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

Low Back Pain Clinical Trial

Official title:

Improvement of Low Back Pain After Surgical Decompression in Patients With Degenerative Lumbar Spinal Canal Stenosis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05791422
• Other study ID #: LBPSD
• Status: Not yet recruiting
• Start date: March 20, 2023
• Est. completion date: March 1, 2024

Study information

• Verified date: March 2023
• Source: Assiut University
• Contact: Mohamed El-Meshtawy, Professor
• Phone: +201005220936
• Email: mohamedel-meshtawy[@]aun.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Degenerative lumbar spine disease is a common indication for lumbar decompression surgery, especially in elderly patients. Moreover, Clinical studies prove that decompression is superior to conservative treatment with more favorable outcomes . Surgical options for decompressing the lumbar spine vary from minimally invasive disc decompression to open laminectomy and foraminotomy. The surgery aims to improve the quality of life in appropriately selected patients , in the form of improvement of walking distance, lower limbs pain, and other symptoms of spinal compression. Few papers assessed LBP improvement after lumbar decompression surgery . The common practice that patients with degenerative canal stenosis and low back pain should undergo fusion surgery is not evidence based. In this study the investigators aim to assess the improvement of clinical symptoms, especially low back pain and lower limbs pain in patients with degenerative lumbar spine disease after undergoing lumbar decompression surgery.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: March 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

Inclusion Criteria:

1. 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.

2. Patients with grade one spondylolisthesis without evident instability can be added.

Exclusion Criteria:

1. Patients who are not available for follow up

2. Patients who refuse to participate in the study

3. Patients with evidence of instability

4. Previously operated patients on the same or adjacent segment.

Related Conditions & MeSH terms

• Back Pain
• Constriction, Pathologic
• Low Back Pain
• Lumbar Spinal Stenosis
• Spinal Stenosis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Changes in ODI following decompression surgery and in the follow up visits.	ODI is a 10-item self-assessing questionnaire, each item contains 6 levels of answers that can be scored from 0 to 5	1 year post operative
Secondary	Changes in EQ 5D 5l following decompression surgery and in the follow up visits.	EQ-5D-5L is a descriptive system that comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression	1 year post operative