Actively Recruiting

Age: 18Years +
All Genders
ID04273828

Impact of Muscle Degeneration in Chronic Low Back Pain in Patients Undergoing Neural Decompression Surgery

Led by Hospital Israelita Albert Einstein · Updated on 2025-03-13

168

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying adults with lumbar degenerative diseases, such as lumbar spinal stenosis, lumbar disc herniation, and radiculopathy, who experience nerve compression symptoms like radiculopathy or neurogenic claudication. The study aims to understand how muscle degeneration in the paraspinal and trunk muscles affects chronic low back pain after lumbar neural decompression surgery. This information could improve rehabilitation planning and help predict surgical outcomes for patients and health professionals. The treatment under evaluation is lumbar decompressive surgery, including techniques such as discectomy, foraminotomy, or laminectomy, chosen by the surgeon based on the patient's condition. Patients are grouped by surgical approach: minimally invasive microdiscectomy with magnification and retractors, open microdiscectomy with magnification and conventional retractors, endoscopic discectomy using the full endoscopic technique, or open discectomy without magnification using conventional retractors. Imaging tests, including X-rays and MRI scans, are used preoperatively and at six months after surgery to assess muscle fat infiltration and vertebral degeneration. Participants will be followed before surgery, immediately after, and at 6, 12, and 24 months post-surgery. Assessments include pain intensity changes, radiological evaluations, and changes in kinesiophobia, psychosocial risk, global recovery impression, mood disorders, disability, and quality of life. The study tracks medical records and imaging results to monitor outcomes, with a total follow-up period of two years after surgery. Statistical analyses will be conducted to evaluate the relationship between muscle degeneration and chronic low back pain.

CONDITIONS

Brief Title

Impact of Muscle Degeneration in Chronic Low Back Pain

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults 18 years of age and older
  • Symptoms of lumbosacral neural compression such as radiculopathy or neurogenic claudication
  • Failed conservative treatment for at least 6 weeks
  • Undergoing surgery for neural decompression (discectomy, foraminotomy, or hemilaminectomy)
  • Complete preoperative and postoperative medical records available for all evaluations
Not Eligible

You will not qualify if you...

  • Need for lumbar arthrodesis
  • Presence of deep infection requiring surgical cleaning
  • Prior joint facet rhizotomy
  • Active rheumatologic disease, including seronegative arthropathies

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - 1 day

Participants undergo lumbar decompression surgery, which may include discectomy, foraminotomy, or laminectomy. Immediate post-operative care occurs 12 to 24 hours after the procedure.

1 visit (in-person)

Post-operative Follow-up

Duration - 24 months

Participants are followed for recovery and outcomes at 6, 12, and 24 months after surgery. Imaging tests are performed preoperatively and at 6 months post-operation to evaluate outcomes.

5 visits (1 preoperative, 1 immediate post-operative, and 3 follow-up visits at 6, 12, and 24 months)

Trial Site Locations

Total: 1 location

1

Hospital Israelita Albert Einstein

São Paulo, São Paulo, Brazil, 05601-901

Actively Recruiting

Loading map...

Research Team

A

Alberto Gotfryd, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

Similar Trials

Study on the Stress-Strain and Flow-Solid Coupling Effects o...

Lumbar Disc Herniation

Actively Recruiting

1 location

Activity Levels Amongst Elderly Patients With Symptomatic Lu...

Lumbar Spinal Stenosis

Actively Recruiting

2 locations

Analysis of Lumbar Spine Stenosis Specimens for Identificati...

Lumbar Spinal Stenosis

Actively Recruiting

6 locations

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

Surgery versus conservative treatment for symptomatic lumbar spinal stenosis: a systematic review of randomized controlled trials.

Francisco M Kovacs, Gerard Urrútia, José Domingo Alarcón

https://pubmed.ncbi.nlm.nih.gov/21311394

Lumbar fusion versus nonoperative management for treatment of discogenic low back pain: a systematic review and meta-analysis of randomized controlled trials.

Mohamad Bydon, Rafael De la Garza-Ramos, Mohamed Macki...

https://pubmed.ncbi.nlm.nih.gov/24346052

The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies.

Erik von Elm, Douglas G Altman, Matthias Egger...

https://pubmed.ncbi.nlm.nih.gov/18313558

Development of a Brazilian Portuguese version of the Oswestry Disability Index: cross-cultural adaptation, reliability, and validity.

Ricardo Vigatto, Neusa Maria Costa Alexandre, Heleno Rodrigues Correa Filho

https://pubmed.ncbi.nlm.nih.gov/17304141