Impact of muscle degeneration on chronic low back pain after surgery
Impact of Muscle Degeneration in Chronic Ow Back Pain in Patients Undergoing Neural Decompression
Hospital Israelita Albert Einstein · NCT04273828
This study looks at how muscle loss affects ongoing back pain in people who have surgery for spine problems, to help improve recovery and predict results.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 168 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital Israelita Albert Einstein (other) |
| Locations | 1 site (São Paulo, São Paulo) |
| Trial ID | NCT04273828 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the relationship between muscle atrophy and chronic low back pain in patients undergoing lumbar decompression surgery for conditions like lumbar spinal stenosis and disc herniation. It follows a cohort of patients preoperatively and at multiple postoperative intervals to assess outcomes and the role of muscle degeneration in pain persistence. The study aims to improve rehabilitation strategies and predict surgical outcomes based on muscle condition. Imaging tests will be conducted to evaluate muscle status before and after surgery.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with symptoms of lumbosacral neural compression who have not responded to conservative treatment for at least six weeks.
Not a fit: Patients requiring lumbar arthrodesis or those with active rheumatologic diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved rehabilitation strategies and better surgical outcome predictions for patients with chronic low back pain.
How similar studies have performed: Other studies have explored similar relationships between muscle degeneration and pain outcomes, suggesting potential for meaningful insights, though this specific approach may be novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. adults 18 years of age and older; 2. with symptoms of lumbosacral neural compression (radiculopathy or neurogenic lameness); 3. failed conservative treatment for at least 6 weeks; 4. undergoing surgery for neural decompression (discectomy and / or foraminotomy and / or hemilaminectomy); 5. with complete pre and postoperative medical records in all evaluations. Exclusion Criteria: 1. need for lumbar arthrodesis; 2. deep infection requiring surgical cleaning; 3. patients submitted to joint facet rhizotomy; 4. active rheumatologic disease, including seronegative arthropathies.
Where this trial is running
São Paulo, São Paulo
- Hospital Israelita Albert Einstein — São Paulo, São Paulo, Brazil (RECRUITING)
Study contacts
- Principal investigator: Alberto Gotfryd, PhD — Phisician
- Study coordinator: Alberto Gotfryd, PhD
- Email: albertocoluna@yahoo.com.br
- Phone: 5511995925225
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Lumbar Spinal Stenosis, Lumbar Disc Herniation, Radiculopathy, Back Pain, back pain, lumbar disc herniation, lumbar spinal stenosis, Decompression, surgical