Clinical trial NCT05190289: Paraspinal Muscle Degeneration, Bone Mass and Clinical Outcomes in Patients With Lumbar Degenerative Diseases
Official title: The Relationship Between Paraspinal Muscle Degeneration and Bone Mass and Clinical Outcomes After Surgery in Patients With Lumbar Degenerative Diseases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Degenerative Lumbar Spinal Stenosis
Degenerative Scoliosis
Keywords: Degenerative Lumbar Disease
Clinical Outcome
Complication
Paraspinal Muscle
Bone Mass
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2022-01-13
Enrollment: 600
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Disability
timeFrame: 12 months; through study completion, an average of 3 years
measure: Low Back pain
timeFrame: 12 months; through study completion, an average of 3 years
measure: Leg pain
timeFrame: 12 months; through study completion, an average of 3 years
measure: Sagittal balance
timeFrame: 12 months; through study completion, an average of 3 years
measure: Bone nonunion
timeFrame: 12 months; through study completion, an average of 3 years
measure: Screw loosening
timeFrame: 12 months; through study completion, an average of 3 years
measure: Proximal junctional kyphosis
timeFrame: 12 months; through study completion, an average of 3 years
measure: Proximal scoliosis progression
timeFrame: 12 months; through study completion, an average of 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Wei-Shi Li, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
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):351. doi: 10.1186/s12891-018-2266-5.
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. BMC Musculoskelet Disord. 2017 Jan 19;18(1):25. doi: 10.1186/s12891-016-1378-z.
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.
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 Oct;26(10):2589-2597. doi: 10.1007/s00586-017-4986-x. Epub 2017 Feb 8.
citation: 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.
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 thoracolumbar fusion. J Neurosurg Spine. 2019 May 31;31(3):380-388. doi: 10.3171/2019.3.SPINE19108. Print 2019 Sep 1.
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 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.