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Impact of Muscle Degeneration in Chronic Low Back Pain

StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Notable Primary completion date changed from estimate of Dec 27, 2022 to Dec 27, 2024
    • Study completion date: Nov 1, 2023 to Jun 27, 2025
    v5
  2. Notable Enrollment target: 276 to 168v4
  3. Notable Primary completion date: Dec 27, 2021 to Dec 27, 2022
    • Secondary endpoints: 6 to 7
    • Study description expanded, about 32 words
    v3
  4. Notable Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04273828
Lead Sponsor Hospital Israelita Albert Einstein
Conditions
(from sponsor)
Lumbar Spinal Stenosis, Lumbar Disc Herniation, Radiculopathy, Back Pain
Related terms Back Pain, Intervertebral Disc Displacement, Radiculopathy, Spinal Stenosis
Enrollment 168 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov