Research Studies

The Denver Spine and Pain Institute offers a range of clinical research studies to our patients to offer novel treatment options for conditions that can be difficult to treat. Many patients consider participating in a research study to receive care with a therapy they otherwise would not have access to, or if they feel they have exhausted all other treatment options.

We are currently participating or have participated in the following research studies:

Currently Enrolling:

• BIORESORATIVE – Phase 2 Clinical Trial to Treat Chronic Lumbar Disc Disease (cLDD). This study is looking at the safety and efficacy of stem cells injected into painful lumbar discs.
• ZYNEX MEDICAL – Randomized Blinded Evaluation of the Effects of Transcutaneous Electrical Nerve Stimulation and Interferential Current to a Sham Device and Standard of Care in Patients with Nonspecific Chronic Low Back Pain.
• VIA Disc NP – Intradiscal therapy for the treatment of degenerative disc related low back pain.
• Saluda – The purpose of this study is to evaluate the clinical utility of neurophysiological measurements of ECAP-controlled closed-loop SCS (i.e., neural panel metrics) to guide treatment of chronic pain of the trunk and/or limbs.
• Mesoblast – Phase 3 study to treat lumbar degenerative disc disease (DDD). The study is looking to evaluate the efficacy of donor stem cells plus hyaluronic acid (HA) injected into painful lumbar discs.
• HYDRAFIL-D – This pivotal study is designed to evaluate the safety and effectiveness of the ReGelTec HYDRAFIL System in subjects with axial chronic low back pain (CLBP) due to degenerative disc disease (DDD) who continue to have severe back pain and dysfunction after at least six (6) months of conservative care.

Closed to enrollment:

• SOLIS – Interventional treatment for patients with low back and/or leg pain with no prior surgery. This study is looking at the safety and effectiveness of spinal cord stimulation (SCS) for these patients.
• DISCovery – This is an interventional treatment involving an injection of a new medication into a herniated disc, in patients who are experiencing leg pain or sciatica.
• Treatment of Leg Pain – This is a study of an oral medication, evaluating its safety and effectiveness in patients who have lumbosacral radiculopathy, or radiating leg pain, also known as sciatica.
• CASCADE
• INTRACEPT
• SAOL – Phase 2 clinical trial for patients with chronic knee pain associated with osteoarthritis. This study is looking at the safety and efficacy of an investigational injectable medication.
• FAST – Interventional treatment for patients with low back and/or leg pain. This study is looking at the safety and effectiveness of a special kind of spinal cord stimulation (SCS) for these patients.
• SPRINT – This is an interventional treatment involving peripheral nerve stimulation in the treatment of chronic lower back pain.
• COMFORT – This post market study aims to document the comparative effectiveness and safety of peripheral nerve stimulation plus conventional medical management versus conventional medical management alone in the treatment of chronic, intractable peripheral neuralgia of post-traumatic or post-surgical origin.
• COMFORT 2 – This post market study aims to document the comparative effectiveness and safety of peripheral nerve stimulation plus conventional medical management versus conventional medical management alone in the treatment of chronic, intractable peripheral neuralgia of post-traumatic or post-surgical origin.