Clinical Research Directory

Measuring the Effects of Complementary Therapies in Chronic Neuropathic Pain

The objective of the study is to a) assess the presence of a maladaptive stress response, a decreased pain modulation and any cognitive impairment in patients with chronic neuropathic pain in comparison to healthy controls. and b) evaluate the efficacy of a treatment of hypnosis and of an open label placebo on these neuro-cognitive factors and on clinical pain. This will be done through a) a prospective observational comparative study of patients (base line measures) with Healthy Controls (HC) and b) an Open label; randomised, hypnosis vs. open label placebo (OLP) vs. treatment as usual control design; with a second phase of exploratory cross-over.

Calcitonin Therapy on Incidence and Severity of Neuropathic Pain After Spinal Cord Injury

This prospective randomized double blinded study will be conducted to evaluate the effect of early pharmacologic intervention with calcitonin on the incidence or the severity of neuropathic pain after spinal cord injury

Vitamin D Supplementation on Reported Rates of Taxane-Induced Neuropathy

This is a two-arm randomized clinical trial in which 80 participants with Vitamin D deficiency and scheduled to begin taxane-based chemotherapy will be randomized to either: 1) prescribed vitamin D replacement or 2) standard of care.

A Study to Assess Safety, Tolerability and Exposure of 4ET1103 in Healthy Human Volunteers

This study will dose healthy human volunteers with either active drug (4ET1103) or placebo. Each study subject will receive a single dose of either active drug or placebo, and will then be monitored for safety, tolerability and exposure of active drug.

USG-Guided Shoulder Injections in Frozen Shoulder

Frozen shoulder (adhesive capsulitis) is characterized by pain and a progressive restriction of both active and passive shoulder range of motion, significantly impairing daily activities and quality of life. This study aims to evaluate the effectiveness of USG-guided shoulder injections, when added to a home-based exercise program, in the conservative management of patients with chronic, painful frozen shoulder. In this prospective randomized study, patients diagnosed with painful frozen shoulder will be included. In addition to a standardized home-based exercise program, patients will receive either USG-guided suprascapular nerve block alone or a combination of suprascapular nerve block and subacromial injection. The effects of these approaches on clinical outcomes will be assessed over a 20-week follow-up period. Primary outcome measures include pain intensity assessed by the Visual Analog Scale (VAS), functional status evaluated by the Shoulder Pain and Disability Index (SPADI), and shoulder range of motion. Secondary outcomes include depression level (Beck Depression Inventory), sleep quality, pain phenotype (nociplastic, neuropathic, or nociceptive), hand grip strength, ultrasonographic findings ( (coracohumeral ligament thickness, subacromial bursa thickness) , and patient satisfaction (subjective impression of improvement). The results of this study are expected to provide evidence on the comparative effectiveness and additional benefits of different shoulder injection approaches when combined with home-based exercise therapy in patients with chronic frozen shoulder.

Efficacy of Chemically Distinct Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) and Pain Phenotypes in Adhesive Capsulitis

Patients aged 18-75 years who present to a tertiary rehabilitation hospital with shoulder pain and restricted range of motion, and who consent to participate, will be included in the study. Eligibility will be determined based on predefined inclusion and exclusion criteria. Eligible patients will be randomly assigned to receive one of several nonsteroidal anti-inflammatory drugs (NSAIDs) with differing chemical properties (e.g., diclofenac, meloxicam, or indomethacin), in combination with a home-based exercise program for shoulder adhesive capsulitis. Patients' sociodemographic data, as well as detailed clinical and examination findings and baseline outcomes, will be recorded. Patients will be informed about their condition, and modifications to activities of daily living will be recommended.Patients' pain phenotypes (nociceptive, neuropathic, nociplastic) will be categorized based on clinical history and questionnaires, and it will be determined which pain types derive greater benefit from NSAIDs. Follow-up assessments will be conducted at the end of the first and second weeks. At the first-week follow-up, pain intensity will be evaluated using the Visual Analog Scale (VAS). If the treatment is deemed effective (defined as a ≥3-point reduction or ≥50% decrease in VAS), the same NSAID will be continued for an additional week; otherwise, it will be switched to an alternative NSAID with a different biochemical profile (group). The outcomes assessments will be performed by a blinded evaluator to minimize bias.

Efficacy and Feasibility of BurstDR SCS in Painful Diabetic Neuropathy

This prospective, single-arm clinical study evaluates the therapeutic efficacy and feasibility of BurstDR spinal cord stimulation (SCS) using Abbott's Proclaim XR and Eterna systems in patients with painful diabetic neuropathy (PDN). Adults with confirmed PDN will undergo a one-week temporary SCS trial, and those achieving meaningful improvement (≥50% reduction in average pain on the Visual Analog Scale) will proceed to permanent implantation. Outcomes will be assessed at baseline, end of trial, and at 1-, 3-, and 6-month follow-up visits using validated instruments including VAS, DN4, DQoL, PSQ-3, the Patient Global Impression of Change, and the Clinician Global Impression of Change. All procedures follow standard clinical practice for SCS therapy. The study aims to characterize real-world effectiveness, patient-reported outcomes, feasibility of implementation, and device-related safety in a rural PDN population.

Efficacy and Safety of High-Concentration 35 kDa Hyaluronan Gel for Herpes Zoster-Associated Pain

This is a prospective, single-arm, open-label, pilot clinical study to evaluate the efficacy and safety of topical 10% high-concentration 35 kDa hyaluronan (HA35) gel in subjects with herpes zoster-associated pain (ZAP). Eligible participants will receive a single topical application of the study gel. The primary objective is to assess rapid pain reduction within 2 minutes and 24hours after application. Secondary objectives include evaluation of analgesic duration, local tolerability, erythema improvement, and overall safety throughout the observation period. This is a minimal-risk, non-pharmacological supportive care intervention.

rTMS Efficacy Coupled With Mirror Therapy

Neuropathic pain is particularly difficult to treat with classic first-line drugs. Neuromodulation techniques using repetitive transcranial magnetic stimulation (rTMS) are useful alternative, but there is a need to improve their analgesic effect.Virtual reality mirror therapy has shown the capacity to alleviate pain and may be easily coupled with rTMS.The present project will investigate in individuals with neuropathic pain the effects of the rTMS coupled with virtual reality mirror therapy.

Thalamic-Burst-DBS for Neuropathic Pain

Central post-stroke pain (CPSP) is a neuropathic pain syndrome and one of the major sequelae after ischemic or hemorrhagic cerebral stroke. Recently, a modified stimulation paradigm has been developed in the field of spinal cord stimulation (SCS) for a variety of neuropathic pain disorders. To date, this stimulation paradigm has not yet been evaluated systematically for deep brain stimulation to treat neuropathic pain disorders. The purpose of this clinical investigation is to investigate if Burst-DBS of the thalamus is more effective compared to classical continuous low-frequency stimulation DBS to reduce the subjective pain intensity in patients with chronic neuropathic pain after stroke or in patients with neuropathic facial pain.

Severe Chronic Neuropathic Pain: A Treatment Bundle, Using Spinal Cord Stimulation and Multidisciplinary Treatment, to Reduce Pain and Improve Physical Function.

People with nerve damage can develop nerve pain. The pain can sometimes be severe and unpredictable, causing odd or alarming sensations - for example, lightning-like or electric shock feelings in the area served by the damaged nerve. The investigators will examine a treatment for nerve pain in the legs caused by nerve damage, which can occur after a herniated disc or a bone fracture, with or without surgery. Previous research suggests that spinal cord stimulation can relieve nerve pain in the legs after surgery or injury, but its effectiveness is still debated. Other studies show that multidisciplinary treatment helps people with long-term pain to improve their quality of life and to better cope in life. National and international guidelines recommend this kind of multidisciplinary care for long-term pain. There has yet been published research on spinal cord stimulation combined with multidisciplinary treatment as a bundle intervention. The investigators therefore want to find out whether this combined approach can reduce nerve pain in the legs and improve physical functioning.

Evaluation of Chronic Postsurgical Pain Risk in Patients Undergoing CIED Implantation Using an AID Support System

Chronic postsurgical pain (CPSP) remains a significant clinical and public health challenge despite major advances in surgical and anesthetic techniques. Patients receiving cardiac implantable electronic devices (CIEDs)-including pacemakers, implantable cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy devices (CRTs)-constitute a unique population with high rates of multimorbidity, psychological vulnerability, and limited analgesic options due to cardiovascular comorbidities. Insufficient postoperative pain management in this group may lead to persistent pain at the generator site, neuropathic pain features, reduced quality of life, and increased healthcare utilization. The present study aims to evaluate the prevalence, risk factors, and clinical predictors of CPSP following CIED implantation using both subjective and objective pain assessments. Pain intensity will be measured using validated self-report scales (Visual Analog Scale and DN-4 questionnaire), and objective pain thresholds will be determined using a calibrated digital pressure algometer. Quality of life will be assessed with the validated Turkish version of the Short Form-12 (SF-12) instrument. This prospective observational study will include 180 adult patients who underwent first-time CIED implantation at Istanbul University-Cerrahpaşa, Cardiology Institute. Participants will be evaluated at 3, 6, and 12 months post-implantation. Collected data will include preoperative, intraoperative, and postoperative variables such as demographics, comorbidities, anesthesia type, surgical duration, and acute postoperative pain control. Using the obtained data, an artificial intelligence-based clinical decision support system will be developed to predict individual CPSP risk before implantation. The model will integrate subjective scales, objective algometric data, and clinical factors to generate personalized risk estimates. Ultimately, this system aims to improve early detection and prevention of CPSP, optimize postoperative pain management strategies, and enhance patient quality of life.

Evaluation of the Clinical Efficacy and Mechanisms of Cord Plasma Eye Drops in the Treatment of Neuropathic Corneal Pain

The goal of this clinical trial is to investigate the efficacy and work of action of cord plasma eye drops in the treatment of neuropathic corneal pain (NCP). The main question it aims to answer if the cord plasma eye drops are effective for the treatment of NCP through its neurotrophic and anti-neuroinflammatory effects.

Effects of LY3848575 Versus Placebo in Participants With Painful Distal Sensory Polyneuropathy

The purpose of this study is to evaluate how safe and how well a treatment works compared to placebo for people with nerve pain that begins in their feet and moves up the leg to just below the knee. Participation may last up to 30 weeks including screening.

Central Sensitisation in Nociceptive and Neuropathic Pain

This study aims to investigate differences in central sensitization among patients with chronic nociceptive pain, neuropathic pain, and mixed pain conditions. Chronic pain is a complex and multidimensional phenomenon involving sensory, cognitive, emotional, and behavioral components, often sustained by mechanisms of central sensitization that contribute to pain persistence and treatment resistance. Using a multidimensional assessment approach, the study integrates self-report questionnaires, neuropsychological evaluation, psychological measures, treatment adherence assessment, and neurophysiological investigation through laser-evoked potentials (LEP). Participants will be evaluated at baseline and after 12 months to explore differences between pain types and longitudinal changes in central sensitization, cognitive functioning, emotional status, and engagement with treatment. The findings are expected to improve the understanding of neurobiological and psychosocial mechanisms underlying different chronic pain phenotypes and to support more personalized and effective pain management strategies.

Pain Outcomes After Digital Amputation Using Tulavi Allay™ Nerve Cap

In 2016, one in five individuals in the United States (US) experienced chronic pain, and approximately 40% of them suffered from neuropathic pain. The physical and emotional burden on patients results in costs of billions of dollars annually. Digital amputations affect over 23,000 people each year in the US and may lead to neuropathic pain and neuroma formation in the transected nerves. Previous studies have reported a 6.6% incidence of symptomatic neuroma, and more than 60% of these patients require surgery to reduce the negative impact on their daily living activities. To minimize neuroma formation after digital amputation, various techniques have been described, such as traction neurectomies (TN) and dorsal transpositions (DT), with and without nerve coaptation. However, it remains unclear whether these techniques improve patient-reported outcome measures in individuals undergoing this type of procedure. Previously published studies are descriptive in nature, focus on a single surgical technique, or include patients with established symptomatic neuromas. The only prospective trial on this topic was published in 2000 and compared two conventional techniques that have since been modified to better minimize neuroma formation or to reduce mechanical pressure by transposing the nerve ends to the dorsal aspect of the hand. However, that study used different scales to measure outcomes and did not incorporate aspects of pain that affect patients' emotional and social well-being. Currently, two randomized controlled trials are enrolling patients. One compares surgical techniques for the treatment of neuroma rather than its prevention. The other excludes digits with injuries located distal to the interphalangeal joints. Both studies focus on more complex surgical techniques. Given the extent of this problem, there has been recent innovation aimed at preventing neuroma formation. One promising product is the Tulavi Allay™ Nerve Cap, which has demonstrated encouraging results in basic science studies and anecdotally in early clinical use cases. In this study, the investigators have designed a prospective trial to assess the efficacy of the Tulavi Allay™ Nerve Cap when used to prevent symptomatic digital nerve neuroma following traumatic digital amputation.

Neuropathic Characteristics of Subacromial Pain Syndrome

This single-center observational study aims to investigate neuropathic pain descriptors and their relationship with central sensitization in patients diagnosed with subacromial pain syndrome (SAPS) who have had shoulder pain for at least 3 months. A total of 82 participants aged 19 years or older will be recruited from the Physical Medicine and Rehabilitation outpatient clinic of Izmir City Hospital. After obtaining informed consent, participants will complete validated questionnaires assessing pain severity (VAS), neuropathic pain characteristics (painDETECT), central sensitization (Central Sensitization Inventory), and shoulder function (SPADI). Range of motion will be measured using a goniometer. No imaging or invasive procedures will be performed. Using the central sensitization scale and pain detect, the presence or absence of the 7 pain descriptors will be investigated in patients with subacromial pain syndrome with or without central sensitization and neuropathic pain pattern and it will be investigated whether the contribution of hyperalgesia, one of these pain descriptors, to neuropathic pain and central sensitization in patients with subacromial pain syndrome is greater than the contribution of other pain descriptors.The results of this study are expected to provide insight into pain mechanisms and guide clinical management in patients with SAPS.

High-frequency Alternating Current Stimulation for Neurophatic Pain in Spinal Cord Injury

To investigate the safety and effectiveness of transcutaneous electrical stimulation with 40 kHz alternating currents combined with standard treatment compared to placebo electrical stimulation plus standard treatment for neuropathic pain in people with spinal cord injury.

Virtual Reality (VR) Self-Hypnosis Software

This single-site study of self-hypnosis software using an off-the-shelf virtual reality (VR) device (OculusGo™) to determine the software's safety, usability, and preliminary efficacy in pain relief for HIV-associated chronic pain patients. This is funded under the i Prism Funding through Mount Sinai Innovations.

Chronic Unilateral Lumbar Radicular Pain

Chronic neuropathic lumbar pain is among one of the most widespread complaints of patients.Many approaches have been attempted to target chronic pain, with varying efficacy and risks. Transgrade (TG) epidural injection is a new technique using a Racz- Coudé needle for epidural access at a "transgrade" angle without requiring any specialized hardware or accessories. Interlaminar (IL) epidural steroid injection (ESI) is one of the procedures that involves the delivery of injectate to the epidural space through directing a needle between the laminae of two adjacent vertebrae.

Neurosurgical Outcome Network

The evaluation of neurosurgical outcomes varies from center to center, and the predictive factors that determine these outcomes are not fully known or shared. This study aims to assess outcomes and their predictors using measures agreed upon by the participating centers. Standardizing the evaluation of outcomes and predictors improves the quality of research, allows for data comparison, and facilitates a "common language" in routine clinical practice. Most importantly, it influences therapeutic decisions in various neurosurgical conditions. Clinically, the identified predictors can also be used during preoperative assessments to provide more precise guidance to patients undergoing surgery.

Deep rTMS (H-coil) for Neuropathic Pain or Fibromyalgia

This study will investigate the efficacy and safety of "deep" rTMS on neuropathic pain or fibromyalgia. It will be randomized and sham controlled and will last 3 months. Patients will be randomized to receive acctive rTMS or sham rTMS and will receive repeated rTMS sessions (5 daily sessions then one session per week then every 2 to 3 weeks for up to 10 weeks).

Relationship Between Neuropathic Pain and Geriatric Assessment Parameters in Patients Aged 80 Years and Older

This study aimed to determine the frequency of neuropathic pain in individuals aged 80 years and older and to evaluate the relationship between neuropathic pain and comprehensive geriatric assessment parameters.

Pediatric Electrocutaneous Analgesia for Children Experiencing Neuropathic Pain

This is a study evaluating the Scrambler Therapy device as a non-invasive treatment for neuropathic pain in pediatric oncology patients with metastatic bone disease. The primary goal is to assess changes in pain intensity and medication use, aiming to improve quality of life and reduce reliance on systemic pain medications.