Clinical Research Directory

Dose Dependent Steroid Injections

This study aims to evaluate the efficacy of interlaminar steroid injections at treating pain in lumbar radiculopathy at varying doses, to evaluate the efficacy of interlaminar steroid injections at improving quality of life and function in lumbar radiculopathy at varying doses, and to evaluate difference in efficacy between triamcinolone and dexamethasone interlaminar steroid injections at treating pain in lumbar radiculopathy at varying doses, with the overarching hypotheses that there is no difference in reported pain reduction, quality of life, or function among patients receiving low, moderate, or high doses, and no difference in reported pain reduction between triamcinolone and dexamethasone.

Study to Evaluate Safety of C-1101 Versus Sterile Saline in Adults With Chronic Painful Lumbosacral Radiculopathy

The purpose of this study is to evaluate the safety and tolerability of C-1101 administered as a single dose, transforaminal epidural injection compared to sterile saline

FINDISC-Pain, Finnish Discectomy Trial on the Benefits and Harms of Surgery in Patients With Lumbar Disc Herniation

The FINDISC trial studies whether common back operation, microdiscectomy, is effective and safe for treating sciatica caused by a lumbar disc herniation. The study includes people whose leg pain has not improved after at least six weeks of non-surgical treatment. The FINDISC trial aims to recruit and randomly allocate 122 participants to receive either the actual operation (discectomy) or a placebo (sham) surgery. The placebo (sham) procedure involves anesthesia and an approach similar to the real operation, but no removal of disc material or bone. Participants and healthcare staff, excluding the surgical team, will not know which treatment was given. The study compares pain relief, recovery, daily functioning, quality of life, and harms between the two groups. The goal of the study is to provide reliable evidence to help patients and clinicians decide whether microdiscectomy offers meaningful benefits compared with placebo surgery.

Immediate and 1-week Efficacy of a Single Session of Sciatic Nerve Electrical Stimulation in the Management of Low-back Related Leg Pain

This clinical study focuses on people who experience long-term low-back related leg pain (commonly called sciatica). This type of pain is often associated with nerve irritation or compression in the lower spine and can cause symptoms like shooting or burning pain, tingling, numbness, or weakness in the leg. Many patients continue to suffer from this problem for months or years, and available treatments (including painkillers, anti-inflammatory drugs, or even surgery) do not always provide lasting relief. Because of this, there is a strong need to explore safe, non-drug, non-surgical therapies. The purpose of this study is to test the immediate and short-term efficacy and safety of a single session of a treatment called Percutaneous Electrical Nerve Stimulation (PENS) when applied near the sciatic nerve, the large nerve that runs from the lower back through the buttock and down the leg. PENS uses very thin sterile needles inserted under ultrasound guidance next to the nerve. A gentle electrical current is then applied for about 30 minutes to stimulate the nerve in a controlled way. This may help calm down nerve sensitivity, reduce inflammation, and decrease pain. The investigators will compare PENS with three other options: Transcutaneous Electrical Nerve Stimulation (TENS): A commonly used therapy where mild electrical stimulation is applied through adhesive patches placed on the skin; Dry needling without electrical current: Thin needles are inserted under ultrasound guidance but no current is applied; and placebo treatment: A simulated version of the therapy with no active current, designed to look and feel similar so that participants do not know which treatment they are receiving. The study is designed as a randomized, controlled, double-blind trial, which means that participants are assigned to one of the four groups by chance (like flipping a coin), and neither the patients nor the therapists who collect the measurements will know which treatment has been given. This design ensures fairness and reliability of the results. The investigators will measure: Back and leg pain levels, using a simple 0-10 scale; Disability, meaning how much the pain limits daily activities, measured with a well-known questionnaire; Quality of life, both physical and mental health aspects; Nerve-related pain features, like burning or electric-like sensations; Flexibility and movement, through the Straight Leg Raise test; Sensitivity to pressure and nerve stiffness, using ultrasound elastography, which is a safe imaging technique; and patients' global impression of improvement and any side effects. Assessments will take place before and immediately after the treatment session and after 1 week, allowing the investigators to see both the immediate and short-term effects. Safety considerations: Previous research shows that PENS and similar techniques are generally very safe. The most common side effects are mild and short-lasting, including temporary soreness, heaviness in the leg, or a small bruise. Serious complications are extremely rare. To minimize risks, all procedures will be carried out by experienced physiotherapists, using real-time ultrasound to guide needle placement and ensure accuracy. Only sterile, single-use needles are employed. By comparing PENS, TENS, dry needling, and placebo, this study seeks to determine whether a single session of PENS provides superior benefits in reducing pain, improving function, and enhancing quality of life for patients with sciatica-type low back pain. If successful, this treatment could become a valuable alternative to drugs or surgery, offering patients a safe and effective therapy to better manage their condition and regain daily function.

Efficacy of Sciatic Nerve Electrical Stimulation and Therapeutic Exercise in the Management of Low-back Related Leg Pain

This clinical study focuses on people who experience long-term low-back related leg pain (commonly called sciatica). This type of pain is often associated with nerve irritation or compression in the lower spine and can cause symptoms like shooting or burning pain, tingling, numbness, or weakness in the leg. Many patients continue to suffer from this problem for months or years, and available treatments (including painkillers, anti-inflammatory drugs, or even surgery) do not always provide lasting relief. Because of this, there is a strong need to explore safe, non-drug, non-surgical therapies. The purpose of this study is to test the efficacy and safety of a treatment called Percutaneous Electrical Nerve Stimulation (PENS) when applied near the sciatic nerve, the large nerve that runs from the lower back through the buttock and down the leg, in combination with a therapeutic exercise program. PENS uses very thin sterile needles inserted under ultrasound guidance next to the nerve. A gentle electrical current is then applied for about 30 minutes to stimulate the nerve in a controlled way. This may help calm down nerve sensitivity, reduce inflammation, and decrease pain. We will compare PENS with three other options: Transcutaneous Electrical Nerve Stimulation (TENS): A commonly used therapy where mild electrical stimulation is applied through adhesive patches placed on the skin; Dry needling without electrical current: Thin needles are inserted under ultrasound guidance but no current is applied; and placebo treatment: A simulated version of the therapy with no active current, designed to look and feel similar so that participants do not know which treatment they are receiving. In addition to these treatments, all participants will take part in a structured exercise program aimed at strengthening the lower back, pelvis, and legs. Exercises like curl-ups, planks, bridges, bird-dogs, and squats will be supervised weekly for six weeks, with guidance to continue practicing at home. Exercise is included because it is known to help improve mobility, strength, and recovery in people with back problems. The study is designed as a randomized, controlled, double-blind trial, which means that participants are assigned to one of the four groups by chance (like flipping a coin), and neither the patients nor the therapists who collect the measurements will know which treatment has been given. This design ensures fairness and reliability of the results. We will measure: Back and leg pain levels, using a simple 0-10 scale; Disability, meaning how much the pain limits daily activities, measured with a well-known questionnaire; Quality of life, both physical and mental health aspects; Nerve-related pain features, like burning or electric-like sensations; and patients' global impression of improvement and any side effects. Assessments will take place before starting the treatment, at the end of the 6-week program, and then again at 3 and 6 months. This allows us to see both the short-, mid- and long-term effects. Safety considerations: Previous research shows that PENS and similar techniques are generally very safe. The most common side effects are mild and short-lasting, including temporary soreness, heaviness in the leg, or a small bruise. Serious complications are extremely rare. To minimize risks, all procedures will be carried out by experienced physiotherapists, using real-time ultrasound to guide needle placement and ensure accuracy. Only sterile, single-use needles are employed. By comparing PENS, TENS, dry needling, and placebo, this study seeks to determine whether PENS in combination with therapeutic exercise provides superior benefits in reducing pain, improving function, and enhancing quality of life for patients with sciatica-type low back pain. If successful, this treatment could become a valuable alternative to drugs or surgery, offering patients a safe and effective therapy to better manage their condition and regain daily function.

The Role of Temporal Changes in Pain Response After Transforaminal Epidural Steroid Injection on Treatment Success

Transforaminal epidural steroid injection (TFESI) is a commonly used minimally invasive procedure for the treatment of lumbar radicular pain secondary to disc herniation. Although TFESI has been shown to provide significant pain relief in a substantial proportion of patients, the onset, duration, and temporal pattern of pain relief after the procedure vary considerably among individuals. The relationship between early pain response patterns and long-term treatment success remains poorly understood. This prospective observational study aims to evaluate whether temporal changes in pain intensity following TFESI, particularly during the early post-procedural period, are associated with clinical treatment success at mid- and long-term follow-up. Pain intensity will be assessed using the Numeric Rating Scale (NRS) at predefined time points following the procedure, and treatment success will be defined as a ≥50% reduction in NRS score compared with baseline.

Effectiveness and Safety of Korean Medicine for Low Back Pain or Sciatica Due to Lumbar Stenosis/Spondylolisthesis

A prospective observational study investigating the effectiveness and safety of integrative Korean medicine treatment in lumbar stenosis or spondylolisthesis patients with low back pain or sciatica at 3 locations of Jaseng Hospital of Korean Medicine as assessed through of pain, functional disability, walking ability, and quality of life patient-reported outcomes

A Multicomponent Intervention for Patients With Lumbosacral Radiculopathy: Move-MORE

The Move-MORE study is designed to evaluate a multicomponent mindfulness and movement program for patients with lumbosacral radiculopathy. The program brings together mindfulness training to help participants develop awareness of their body and manage pain-related stress, gentle movement practice to improve comfort with physical activity and support function, and motivational interviewing to strengthen motivation, confidence, and the ability to make healthy changes. The main objectives are to determine whether it is feasible for participants to use each component of the program when delivered online, to assess how acceptable and engaging each component is, and to evaluate the impact on pain, physical function, and daily activity levels. The study intervention will be conducted entirely remotely. Participants will complete online surveys, brief daily check-ins on their phone, and wear a small activity monitor on the hip to measure movement. They will also undergo quantitative sensory testing to evaluate pain sensitivity. At the end of the program, participants will share feedback about their experiences via qualitative interviews. The findings will help identify which parts of the program provide the greatest benefit, with the ultimate goal of developing a more targeted and effective digital program for people with this condition.

Artificial Intelligence (AI)-Based Prediction of Treatment Response in Sciatica Patients Receiving Transforaminal Epidural Steroid Injection

This prospective observational study aims to develop artificial intelligence (AI)-based predictive models to estimate treatment response in patients with sciatica undergoing transforaminal epidural steroid injection (TFESI). Approximately 1500 adult patients diagnosed with sciatica and scheduled for TFESI at Marmara University Training and Research Hospital Algology Clinic will be enrolled. Clinical, radiological, laboratory, and psychological data will be systematically collected before the procedure and at multiple follow-up points (1 hour, 3 weeks, 3 months, and 6 months post-treatment). Pain relief, measured by a 50% or greater reduction in the Numeric Rating Scale (NRS), will be the primary outcome. The study will use these comprehensive data sets to train and validate AI algorithms, aiming to create a decision-support system that can predict individual patient responses to TFESI and improve personalized treatment planning.

Total Lumbar Disc Prosthesis and Subsequent Work Activity at at Least Five Years After Total Lumbar Disc Replacement

Lumbosciatica is a very prevalent pathology. When conservative treatments fail, surgery should be considered. The traditional surgical treatment is lumbar arthrodesis. The vast majority of patients who undergo spinal fusion cannot return to their same job and a good number of them never work again. Another form of treatment for lumbosciatica is the implantation of a lumbar disc prosthesis. This technique preserves the mobility of the lumbar area that has been operated on. This allows for a greater return to work and a higher percentage of those who return to the same job. This study aims to quantify how many of the patients who have had a lumbar disc prosthesis implanted in the last twenty years have returned to their same job, how many have had to change their jobs, and how many have not returned to work and are now totally or completely disabled from work.

Comparative Effects of Sciatic Nerve Flossing and Active Release Technique in Cyclists With Sciatica

Thus the aim of my study is to determine the comparative effects of sciatic nerve flossing and active release technique on pain, flexibility, and functionality in lower limbs of cyclists with sciatica.

Comparing the Efficacy of Steroid, Acupuncture and Platelet Rich Plasma Injection in Patients With Sciatica

Disc herniation, stenosis of the spine and spondylolisthesis are the common causes of radiculitis in medical practice today, and can cause symptoms of sciatica. Steroid injection, acupuncture and platelet-rich plasma injection are often used interventions for the treatments of sciatica. The investigators will investigate the efficacy and safety of steroid injection, acupuncture and platelet-rich plasma injection for sciatica in this single center, parallel, randomized-controlled clinical trial.

Effects of SSMC With and Without Myofascial Release in Patients With Sciatica

Sciatica involves a radiating pain along the sciatic nerve, extending from the lower back through the hips and buttocks to each leg. Typically resulting from a herniated disk or spinal stenosis, this condition causes nerve compression that leads to pain, inflammation, and often numbness in the affected leg. Studies have shown that sensorimotor training with myofascial release can be effective in improving pain, lumbar range of motion and functional disability. The aim of this study is to evaluate the effects of Sensorimotor control training with and without myofascial releases on Pain, Lumbar range of motion and functional disability due to sciatica. Participants which meet inclusion criteria will be randomly allocated using online randomization tool into two groups. Group A will receive somatosensory control training with Routine Physical Therapy for 45 minutes with short resting interval for Group B will receive Somatosensory training with myofascial release technique for 45min. Each group will receive treatment sessions of 3 days per week for 12 weeks.

Effects of Myofacial Release Technique and Sciatic Nerve Slider Technique in Sciatica

Sciatica is not a medical condition itself, but is a symptom of whatever condition is affecting your sciatic nerve. Pain in the lower back, hip and legs is the most common symptom. However, tingling, numbness and weakness are also symptoms of a damaged sciatic nerve. Physical therapy is a popular and effective way of treating the pain from sciatica. Myofascial release (MFR) is another useful option for sciatica due to the fact that it focuses the connective tissues of the body, including muscles and the fibrous tissues, often called fascia, encircling the joints.This study will be conducted to compare the Effects of myofacial release technique with and without sciatic nerve slider technique on Pain, Range of Motion and Functional Disability among cricket players with Sciatica. This study will be conducted because, no such evidence found in literature to find out the effects of myofacial release technique with sciatic nerve slider technique for sciatica. Myofacial release technique and sciatic nerve slider technique are useful, because these can reduce patients number of visits for the treatment and are easy to use, feasible and cost effective. The sciatic nerve is the largest nerve in the human body. It is formed at the point where five nerves from the lower back all come together, and stretches all the way from the hips to the bottoms of the feet. When this important nerve becomes compressed, inflamed or irritated, it causes the pain in the lower back and legs known as sciatica. A physical therapist uses a number of proven methods to help relieve sciatic pain. One of the most commonly employed methods is known as myofascial release therapy. Myofascial release is a method that a physical therapist can use to treat many sources of pain that are caused by damage to the nervous system. It involves the therapist using hands-on, manual techniques to release areas of tension and pain in the body. Here are three reasons that myofascial release is an effective tool for treating sciatica.

Transforaminal Epidural Injection in Acute Sciatica

Patients suffering from sciatica are treated conservatively for the first 8 weeks due to the favourable prognosis. This period is preferably extended up to 14-16 weeks after which patients may opt for surgery. However, patients may experience severe discomfort due to pain in the leg which can lead to decreased physical activity and socio-economic problems. An adequate therapy to alleviate symptoms during this period of 'wait-and-see' is lacking. In this study, patients will be randomized to treatment with transforaminal epidural injections or standard oral pain medication.