Clinical Research Directory

Pilot Study: Clinical Trial of Ultrasound Guiding Pharmacopuncture Therapy for Acute Low Back Pain

This pilot randomized controlled clinical trial aims to evaluate the effectiveness and safety of ultrasound-guided deep pharmacopuncture therapy for acute low back pain (LBP) that occurs within seven days following a traffic accident. While traditional Korean medicine-including acupuncture, herbal medicine, pharmacopuncture, and Chuna manual therapy-is commonly used for post-accident injuries, few studies have focused on deep pharmacopuncture administered under ultrasound guidance. This study will provide preliminary evidence to assess whether ultrasound-guided techniques offer added clinical benefits. A total of 40 patients hospitalized at Jaseng Hospital of Korean Medicine in Haeundae, Korea, will be recruited and randomly assigned into two groups: the intervention group will receive integrative Korean medicine therapy plus ultrasound-guided pharmacopuncture, while the control group will receive integrative Korean medicine therapy alone. Both groups will undergo treatment during hospitalization, with the pharmacopuncture administered up to three times between hospital day 2 and day 4 in the intervention group. Baseline assessment will be done on day 2 before treatment, and the primary outcome will be measured on day 5. Follow-up assessments will be conducted at 2 and 4 weeks via telephone. The primary outcome is the change in low back pain intensity as measured by the Numeric Rating Scale (NRS). Secondary outcomes include radiating pain, lumbar range of motion, Oswestry Disability Index (ODI), EQ-5D for quality of life, and the Patient Global Impression of Change (PGIC). Adverse events will also be monitored and classified according to established safety criteria. This study will utilize both intention-to-treat (ITT) and per-protocol (PP) analyses, with linear mixed models and multiple imputation used to address missing data. Given the limited existing evidence on ultrasound-guided deep pharmacopuncture, this trial is designed to explore its feasibility and provide the groundwork for future large-scale trials. Participants will be selected based on strict inclusion and exclusion criteria to ensure safety and consistency. Ethical standards including informed consent, data privacy, and ongoing safety monitoring will be rigorously upheld throughout the study.

Investigation of the Acute Effects of Core Stabilization and 360-Degree Breathing Exercises on Balance and Proprioception in Individuals With Non-Specific Low Back Pain

This study is designed as a single-blind randomized controlled trial. Male and female patients aged 18-65 years with complaints of non-specific low back pain (NSLBP) lasting longer than 12 weeks will be included in the study. Participants will be randomly assigned into two parallel groups: control and intervention. The control group will perform core stabilization exercises five days a week for three weeks. In the intervention group, core stabilization exercises will be combined with 360-degree breathing exercises. To our knowledge, there is no randomized controlled trial investigating the effect of combining core stabilization with 360-degree breathing in individuals with NSLBP. The aim of this study is to examine the acute effects of combining 360-degree breathing techniques with core stabilization exercises on balance and proprioception in individuals with NSLBP.

Telerehabilitation in Managing Chronic Low Back Pain

The purpose of this study is to determine whether telerehabilitation is as effective as in-person rehabilitation in treating patients with chronic back pain in actual clinical practice settings.T he study will recruit eighty-four individuals with chronic LBP, who will be randomly assigned to one of two groups: telerehabilitation (TR) or the control group, who will receive standard clinic therapy. The TR group will be treated remotely via phone calls and the Zoom platform. The intervention program will be customized according to the requirements and abilities of each patient. It will include self-management skills, education and support, including Pain Neuroscience Education , and customized exercises.

The Effect of Needle Insertion Angle on Contrast Distribution and Treatment Outcomes in S1 Transforaminal Epidural Steroid Injections

Nerve compression due to lumbar disc herniation (lumbosacral radiculopathy) is a condition characterized by pain in the lower back and legs and restricted lumbar joint movement due to the compression of nerves emerging from the lumbar spine caused by the protrusion of the intervertebral disc. Back pain negatively impacts patients' quality of life and emotional well-being. Treatment approaches aim to alleviate pain, improve joint mobility, and restore functionality through the use of pain-relief medications (topical or oral), physical therapy methods, and rehabilitation programs that include exercises for range of motion, stretching, and strengthening. When these approaches prove insufficient, interventional procedures (injection therapy) or surgical interventions come to the forefront. One of the proven interventional treatment methods for herniated disc disease is the transforaminal epidural steroid injection (TFESE), which involves the injection of cortisone around the compressed nerve due to the herniation and is frequently performed in our clinic. Transforaminal injections require imaging guidance and the use of contrast media to enhance the safety and effectiveness of the procedure. To visualize the S1 foramen, needle entry is performed using various angles under fluoroscopy guidance. This study will investigate the effect of the needle entry angle on the spread and pattern of contrast media, complications, and treatment outcomes in fluoroscopy-guided S1 transforaminal epidural steroid injections. The research aims to determine whether the needle entry angle influences the pattern of contrast spread and the treatment outcomes in S1 TFESE. Based on the findings of this study, the goal is to refine the procedure for patients requiring injections at this level in the future, optimizing the technique and clinical outcomes. This will provide essential insights to practitioners, maximize the benefits for the patient group undergoing the procedure, and make a significant contribution to medical science. Detailed information regarding the planned injection therapy by your algology specialist will be provided, and written and verbal consent will be obtained through the "Epidural Steroid Injection Consent Form." Various scales and questionnaires will be administered at specific intervals-prior to the procedure, 1 hour after, 3 weeks after, and 3 months after-to evaluate pain levels, treatment response, and the impact on daily activities. The content of these evaluations will be explained in detail by your physician. Temporary side effects related to the injection may include increased pain at the injection site, low blood pressure, dizziness, fainting, and allergic reactions, all of which can be managed with appropriate treatment. Although rare, severe side effects such as nerve damage, spinal cord injury, or stroke have been reported in some cases. However, adherence to the guidelines outlined in treatment protocols and the performance of the procedure by adequately trained and experienced physicians significantly reduce the likelihood of these serious side effects. This injection will be performed by an algology specialist with at least 10 years of experience in this field. All necessary precautions will be taken against potential side effects, and the performing team will provide immediate medical intervention in case of complications. Approximately 66 volunteers will participate in this study, with each follow-up evaluation expected to take about 15 minutes. The identities of participants will remain confidential, and they have the right to withdraw from the study at any time by notifying the researchers. If deemed necessary by the researchers, participants may also be excluded from the study. If a participant declines to participate or is excluded from the study, their treatment will not be interrupted. Participants will not bear any financial responsibility for research-related expenses, and no additional travel costs will be incurred as evaluations will coincide with regular clinic visits.