The Impact of Paraspinal Muscle Atrophy in Spine Surgeries

NCT07002918 | Not Yet Recruiting

• 1 other identifier: Paraspinal muscle atrophy
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Paraspinal Muscles; Degenerative Lumbar Diseases

Keywords

paraspinal muscles atrophy; Degenerative lumbar spine diseases; lumbar spine fusion

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 2 weeks postoperative, 6 weeks postoperative, 3 months postoperative, 6 months postoperative and 1 year postoperative.

Secondary Outcomes (4)

• Visual analogue scale (VAS)

  Baseline, 2 weeks postoperative, 6 weeks postoperative, 3 months postoperative, 6 months postoperative and 1 year postoperative.

• Local kyphotic angle

  Baseline, 1 day postoperative, 6 months postoperative and 1 year postoperative.

• Lumbar lordosis

  Baseline, 1 day postoperative, 6 months postoperative and 1 year postoperative.

• EuroQol-5-dimension 5-level Arabic version (EQ-5D-5L)

  Baseline, 2 weeks postoperative, 6 weeks postoperative, 3 months postoperative, 6 months postoperative and 1 year postoperative.

Eligibility Criteria

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

Study Population

Patients undergoing lumbar spinal fusion at Assiut University Hospitals, Department of Orthopedic surgery and Traumatology.

You may qualify if:

• Patients with degenerative lumbar spine diseases undergoing lumbar spinal fusion.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University

Asyut, Asyut Governorate, 71515, Egypt

Location

Related Publications (9)

• 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.

  PMID: 38654180 BACKGROUND

• Algarni 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.

  PMID: 25262247 BACKGROUND

• Waschke 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.

  PMID: 24384989 BACKGROUND

• Mayer 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.

  PMID: 2913665 BACKGROUND

• Cooper 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.

  PMID: 1534505 BACKGROUND

• You 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.

  PMID: 37218352 BACKGROUND

• Alhaug 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.

  PMID: 36343913 BACKGROUND

• Sihvonen 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.

  PMID: 8484148 BACKGROUND

• Ravindra 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.

  PMID: 30560029 BACKGROUND

Study Officials

• Ahmed S Abdelgawaad, Professor Doctor

  Assiut University

  STUDY CHAIR

• Amr H Ahmed, MD

  Assiut University

  STUDY DIRECTOR

• Adnan A Elkamel, Bachelor degree

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adnan A Elkamel, Bachelor degree

CONTACT

+201144151444; adnan.16266041@med.aun.edu.eg

Amr H Ahmed, MD

CONTACT

+201027021317; amrhatemhassan@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Doctor

Study Record Dates

• First Submitted: May 25, 2025
• First Posted: June 4, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: June 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)