Low Back PainNCT05791422
Improvement of Low Back Pain After Decompression in Patients with Degenerative Spinal Canal Stenosis
An observational study of Low Back Pain and Lumbar Spinal Stenosis, run by Assiut University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Low Back Pain, Lumbar Spinal Stenosis
- How many people
- 55 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Mar 2023to 20 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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 .
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improvement of Low Back Pain After Surgical Decompression in Patients with Degenerative Lumbar Spinal Canal Stenosis
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.
Read the detailed 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.
- Conditions
- Low Back Pain, Lumbar Spinal Stenosis
- Medical subject headings
- Low Back Pain, Spinal Stenosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: 1 year post operative
Secondary outcomes (2)
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
Measured: 1 year post operative
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
Measured: 1 year post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start20 Mar 2023
- Primary completion20 Dec 2024
- Study completion20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Ahmed Fayek Amin, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05791422
- Sponsor's protocol ID
- LBPSD
- Status last verified
- Mar 2023
- First submitted
- 15 Mar 2023
- Last updated
- 23 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 10828926Berthelot 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.
PubMed 9190005Arnoldi 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.
PubMed 1253495Athiviraham 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.
PubMed 17308483Benz 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.
PubMed 11249182Sunderland 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.
PubMed 32875849Radcliff 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.
PubMed 21912308Jones 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.
PubMed 23963487Boonstra 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.
PubMed 18467932Aburuz 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.
PubMed 19584581
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement of Low Back Pain After Surgical Decompression in Patients with Degenerative Lumbar Spinal Canal Stenosis
- ClinicalTrials.gov ID
- NCT05791422
- Acronym / sponsor ID
- LBPSD
- Conditions
- Low Back Pain, Lumbar Spinal Stenosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 30 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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 .
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes in VAS score for low back pain following decompression surgery and in the follow up visits .
Time frame: 1 year post operative
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."
2 secondary outcomes
Changes in ODI following decompression surgery and in the follow up visits.
Time frame: 1 year post operative
Changes in EQ 5D 5l following decompression surgery and in the follow up visits.
Time frame: 1 year post operative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2025.
- Background: PubMed 10828926Amundsen 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.
- Background: PubMed 9190005Berthelot 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.
- Background: PubMed 1253495Arnoldi 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.
- Background: PubMed 17308483Athiviraham 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.
- Background: PubMed 11249182Benz 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.
- Background: PubMed 32875849Sunderland 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.
- Background: PubMed 21912308Radcliff 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.
- Background: PubMed 23963487Jones 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.
- Background: PubMed 18467932Boonstra 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.
- Background: PubMed 19584581Aburuz 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.
- Individual participant dataSharing planned: Undecided
Related trials for Low Back Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain and Lumbar Spinal Stenosis, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in VAS score for low back pain following decompression surgery and in the follow up visits . (time frame: 1 year post operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05791422, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2025.