Sheffield, Alabama 35660

  • Lumbar Disc Herniation

Purpose:

This study is to evaluate the effectiveness of a single-dose intervertebral disc injection of SI-6603 in subjects with lumbar disc herniation (LDH)


Criteria:

Inclusion Criteria: - Subjects with single-level LDH (L4-L5 or L5-S1 (or L5-L6)) with clear, demonstrable nerve root impingement as assessed by magnetic resonance imaging (MRI) and clinical symptoms corresponding to position of the impaired nerve root. - Subjects with radiculopathy/radicular leg pain in the unilateral leg for 6 weeks or more but 1 year or less. - Subjects with positive result of Straight Leg Raise (SLR) test (≤70°) only on the ipsilateral leg having chief complaint of radiculopathy - Subjects with inadequate improvement in pain caused by LDH despite 6 weeks or more of conservative treatment. Exclusion Criteria: - Subjects who have 2 or more lumbar disc herniations as assessed by MRI. - Subjects who have undergone a lumbar operation, lumbar percutaneous nucleotomy, or lumbar intradiscal therapies at the affected level of lumbar spine. - Subjects who have received block procedure (e.g., spinal injection, epidural injection or nerve block) for treatment of LDH, oral or injectable corticosteroids within 28 days prior to randomization. - Subjects who have received opioids or cannabis by any route of administration, local anesthesia to the back, buttock, or posterior/lateral aspects of the affected leg within 7 days prior to randomization. - Subjects with a body mass index (BMI) ≥40. - Subjects who are receiving compensation according to the Workers' Compensation Act or are involved in personal injury litigation due to a lumbar-related injury.


NCT ID:

NCT03607838


Primary Contact:

Kyoichi Osano (for overall study)
Phone: +81-3-5220-8948
Email: reply@seikagaku.co.jp


Backup Contact:

CSSi (for patients)
Phone: 877-770-1411


Location Contact:

Sheffield, Alabama 35660
United States



There is no listed contact information for this specific location.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 23, 2021

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