Paraspinal MusclesNCT07002918
The Impact of Paraspinal Muscle Atrophy in Spine Surgeries
An observational study of Paraspinal Muscles and Degenerative Lumbar Diseases, run by Assiut University at 1 site in Egypt.
Trial summary
The goal of this observational study is to learn about the role of pre-operative paraspinal muscle atrophy in outcomes of lumbar spine fusion surgeries in patients with degenerative lumbar spine diseases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Paraspinal Muscles, Degenerative Lumbar Diseases
- How many people
- 55 participants
- Where
- 1 siteEgypt
- Study dates
- Jun 2025to Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing lumbar spinal fusion at Assiut University Hospitals, Department of Orthopedic surgery and Traumatology.
Who may be able to join
- Patients with degenerative lumbar spine diseases undergoing lumbar spinal fusion.
Who cannot join
- Long-level fusion ≥ 3 levels.
- History of previous lumbar surgery.
- Patients diagnosed with spondylolysis.
- Other pathological conditions such as fractures, infections or tumors.
- Uncontrolled comorbidities.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Assiut University
Asyut, Asyut Governorate, 71515
Vice President of graduate studies of Assiut University, +208822080150, vp_grad@aun.edu.eg
About this study
Official title: The Impact of Paraspinal Muscle Atrophy in Lumbar Spinal Fusion Outcomes
The goal of this observational study is to learn about the role of pre-operative paraspinal muscle atrophy in outcomes of lumbar spine fusion surgeries in patients with degenerative lumbar spine diseases. The main question it aims to answer is:
Does paraspinal muscle atrophy worsen lumbar spine fusion surgeries outcomes? Participants undergoing lumbar spine fusion surgeries as part of their treatment for degenerative lumbar spine diseases will answer survey questions about their low back pain and daily activities for 1 year.
Read the detailed description
Lumbar spine fusion surgery is a widely performed intervention worldwide with the rate steadily increasing. This trend reflects the growing burden of degenerative spinal disorders (DSD) and low back pain (LBP), which globally affect an estimated 266 million individuals (3.63% of the global population) each year. Socioeconomic factors are important risk aspects for lumbar pain and disability both directly and indirectly. Despite the widespread use of lumbar fusion surgery, outcomes are not uniformly successful. A significant proportion of patients experience poor postoperative results, with studies indicating that 33% of patients report treatment failure, including a 22% worsening rate after surgery for lumbar spinal stenosis. Factors associated with these poor outcomes include prolonged back pain duration (>12 months), prior spinal surgery, and advanced age (>70 years). One critical yet often overlooked factor contributing to poor outcomes is paraspinal muscle atrophy. The paraspinal muscles and vertebrae are interdependent tissues, and the health of these muscles plays a vital role in spinal stability and function. The multifidi, erector spinae, psoas, and quadratus lumborum muscles provide support for the lower back. Numerous studies have explored the degeneration or atrophy of back muscles and the reduction in back extensor muscle strength in patients with lower back pain. Patients with high lumbar muscularity and mild fatty infiltration ratio observed on preoperative MRI demonstrated more promising clinical and radiographic outcomes after lumbar interbody fusion. As the prevalence of degenerative spinal conditions continues to rise globally, understanding the role of paraspinal muscle health in surgical success is critical. By prioritizing patient selection based on modifiable risk factors, clinicians can enhance postoperative outcomes and mitigate the economic and clinical burdens associated with lumbar fusion surgery.
- Sample Size Calculation:
Based on determining the main outcome variable, The estimated minimum required sample size is 55 patients.
The sample size was calculated using Epi-info version 7 software, based on the following assumptions:
Main outcome variable is to determine the impact of paraspinal muscle atrophy on lumbar spine fusion outcomes. Previous studies indicate a significant decrease in paraspinal muscle volume one year after surgery, dropping from 67.8% to 60.4%. This reduction correlates significantly with physical and mental outcomes, as well as pain levels. With 80% confidence, the margin of error for these findings is estimated to be within 3%.
- Study tools (in detail, e.g., lab methods, instruments, steps, chemicals, …):
- Preoperative:
- Magnetic resonance imaging (MRI) of lumbar spine will be used to measure the total cross-sectional area (TCSA), functional cross-sectional area (FCSA) and fatty infiltration (FI) of erector spinae (ES), multifidus (MF) and psoas major (PM) at the level of diseased segment together with one level above \& below using ImageJ software v1.54p.
- plain X-rays will be used to measure local kyphotic angle and lumbar lordosis using Surgimap software v2.3.2.1.
- Oswerty disability index Arabic version (ODI)
- EuroQol-5-dimension 5-level Arabic version (EQ-5D-5L)
- Visual analogue scale (VAS) B. Day one postoperative: Postoperative X-ray. C. Two weeks postoperative: Wound check. ODI, EQ-5D-5L, Visual Analogue Score. D. Six weeks postoperative: Wound check. ODI, EQ-5D-5L, Visual Analogue Score. E. Three months postoperative: ODI, EQ-5D-5L, Visual Analogue Score. F. Six months Postoperative: ODI, EQ-5D-5L, Visual Analogue Score, X-ray. G. One year Postoperative: ODI, EQ-5D-5L, Visual Analogue Score, X-ray, MRI if the patient is still complaining.
- Conditions
- Paraspinal Muscles, Degenerative Lumbar Diseases
- Keywords
- paraspinal muscles atrophy, Degenerative lumbar spine diseases, lumbar spine fusion
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswerty disability index Arabic version (ODI)
The Oswestry Disability Index (ODI) translates low back pain disability into a numerical score for better understanding and communication. It's a questionnaire used to assess the impact of low back pain on a person's daily life, work, and ability to perform specific tasks. The ODI translates into a score from 0-100, with higher scores indicating greater disability. This score helps clinicians and researchers quantify the functional disability caused by low back pain.
Measured: Baseline, 2 weeks postoperative, 6 weeks postoperative, 3 months postoperative, 6 months postoperative and 1 year postoperative.
Secondary outcomes (4)
Visual analogue scale (VAS)
A Visual Analogue Scale (VAS) is a measurement tool used to assess subjective experiences like pain or discomfort by having a person mark a point on a continuous line representing the range from "no pain" to "worst imaginable pain". Zero is equivalent to no pain and 10 indicates the worst possible pain.
Measured: Baseline, 2 weeks postoperative, 6 weeks postoperative, 3 months postoperative, 6 months postoperative and 1 year postoperative.
Local kyphotic angle
In the context of degenerative spine disease, the local kyphotic angle refers to the increased forward curvature (kyphosis) at a specific level of the spine, often between two adjacent vertebral bodies. This local kyphosis can result from various factors, including vertebral collapse, disc degeneration, or changes in vertebral shape associated with aging. The local kyphotic angle is typically measured using X-ray images, with the angle formed by the upper and lower endplates of the vertebral bodies.
Measured: Baseline, 1 day postoperative, 6 months postoperative and 1 year postoperative.
Lumbar lordosis
In degenerative lumbar spine disease, the normal inward curve of the lower back (lumbar lordosis) can change. This change can manifest as a loss of lordosis (flattening of the curve) or an increase in lordosis (excessive curve). It is measured using X-rays of lateral view of lumbar spine by using the lumbosacral angle (LSA), which is the angle between the top of L1 (the first lumbar vertebra) and the top of the sacrum. The Cobb angle method, using lines drawn along the superior endplates of L1 and S1.
Measured: Baseline, 1 day postoperative, 6 months postoperative and 1 year postoperative.
EuroQol-5-dimension 5-level Arabic version (EQ-5D-5L)
The EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire measures health-related quality of life by assessing five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each with five levels of severity. These levels range from "no problems" to "extreme problems" and the responses are combined to create a unique health state profile.
Measured: Baseline, 2 weeks postoperative, 6 weeks postoperative, 3 months postoperative, 6 months postoperative and 1 year postoperative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study startJun 2025 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Paraspinal MusclesStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adnan Ahmad Elkamel, Assiut University
- Investigators
- Ahmed S Abdelgawaad, Professor Doctor, Study chair, Assiut UniversityAmr H Ahmed, MD, Study director, Assiut UniversityAdnan A Elkamel, Bachelor degree, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07002918
- Sponsor's protocol ID
- Paraspinal muscle atrophy
- Status last verified
- May 2025
- First submitted
- 25 May 2025
- Last updated
- 4 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Shawky Abdelgawaad A, El-Sharkawi M, Sarhan AM, Hassanien MA, Aziz M. Validation of the arabic version of the EuroQol-5-dimension 5-level (EQ-5D-5 L) in patients with spinal degenerative diseases. BMC Public Health. 2024 Apr 23;24(1):1119. doi: 10.1186/s12889-024-18367-3.
PubMed 38654180Algarni AS, Ghorbel S, Jones JG, Guermazi M. Validation of an Arabic version of the Oswestry index in Saudi Arabia. Ann Phys Rehabil Med. 2014 Dec;57(9-10):653-63. doi: 10.1016/j.rehab.2014.06.006. Epub 2014 Aug 4.
PubMed 25262247Waschke A, Hartmann C, Walter J, Dunisch P, Wahnschaff F, Kalff R, Ewald C. Denervation and atrophy of paraspinal muscles after open lumbar interbody fusion is associated with clinical outcome--electromyographic and CT-volumetric investigation of 30 patients. Acta Neurochir (Wien). 2014 Feb;156(2):235-44. doi: 10.1007/s00701-013-1981-9. Epub 2014 Jan 3.
PubMed 24384989Mayer TG, Vanharanta H, Gatchel RJ, Mooney V, Barnes D, Judge L, Smith S, Terry A. Comparison of CT scan muscle measurements and isokinetic trunk strength in postoperative patients. Spine (Phila Pa 1976). 1989 Jan;14(1):33-6. doi: 10.1097/00007632-198901000-00006.
PubMed 2913665Cooper RG, St Clair Forbes W, Jayson MI. Radiographic demonstration of paraspinal muscle wasting in patients with chronic low back pain. Br J Rheumatol. 1992 Jun;31(6):389-94. doi: 10.1093/rheumatology/31.6.389.
PubMed 1534505You KH, Cho M, Lee JH. Effect of Muscularity and Fatty Infiltration of Paraspinal Muscles on Outcome of Lumbar Interbody Fusion. J Korean Med Sci. 2023 May 22;38(20):e151. doi: 10.3346/jkms.2023.38.e151.
PubMed 37218352Alhaug OK, Dolatowski FC, Solberg TK, Lonne G. Predictors for failure after surgery for lumbar spinal stenosis: a prospective observational study. Spine J. 2023 Feb;23(2):261-270. doi: 10.1016/j.spinee.2022.10.010. Epub 2022 Nov 5.
PubMed 36343913Sihvonen T, Herno A, Paljarvi L, Airaksinen O, Partanen J, Tapaninaho A. Local denervation atrophy of paraspinal muscles in postoperative failed back syndrome. Spine (Phila Pa 1976). 1993 Apr;18(5):575-81. doi: 10.1097/00007632-199304000-00009.
PubMed 8484148Ravindra VM, Senglaub SS, Rattani A, Dewan MC, Hartl R, Bisson E, Park KB, Shrime MG. Degenerative Lumbar Spine Disease: Estimating Global Incidence and Worldwide Volume. Global Spine J. 2018 Dec;8(8):784-794. doi: 10.1177/2192568218770769. Epub 2018 Apr 24.
PubMed 30560029
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Paraspinal Muscle Atrophy in Lumbar Spinal Fusion Outcomes
- ClinicalTrials.gov ID
- NCT07002918
- Acronym / sponsor ID
- Paraspinal muscle atrophy
- Conditions
- Paraspinal Muscles, Degenerative Lumbar Diseases
- Keywords
- paraspinal muscles atrophy, Degenerative lumbar spine diseases, lumbar spine fusion
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jun 2025 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 4 Jun 2025 (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.
The goal of this observational study is to learn about the role of pre-operative paraspinal muscle atrophy in outcomes of lumbar spine fusion surgeries in patients with degenerative lumbar spine diseases. The main question it aims to answer is:
Does paraspinal muscle atrophy worsen lumbar spine fusion surgeries outcomes? Participants undergoing lumbar spine fusion surgeries as part of their treatment for degenerative lumbar spine diseases will answer survey questions about their low back pain and daily activities for 1 year.
Detailed description
Lumbar spine fusion surgery is a widely performed intervention worldwide with the rate steadily increasing. This trend reflects the growing burden of degenerative spinal disorders (DSD) and low back pain (LBP), which globally affect an estimated 266 million individuals (3.63% of the global population) each year. Socioeconomic factors are important risk aspects for lumbar pain and disability both directly and indirectly. Despite the widespread use of lumbar fusion surgery, outcomes are not uniformly successful. A significant proportion of patients experience poor postoperative results, with studies indicating that 33% of patients report treatment failure, including a 22% worsening rate after surgery for lumbar spinal stenosis. Factors associated with these poor outcomes include prolonged back pain duration (>12 months), prior spinal surgery, and advanced age (>70 years). One critical yet often overlooked factor contributing to poor outcomes is paraspinal muscle atrophy. The paraspinal muscles and vertebrae are interdependent tissues, and the health of these muscles plays a vital role in spinal stability and function. The multifidi, erector spinae, psoas, and quadratus lumborum muscles provide support for the lower back. Numerous studies have explored the degeneration or atrophy of back muscles and the reduction in back extensor muscle strength in patients with lower back pain. Patients with high lumbar muscularity and mild fatty infiltration ratio observed on preoperative MRI demonstrated more promising clinical and radiographic outcomes after lumbar interbody fusion. As the prevalence of degenerative spinal conditions continues to rise globally, understanding the role of paraspinal muscle health in surgical success is critical. By prioritizing patient selection based on modifiable risk factors, clinicians can enhance postoperative outcomes and mitigate the economic and clinical burdens associated with lumbar fusion surgery.
- Sample Size Calculation:
Based on determining the main outcome variable, The estimated minimum required sample size is 55 patients.
The sample size was calculated using Epi-info version 7 software, based on the following assumptions:
Main outcome variable is to determine the impact of paraspinal muscle atrophy on lumbar spine fusion outcomes. Previous studies indicate a significant decrease in paraspinal muscle volume one year after surgery, dropping from 67.8% to 60.4%. This reduction correlates significantly with physical and mental outcomes, as well as pain levels. With 80% confidence, the margin of error for these findings is estimated to be within 3%.
- Study tools (in detail, e.g., lab methods, instruments, steps, chemicals, …):
- Preoperative:
- Magnetic resonance imaging (MRI) of lumbar spine will be used to measure the total cross-sectional area (TCSA), functional cross-sectional area (FCSA) and fatty infiltration (FI) of erector spinae (ES), multifidus (MF) and psoas major (PM) at the level of diseased segment together with one level above \& below using ImageJ software v1.54p.
- plain X-rays will be used to measure local kyphotic angle and lumbar lordosis using Surgimap software v2.3.2.1.
- Oswerty disability index Arabic version (ODI)
- EuroQol-5-dimension 5-level Arabic version (EQ-5D-5L)
- Visual analogue scale (VAS) B. Day one postoperative: Postoperative X-ray. C. Two weeks postoperative: Wound check. ODI, EQ-5D-5L, Visual Analogue Score. D. Six weeks postoperative: Wound check. ODI, EQ-5D-5L, Visual Analogue Score. E. Three months postoperative: ODI, EQ-5D-5L, Visual Analogue Score. F. Six months Postoperative: ODI, EQ-5D-5L, Visual Analogue Score, X-ray. G. One year Postoperative: ODI, EQ-5D-5L, Visual Analogue Score, X-ray, MRI if the patient is still complaining.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing lumbar spinal fusion at Assiut University Hospitals, Department of Orthopedic surgery and Traumatology.
Key inclusion criteria (1 listed)
- Patients with degenerative lumbar spine diseases undergoing lumbar spinal fusion.
Key exclusion criteria (5 listed)
- Long-level fusion ≥ 3 levels.
- History of previous lumbar surgery.
- Patients diagnosed with spondylolysis.
- Other pathological conditions such as fractures, infections or tumors.
- Uncontrolled comorbidities.
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
Oswerty disability index Arabic version (ODI)
Time frame: Baseline, 2 weeks postoperative, 6 weeks postoperative, 3 months postoperative, 6 months postoperative and 1 year postoperative.
The Oswestry Disability Index (ODI) translates low back pain disability into a numerical score for better understanding and communication. It's a questionnaire used to assess the impact of low back pain on a person's daily life, work, and ability to perform specific tasks. The ODI translates into a score from 0-100, with higher scores indicating greater disability. This score helps clinicians and researchers quantify the functional disability caused by low back pain.
4 secondary outcomes
Visual analogue scale (VAS)
Time frame: Baseline, 2 weeks postoperative, 6 weeks postoperative, 3 months postoperative, 6 months postoperative and 1 year postoperative.
Local kyphotic angle
Time frame: Baseline, 1 day postoperative, 6 months postoperative and 1 year postoperative.
Lumbar lordosis
Time frame: Baseline, 1 day postoperative, 6 months postoperative and 1 year postoperative.
EuroQol-5-dimension 5-level Arabic version (EQ-5D-5L)
Time frame: Baseline, 2 weeks postoperative, 6 weeks postoperative, 3 months postoperative, 6 months postoperative and 1 year postoperative.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Background: PubMed 38654180Shawky Abdelgawaad A, El-Sharkawi M, Sarhan AM, Hassanien MA, Aziz M. Validation of the arabic version of the EuroQol-5-dimension 5-level (EQ-5D-5 L) in patients with spinal degenerative diseases. BMC Public Health. 2024 Apr 23;24(1):1119. doi: 10.1186/s12889-024-18367-3.
- Background: PubMed 25262247Algarni AS, Ghorbel S, Jones JG, Guermazi M. Validation of an Arabic version of the Oswestry index in Saudi Arabia. Ann Phys Rehabil Med. 2014 Dec;57(9-10):653-63. doi: 10.1016/j.rehab.2014.06.006. Epub 2014 Aug 4.
- Background: PubMed 24384989Waschke A, Hartmann C, Walter J, Dunisch P, Wahnschaff F, Kalff R, Ewald C. Denervation and atrophy of paraspinal muscles after open lumbar interbody fusion is associated with clinical outcome--electromyographic and CT-volumetric investigation of 30 patients. Acta Neurochir (Wien). 2014 Feb;156(2):235-44. doi: 10.1007/s00701-013-1981-9. Epub 2014 Jan 3.
- Background: PubMed 2913665Mayer TG, Vanharanta H, Gatchel RJ, Mooney V, Barnes D, Judge L, Smith S, Terry A. Comparison of CT scan muscle measurements and isokinetic trunk strength in postoperative patients. Spine (Phila Pa 1976). 1989 Jan;14(1):33-6. doi: 10.1097/00007632-198901000-00006.
- Background: PubMed 1534505Cooper RG, St Clair Forbes W, Jayson MI. Radiographic demonstration of paraspinal muscle wasting in patients with chronic low back pain. Br J Rheumatol. 1992 Jun;31(6):389-94. doi: 10.1093/rheumatology/31.6.389.
- Background: PubMed 37218352You KH, Cho M, Lee JH. Effect of Muscularity and Fatty Infiltration of Paraspinal Muscles on Outcome of Lumbar Interbody Fusion. J Korean Med Sci. 2023 May 22;38(20):e151. doi: 10.3346/jkms.2023.38.e151.
- Background: PubMed 36343913Alhaug OK, Dolatowski FC, Solberg TK, Lonne G. Predictors for failure after surgery for lumbar spinal stenosis: a prospective observational study. Spine J. 2023 Feb;23(2):261-270. doi: 10.1016/j.spinee.2022.10.010. Epub 2022 Nov 5.
- Background: PubMed 8484148Sihvonen T, Herno A, Paljarvi L, Airaksinen O, Partanen J, Tapaninaho A. Local denervation atrophy of paraspinal muscles in postoperative failed back syndrome. Spine (Phila Pa 1976). 1993 Apr;18(5):575-81. doi: 10.1097/00007632-199304000-00009.
- Background: PubMed 30560029Ravindra VM, Senglaub SS, Rattani A, Dewan MC, Hartl R, Bisson E, Park KB, Shrime MG. Degenerative Lumbar Spine Disease: Estimating Global Incidence and Worldwide Volume. Global Spine J. 2018 Dec;8(8):784-794. doi: 10.1177/2192568218770769. Epub 2018 Apr 24.
- Individual participant dataSharing planned: Yes
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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.
Ahmed S Abdelgawaad, Professor Doctor study chair
Assiut University
Amr H Ahmed, MD study director
Assiut University
Adnan A Elkamel, Bachelor degree principal investigator
Assiut University
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 Paraspinal Muscles and Degenerative Lumbar Diseases, 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 1 inclusion and 5 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: opening soon, as of the sponsor's last update on 4 Jun 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adnan A Elkamel, Bachelor degree (+201144151444, adnan.16266041@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oswerty disability index Arabic version (ODI) (time frame: Baseline, 2 weeks postoperative, 6 weeks postoperative, 3 months postoperative, 6 months postoperative and 1 year postoperative.). 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 NCT07002918, which also lists 9 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 4 Jun 2025.