Research
The Spinal Research Foundation collaborates with our regional research partners around the country to prove the success of traditional approaches as well as develop new techniques and technologies. These results are shared with the medical profession and the general public to improve the overall quality and understanding of optimal spinal health care.
There are two areas of primary focus for The Spinal Research Foundation:
- Neck and back pain currently affects Americans in epidemic proportions. The SRF is attempting to identify the degenerative mechanism which leads to disabling neck & back pain and prove the optimal non-operative and operative treatment for this process.
- Patients often see a spinal surgeon for pain, numbness and/or weakness in their arms or legs. Even after the most successful surgical interventions, many patients will be left with permanent nerve damage.
A key goal of The SRF is the prevention and treatment of post-operative numbness in the spine patient. This encompasses the optimal timing of surgical intervention to relieve pressure from the nerves, the development of effective biologic adhesion barriers to prevent scar tissues formation and the investigation of pharmacologic methods of treating acute, sub-acute and chronic nerve disorders associated with the spine.
OTHER ACTIVE RESEARCH PROJECTS AT SRF
Anterior lumbar interbody implants: Importance of the interdevice distance
Evaluation of the success rates(healing, decreased back pain) of different device placement during lumbar fusion from the front of the spine.
Removal of Posterior Instrumentation following spinal fusion
Evaluation of the impact of removing spinal instrumentation on patients’ outcomes: decreased back pain, lower rate of adjacent segment disease or sacroiliac joint pain.
The association between lumbar spine pathology and sacroiliac joint pathology
Determination if sacroiliac joint pain is associated with low back pain and whether sacroiliac joint pain produces or results from low back pain.
Rate of Adjacent Segment Disease: A comparison of ALIF and TLIF procedures.
Assessment of the relative rates of Adjacent Segment Disease following two different fusion procedures (ALIF and TLIF procedures)
Fusion rate and patient outcomes following cervical fusion with the Atlantis Transitional Plate
Comparison of radiographic outcomes(fusion rates) and patient-reported outcomes using two different types of plates in multi-level cervical fusions.
Prevalence of osteoporosis and osteopenia
An evaluation of the prevalence of osteopenia and osteoporosis in candidates for spinal surgery.
PEEK rods versus Titanium rods in lumbar spine fusion
Comparison of radiographic and patient reported outcomes using two different types of rods to stabilize the low back in fusion surgery.
Statin use for surgical recovery
An evaluation of the benefit of satin drugs to improve surgical outcomes.
The effects of smoking on epidural injections outcomes
An evaluation of the impact of smoking on the pain relief provided by epidural injection.
Advanced methods for assessing the pathophysiology of myofascial pain and trigger points in the elderly with cervical or low back pain
Use ultra-sound imaging and muscle biopsies to determine the characteristics associated with cervical and low back pain.
The use of Platelet-Rich Plasma in spine pathologies
Investigation of the use of platelet-rich plasma for soft tissue repair(tendon, ligament) and for the regeneration of degenerated intervertebral discs.
The relationship between specific cardiac pathologies and lumbar pain
Examining the possible association between low back pain and Atrial Fibrillation and Premature Ventricular Contractions.
Use of genetically engineered treatments
Investigating the use of BMP (Bone Morphogenetic Protein) in the cervical spine to minimize post-operative pain and dysfunction.
Scoliosis Genetic Testing
Through SRF partnership with Axial Biotechnology patients now have access to advanced genetic testing for scoliosis.
- This technology allows surgeons to determine the likelihood of scoliosis curve progression.
- It facilitates early correction of scoliosis deformities and allows some patients to avoid surgery.
- Several children and young adults have benefitted from having access to this technology.
- SRF is working with this company to collect genetic data from different patients to expand the gene database of this technology.
- This will make the technology a usable tool in the prediction of scoliosis curve progression in wider range of nationalities thereby widening access to this form of genetic testing across the globe.
Ongoing Studies
The Spinal Research Foundation is involved in numerous ongoing studies.
- The development of non-operative techniques to resolve disabling neck and back pain.
- Investigating the use of BMP (Bone Morphogenetic Protein) in minimally invasive spinal surgery to minimize post-operative pain and dysfunction.
- The development of cervical and lumbar disc replacement technologies.
- The development of disc regeneration technology through the use of stem cells derived from the bone marrow.
- The investigation of lactic acid polymers to prevent fibroblast in-growth in surgical wounds.
- A nation-wide multi-center prospective spine treatment outcomes study.
The Spinal Research Foundation has made remarkable progress in the field of clinical research associated with neck and back pain. Located in Reston, Virginia, the Foundation collects data relative to patients' treatment and outcomes. The research staff carefully documents the indications, symptoms, images, and outcomes associated with patients undergoing treatment. Such an introspective approach allows us to identify successful operative interventions, define associated complication rates, and determine the overall benefit to patients. The time for spine specialists to estimate the effectiveness of surgery or to simply rely upon memory to calculate complication rates has long since passed. The future of spinal health care is dependant upon clinical research documenting and proving the benefits of treatment. Without outcomes data, patients with neck or back problems will be denied appropriate care by government regulators or insurance companies!
SRF continues to significantly increase patient enrollment and data collection of surgical outcome study patients.
- SRF is currently following the outcomes of nearly 1,000 patients who underwent spinal surgery.
- Our follow-up efforts have yielded important long-term data.
- Analyzing patients’ outcomes helps determine appropriate treatments and furthers the advancement of spinal healthcare.
Current Clinical Trials at SRF
What is a clinical research study?
Every clinical study is carefully designed to answer certain research questions. Although there are many definitions of clinical studies, they are generally considered to be health-related research studies in humans that follow a pre-defined protocol. All clinical studies have guidelines about who can qualify to participate. The criteria help ensure that researchers will be able to answer the questions they plan to study.
The E-STIM Trial is designed to collect data on the efficacy of the Empi Select Transcutaneous Electrical Nerve Stimulation (TENS) device for the treatment of chronic low back pain. This clinical trial is a non-significant risk, randomized, double-blinded, placebo-controlled 12-week trial involving the commercially available Empi Select TENS device for treating subjects with chronic (>90 days) low back pain. Multiple centers located in the United States will enroll approximately 300 subjects in this study. Eligible subjects will be randomized 1:1 to either the treatment group or the placebo group. The subjects and investigational staff are blinded to the treatment assignment. Subjects will return to the investigational center for follow-up assessments at 1, 4, 8, and 12 weeks.
ACCESS (This study is no longer recruiting participants)
Long-term treatment of chronic pain with opioids is recognized as an important treatment option for patients with moderate-severe pain related to cancer and other chronic serious illnesses. AVINZA (morphine sulfate extended-release capsules) was approved for marketing by the Food and Drug Administration (FDA) in 2002 as a once daily treatment for the relief of moderate to severe pain requiring continuous opioid therapy for an extended period of time. While opioids, such as AVINZA, are beneficial in the management of chronic pain, they are sometimes associated with illicit activities. Misuse, abuse and diversion of controlled prescription drugs, particularly opioids, are problems that have increased dramatically in the United States (U.S.) since the 1990s.
This study will follow the Federation of State Medical Boards Model Policy for the Use of Controlled Substances for the Treatment of Pain. Patients will be counseled on the proper storage and destruction of unused AVINZA in accordance with federal and applicable state laws. A universal precautions approach to chronic pain management (KAIR) will be utilized in this study. Although not validated as a risk assessment and management instrument, KAIR is designed to assist clinicians with responsibly managing chronic moderate-severe pain patients prescribed AVINZA. The KAIR tools will be used by the Investigator to determine the level of monitoring required based on the patient's potential risk for opioid misuse or abuse (KAIR level). Investigators and staff participating in this study will be required to participate in a training program on the counseling to be given, procedures to be followed and tools to be used in this study.
Maverick (This study is ongoing, but not recruiting participants)
The purpose of this clinical trial is to assess the safety and effectiveness of the MAVERICK™ Total Disc Replacement as a method of treating patients with lumbar degenerative disc disease at one level from L4-S1, with overall success being the primary endpoint of the clinical trial. The primary objective is to show non-inferiority of the investigational device to the control treatment. If non-inferiority is established, superiority will be examined.
This pivotal clinical trial is being conducted to compare treatment data of the investigational implant device,the PRESTIGE® LP Cervical Disc, with a control patient group receiving a plate. The PRESTIGE® LP Cervical Disc device will be implanted using an anterior surgical approach. Data from control patients receiving anterior cervical discectomy and fusion with an ATLANTIS Anterior Cervical Plate from the initial Artificial Cervical Disc study (IDE # G010188)will be compared as both treatment groups receive single-level surgical treatment from C3-C4 to C6-C7 for symptomatic cervical degenerative disc disease.
Cervical Bone Morphogenetic Protein Study
This clinical trial involves anterior cervical interbody fusion in the treatment of patients with symptomatic degenerative cervical disc disease. Corticocancellous allograft interbody devices will be used in the surgical treatment of all trial patients. All patients will also receive recombinant human bone morphogenetic protein (rhBMP-2) soaked into an absorbable collagen sponge (ACS) and implanted into the cervical spine. There is only one study group; all of these patients are in the investigational group receiving both allograft corticocancellous bone as an interbody device with rhBMP-2 bone graft. All patients will undergo anterior cervical plate fixation using the Atlantis Vision Titanium Plate. The control device for this clinical trial will be referred to as Allograft Interbody Spacer/Anterior Cervical Plate Fixation. This will be a study using the patients operated on by the Virginia Spine Institute over the preceding five years without BMP.
