Improvement of Low Back Pain After Decompression in Patients with Degenerative Spinal Canal Stenosis

NCT05791422 | Completed

• 1 other identifier: LBPSD
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

Degenerative lumbar spine disease is a leading cause of disability in the world; it encompasses conditions such as spondylolisthesis, disc degeneration, and lumbar spinal stenosis. Those conditions present with a variety of clinical symptoms, including lower extremity pain, weakness, and low back pain (LBP) of varying levels of severity and in severe cases urine and stool incontinence may result.

Conditions

Low Back Pain; Lumbar Spinal Stenosis

Outcome Measures

Primary Outcomes (1)

• Changes in VAS score for low back pain following decompression surgery and in the follow up visits .

  The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."

  1 year post operative

Secondary Outcomes (2)

• Changes in ODI following decompression surgery and in the follow up visits.

  1 year post operative

• Changes in EQ 5D 5l following decompression surgery and in the follow up visits.

  1 year post operative

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with degenerative lumbar spine disease admitted to Assiut University Hospitals, Department of Orthopaedic and Trauma Surgery to whom lumbar decompression surgery is indicated .

You may qualify if:

• Patients with degenerative lumbar spine disease admitted to Assiut University Hospitals, Department of Orthopaedic and Trauma Surgery between March 2023 and March 2024, to whom lumbar decompression surgery is indicated regardless of age or neurological symptoms.
• Patients with grade one spondylolisthesis without evident instability can be added.

You may not qualify if:

• Patients who are not available for follow up
• Patients who refuse to participate in the study
• Patients with evidence of instability
• Previously operated patients on the same or adjacent segment.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assuit university hospitals

Asyut, Asyut Governorate, 71511, Egypt

Location

Related Publications (10)

• Amundsen T, Weber H, Nordal HJ, Magnaes B, Abdelnoor M, Lilleas F. Lumbar spinal stenosis: conservative or surgical management?: A prospective 10-year study. Spine (Phila Pa 1976). 2000 Jun 1;25(11):1424-35; discussion 1435-6. doi: 10.1097/00007632-200006010-00016.

  PMID: 10828926 BACKGROUND

• Berthelot JM, Bertrand-Vasseur A, Rodet D, Maugars Y, Prost A. Lumbar spinal stenosis: a review. Rev Rhum Engl Ed. 1997 May;64(5):315-25.

  PMID: 9190005 BACKGROUND

• Arnoldi CC, Brodsky AE, Cauchoix J, Crock HV, Dommisse GF, Edgar MA, Gargano FP, Jacobson RE, Kirkaldy-Willis WH, Kurihara A, Langenskiold A, Macnab I, McIvor GW, Newman PH, Paine KW, Russin LA, Sheldon J, Tile M, Urist MR, Wilson WE, Wiltse LL. Lumbar spinal stenosis and nerve root entrapment syndromes. Definition and classification. Clin Orthop Relat Res. 1976 Mar-Apr;(115):4-5. No abstract available.

  PMID: 1253495 BACKGROUND

• Athiviraham A, Yen D. Is spinal stenosis better treated surgically or nonsurgically? Clin Orthop Relat Res. 2007 May;458:90-3. doi: 10.1097/BLO.0b013e31803799a9.

  PMID: 17308483 BACKGROUND

• Benz RJ, Garfin SR. Current techniques of decompression of the lumbar spine. Clin Orthop Relat Res. 2001 Mar;(384):75-81. doi: 10.1097/00003086-200103000-00010.

  PMID: 11249182 BACKGROUND

• Sunderland G, Foster M, Dheerendra S, Pillay R. Patient-Reported Outcomes Following Lumbar Decompression Surgery: A Review of 2699 Cases. Global Spine J. 2021 Mar;11(2):172-179. doi: 10.1177/2192568219896541. Epub 2020 Jan 7.

  PMID: 32875849 BACKGROUND

• Radcliff KE, Rihn J, Hilibrand A, DiIorio T, Tosteson T, Lurie JD, Zhao W, Vaccaro AR, Albert TJ, Weinstein JN. Does the duration of symptoms in patients with spinal stenosis and degenerative spondylolisthesis affect outcomes?: analysis of the Spine Outcomes Research Trial. Spine (Phila Pa 1976). 2011 Dec 1;36(25):2197-210. doi: 10.1097/BRS.0b013e3182341edf.

  PMID: 21912308 BACKGROUND

• Jones AD, Wafai AM, Easterbrook AL. Improvement in low back pain following spinal decompression: observational study of 119 patients. Eur Spine J. 2014 Jan;23(1):135-41. doi: 10.1007/s00586-013-2964-5. Epub 2013 Aug 21.

  PMID: 23963487 BACKGROUND

• Boonstra AM, Schiphorst Preuper HR, Reneman MF, Posthumus JB, Stewart RE. Reliability and validity of the visual analogue scale for disability in patients with chronic musculoskeletal pain. Int J Rehabil Res. 2008 Jun;31(2):165-9. doi: 10.1097/MRR.0b013e3282fc0f93.

  PMID: 18467932 BACKGROUND

• Aburuz S, Bulatova N, Twalbeh M, Gazawi M. The validity and reliability of the Arabic version of the EQ-5D: a study from Jordan. Ann Saudi Med. 2009 Jul-Aug;29(4):304-8. doi: 10.4103/0256-4947.55313.

  PMID: 19584581 BACKGROUND

MeSH Terms

Conditions

Low Back Pain; Spinal Stenosis

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: March 15, 2023
• First Posted: March 30, 2023
• Study Start: March 20, 2023
• Primary Completion: December 20, 2024
• Study Completion: December 20, 2024
• Last Updated: January 23, 2025

Record last verified: 2023-03

Locations

EG (1)