diagnosis of lumbar degenerative diseases, and were performed by posterior surgery will be enrolled.

You may qualify if:

• Underwent posterior surgery for degenerative scoliosis;
• Above the age of 45;
• Satisfy at least one of the following criteria: cobb angle \> 10°, sagittal vertical axis \> 5cm, pelvic tilt \> 25°, or thoracic kyphosis \> 60°.

You may not qualify if:

• Underwent posterior surgery for lumbar spinal stenosis;
• Above the age of 45;
• Diagnosis of lumbar spinal stenosis.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

Related Publications (9)

• Ropponen A, Videman T, Battie MC. The reliability of paraspinal muscles composition measurements using routine spine MRI and their association with back function. Man Ther. 2008 Aug;13(4):349-56. doi: 10.1016/j.math.2007.03.004. Epub 2007 Jun 6.

  PMID: 17556006 RESULT

• Anderson DE, Bean JF, Holt NE, Keel JC, Bouxsein ML. Computed tomography-based muscle attenuation and electrical impedance myography as indicators of trunk muscle strength independent of muscle size in older adults. Am J Phys Med Rehabil. 2014 Jul;93(7):553-61. doi: 10.1097/PHM.0000000000000059.

  PMID: 24508931 RESULT

• Cooley JR, Walker BF, M Ardakani E, Kjaer P, Jensen TS, Hebert JJ. Relationships between paraspinal muscle morphology and neurocompressive conditions of the lumbar spine: a systematic review with meta-analysis. BMC Musculoskelet Disord. 2018 Sep 27;19(1):351. doi: 10.1186/s12891-018-2266-5.

  PMID: 30261870 RESULT

• Crawford RJ, Cornwall J, Abbott R, Elliott JM. Manually defining regions of interest when quantifying paravertebral muscles fatty infiltration from axial magnetic resonance imaging: a proposed method for the lumbar spine with anatomical cross-reference. BMC Musculoskelet Disord. 2017 Jan 19;18(1):25. doi: 10.1186/s12891-016-1378-z.

  PMID: 28103921 RESULT

• Hong X, Shi R, Wang YT, Liu L, Bao JP, Wu XT. Lumbar disc herniation treated by microendoscopic discectomy : Prognostic predictors of long-term postoperative outcome. Orthopade. 2018 Dec;47(12):993-1002. doi: 10.1007/s00132-018-3624-6.

  PMID: 30171289 RESULT

• Zotti MGT, Boas FV, Clifton T, Piche M, Yoon WW, Freeman BJC. Does pre-operative magnetic resonance imaging of the lumbar multifidus muscle predict clinical outcomes following lumbar spinal decompression for symptomatic spinal stenosis? Eur Spine J. 2017 Oct;26(10):2589-2597. doi: 10.1007/s00586-017-4986-x. Epub 2017 Feb 8.

  PMID: 28180981 RESULT

• Storheim K, Berg L, Hellum C, Gjertsen O, Neckelmann G, Espeland A, Keller A; Norwegian Spine Study Group. Fat in the lumbar multifidus muscles - predictive value and change following disc prosthesis surgery and multidisciplinary rehabilitation in patients with chronic low back pain and degenerative disc: 2-year follow-up of a randomized trial. BMC Musculoskelet Disord. 2017 Apr 4;18(1):145. doi: 10.1186/s12891-017-1505-5.

  PMID: 28376754 RESULT

• Pennington Z, Cottrill E, Ahmed AK, Passias P, Protopsaltis T, Neuman B, Kebaish KM, Ehresman J, Westbroek EM, Goodwin ML, Sciubba DM. Paraspinal muscle size as an independent risk factor for proximal junctional kyphosis in patients undergoing thoracolumbar fusion. J Neurosurg Spine. 2019 May 31;31(3):380-388. doi: 10.3171/2019.3.SPINE19108. Print 2019 Sep 1.

  PMID: 31151107 RESULT

• Betz M, Burgstaller JM, Held U, Andreisek G, Steurer J, Porchet F, Farshad M; LSOS Study Group. Influence of Paravertebral Muscle Quality on Treatment Efficacy of Epidural Steroid Infiltration or Surgical Decompression in Lumbar Spinal Stenosis-Analysis of the Lumbar Spinal Outcome Study (LSOS) Data: A Swiss Prospective Multicenter Cohort Study. Spine (Phila Pa 1976). 2017 Dec 1;42(23):1792-1798. doi: 10.1097/BRS.0000000000002233.

  PMID: 28542102 RESULT

MeSH Terms

Interventions

Bone Density

Intervention Hierarchy (Ancestors)

Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Wei-Shi Li, M.D.

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gengyu Han, M.D.

CONTACT

+86 15701206146; 475210693@qq.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2021
• First Posted: January 13, 2022
• Study Start: April 3, 2021
• Primary Completion: September 1, 2022
• Study Completion: September 30, 2022
• Last Updated: January 13, 2022

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: The individual participant data (IPD) will become available for half a year after the publication of the results of the study.
• Access Criteria: The IPD is available to the readers of the journal in which our research is published. The corresponding author of the published papers will review the requests.

Locations

CN (1)