NCT04273828 Impact of Muscle Degeneration in Chronic Low Back Pain
| NCT ID | NCT04273828 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospital Israelita Albert Einstein |
| Condition | Lumbar Spinal Stenosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 168 participants |
| Start Date | 2020-04-06 |
| Primary Completion | 2024-12-27 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 168 participants in total. It began in 2020-04-06 with a primary completion date of 2024-12-27.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Surgical interventions for the removal of intervertebral disc fragments or to enlarge a narrow spine canal are commonly performed worldwide and are considered efficient. Concomitant low back pain is not uncommon among patients with lumbar nerve compression and neurological symptoms. When present, controversy persists in the literature regarding its ideal management. Although neurological symptoms improve after decompressive surgery, the presence of residual chronic low back pain may worsen satisfaction scores and cause functional disability. The hypothesis of the present study is that the presence of atrophy of the paraspinal and trunk muscles predicts chronic low back pain after lumbar neural decompression. If confirmed, this finding will aid in better planning of physical rehabilitation strategies for this group of patients, as well as a clearer prediction regarding surgical treatment outcomes for patients and health professionals.
Eligibility 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.
Contact & Investigator
Alberto Gotfryd, PhD
PRINCIPAL INVESTIGATOR
Phisician
Frequently Asked Questions
Who can join the NCT04273828 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lumbar Spinal Stenosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04273828 currently recruiting?
Yes, NCT04273828 is actively recruiting participants. Contact the research team at albertocoluna@yahoo.com.br for enrollment information.
Where is the NCT04273828 trial being conducted?
This trial is being conducted at São Paulo, Brazil.
Who is sponsoring the NCT04273828 clinical trial?
NCT04273828 is sponsored by Hospital Israelita Albert Einstein. The principal investigator is Alberto Gotfryd, PhD at Phisician. The trial plans to enroll 168 participants.