Pain – Clinical
Pain – Clinical Studies
| Study Title and PI | Funding Source | ClinicalTrials.gov Number (if applicable) | Brief Summary |
|---|---|---|---|
| Impact of Gender Affirming Hormone Therapy on Pain in Gender Minority Adults (TRANSPIRE) PI: Andrea Chadwick |
NIH: National Institutie of Neurological Disorders and Stroke NINDS (1R01NS135833-01A1) | NCT06939257 | TRANSPIRE is an observational study of ~200 individuals who (1) will be initiating gender-affirming hormone therapy (GHT) or (2) are gender minority individuals who do not use GHT. The primary outcome will be to identify how the presence of chronic pain changes overtime with GHT through the use of surveys, quantitative sensory testing (QST), brain MRIs, and qualitative interviews. |
| Mechanisms of Action for Pain Peripheral Nerve Stimulation (MAP-PNS) (MSPA) PI: Andrea Chadwick |
NIH/Stanford University Subaward | NCT06741579 | The research project is studying methods to treat chronic pain of peripheral nerve injury using a standard of care PNS stimlulator and Quantitative Sensory Testing (QST). |
| CARES for Spine Surgery (Comprehensive Analgesic, Recovery, and Education Support for Spine Surgery) Trial PI: Andrea Chadwick |
NIH/Stanford University Subaward | NCT06027099 | The present study is a type-1 hybrid effectiveness-implementation three-arm randomized clinical trial to investigate the effectiveness of opioid tapering. Patients will be randomized to one of three groups (1) MI-Opioid Taper and tizanidine (MTT), (2) MI-Opioid Taper and Placebo (MTP), or (3) Enhanced Usual Care (EUC). The goal of the study is to determine whether behavioral intervention with tizanidine is effective for opioid tapering in patients who receive spinal surgery |
| A study of clinician satisfaction and likelihood of clinical adoption of the VERABAND™ PI: Andrea Chadwick |
University of Michigan | NCT06080464 | The VERABAND™ is a newly-developed, disposable, wearable activity monitor. The researchers will assess clinician satisfaction with the usability and likelihood of clinical adoption of the device across multiple clinical sites involved in treating patients with chronic low back pain (cLBP). |
| RECOVER-AUTONOMIC: A Platform Protocol for Evaluation of Interventions for Autonomic Dysfunction in Post-Acute Sequelae of SARS-CoV-2 Infection (PASC) PI: Seth Holwerda |
National Institutes of Health (NIH) Direct Funder: Duke Award: OT2HL156812 |
NCT06305780 | This study is a platform protocol designed to be flexible so that it is suitable for a wide range of settings within health care systems, and in community settings, where it can be integrated into COVID-19 programs and subsequent treatment plans. This protocol is a prospective, multi-center, multi-arm, randomized, controlled platform trial evaluating various interventions for use in the treatment of autonomic dysfunction symptoms, including cardiovascular complications and postural orthostatic tachycardia syndrome (POTS), in PASC participants. The interventions tested will include non-pharmacologic care and pharmacologic therapies with study drugs. |
| Epidural Spinal Cord Stimulation for Hypertension in Patients with Neuropathic Pain (ESCAPE) PI: Seth Holwerda |
Investigator Initiated | The goal of the ESCAPE Study is to evaluate the effect of spinal cord stimulation (SCS) on blood pressure (BP) and the autonomic nervous system in patients undergoing a new spinal cord simulator implant in a prospective manner. | |
| Reproducibility of Pressure Pain and Central Sensitization (PROCEED Study) PI: Seth Holwerda |
Investigator Initiated | The purpose of the PROCEED study is to determine the extent to which indices of pain threshold and tolerance and central sensitization of pain is altered in patients with chronic pain and to determine the reproducibility of these indices. | |
| Improving pain management via spinal cord stimulation and blood pressure reduction (PASSION) PI: Seth Holwerda |
Investigator Initiated | The purpose of the PASSION Study is to determine the extent to which reductions in blood pressure improve chronic pain management using a spinal cord stimulation device. Findings from the study will help further our understanding of best practices for treating chronic pain. | |
| Integrated Neurovascular and Sensory Investigation of Hyperadrenergic POTS in Long-COVID (INSIGHT-COVID study) PI: Seth Holwerda |
National Institutes of Health (NIH) | The main purpose of this research is to determine how Long-COVID affects the nervous system and brain blood flow. Some people who had COVID-19 develop a condition called postural orthostatic tachycardia syndrome (POTS). This condition involves dizziness, rapid heart rate, and fatigue when standing up. We want to find out how the body’s nervous system and blood vessels work in individuals with Long-COVID POTS, compared to individuals who are healthy or fully recovered from COVID | |
| Post-Market Clinical Study of Functional Motion Outcomes in Subjects Treated With the Minuteman Device (STABILITY) PI: Usman Latif |
Spinal Simplicity, LLC | NCT06355791 | This is a prospective, multi-center open-label single arm post-market study where the purpose is to evaluate the effectiveness and safety of the market approved Spinal Simplicity Minuteman G5 MIS Fusion Plate and bone graft material in patients with degenerative conditions of the lumbar spine resulting in chronic low back pain with lower extremity symptoms and concurrent neurogenic claudication. |
| Clinical Trial Evaluating the Safety and Efficacy of Nucleus Pulposus Allograft in Participants With Degenerative Disc Disease (RESTORE) PI: Usman Latif |
Vivex Biologics, Inc | NCT06778447 | VIA Disc NP is a non-surgical intervention intended to supplement nucleus pulposus tissue in degenerated intervertebral discs. |
| A 5-year Superion® IDS Clinical Outcomes Post-Approval Evaluation (SCOPE) PI: Dawood Sayed |
Boston Scientific | The purpose of this study is to better understand real-world outcomes of the Superion™ IDS in routine clinical practice. | |
| Evaluation of Multi-Tined Expandable Electrode (MEE) Efficacy and Safety in Treatment of Lumbar Facet Arthropathy by Radiofrequency Neurotomies Compared to Conservative Medical Management PI: Dawood Sayed |
Investigator Initiated | NCT04730700 | The purpose of this study is to better understand how people feel after a radiofrequency ablation standard of care surgery using a different type of needle (multi-tined expandable electrode/MEE) in comparison to receiving conventional medical management (CMM) techniques. |
| Efficacy and Safety of Rexlemestrocel-L Combined With Hyaluronic Acid in Participants With Moderate to Severe Chronic Low Back Pain PI: Dawood Sayed |
Mesoblast, Ltd | NCT06325566 | The primary purpose of this study is to evaluate the efficacy of rexlemestrocel-L+HA compared to control in reducing low back pain at 12 months post-treatment and safety of a single injection of rexlemestrocel-L+HA injected into a lumbar intervertebral disc compared to control through 12 months post-treatment. |
| Study of the AGN1 LOEP SV Kit Compared to PMMA in Patients With Vertebral Compression Fractures (STAND Study) PI: Dawood Sayed |
AgNovos Healthcare, LLC | NCT04835428 | This is a multicenter, single-blinded, randomized controlled clinical trial evaluating the safety and efficacy of the AGN1 LOEP SV Kit for the treatment of painful vertebral compression fragility fractures (VCFs). The objective of this study is to demonstrate non-inferiority of the AGN1 LOEP SV Kit for the treatment of VCFs to standard of care vertebroplasty treatment using bipedicular injection of PMMA bone cement. |
| Clinical Study Of A Micro-Implantable Pulse Generator For the Treatment of Peripheral Neuropathic Pain (COMFORT-2). PI: Dawood Sayed |
Boston Scientific | NCT05870124 | This is a multi-center, prospective, minimal risk, randomized controlled clinical study to document the comparative effectiveness and safety of the addition of peripheral nerve stimulation (PNS) to conventional medical management (CMM) with CMM alone in the treatment of chronic, intractable peripheral neuralgia. |
| Ultrasound guided radiofrequency ablation of the occipital nerve PI: Timothy Sowder |
Investigator Initiated | NCT06583122 | This study is designed to study an ultrasound guided approach to radiofrequency ablation of the occipital nerve that makes it possible to see the needle during treatment procedure. It is hoped this will reduce the amount of pain after the standard of care procedure. |
| Genetic Analysis of Cerebral Spinal Fluid and Blood for Markers of Tolerance in Cancer Pain PI: Erin Young |
Investigator Initiated | This study evaluates the psychological, somatosensory, and biomarker differences in cancer patients implanted with intrathecal pumps or “pain pumps” (ITPs) to determine if there are ways to see if patients are at risk of developing tolerance to prescribed narcotics post-surgery. |
Recent Publications
Dual-Action Regenerative Therapies: Regeneration and Antimicrobial Effects of Platelet- and Marrow-Derived Biologics.
Yuan C, Ang SP, Hasoon JJ, Tolba R, Ruan QZ, Lam CM, Lo Bianco G, Christo PJ, Robinson CL. Biomedicines. 2025;13(11).
Patient-centered development of a cognitive behavioral pain intervention for cystic fibrosis: The pace CF program.
Bruce AS, Mullen TMD, Behrman M, Robichaud J, Wei R, Chaudhary N, Georgiopoulos AM, Yonker LM, He J, Chadwick AL, Greenberg J, Friedman D. Pain Med. 2025. [Epub ahead of print]
Consensus Guidelines for the Use of Peripheral Nerve Stimulation in the Treatment of Chronic Pain and Neurological Diseases: A Neuron Project from the American Society of Pain and Neuroscience.
Latif U, Moghim R, Valimahomed A, Lam CM, Abd-Elsayed A, Gulati A, Aman MM, Desai MJ, Dickerson DM, Tieppo Francio V, Gilmore C, Gish B, Hah JM, Hunter C, Ilfeld BM, Kalia H, Lester D, Li S, Mata R, Naidu R, Ottestad E, Pritzlaff SG, Sayed D, et al. J Pain Res. 2025;18:5949-5990.
Role of Peripheral Nerve Blocks for Management of Chronic Pain From Inoperable Neurofibromatosis Type 1-Associated Neurofibromas: A Case Report.
Kuester K, Latif U, Francio VT, Vu DT, Gustafson K, Abd-Elsayed A, Lam CM. Pain Med Case Rep. 2025;9(6):323-327.
First Objective Evidence Characterizing Differences in Cervical and Thoracic Spinal Cord Neurophysiology Using ECAP-Controlled Closed-Loop Technology.
Goree JH, Nijhuis H, Smith GL, Petersen EA, Pope JE, Antony AB, Vu CM, Sayed D, Lam CM, Latif U, Costandi SJ, Verrills P, Venkatesan L, Ge W, Gould I, Kallewaard JW. Pain Ther. 2025;14(6):1833-1846.