CLINICAL TRIALS

OPEN ENROLLMENT

Lateral Branch Cooled Radiofrequency Denervation For Sacroiliac Joint Pain

This study will be a 12-month prospective, randomized, controlled, prospective, open-label, multi-center clinical study. Adult subjects over the age of 21 with diagnosed chronic intractable sacroiliac joint pain (≥ 3 months), who have been previously unresponsive to conservative therapy and who meet the selection criteria are eligible to participate in this study. Approximately 208 subjects will be enrolled at up to 15 sites in a 1:1 randomization ratio to receive either denervation using the SInergy System (cooled radiofrequency (CRF), treatment group) or standard medical management (SMM, control group). Follow-up will be conducted for a total of 12 months post-Coolief (cooled radiofrequency ablation) procedure, with the primary endpoint being completed at month 3.

ELECTRICAL STIMULATION FOR THE TREATMENT OF BACK PAIN USING PERIPHERAL NERVE STIMULATION (PNS)

The purpose of this study is to evaluate the safety and effectiveness of electrical stimulation (low levels of electricity) on low back pain. This study involves a Peripheral Nerve Stimulation (PNS) system. The System delivers mild electrical stimulation to the muscles in the low back. The System includes up to four small wires (called “Leads”) that are placed through the skin into the muscles in the low back. It also includes up to two devices worn on the body that deliver stimulation (called Stimulators).

Clinical Trial of Wireless CranioFacial Nerve Stimulation (CFNS) for the Treatment of cranial and FACIAL PAIN

The purpose of this study is to assess the effectiveness of craniofacial nerve stimulation for the treatment of neuropathic pain.

dorsaVi Back Pain and Movement Registry (BPAM)

This study will compare patients with low back pain (LBP) to age and gender matched controls to determine if there are differences between the two groups related to: range of movement, secondary outcomes (level of disability, quality of life, evidence of depression, anxiety or stress), movement patterns and demographic characteristics. The first phase will include a baseline and 3 month follow-up assessment of the LBP patients and controls, including demographic characteristics, outcome measures, and a physical assessment. The second phase is an ongoing phase with continued interim assessments of LBP patients only, at 6 and 12 months.

Cooled Radiofrequency Denervation as Treatment for Chronic Pain

This Prospective, Single-center, Pilot Study will assist in gaining an understanding of the actual CRFA lesions in an in vivo situation in areas where CRFA is utilized as a standard of care treatment option for the relief of chronic pain (cervical facet joints, thoracic facet joints, lumbar facet joints, Sacroiliac (SI) and knee region). Each patient will need to receive an MRI, with contrast, in order to participate in this study.

Postmarket Registry for Evaluation of the Superion® Spacer

Superion is a completely new, minimally invasive approach to treating lumbar stenosis that fills a gap in the continuum between conservative care and invasive surgery. Designed with patient safety and comfort in mind, Superion is implanted through a small tube the size of a dime to reduce tissue damage and blood loss. It’s a simple outpatient procedure with a rapid recovery time and no destabilization of the spine.

A Prospective Observational Multicenter Study of HF10 Therapy in Patients who Previously Failed Traditional spinal cord stimulation (SCS)

SCS is a well-established pain treatment used in the U.S. for over 30 years. It includes a small implanted device that transmits mild electrical pulses to the spinal cord. The pulses calm the nerves and reduce pain signals to the brain. HF10 is the only SCS treatment designated as superior by the FDA for getting the best results in both chronic back and leg pain.

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