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

Degenerative Lumbar Spinal Stenosis Clinical Trial

Official title:

The Relationship Between Paraspinal Muscle Degeneration and Bone Mass and Clinical Outcomes After Surgery in Patients With Lumbar Degenerative Diseases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05190289
• Other study ID #: M2021134
• Status: Recruiting
• Start date: April 3, 2021
• Est. completion date: September 30, 2022

Study information

• Verified date: June 2021
• Source: Peking University Third Hospital
• Contact: Gengyu Han, M.D.
• Phone: +86 15701206146
• Email: 475210693[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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 our 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. The investigators intended to review the patients who underwent posterior surgery for degenerative lumbar diseases from January 2010 to December 2019. 1. To review the patients who underwent posterior surgery in orthopedic department for degenerative scoliosis. The inclusion criteria were: (1) above the age of 45; (2) satisfy at least one of the following criteria: cobb angle > 10°, sagittal vertical axis (SVA) > 5cm, pelvic tilt (PT) > 25°, or thoracic kyphosis (TK) > 60°. The exclusion criteria were: (1) with a history of arthritic tumor or neuromuscular disease (2) with a history of spinal surgery. 2. To review the patients who underwent posterior surgery in orthopedic department for lumbar spinal stenosis. The inclusion criteria were: (1) above the age of 45; (2) diagnosis of lumbar spinal stenosis. The exclusion criteria were: (1) with a history of arthritic tumor or neuromuscular disease (2) with a history of spinal surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: September 30, 2022
• Est. primary completion date: September 1, 2022
• Gender: All
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

• 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°.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Degenerative Lumbar Spinal Stenosis
• Degenerative Scoliosis
• Scoliosis
• Spinal Stenosis

Intervention

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

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

References & Publications (9)

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):5 — View Citation

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 o — View Citation

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): — View Citation

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. B — View Citation

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. — View Citation

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 thoracolumb — View Citation

Ropponen A, Videman T, Battié 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. Epub 2007 Jun 6. — View Citation

Storheim K, Berg L, Hellum C, Gjertsen Ø, 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 patient — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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