Value of Three-dimensional Rotational Epidurography on Percutaneous Epidural Adhesiolysis

NCT04216992 | Completed FDA Device

• 1 other identifier: 1-105-05-141
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Conventional epidurography (CE) is thought to have insufficient usefulness on percutaneous epidural adhesiolysis (PEA). The investigators aimed to evaluate the association between the outcome of PEA and three dimensional-rotational epidurography (3D-RE). The investigators performed 30 PEA in 26 patients, and evaluated their post-PEA image findings. Two independent clinicians categorized and recorded the occurrence of contrast at intra-canal ventral and extra-foraminal regions on CE; and contrast at dorsal canal (DC), ventral canal (VC), dorsal foramen (DF), and ventral foramen (VF) on 3D-RE. Reproducibility was assessed using intra-class correlation coefficients (ICCs). The symptom relief after one month for the patients receiving PEA and the contrast distribution patterns of CE and 3D-RE and were determined.

Conditions

Failed Back Surgery Syndrome; Spinal Stenosis

Keywords

Cone beam; Computed tomography; Epidurography; Percutaneous epidural adhesiolysis

Outcome Measures

Primary Outcomes (3)

• Symptoms change after PEA

  For the comparison of clinical outcomes according to the symptoms change, the participants' symptoms change was rated using a Likert scale to defined two groups by exhibiting \>= 50% symptoms change and \< 50% symptoms change.

  1 month

• Reproducibility of CE and 3D-RE

  Inter-reader agreement was evaluated using the intra-class correlation coefficients (ICCs), calculated according to Landis and Koch, for the contrast distribution of CE and 3D-RE.

  1 month

• Usefulness of 3D-RE for predicting the outcome of PEA

  Simple linear regression analysis was used to determine the prediction of the outcome of PEA by the contrast distribution of CE and 3D-RE.

  3 months

Secondary Outcomes (1)

• Radiation exposure of PEA

  1 month

Study Arms (1)

Three dimensional-rotational epidurography (3D-RE)

3D-RE is obtained on a commercial digital bi-plane angiography system. Reconstruction time was 30 seconds. Detailed information regarding technical performance and reconstruction procedure has been reported. Postprocessing techniques provided by the software included real-time 3D volume rendering and multiplanar reformatting. Real-time 3D volume rendering creates a 3D model of the examined object. The software allows emphasizing bony structures or soft tissue by changing intensity, brightness, and opacity of different X-ray structures. Additionally, rotation of the 3D object in all directions is possible, as is a virtual stereoscopic view provided by the software in combination with special glasses. The multiplanar reformatting modus generates virtual sections according to the three main axes and free defined axes. The section planes can be freely chosen, and curved sectioning is also possible.

Device: Cone beam computed tomography

Interventions

Cone beam computed tomography DEVICE

The contrast agent (Omnipaque, GE Healthcare, Ireland) was instilled to confirm the epidural space. With use of a calibrated angiographic C-arm system and a postprocessing workstation, we acquired volume data sets from two dimensional digital projection images obtained to reconstruct the 3D-RE during a C-arm rotation around the patient axis.

Three dimensional-rotational epidurography (3D-RE)

Eligibility Criteria

• Age: Up to 20 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients who had FBSS or SS with unilateral radiculopathy underwent PEA.

You may qualify if:

• FBSS or SS with unilateral radiculopathy.
• History of discogenic or radicular symptoms refractory to conservative treatments and epidural steroid injection for a minimum of 6 weeks.
• The PEA was standardized to all patients receiving the procedure.
• Each patient received an epidural injection, and if the symptoms persisted or the relief was insufficient, the patient received PEA \>6-week interval between the epidural steroid injection.
• Positive provocative test during PEA was used to confirm the affected spinal level.
• All patients underwent CE before and after PEA; and 3D-RE after PEA.

You may not qualify if:

• History of spinal surgery and those with cauda equina syndrome
• Bleeding diathesis
• Associated somatic or psychiatric disease
• Vertebral fractures
• Pregnancy
• Tumors
• Other underlying systemic diseases that could significantly influence the procedural outcomes were excluded.
• Bilateral symptoms
• Did not react to the provocation during PEA

Sponsors & Collaborators

• Tri-Service General Hospital: lead

Study Sites (1)

No. 325, Sec. 2, Cheng-kung Rd., Neihu 114

Taipei, Taiwan, R.o.c., 886, Taiwan

Location

Related Publications (14)

• Manchikanti L, Helm Ii S, Pampati V, Racz GB. Percutaneous adhesiolysis procedures in the medicare population: analysis of utilization and growth patterns from 2000 to 2011. Pain Physician. 2014 Mar-Apr;17(2):E129-39.

  PMID: 24658484 BACKGROUND

• Gerdesmeyer L, Wagenpfeil S, Birkenmaier C, Veihelmann A, Hauschild M, Wagner K, Muderis MA, Gollwitzer H, Diehl P, Toepfer A. Percutaneous epidural lysis of adhesions in chronic lumbar radicular pain: a randomized, double-blind, placebo-controlled trial. Pain Physician. 2013 May-Jun;16(3):185-96.

  PMID: 23703406 BACKGROUND

• Racz GB, Heavner JE, Trescot A. Percutaneous lysis of epidural adhesions--evidence for safety and efficacy. Pain Pract. 2008 Jul-Aug;8(4):277-86. doi: 10.1111/j.1533-2500.2008.00203.x. Epub 2008 May 23.

  PMID: 18503627 BACKGROUND

• Park SH, Ji GY, Cho PG, Shin DA, Yoon YS, Kim KN, Oh CH. Clinical Significance of Epidurography Contrast Patterns after Adhesiolysis during Lumbar Percutaneous Epidural Neuroplasty. Pain Res Manag. 2018 Apr 1;2018:6268045. doi: 10.1155/2018/6268045. eCollection 2018.

  PMID: 29808106 BACKGROUND

• Kim JH, Jung HJ, Nahm FS, Lee PB. Does improvement in epidurography following percutaneous epidural neuroplasty correspond to patient outcome? Pain Pract. 2015 Jun;15(5):407-13. doi: 10.1111/papr.12197. Epub 2014 Apr 21.

  PMID: 24750546 BACKGROUND

• Gupta R, Singh S, Kaur S, Singh K, Aujla K. Correlation between Epidurographic Contrast Flow Patterns and Clinical Effectiveness in Chronic Lumbar Discogenic Radicular Pain Treated with Epidural Steroid Injections Via Different Approaches. Korean J Pain. 2014 Oct;27(4):353-9. doi: 10.3344/kjp.2014.27.4.353. Epub 2014 Oct 1.

  PMID: 25317285 BACKGROUND

• Hong Park C, Ho Lee S. Epidurographic Findings Following Percutaneous Epidural Adhesiolysis Failed to Correlate with Level of Pain Reduction in Patients with Lumbar Spinal Stenosis. Pain Med. 2017 May 1;18(5):842-845. doi: 10.1093/pm/pnw244.

  PMID: 27651508 BACKGROUND

• Shin JW. Is epidurogram a reliable tool for the diagnosis of epidural adhesion? Korean J Pain. 2012 Apr;25(2):133-4. doi: 10.3344/kjp.2012.25.2.133. Epub 2012 Apr 4. No abstract available.

  PMID: 22514786 BACKGROUND

• Kufeld M, Claus B, Campi A, Lanksch WR, Benndorf G. Three-dimensional rotational myelography. AJNR Am J Neuroradiol. 2003 Aug;24(7):1290-3.

  PMID: 12917114 BACKGROUND

• El-Sheik M, Heverhagen JT, Alfke H, Froelich JJ, Hornegger J, Brunner T, Klose KJ, Wagner HJ. Multiplanar reconstructions and three-dimensional imaging (computed rotational osteography) of complex fractures by using a C-arm system: initial results. Radiology. 2001 Dec;221(3):843-9. doi: 10.1148/radiol.2213010606.

  PMID: 11719688 BACKGROUND

• Manchikanti L, Boswell MV, Rivera JJ, Pampati VS, Damron KS, McManus CD, Brandon DE, Wilson SR. [ISRCTN 16558617] A randomized, controlled trial of spinal endoscopic adhesiolysis in chronic refractory low back and lower extremity pain. BMC Anesthesiol. 2005 Jul 6;5:10. doi: 10.1186/1471-2253-5-10.

  PMID: 16000173 BACKGROUND

• Moon SH, Lee JI, Cho HS, Shin JW, Koh WU. Factors for Predicting Favorable Outcome of Percutaneous Epidural Adhesiolysis for Lumbar Disc Herniation. Pain Res Manag. 2017;2017:1494538. doi: 10.1155/2017/1494538. Epub 2017 Jan 26.

  PMID: 28246488 BACKGROUND

• Wiesent K, Barth K, Navab N, Durlak P, Brunner T, Schuetz O, Seissler W. Enhanced 3-D-reconstruction algorithm for C-arm systems suitable for interventional procedures. IEEE Trans Med Imaging. 2000 May;19(5):391-403. doi: 10.1109/42.870250.

  PMID: 11021683 BACKGROUND

• The 2007 Recommendations of the International Commission on Radiological Protection. ICRP publication 103. Ann ICRP. 2007;37(2-4):1-332. doi: 10.1016/j.icrp.2007.10.003.

  PMID: 18082557 BACKGROUND

MeSH Terms

Conditions

Failed Back Surgery Syndrome; Spinal Stenosis

Interventions

Cone-Beam Computed Tomography

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Tomography, X-Ray Computed; Tomography, X-Ray; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography

Study Officials

• Yi-Chih Hsu, M.D.

  Department of Radiology Tri-Service General Hospital National Defense Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: December 28, 2019
• First Posted: January 3, 2020
• Study Start: January 4, 2018
• Primary Completion: October 24, 2019
• Study Completion: December 6, 2019
• Last Updated: January 6, 2020

Record last verified: 2020-01

Locations

TW (1)