Tenex (guanfacine immediate release tablet) / Dr. Reddy’s - LARVOL DELTA

A stratified precision medicine trial targeting α2A-adrenergic receptor agonism as a treatment for the cognitive biotype of depression. (PubMed, Nat Ment Health) - P4 | "Here, in line with a precision medicine approach, we evaluated guanfacine immediate release (GIR), an α2A receptor agonist, as a novel treatment aimed at enhancing cognitive control circuit function and behavioral performance in a neurobiologically defined subtype of depression, the cognitive biotype NCT04181736...GIR also led to significant improvements in cognitive control performance, global life satisfaction and quality of life. Here we demonstrate both clinical efficacy and circuit target engagement of GIR as a mechanistically selective treatment for the cognitive biotype of depression."

Journal • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Effect of Guanfacine on the Reversal of Opioid-induced Hyperalgesia (OIH) (clinicaltrials.gov) - P=N/A | N=120 | Terminated | Sponsor: Massachusetts General Hospital | Active, not recruiting ➔ Terminated; End of NIH funding

Trial termination • Pain

Effect of Guanfacine on Opioid-induced Hyperalgesia (OIH) and Tolerance (clinicaltrials.gov) - P4 | N=200 | Terminated | Sponsor: Massachusetts General Hospital | Active, not recruiting ➔ Terminated; End of NIH funding

Trial termination • Pain

An Alternative Procedural Approach to Treating Calcific Tendinitis of the Hip (ASA 2025) - "Two 2x2mm bony fragments were removed, and the patient reported 90% pain relief after the procedure. This case highlights an effective alternative technique for treating calcific tendinitis when standard procedures like Tenex are unavailable."

Musculoskeletal Diseases • Orthopedics

Chronic Morel-Lavallée Lesion Treated With Percutaneous Ultrasonic Debridement. (PubMed, J Clin Ultrasound) - "This case describes the successful use of this technology in a 68-year-old female with a 10-year history of a Morel-Lavallée lesion. Treatment of Morel-Lavallée lesions using the Tenex device is a feasible, minimally invasive alternative to conventional surgery."

Journal • Musculoskeletal Diseases • Pain

Authors' response to the letter to the editor on "Tendon modification with percutaneous ultrasound-guided tenotomy using TENEX®: A histological and macroscopic analysis of a bovine cadaveric model.". (PubMed, Interv Pain Med) - No abstract available

Journal

Percutaneous Tenotomy With Ultrasonic Debridement for Lateral Epicondylitis: Surgical Technique and Short-term Patient Outcomes. (PubMed, Tech Hand Up Extrem Surg) - "This study evaluates the efficacy of percutaneous ultrasonic tenotomy (PUT) with the Tenex TX system as a minimally invasive alternative for treating chronic lateral epicondylitis...Its minimally invasive nature, coupled with rapid recovery and high patient satisfaction, underscores its potential to replace more invasive surgical alternatives. However, further research with larger cohorts and extended follow-ups is warranted to validate long-term outcomes and refine procedural protocols."

Journal • Anesthesia • Musculoskeletal Diseases • Musculoskeletal Pain • Pain

Diagnosis and Minimally Invasive Surgical Treatment for Enhancing Intrathecal/Intrasynovial Tendon Injuries. (PubMed, Vet Clin North Am Equine Pract) - "In these cases, endoscopic evaluation and debridement, not only of the lesion, but also any other secondary injury present, can enhance the healing of the tendon or ligament and improve the athletic prognosis. Careful planning of the approach, positioning, instrumentation, and thorough knowledge of the anatomy are vital features that can enhance a successful outcome."

Journal • Review

Tendon modification with percutaneous Ultrasound-Guided Tenotomy using TENEX®: A histological and macroscopic analysis of a bovine cadaveric model. (PubMed, Interv Pain Med) - "Tukey's Honest Significant Difference (HSD) test revealed significant differences between most groups (p < 0.001), except between the 3-min and 5-min treatments, which showed no significant difference (p = 0.969). PUTT induces significant structural changes in the paratenon and fascicle layer with longer treatment duration, resulting in more pronounced modifications."

Journal • Pain

Minimally invasive ultrasound-guided percutaneous plantar fasciotomy on chronic plantar fasciitis: A retrospective analysis. (PubMed, Foot Ankle Surg) - "MIS ultrasound-guided plantar fasciotomy appears to be a reliable surgical treatment option for chronic plantar fasciitis with high patient satisfaction and safety profile."

Journal • Retrospective data • Musculoskeletal Diseases • Pain

RCT GTPS: Evaluation of TENEX for Greater Trochanteric Pain Syndrome (GTPS) (clinicaltrials.gov) - P=N/A | N=150 | Recruiting | Sponsor: Montefiore Medical Center | Not yet recruiting ➔ Recruiting

Enrollment open • Musculoskeletal Pain • Pain

A Stratified Precision Medicine Trial Targeting Selective Mechanisms of Alpha 2A Agonism as a Treatment for the Cognitive Biotype of Depression: The BIomarker Guided (BIG) Study for Depression. (PubMed, Res Sq) - "We evaluated guanfacine immediate release (GIR), an alpha 2A receptor agonist, as a novel treatment for selectively improving cognitive control circuit function and behavioral performance in a subtype of depression, the cognitive biotype...GIR significantly improved cognitive control performance, quality of life, and global life satisfaction. This study is the first to demonstrate both efficacy and target engagement of GIR as a mechanistically selective treatment specifically for the cognitive biotype of depression."

Biomarker • Journal • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

RCT GTPS: Evaluation of TENEX for Greater Trochanteric Pain Syndrome (GTPS) (clinicaltrials.gov) - P=N/A | N=150 | Not yet recruiting | Sponsor: Montefiore Medical Center | Trial completion date: Feb 2025 ➔ Mar 2027 | Trial primary completion date: Feb 2025 ➔ Mar 2027

Trial completion date • Trial primary completion date • Musculoskeletal Pain • Pain

Randomized Controlled Trial (RCT) of Open Debridement Versus Tenex (clinicaltrials.gov) - P=N/A | N=90 | Recruiting | Sponsor: Virtua Health, Inc. | Trial completion date: Jun 2025 ➔ Jun 2026 | Trial primary completion date: Dec 2024 ➔ Dec 2025

Trial completion date • Trial primary completion date • Musculoskeletal Pain • Orthopedics

The Efficacy of Different Tenotomies in the Treatment of Lateral Epicondylitis: A Systematic Review. (PubMed, J Clin Med) - "Tenotomy is the gold standard for repair, but the research comparing the benefits of specific types of tenotomies (open, arthroscopic, percutaneous, ultrasonically assisted, and Tenex forms) is lacking...The secondary outcomes included patient-reported satisfaction, return-to-work timeframes, and procedural complications. The tenotomy outcomes were similar, regardless of the method, indicating that discussions with patients about their specific outcome preferences may help guide tenotomy method selection."

Journal • Review • Musculoskeletal Pain • Orthopedics • Pain

Ultrasound-Guided Percutaneous Ultrasonic Tenotomy for Refractory Patellar Tendinopathy in High-Level Athletes: A Case Series. (PubMed, Clin J Sport Med) - "PUT for refractory patellar tendinopathy in high-level athletes generally results in favorable treatment outcomes and successful return to sports. This study provides novel insights into the effectiveness of PUT for patellar tendinopathy in athletes, highlighting the need for future studies with larger sample sizes to validate these findings and explore factors associated with poor outcomes."

Journal • Infectious Disease • Orthopedics • Pain

Effectiveness of Percutaneous Needle Tenotomy for Tendinopathies: A Systematic Review. (PubMed, Sports Health) - "Mean risk of bias assessment scores were 8.35 out of 10 assessing internal and external validity for included studies. PNT and TENEX are safe, beneficial, and minimally invasive treatment option for patients, especially for conditions refractory to more conservative treatments options."

Journal • Review • Novel Coronavirus Disease • Pain

Percutaneous Coracohumeral Release for Patients with Adhesive Capsulitis: Two-Year Results from a Randomized Control Crossover Study. (PubMed, Pain Physician) - "While the algorithm for AC care has seen little change for several decades, the authors suggest that PCHLR is a safe, durable, and effective option for cases of AC that are refractory to traditional management."

Clinical • Journal • Anesthesia • Immunology • Osteoarthritis • Pain • Rheumatology

The Effects of Ultrasound-Guided Percutaneous Tenotomy on Patients' Pain and Satisfaction Levels. (PubMed, Cureus) - "Ultrasonic tenotomy provides significant relief for tendinopathy in the shoulder, elbow, and hip for the majority of patients. The knee pain scores were not significantly reduced, likely due to the small sample size of four patients. Some patients did not experience complete relief and benefited from a PRP injection after tenotomy. Some patients did not benefit, likely due to additional pathology, arthritis, and referred pain. Some limitations to our study include the lack of a control group and each procedure was performed by the same physician, which limits its generalizability. The survey responses were subjective, and the sample size was variable between each body region. More high-quality research is needed to establish the efficacy of tenotomy between different tendons and compare it to other treatment methods."

Journal • Fibrosis • Immunology • Inflammation • Musculoskeletal Diseases • Musculoskeletal Pain • Orthopedics • Pain • Rheumatology

A True Pain In The Heel (ACSM 2024) - "XR Ankle revealed enthesophyte at the insertion of the achilles tendon and calcific tendinopathy measuring 1.9 cm in length.MSK US confirmed calcific tendinopathy, insertional enthesophyte and additional achilles tendon tendinosis with intrasubstance partial tearing.FINAL WORKING DIAGNOSIS: Calcific Tendinopathy, Achilles Enthesopathy, Achilles Tendinosis with intra-substance partial tearingTREATMENT AND OUTCOMES: Patient did not want to pursue open surgery. She elected to proceed with ultrasound-guided percutaneous tenotomy utilizing the TENEX-Bone needle on 01/19/2022 followed by 4 wks of CAM boot. She noticed 30% improvement and due to the persistence of calcification and symptoms, she had a second procedure on 06/03/2022."

Chronic Kidney Disease • Genetic Disorders • Musculoskeletal Diseases • Obesity • Orthopedics • Pain

Targeting the Cognitive Biotype of Depression With a Selective Alpha 2A Receptor Agonist Using a Stratified Precision Medicine Design (SOBP 2024) - "Background: For the first time in depression, we present a novel stratified medicine trial in which we enriched for objective cognitive deficits and examined the effect of 8 weeks of open-label guanfacine immediate release (GIR), a selective alpha 2A receptor agonist shown to modulate the cognitive control circuit... This innovative stratified medicine trial provides evidence that objective cognitive testing successfully identifies depressed individuals with prefrontal dysfunction. Targeting this dysfunction with GIR is effective in treating depression, cognitive impairment, and poor function in the cognitive biotype of depression."

Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Randomized Controlled Trial (RCT) of Open Debridement Versus Tenex (clinicaltrials.gov) - P=N/A | N=90 | Recruiting | Sponsor: Virtua Health, Inc. | Trial completion date: Feb 2024 ➔ Jun 2025 | Trial primary completion date: Feb 2024 ➔ Dec 2024

Trial completion date • Trial primary completion date • Musculoskeletal Pain • Orthopedics

Guanfacine to Improve Substance Use Outcomes in Women (clinicaltrials.gov) - P2 | N=74 | Completed | Sponsor: Yale University | Active, not recruiting ➔ Completed

Trial completion

Effect of Guanfacine on the Reversal of Opioid-induced Hyperalgesia (OIH) (clinicaltrials.gov) - P=N/A | N=120 | Active, not recruiting | Sponsor: Massachusetts General Hospital | Trial completion date: Dec 2023 ➔ Dec 2024

Trial completion date • Pain

RCT GTPS: Evaluation of TENEX for Greater Trochanteric Pain Syndrome (GTPS) (clinicaltrials.gov) - P=N/A | N=117 | Not yet recruiting | Sponsor: Montefiore Medical Center | Initiation date: Dec 2023 ➔ Feb 2025

Trial initiation date • Musculoskeletal Pain • Pain