[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"discogenic-low-back-pain\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:discogenic-low-back-pain":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,69],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100566951","examination-of-nociscan-impact-on-discogenic-low-back-pain-surgical-outcomes-100566951",false,"NCT06661850","Examination of Nociscan Impact on Discogenic Low Back Pain Surgical Outcomes","A Multi-Center Randomized Clinical Study of the NOCISCAN MR Spectroscopy (MRS) in Patients Treated for Discogenic Low Back Pain","CLARITY","Inclusion Criteria:\n\n1. Subject is a skeletally mature male or female (non-pregnant) aged 18 to 70 years (inclusive);\n2. Subject plans to undergo surgical treatment of their discogenic back pain independent of this research protocol;\n3. Subject is to be treated with on-label use of FDA-cleared or FDA-approved devices independent of this research protocol;\n4. Subject has a diagnosis of discogenic back pain that requires treatment in up to two lumbar levels caused by degenerative disc disease (identified via MRI);\n5. Subject has a preoperative Oswestry Disability Questionnaire score ≥35 out of 100 points (35\u002F100);\n6. Subject has a VAS back pain score of ≥40mm and that is greater than the worst VAS leg pain score;\n7. Subject has failed at least ≥ 6 months of non-operative treatment (for example: physical therapy, bed rest, anti-inflammatory or analgesic medications, chiropractic care, acupuncture, massage therapy or home-directed lumbar exercise programs) OR requires urgent surgical treatment per the investigator;\n8. Subject has signed the IRB approved Informed Consent Form; and\n9. Subject is psychosocially, mentally and physically able and willing to fully comply with this protocol including adhering to follow-up schedule and requirements and filling out forms.\n\nExclusion Criteria:\n\n1. Subject has a primary diagnosis of spinal condition other than degenerative disc disease at the involved level (i.e., facet joint pain\u002FSI pain);\n2. Subject has had prior lumbar back surgery or intradiscal treatments at any lumbar level (Note: diagnostic provocative or anesthetic discography are not excluded; micro-discectomy, decompression, or laminectomy patients greater than 6 months postop are not excluded);\n3. Surgery is planned for more than 2 lumbar levels.\n4. Subject has severe spinal canal stenosis as assessed by the Investigator;\n5. Subject has a motor strength deficit(s) in lower extremities\n6. Subject has a lumbar spine diagnosis, based on radiographic evidence, of clinically relevant lumbar vertebral abnormalities (except Modic end-plate changes, which are not excluded), including:\n\n   * Spondylolisthesis Grade 2 or greater (up to Grade 1 is accepted)\n   * Pars fracture, at the involved level\n   * Spondylolysis\n   * Lumbar scoliosis with a Cobb angle of greater than 15°\n   * Evidence of prior fracture or trauma to the L1, L2, L3, L4, or L5 levels in either compression or burst\n   * Lumbar kyphosis\n7. Subject has radiologic evidence of an uncontained lumbar disc herniation or lumbar disc extrusion.\n8. Subject is contraindicated for a standard lumbar MRI exam\n9. Women who are currently pregnant (or believe they may be at risk of being or becoming pregnant), or are breast feeding, during the study period when scans will be performed\n10. Subject is currently receiving worker's compensation or is involved in in any litigation for personal injury, medical negligence, trauma, or worker's compensation.\n11. Subject has a chronic disease (other than degenerative disc disease), chronic pain (other than discogenic low back pain), or psychological dysfunction, which may, in the opinion of the Principal Investigator, compromise a subject's ability to comply with study procedures, and\u002For may confound data\n12. Subject has a BMI \\> 40","ALL","18 Years","70 Years",{"count":21,"type":22},300,"ESTIMATED","OBSERVATIONAL","This study is looking into how safe and useful NOCISCAN is. NOCISCAN is a software as a Service (SaaS) tool that uses Magnetic Resonance (MR) spectroscopy. Nociscan (instead of 'It') leverages MRS to noninvasively help physicians distinguish between painful and nonpainful discs in the lumbar spine. The randomized controlled trial will compare the blinded and unblinded cohorts and their corresponding surgical outcomes with the Nocigram reports, generated prior to treatment, for each patient.\"",[26],"Discogenic Low Back Pain",[28,29,30,31],"MR Spectroscopy","MRI","back pain","Nociscan","RECRUITING","2026-05-27",{"date":35,"type":36},"2026-05-28","ACTUAL",{"date":38,"type":36},"2025-06-11",{"date":40,"type":22},"2027-12-31",{"name":42,"class":43},"Aclarion","INDUSTRY",8,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":19,"enrollmentInfo":53,"targetDuration":4,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":44},"100582250","perqdisc-traditional-feasibility-trial-100582250","NCT06860867","PerQdisc Traditional Feasibility Trial.","A Multi-center Traditional Feasibility Trial of the PerQdisc Artificial Implant in Treatment of Single-level Discogenic Back Pain.","Inclusion Criteria:\n\n1. Skeletally mature male or female subjects aged 22-70 (inclusive).\n2. Subject has a primary diagnosis of single level discogenic back pain caused by degenerative disc disease (L1 to L5) identified via MRI.\n3. Subject has an intact annulus (as determined by MRI) and endplates (as determined by MRI and X-ray) at the level to be treated.\n4. Subject must have failed to respond to a minimum of 6 months of conservative treatment for their back pain (e.g., physical therapy, medications, injections, ablations, lifestyle changes, etc.).\n5. Subject has a low back pain VAS ≥40 mm (4 cm).\n6. Subject has adequate disc height (≥6mm measured at the center of the disc) at the level to be treated. \\[As measured by the investigator\\]\n7. Subject is psychosocially, mentally and physically able and willing to fully comply with this protocol including adhering to follow-up schedule and requirements and filling out forms.\n8. Subject has read and understands the IRB approved informed consent document prior to signing and dating the document and before the initiation of any study-related procedures\n9. Subject is appropriate candidate for the PerQdisc surgical approach \\[as defined in the surgical technique guide\\].\n\nExclusion Criteria:\n\n1. Subject has symptomatic degenerative disc disease at more than one lumbar level\n2. Subject has had a prior spinal fusion in the lumbar or thoracic intervertebral spaces.\n3. Subject has had a prior SI-joint fusion.\n4. Subject has a spinal cord stimulator.\n5. Subject has had any prior lumbar spine surgery (instrumented or non-instrumented)\n6. Subject has a significant disc herniation at the level to be treated. Significant is defined as a large, extruded herniation that creates a risk for expulsion.\n7. Subject has congenital moderate or severe spinal stenosis or epidural lipomatosis.\n8. Subject has spondylolisthesis (antero- or retrolisthesis) in static X-ray ≥3 mm \\[measured via neutral lateral x-ray\\]\n9. Subject has ≥4 mm dynamic spondylolisthesis \\[measured via flexion\u002Fextension x-rays\\]\n10. Subject has \\> 20 degree range of motion at the index level \\[measured via flexion\u002Fextension x-rays\\]\n11. Subject has a history of any invasive malignancy (except non-melanoma skin cancer) unless treated with curative intent and there have been no clinical signs or symptoms of malignancy for at least 5 years (in particular, spinal tumors).\n12. Subject has an active systemic infection or infection at the operative site.\n13. Subject has evidence of symptomatic facet joint degeneration or disease where the investigator feels the facet is a major contributor to the subject's pain as diagnosed by injection and\u002For imaging.\n14. Subject has a known allergy to silicone or barium sulfate.\n15. Subject has been diagnosed with fibromyalgia, hepatitis, rheumatoid arthritis, lupus erythematosus, AIDs, ARC, HIV, or an autoimmune disease that affects the musculoskeletal system.\n16. Subject has been diagnosed with Paget's disease, osteomalacia or any other metabolic bone disease.\n17. Subject has current or recent history (defined ≤ 1 year prior to screening) of substance abuse (alcoholism and\u002For narcotic addiction) using standard medical definitions of DSM-5\n18. Subject has morbid obesity defined as a body mass index (BMI) \\> 40.\n19. Subject participated in an investigational drug or another medical device study within the last 30 days prior to surgery.\n20. Subject has Osteoporosis, defined as a T-score ≤ -2.5.\n\n    1. An existing DEXA is allowed if completed within 6 months of subject surgery.\n    2. For all subjects without an existing DEXA, the SCORE\u002FMORES will be utilized to screen if a DEXA scan is indicated. If SCORE\u002FMORES value ≥ 6, then a DEXA scan is required.\n21. Female subjects who are pregnant or are trying to become pregnant during the course of the trial.\n22. Subject has diabetes mellitus (Type 1 or 2) requiring daily insulin management.\n23. Subject belongs to a vulnerable population or has a condition such that his\u002Fher ability to provide informed consent, comply with follow-up requirements, or provide self-assessments is compromised (e.g. developmentally disabled, prisoner, chronic alcohol\u002F substance abuser)\n24. Subject is currently receiving worker's compensation or is involved in any litigation for medical negligence, trauma, or worker's compensation.\n25. Subject has lumbar scoliosis \\> 10 degrees at index level.\n26. Subject has a large, rectangular or irregularly shaped Schmorl's node with an associated active inflammatory process (Modic I changes).\n27. Subject has motion of \\\u003C 3 degrees on pre-operative lateral flexion\u002Fextension radiographs at index level.\n28. Subject has opioid medication usage \\> 60 MME (morphine milligram equivalent)\u002Fday or change in opioid prescription within 60 days of surgery.\n29. Subject has a preoperative VAS right or left leg pain score \\> the preoperative VAS Back score.\n30. Subject has a history of vertebral fractures in the lumbar spine.\n31. Subject has evidence of severe compression of cauda equina.\n32. Subject is on chronic anticoagulation therapy due to a bleeding disorder and is unable to safely stop anticoagulants or has taken anticoagulants within 3 days prior to procedure.\n33. Subject has low back pain (LBP) of non-spinal or unknown etiology.\n34. Subject is unable to undergo X-ray, MRI, or other radiographic assessments, including discography.\n35. Subject has a degenerative muscular or neurological condition that would interfere with evaluation of outcomes, including but not limited to spinal disease (not at index level), Parkinson's disease, amyotrophic lateral sclerosis (ALS), or multiple sclerosis.\n36. Subject has, in the opinion of the investigator, a behavioral, cognitive, social or medical problem that may interfere with the assessment of the safety or effectiveness of the device.\n37. In the opinion of the investigator the subject has a major psychiatric disorder that may interfere with the assessment of the safety or effectiveness of the device.\n38. Subject has myelopathy.\n39. Subject has primarily leg pain with associated nerve root compression, in the opinion of the investigator.\n40. Subject has an annular defect greater than 6mm that extends from the interior of the disc to the outer margin of the annulus as evaluated on MRI.","22 Years",{"count":54,"type":22},5,"INTERVENTIONAL",[57],"NA","This is a traditional feasibility study (TFS) study to evaluate the safety and effectiveness of the PerQdisc. The study is prospective, multicenter, and open label.\n\nAfter a screening period, qualified participants will be enrolled and treated with the PerQdisc. Patients will not be blinded to their treatment. Participants will then complete the safety follow-up period.",[26],"2026-05-06",{"date":62,"type":36},"2026-05-08",{"date":64,"type":36},"2025-01-10",{"date":66,"type":22},"2030-03-31",{"name":68,"class":43},"Spinal Stabilization Technologies",{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":76,"targetDuration":4,"studyType":55,"phases":78,"briefSummary":79,"conditions":80,"keywords":81,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":96},"100570163","electroacupuncture-treatment-for-discogenic-low-back-pain-100570163","NCT06703671","Electroacupuncture Treatment for Discogenic Low Back Pain","The Efficacy and Safety of Electroacupuncture Compared With Sham Acupuncture in Patients With Discogenic Low Back Pain: A Multicenter Randomized Controlled Trial","Inclusion Criteria:\n\n1. It meets the diagnostic criteria of discogenic low back pain\n2. Betweening 18 and 70 years of age (both 18 and 70) and of either sex\n3. Visual analog score (VAS) for low back pain ≥40 mm within the last 1 month\n\nExclusion Criteria:\n\n1. Patients with symptoms such as lower limb numbness, weakness and claudication as shown by lumbar disc herniation pressing the spinal nerve on imaging\n2. Lumbar tuberculosis, tumor, infection, spinal fracture, lumbar spondylolisthesis, severe osteoporosis\n3. Patients with a history of spinal and intervertebral disc surgery\n4. Patients with rheumatism, rheumatoid disease, systemic lupus erythematosus, hematopoietic system, endocrine system and psychiatric diseases\n5. Patients who have received radiofrequency, minimally invasive, ozone, small needle-knife, acupuncture, manipulation, traction, block therapy and other clinical trials within the last 1 month\n6. Patients with severe needle fainting intolerance\n7. Women who are pregnant, planning pregnancy or breastfeeding\n8. People with a history of opioid analgesics, sedatives and hypnotics and alcohol abuse\n9. Patients who plan to undergo acupuncture, massage, traction and other treatments related to this disease and other clinical research trials within 3 months of participating in the study\n10. Patients with skin damage or infection, concomitant bleeding tendency, tumor metastasis, serious heart disease, or embedded pacemaker",{"count":77,"type":22},240,[57],"Low back pain (LBP) is a prevalent clinical condition characterized by pain localized between the lower edge of the 12th rib and the gluteal fold.The incidence of LBP has been escalating annually.An epidemiological survey encompassing 204 countries and territories globally projects a stark increase in the affected population, from an estimated 619 million in 2020 to a projected 843 million by 2050.LBP can affect individuals across all age groups, with a lifetime prevalence ranging from 60% to 80%, significantly impairing quality of life. Discogenic low back pain (DLBP), attributed to degenerative changes in the intervertebral discs, is the predominant subtype of LBP, comprising approximately 39% of all LBP cases. Disc degeneration typically initiates in early adulthood and progresses with age, potentially leading to DLBP.As the population ages, DLBP has emerged as a major contributor to disability worldwide, imposing a substantial burden on both individuals and society. Current international guidelines establish the foundation for surgical and pharmacological interventions for DLBP.However, considering the adverse effects and economic implications associated with surgical and medical treatments, there is a growing inclination towards recommending non-pharmacological therapies.These include physiotherapy, self-management, and psychotherapy, with a concurrent reduction in emphasis on pharmacological and surgical options.\n\nAcupuncture and moxibustion are integral components of traditional Chinese medicine, garnering global recognition for their role in restoring the equilibrium of yin and yang within the human body . Electroacupuncture, a modern derivation of traditional acupuncture, has been extensively applied worldwide for the management of various painful conditions, including headache, myofibromyalgia, neck pain, and cancer-related pain. Despite its broad application, a limited number of clinical efficacy and safety studies have been conducted on electroacupuncture for the treatment of discogenic low back pain (DLBP), thereby necessitating a scientific foundation for its therapeutic use .\n\nThe present study aims to investigate the clinical efficacy and safety of electroacupuncture in the treatment of DLBP using an evidence-based medical approach. By employing a multicenter, randomized, and sham-controlled study design, this investigation seeks to provide a robust evidence-based medical foundation for the use of electroacupuncture in DLBP treatment.\n\nParticipants will be randomly assigned to either the acupuncture group (experimental group) or the sham acupuncture group (control group) in a 1:1 ratio, akin to a lottery drawing. Following enrollment, participants will undergo a 4-week, 12-session intervention, followed by three follow-up visits at 4, 12, and 24 weeks post-treatment. The investigators will assess participants' low back pain, lumbar spine function, and quality of life through telephone communication or on-site questioning at these designated follow-up intervals.\n\nNeedling may result in minor bleeding, pain, or hematoma at the needle site, and rare infections or allergic reactions may occur. Adverse reactions to needling, such as dizziness or nerve damage, are exceedingly rare.\n\nParticipants in this study may confer direct medical benefits, such as remission of symptoms, or may not, with outcomes ranging from no remission to potential exacerbation of the condition . However, the knowledge gained from this study is anticipated to benefit future people with similar conditions .\n\nIn addition to this study , participations may opt for treatment with modern rehabilitation medicine modalities or medications, including shortwave therapy, intermediate frequency therapy, or oral analgesics . This study would not impose any costs beyond the participants' regular medical treatment, and the investigators will cover all study-related medical expenses (including acupuncture treatment costs, needle costs, and scale evaluation costs) . The investigators are legally committed to maintaining the confidentiality of the participants' study records.",[26],[82,83,84,85],"Discogenic low back pain","electroacupuncture","Sham Acupuncture","A Randomized Clinical Trial","2026-02-02",{"date":88,"type":36},"2026-02-04",{"date":90,"type":36},"2025-03-08",{"date":92,"type":22},"2026-06-01",{"name":94,"class":95},"Beijing Hospital","OTHER_GOV",1]