This is a Phase III, randomized, double-blinded, Sham-controlled, multi-center study in subjects with single-level, symptomatic lumbar (L3- S1) intervertebral disc degeneration. The study will have a 52-week primary period followed by 52 week Follow-up Period (total of 104 weeks).
The study protocol will be approved by the Institutional Review Board (IRB) or Independent Ethics Committee (IEC), and the study will be conducted in accordance with Good Clinical Practice (GCP). All subjects will provide written informed consent prior to Screening.
Approximately 162 subjects will be enrolled in the study. Up to 45 days prior to treatment, subjects will be screened for study inclusion, which includes obtaining baseline MRI and X-ray imaging. Imaging results for subjects initially eligible for study participation will be sent to a central imaging vendor for review and confirmation of eligibility, including the number of levels with degeneration. Subjects meeting all inclusion/exclusion criteria will be assigned to the corresponding treatment arm group and subsequently randomized to IDCT or Sham.
Randomization will occur approximately 7 to 14 days prior to the scheduled treatment administration date.
Overall, 162 subjects will be enrolled and randomized to IDCT or Sham in a 2:1 ratio.
* IDCT (n=108) * Sham (n=54)
Has a diagnosis of mild to moderate, symptomatic, single-level degenerative disc disease (DDD) from L3-S1.
Has a target disc that meets Modified Pfirrmann Grade 3-7, as determined by a central radiologist.
Is ≥18 and ≤75 years of age, skeletally mature, and has a body mass index (BMI) ≥18 kg/m2 and ≤38 kg/m2 at Screening.
Has been experiencing chronic low back pain for at least 6 months prior to Screening.
Has low back pain that in the Investigator's opinion is predominately myofascial in nature.
Has constant, unchanging low back pain that is not improved in any spinal position.
Has radiculopathy resulting from nerve compression.
Has non-radicular unilateral or bilateral leg pain with intensity greater than 50% of the intensity of the low-back pain, as measured by VAS.