Is it Really Necessary Going All Over the Top in Patients With Symptomatic Lumbar Spinal Stenosis?

NCT07026305 | Recruiting

• 1 other identifier: 24/605-EC-X_Tesis
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate the theory of epidural pressure by comparing a surgical procedure that aims to perform less bone resection compared to conventional surgery in patients with lumbar spinal stenosis. The main questions it aims to answer is: Is bony decompression of the lumbar canal performed until normalization of epidural pressure not inferior to conventional surgery in achieving clinical improvement in patients with symptomatic lumbar canal stenosis? Researchers will: Compare conventional open laminectomy to bony decompression of the lumbar canal until normalization of epidural pressure is achieved. Participants will:

• Be randomized to one of the two surgical interventions: laminectomy guided by epidural pressure measure or conventional laminectomy.
• Visit the clinic for checkups and tests until 1 year of follow-up.

Conditions

Lumbar Canal Stenosis; Lumbar Spinal Stenosis; Lumbar Spinal Stenosis (LSS)

Keywords

lumbar canal stenosis; spinal epidural pressure; lumbar spinal stenosis; LSS

Outcome Measures

Primary Outcomes (1)

• Zurich Claudication Questionnaire (ZCQ) - Symptom Severity subcategory.

  This scale consists of 7 items that evaluate the severity of symptoms over the last month on a numeric scale from 1 to 5, where 5 represents greater severity. A mean score of the items is calculated.

  At enrollment and at the follow-up visits at 1, 3, 6, and 12 months post-surgery.

Secondary Outcomes (7)

• Zurich Claudication Questionnaire (ZCQ) - Physical Function subcategory.

  At enrollment and at the follow-up visits at 1, 3, 6, and 12 months post-surgery.

• Zurich Claudication Questionnaire (ZCQ) - Patient Satisfaction subcategory.

  At enrollment and at the follow-up visits at 6 and 12 months post-surgery.

• Numeric Pain Rating Scale (NPRS).

  At enrollment and at the follow-up visits at 1, 3, 6, and 12 months post-surgery.

• Oswestry Disability Index (ODI).

  At enrollment and at the follow-up visits at 1, 3, 6, and 12 months post-surgery.

• Japanese Orthopaedic Association Back Pain Evaluation Questionnaire (JOABPEQ).

  At enrollment and at the follow-up visits at 1, 3, 6, and 12 months post-surgery.

Study Arms (2)

Pressure-guided laminectomy (PGL)

EXPERIMENTAL

Osseous resection of the lamina and ligamentum flavum until the epidural pressure reaches a normal value at the stenotic segment.

Procedure: Pressure-guided laminectomy (PGL)

Non-pressure-guided laminectomy (NPGL)

ACTIVE COMPARATOR

Complete resection of both the lamina and the ligamentum flavum at the stenotic segment.

Procedure: Laminectomy without pressure guidance (LWPG)

Interventions

Pressure-guided laminectomy (PGL) PROCEDURE

Osseous resection of the lamina and ligamentum flavum until the epidural pressure reaches a normal value at the stenotic segment.

Pressure-guided laminectomy (PGL)

Laminectomy without pressure guidance (LWPG) PROCEDURE

Complete resection of both the lamina and the ligamentum flavum at the stenotic segment.

Non-pressure-guided laminectomy (NPGL)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Surgical indication determined by:
• Lower back pain and/or lower extremity pain for more than 3 months.
• Pain refractory to conservative medical management (analgesics, physical therapy, epidural block).
• Clinical criterion of neurogenic claudication defined as a score ≥11 on the N-CLASS scale.
• Preoperative magnetic resonance imaging (MRI) showing lumbar canal stenosis.
• Patient consents to the proposed surgical intervention.
• Patient agrees to participate in the study by signing the informed consent form.

You may not qualify if:

• Foraminal or lateral recess stenosis.
• Symptomatic disc herniation at the segment to be treated.
• Spondylolisthesis \> Grade I (Meyerding) (translation \>25% of the vertebra) or spondylolysis.
• Radiological instability defined as \>5 mm of anteroposterior translation on dynamic flexion-extension spine X-rays.
• Scoliosis with Cobb angle \>30°.
• Compression fracture at the level to be treated.
• Prior surgery at the same segment to be treated.
• Prior infection at the segment to be treated.
• Contraindication for MRI.
• Diagnosis of major depressive disorder or dysthymia according to DSM-V criteria.

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead
• Hospital San Carlos, Madrid: collaborator
• FUNDACION PARA LA INVESTIGACION HOSPITAL CLINICO SAN CARLOS: collaborator

Study Sites (1)

Hospital Clínico San Carlos

Madrid, 28040, Spain

RECRUITING

Related Publications (15)

• Zhang C, Chen L, Li J, Huang D, Zhang W, Lin J. Should Posterior Midline Structures Be Preserved in Decompression Surgery for Lumbar Spinal Stenosis?: A Systematic Review and Meta-analysis. Clin Spine Surg. 2022 Oct 1;35(8):341-349. doi: 10.1097/BSD.0000000000001268. Epub 2021 Oct 28.

  PMID: 34711752 BACKGROUND

• Soliman MAR, Ali A. Decompression of lumbar canal stenosis with a bilateral interlaminar versus classic laminectomy technique: a prospective randomized study. Neurosurg Focus. 2019 May 1;46(5):E3. doi: 10.3171/2019.2.FOCUS18725.

  PMID: 31042649 BACKGROUND

• Boukebir MA, Berlin CD, Navarro-Ramirez R, Heiland T, Scholler K, Rawanduzy C, Kirnaz S, Jada A, Hartl R. Ten-Step Minimally Invasive Spine Lumbar Decompression and Dural Repair Through Tubular Retractors. Oper Neurosurg. 2017 Apr 1;13(2):232-245. doi: 10.1227/NEU.0000000000001407.

  PMID: 28927213 BACKGROUND

• Takahashi K, Miyazaki T, Takino T, Matsui T, Tomita K. Epidural pressure measurements. Relationship between epidural pressure and posture in patients with lumbar spinal stenosis. Spine (Phila Pa 1976). 1995 Mar 15;20(6):650-3.

  PMID: 7604339 BACKGROUND

• Barz T, Melloh M, Staub LP, Lord SJ, Lange J, Merk HR. Increased intraoperative epidural pressure in lumbar spinal stenosis patients with a positive nerve root sedimentation sign. Eur Spine J. 2014 May;23(5):985-90. doi: 10.1007/s00586-013-3071-3. Epub 2013 Oct 29.

  PMID: 24166020 BACKGROUND

• Takahashi K, Kagechika K, Takino T, Matsui T, Miyazaki T, Shima I. Changes in epidural pressure during walking in patients with lumbar spinal stenosis. Spine (Phila Pa 1976). 1995 Dec 15;20(24):2746-9. doi: 10.1097/00007632-199512150-00017.

  PMID: 8747254 BACKGROUND

• Hermansen E, Myklebust TA, Weber C, Brisby H, Austevoll IM, Hellum C, Storheim K, Aaen J, Banitalebi H, Brox JI, Grundnes O, Rekeland F, Solberg T, Franssen E, Indrekvam K. Postoperative Dural Sac Cross-Sectional Area as an Association for Outcome After Surgery for Lumbar Spinal Stenosis: Clinical and Radiological Results From the NORDSTEN-Spinal Stenosis Trial. Spine (Phila Pa 1976). 2023 May 15;48(10):688-694. doi: 10.1097/BRS.0000000000004565. Epub 2023 Feb 20.

  PMID: 36809364 BACKGROUND

• Gupta S, Bansal T, Kashyap A, Sural S. Correlation between clinical scoring systems and quantitative MRI parameters in degenerative lumbar spinal stenosis. J Clin Orthop Trauma. 2022 Oct 20;35:102050. doi: 10.1016/j.jcot.2022.102050. eCollection 2022 Dec.

  PMID: 36317084 BACKGROUND

• Boden SD, Davis DO, Dina TS, Patronas NJ, Wiesel SW. Abnormal magnetic-resonance scans of the lumbar spine in asymptomatic subjects. A prospective investigation. J Bone Joint Surg Am. 1990 Mar;72(3):403-8.

  PMID: 2312537 BACKGROUND

• Suner HI, Castano JP, Vargas-Jimenez A, Wagner R, Mazzei AS, Velazquez W, Jorquera M, Sallabanda K, Barcia Albacar JA, Carrascosa-Granada A. Comparison of the Tubular Approach and Uniportal Interlaminar Full-Endoscopic Approach in the Treatment of Lumbar Spinal Stenosis: Our 3-Year Results. World Neurosurg. 2023 May;173:e148-e155. doi: 10.1016/j.wneu.2023.02.022. Epub 2023 Feb 10.

  PMID: 36775236 BACKGROUND

• Carrascosa-Granada A, Velazquez W, Wagner R, Saab Mazzei A, Vargas-Jimenez A, Jorquera M, Albacar JAB, Sallabanda K. Comparative Study Between Uniportal Full-Endoscopic Interlaminar and Tubular Approach in the Treatment of Lumbar Spinal Stenosis: A Pilot Study. Global Spine J. 2020 Apr;10(2 Suppl):70S-78S. doi: 10.1177/2192568219878419. Epub 2020 May 28.

  PMID: 32528810 BACKGROUND

• Chen X, Zheng Z, Lin J. Clinical Effectiveness of Conservative Treatments on Lumbar Spinal Stenosis: A Network Meta-Analysis. Front Pharmacol. 2022 Jun 6;13:859296. doi: 10.3389/fphar.2022.859296. eCollection 2022.

  PMID: 35734403 BACKGROUND

• Chad DA. Lumbar spinal stenosis. Neurol Clin. 2007 May;25(2):407-18. doi: 10.1016/j.ncl.2007.01.003.

  PMID: 17445736 BACKGROUND

• Kobayashi H, Sekiguchi M, Yonemoto K, Kakuma T, Tominaga R, Kato K, Watanabe K, Nikaido T, Otani K, Yabuki S, Kikuchi SI, Konno SI; DISTO project working group. Reference values of the Japanese Orthopaedic Association Back Pain Evaluation Questionnaire in patients with lumbar spinal stenosis and characteristics of deterioration of QOL: Lumbar Spinal Stenosis Diagnosis Support Tool: DISTO project. J Orthop Sci. 2019 Jul;24(4):584-589. doi: 10.1016/j.jos.2018.11.022. Epub 2019 Jan 5.

  PMID: 30616940 BACKGROUND

• Katz JN, Zimmerman ZE, Mass H, Makhni MC. Diagnosis and Management of Lumbar Spinal Stenosis: A Review. JAMA. 2022 May 3;327(17):1688-1699. doi: 10.1001/jama.2022.5921.

  PMID: 35503342 BACKGROUND

MeSH Terms

Conditions

Spinal Stenosis

Interventions

Laminectomy

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Orthopedic Procedures; Therapeutics; Decompression, Surgical; Surgical Procedures, Operative; Neurosurgical Procedures

Study Officials

• Juan P Castaño-Montoya, M.D.,M.Sc.

  Universidad Complutense de Madrid

  PRINCIPAL INVESTIGATOR

• Angela M Carrascosa-Granada, M.D.,M.Sc.,Ph.D.

  Universidad Complutense de Madrid

  STUDY DIRECTOR

Central Study Contacts

Juan P Castaño-Montoya, M.D., M.Sc.

CONTACT

+34669345474; juanpcas@ucm.es

Angela M Carrascosa-Granada, M.D., M.Sc.,Ph.D.

CONTACT

+34654849458; amaca3582@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., M.Sc.

Model Details: This is a non-inferiority, controlled, randomized, single-blind clinical trial comparing the effectiveness of full lumbar canal bony decompression up to normalization of epidural pressure versus open laminectomy in patients with symptomatic lumbar canal stenosis.

Study Record Dates

• First Submitted: June 5, 2025
• First Posted: June 18, 2025
• Study Start: April 21, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: June 24, 2025

Record last verified: 2025-06

Locations

ES (1)