Clinical Research Directory

Perioperative Nutrition Management in Patients Undergoing Open Posterior Lumbar Surgery

Patients undergoing open posterior lumbar fusion surgery often experience postoperative gastrointestinal problems, such as bloating, constipation, and delayed passage of gas and stool, and may be at nutritional risk. These problems may hinder recovery and prolong hospital stay. This study enrolled 90 patients undergoing open posterior lumbar fusion surgery at the Department of Orthopedics, First Affiliated Hospital of Kunming Medical University. Participants were randomly assigned in a 1:1:1 ratio to three groups: a control group receiving routine perioperative care with standard dietary guidance; experimental group A receiving perioperative oral nutritional supplements (ONS) together with preoperative and postoperative carbohydrate loading; and experimental group B receiving the same ONS and carbohydrate loading plus a probiotic preparation. The primary outcome was the length of postoperative hospital stay. Other assessments included time to first postoperative flatus, time to first postoperative bowel movement, cumulative postoperative drainage volume, drainage duration, and time to first postoperative mobilization out of bed. Surgical wound healing, postoperative infections, and overall postoperative complications were assessed during hospitalization and at the outpatient follow-up visit 1 month after surgery. Additional assessments included anthropometric measurements, laboratory tests, and scores evaluating pain, function, nutritional risk, nutritional status, dietary intake, and gastrointestinal function. Anthropometric measurements were obtained at hospital admission and at the pre-discharge assessment. The Visual Analog Scale (VAS) for overall pain, Japanese Orthopaedic Association (JOA) low back pain score, Nutritional Risk Screening 2002 (NRS-2002), full Mini Nutritional Assessment (MNA), Simple Diet Self-Assessment Tool (SDSAT), and simplified gastrointestinal function score were assessed at hospital admission, on postoperative day 3, at the pre-discharge assessment, and at 1 month after surgery. Laboratory tests were performed before surgery and on postoperative days 1, 3, and 6. The aim was to evaluate the clinical value of perioperative nutrition management in spinal surgery and explore whether adding probiotics provided further benefit. The study was intended to inform the development of a practical perioperative nutrition management plan to support recovery, shorten hospital stay, and reduce postoperative complications.

Intradiscal Ozone/Oxygen Injection for Treatment of Contained Lumbar Disc Herniation

This study is retrospectively designed and aims to evaluate and summarize safety and performance data in eligible participants who have undergone Intradiscal ozone-oxygen injection for treatment of lumbar disc herniation with the Triojection® System in Canada under Special Access Program (SAP) between April 2022 and 31 March 2026 at one(1) participating site. The primary objectives of the study are : 1. To evaluate the clinical success in eligible participants who have undergone intradiscal ozone-oxygen injection procedure with the Triojection® System for treatment of lumbar disc herniation. 2. To evaluate the safety in eligible participants who have undergone the procedure. Retrospective data will be collected from existing medical records across three predefined periods: * Baseline, defined as within 180 days prior to treatment (index procedure); * Treatment, of variable duration, encompassing clinic admission, performance of the index procedure, post-procedure recovery, and discharge; * Follow-up, of variable duration, including any follow-up visits performed after discharge as part of the standard course of medical care. In addition, prospective data collection will be performed during a separate follow-up period of variable duration, consisting of follow-up visits conducted either remotely or in person to collect participant-reported outcomes including pain, function, work status, updated medical history, and medication use.

Flexion-Distraction Technique

This prospective, two-center, non-randomized controlled study compared the effects of conventional physical therapy (CPT) and Cox flexion-distraction therapy (CFT) on pain, lumbar range of motion, disability, and health-related quality of life in patients with lumbar disc herniation (LDH). The study included adults aged 30-60 years diagnosed with L4-L5 lumbar disc herniation who received treatment at Bursa VM Medical Park Hospital or Nilüfer Spine Health Center in Türkiye. Participants were allocated to treatment groups according to their preferred treatment centers, without randomization. A total of 68 participants were enrolled, and 66 were included in the final analysis (32 in the CFT group and 34 in the CPT group). Both groups received treatment three times per week for four weeks. The CPT group received therapeutic ultrasound, transcutaneous electrical nerve stimulation (TENS), superficial heat application, and home exercises. The CFT group received Cox flexion-distraction therapy, superficial heat application, and home exercises. Pain intensity was assessed using the Visual Analog Scale (VAS), disability using the Oswestry Disability Index (ODI), lumbar range of motion using a standard goniometer, and health-related quality of life using the Short Form-36 Health Survey (SF-36). The study evaluated clinical outcomes associated with these two conservative treatment approaches, taking into account the non-randomized nature of treatment allocation.

IASTM and Vibration Effects on Pain, Functionality, and Kinesiophobia in Lumbar Disc Herniation

The aim of this study is to investigate the effects of Instrument-Assisted Soft Tissue Mobilization and vibration massage therapy on pain, functionality, and kinesiophobia in individuals with lumbar disc herniation.

Comparison Of Early Mobilization And Electrical Stimulation On Functional Recovery After Lumbar Disc Herniation Surgery

This randomized controlled trial aims to compare the effectiveness of early mobilization alone versus early mobilization combined with electrical stimulation on functional recovery following lumbar disc herniation surgery. Lumbar disc herniation is a common cause of low back pain and functional limitation, significantly affecting quality of life. Although surgical intervention is effective in patients who do not respond to conservative treatment, optimal postoperative recovery largely depends on appropriate rehabilitation strategies. Early mobilization is widely recommended to prevent complications, preserve muscle function, and facilitate return to daily activities. In addition, electrical stimulation modalities such as neuromuscular electrical stimulation (NMES) and transcutaneous electrical nerve stimulation (TENS) have been increasingly integrated into rehabilitation programs to enhance pain control, muscle activation, and neuromuscular re-education. In this study, a total of 60 participants who have undergone primary lumbar disc herniation surgery will be randomly assigned into two groups. The first group will receive an early mobilization program alone, while the second group will receive early mobilization combined with electrical stimulation (NMES/TENS). The intervention period will last 6 to 8 weeks, with sessions conducted three times per week. Primary outcomes include functional disability measured by the Oswestry Disability Index (ODI) and pain intensity measured by the Visual Analog Scale (VAS). Secondary outcomes include functional mobility assessed by the Timed Up and Go (TUG) test, walking speed assessed by the 10-Meter Walk Test (10MWT), and muscle strength evaluated using manual muscle testing (MMT). The findings of this study are expected to contribute to the development of evidence-based postoperative rehabilitation protocols and to clarify the clinical effectiveness of electrical stimulation in patients undergoing lumbar disc herniation surgery

The Effect of Ney Music on Patients Undergoing Lumbar Disc Surgery

This randomized controlled study aims to investigate the effects of ney music listening, a traditional Turkish wind instrument, on pain, anxiety, sleep quality, and vital signs in patients undergoing lumbar disc herniation surgery. Participants will be randomly assigned to intervention and control groups. The intervention group will receive a 15-minute ney music session at three different time points: preoperative (on the day of surgery), postoperative 3rd hour, and postoperative day 1. The control group will receive standard postoperative nursing care without music intervention. Data will be collected at the same time points in both groups using the Visual Analog Scale (VAS), State-Trait Anxiety Inventory (STAI-I), Richard-Campbell Sleep Questionnaire, and vital signs. The study seeks to evaluate the non-pharmacological benefits of therapeutic music in postoperative recovery.

Selective Nerve Root Block Versus Sham to Reduce Surgery for Lumbar Disc Herniation

The SELDISC trial will investigate whether a selective nerve root block can reduce the need for surgery in adults with a herniated disc in the lower back. A herniated disc can irritate a nerve and cause pain that travels down the leg. A nerve root block delivers a local anaesthetic and a corticosteroid near the affected nerve to relieve pain and inflammation. The study will include 262 adults aged 18-66 years who have persistent leg symptoms despite non-surgical treatment and have been assessed by a spine surgeon as eligible for surgery. Participants will be randomly assigned to receive either a selective nerve root block or a sham procedure that mimics the treatment without delivering the active medication near the nerve. Each participant will have an equal chance of receiving either procedure. Participants and the study staff assessing their outcomes will not know which procedure was given. The radiologist performing the procedure will know the allocation. The main question is whether fewer participants in the nerve root block group undergo surgery within 12 months after randomisation. The study will also compare pain, disability, quality of life, time to surgery, medication use, sick leave, healthcare use and adverse events between the groups.

Baduanjin With Resistance Training Program

The purpose of this study is to improve symptoms of Lumbar Disc Herniation (LDH) and Osteoporosis (OP) by implementing an evidence-based Baduanjin exercise to reduce pain and increase muscle strength and quality of life in Chinese patients. This study will provide new sights of exercise of elderly patients with LDH and OP for elderly patients.

Comparison of the Effects of Quadratus Lumborum Block and Retrolaminar Block on Postoperative Pain in Lumbar Disc Herniation Surgery

This study aims to compare the analgesic efficacy of quadratus lumborum block (QLB) and retrolaminar block (RLB) in patients undergoing lumbar disc herniation surgery. Both regional anesthesia techniques are increasingly used for postoperative pain management, but there is limited evidence directly comparing their effectiveness. The primary outcome is postoperative opioid consumption, while secondary outcomes include postoperative pain scores

Telerehabilitation After Lumbar Disc Herniation Surgery

This randomized controlled trial evaluated the effectiveness of a telerehabilitation-based exercise program in individuals who had undergone surgery for lumbar disc herniation. Participants were assigned to a control group, a home exercise group, or a telerehabilitation group. The exercise programs started four weeks after surgery and continued for eight weeks, three days per week, with each session lasting 30-45 minutes. The home exercise group performed the exercise program independently at home, while the telerehabilitation group performed the same program under remote supervision of a physiotherapist using video calls. The control group continued their routine daily activities without participating in a structured exercise program during the study period. Pain, disability, physical activity, and health-related quality of life were assessed before and after the eight-week intervention period.

Effect of Electromagnetic Field in Lumbar Disc Prolapse Patients

to investigate the effect of electromagnetic field therapy on sciatica and postural control in lumbar disc prolapse patients BACKGROUND: lumbar disc prolapse is a clinical condition resulting from compression of lumbar nerve roots resulting in decreased postural control and alleviating sciatic pain Pulsed electromagnetic field (PEMF) therapy is an easy, non-invasive, safe, and relatively new treatment method that is used with growing interest in physical and rehabilitation medicine. Historically, the benefits from magnetotherapy have been reported for patients with musculoskeletal and neurological disorders

Nurse-Led Early Standing Exercise After Lumbar Fusion in Older Adults

This single-center, randomized controlled trial aimed to evaluate the effects of a nurse-led early standing active exercise program on postoperative functional recovery in older adults undergoing short-segment lumbar fusion. A total of 108 participants aged 65 years or older were randomly assigned in a 1:1 ratio to an intervention group or a control group. Both groups received routine postoperative rehabilitation. The intervention group additionally received a nurse-led standing exercise program initiated 16-24 hours after surgery, following a clinical safety assessment, and continued daily until hospital discharge. The primary outcome was the six-minute walk distance, assessed before surgery and one day before discharge. Secondary outcomes included functional disability, pain intensity, and exercise adherence.

Pulmonary Mechanics and Cerebral Oxygenation During Prone Lumbar Disc Surgery

This prospective observational study aims to evaluate the relationship between changes in respiratory mechanics and cerebral oxygenation in adult patients undergoing elective lumbar disc surgery in the prone position under general anesthesia. Cerebral regional oxygen saturation will be monitored using bilateral frontal near-infrared spectroscopy (NIRS), while respiratory parameters including tidal volume, respiratory rate, peak airway pressure, plateau pressure, positive end-expiratory pressure, and dynamic compliance will be recorded from the anesthesia ventilator. Measurements will be obtained at predefined time points before and after positioning the patient prone and after returning to the supine position at the end of surgery. No changes will be made to anesthesia, ventilation, medication doses, or surgical management for research purposes. All clinical care will be provided according to routine practice by the responsible anesthesia team. The study will investigate whether changes in respiratory mechanics during prone positioning are associated with changes in cerebral regional oxygen saturation.

Randomized Evaluation of Lumbar Injection Effectiveness and Function

The goal of this clinical trial is to learn whether the Triojection® System is safe and effective for treating symptomatic lumbar radiculopathy (leg pain caused by nerve irritation or compression) resulting from a contained herniated lumbar disc. The study will enroll adults 18 to 75 years of age with a single-level contained lumbar disc herniation who continue to have symptoms despite at least 6 weeks of non-surgical treatment and a previous lumbar spine injection. The main questions it aims to answer are: * Does treatment with the Triojection® System improve leg pain and overall clinical outcomes compared with Selective Nerve Root Block (SNRB) alone? * Is treatment with the Triojection® System safe, as measured by the absence of device- or procedure-related serious adverse events and persistent neurological deficits? Researchers will compare participants who receive Triojection® followed by SNRB with participants who receive SNRB alone to determine whether the investigational treatment provides improved clinical outcomes. Participants will: * Be randomly assigned to receive either Triojection® plus SNRB or SNRB alone. * Complete questionnaires about leg pain, back pain, disability, quality of life, sleep, anxiety, depression, and overall improvement. * Undergo physical and neurological examinations during study follow-up visits. * Have MRI scans performed at selected study visits to evaluate changes in the treated disc. * Attend follow-up visits at 1, 3, 6, 12, 18, and 24 months after treatment. Up to 300 participants will be enrolled at up to 30 investigational sites in the United States and Canada and followed for approximately 24 months after treatment.

Effect of Irrigation Pressure on Postoperative Complications and Surgical Field Clarity in Unilateral Biportal Endoscopic Surgery

This study is being done to find out if the height of the fluid bag and the direction of the surgical cut affect the pressure of the fluid used during unilateral biportal endoscopic (UBE) spine surgery. UBE is a minimally invasive surgery for the spine. During this surgery, fluid is used to keep the surgical area clear and to control bleeding. The pressure of this fluid may affect how clear the surgical view is, how much bleeding occurs, and how well patients recover after surgery. We will also collect disc tissue removed during surgery to study how disc degeneration is related to factors such as sex, age, mechanical stress, and injury. About 80 patients aged 18 to 75 who are scheduled for UBE surgery at our hospital will take part. Patients will be randomly assigned to one of four groups based on two things: the height of the fluid bag (0.9 meters or 1.0 meters) and the direction of the surgical cut (horizontal or vertical). We will measure the fluid pressure around the spinal covering during surgery and record how clear the surgical view is. After surgery, we will track patients' pain and recovery for at least 6 months. This study has been approved by the hospital ethics committee.

Non-pharmacological Treatment vs Pharmacological Treatment for Non-acute Lumbar Disc Herniation

This is a randomized controlled study comparing non-pharmacological treatment to proactive pharmacological treatment for patient with non-acute lumbar disc herniation with moderate or higher levels of pain. The study involves 200 adult patients aged 19-69, with 50 patients from each participating hospital. Patients will be randomly assigned to either the non-pharmacological treatment group or the pharmacological treatment group 1:1 ratio. Specific interventions will be determined by doctors and Korean medicine doctors without predefined treatment strategies. The non-pharmacological treatment include acupuncture, electroacupuncture, spinal manual therapy and motion style acupuncture. The pharmacological treatment include medication prescription, injection, and nerve block. Treatment period is 8 weeks, and f/u for 3 years.

Comparing Three Epidural Steroid Injection Approaches for Lumbar Radicular Pain

This study will compare three fluoroscopy-guided epidural steroid injection approaches for adults with unilateral lumbosacral radicular pain caused by lumbar disc herniation. The study will evaluate whether the pattern of contrast spread in the epidural space predicts meaningful pain relief. Ninety-nine participants will be randomly assigned in equal numbers to receive one of three treatments: high-volume parasagittal interlaminar injection, low-volume parasagittal interlaminar injection, or transforaminal epidural steroid injection. Participants will not be told which injection approach they receive. Pain and disability will be assessed before treatment and at 2 weeks, 1 month, 3 months, and 6 months after injection. The main outcome is the proportion of participants with clinically meaningful improvement in pain at 3 months.

The Effect of Physiotherapy on Respiratory Function and Psychosocial Status in Lumbar Discopathy

The aim of this study is to investigate the effects of physiotherapy on pulmonary function tests and psychosocial status in patients with lumbar discopathy. Participants undergo a 15-session physiotherapy program. Respiratory function tests and questionnaires, including the Visual Analogue Scale (VAS) for pain, Short Form-36 (SF-36), and Roland Morris Disability Questionnaire (RMQ), are performed before and after the physiotherapy program to evaluate the outcomes.

Lower Back Muscle Size and Recovery After Lumbar Disc Herniation Surgery

Recovery after surgery for a herniated disc in the lower back differs from person to person. The size of the muscles around the lower spine may be related to recovery, but this relationship is not well understood. The purpose of this observational study is to determine whether the size of two lower-back muscles, the psoas and multifidus muscles, measured on magnetic resonance imaging (MRI) scans obtained before surgery is related to recovery after surgery. The study will include 100 adults aged 18 to 75 years who are scheduled for elective surgery for lumbar disc herniation. Participants will receive their usual anesthesia, surgery, and postoperative care. The study will not require any additional imaging, blood tests, medicines, or procedures. Researchers will use each participant's existing preoperative lumbar MRI scan to measure the psoas and multifidus muscles. Participants will complete the 15-item Quality of Recovery questionnaire (QoR-15) before surgery and again 24 hours, 48 hours, and 7 days after surgery. Researchers will also collect information routinely recorded during care, including pain scores, pain medicine use, nausea and vomiting, time spent in the recovery unit, time to first walking, and length of hospital stay. The primary objective is to determine whether preoperative psoas muscle index and multifidus muscle cross-sectional area are independently associated with postoperative Quality of Recovery-15 (QoR-15) scores 24 hours after lumbar disc herniation surgery.

Validation of a Methodology Using Isometric Dynamometer for Ankle STrength Assessment to Quantify LDH-induced Paresis

Lumbar disc herniation (LDH) is a common condition that may cause lower limb motor weakness (paresis), particularly affecting ankle dorsiflexion and plantarflexion. Although motor deficits are clinically important and may influence treatment decisions, objective and standardized methods for quantifying the severity of paresis are lacking. Current clinical assessment mainly relies on manual muscle testing, which is subjective and has limited sensitivity, while isokinetic dynamometry, the reference standard for muscle strength assessment, is expensive and impractical for routine clinical use. This prospective validation study aims to evaluate a clinically feasible isometric ankle strength measurement method based on a handheld dynamometer fixed with an external strap to eliminate examiner-dependent resistance. The study will be conducted in two sequential phases. First, validity and reliability of the method will be established in healthy adult volunteers by comparing measurements with those obtained using an isokinetic dynamometer. Second, the method will be applied in patients with LDH-induced lower limb paresis to determine its performance across a broader range of muscle strength values and its clinical applicability. Outcome measures include maximal isometric ankle dorsiflexion and plantarflexion force, time to peak force, manual muscle testing (Medical Research Council scale), patient-reported weakness using a Numeric Rating Scale, Lower Extremity Functional Scale (LEFS) scores, and functional ankle strength tests. Validity will be assessed using correlation analyses and Bland-Altman agreement analysis, while intra- and inter-rater reliability will be evaluated using intraclass correlation coefficients, coefficient of variation, standard error of measurement, and minimum detectable change. The study seeks to establish a reliable, valid, and clinically practical method for objective assessment of ankle muscle strength in patients with LDH-induced paresis. Such a method could improve clinical evaluation, enable objective monitoring of recovery, facilitate future clinical research, and support treatment decision-making.

Comparison of 5 vs 8 cmH₂O PEEP on Respiratory Mechanics in Prone Lumbar Surgery

This randomized controlled clinical trial aims to compare the effects of two different positive end-expiratory pressure (PEEP) levels (5 cmH₂O and 8 cmH₂O) on respiratory mechanics in patients undergoing lumbar spine surgery in the prone position under total intravenous anesthesia (TIVA). Prone positioning may adversely affect lung compliance and gas exchange, making optimal ventilatory strategies essential. Driving pressure and mechanical power are considered key determinants of ventilator-induced lung stress. This study will evaluate the impact of different PEEP levels on respiratory parameters and intraoperative physiological changes.

Bladder Meridian Gua Sha for Lumbar Disc Herniation: Efficacy and CRP Regulation Via Cutaneous-Meridian-Visceral Axis in Shen Period

Based on the "Cutaneous Region-Meridian-Visceral" axis theory, in this study, we investigated clinical efficacy of the Gua Sha intervention on the Bladder Meridian during the Shen Period (3:00-5:00 p.m.) for lumbar disc herniation (LDH) and its regulatory effect on serum C-reactive protein (CRP).This randomized controlled study enrolled 128patients with LDH admitted to the Department of Rehabilitation at Guangdong Hospital of Integrated Traditional Chinese and Western Medicine between January 2023 and December 2024. They were randomly assigned to a control group (n=64) and an observation group (n=64). The control group consisted of standard treatment and care according to the diagnostic and treatment guidelines for LDH. The observation group consisted of standard treatment and care supplemented with Gua Sha on the Bladder Meridian during the Shen Period. The Japanese Orthopedic Association (JOA) scores, Visual Analog Scale (VAS) pain scores, changes in CRP levels, and traditional Chinese medicine (TCM) efficacy evaluations were assessed for both groups before the intervention and at 2-week and 4-week after the intervention.

Comparison of TLIP Block and QIP Block for Postoperative Analgesia After Lumbar Spine Surgery

This study compares two regional anesthesia techniques used for pain control after lumbar spine surgery: the classic thoracolumbar interfascial plane (TLIP) block and the quadratus lumborum-iliac plane (QIP) block. Patients between 18 and 65 years of age who undergo elective lumbar discectomy (up to two spinal levels) will be observed based on which block their treating anesthesiologist chooses to use as part of routine clinical practice. No randomization or additional intervention beyond standard care will be performed. Researchers will record the total amount of opioid pain medication used in the first 24 hours after surgery, the time until the first request for pain medication, pain scores at several time points after surgery (0, 1, 2, 4, 8, 12, and 24 hours), and any side effects (such as nausea, vomiting, or sedation) or complications related to the block. The aim is to compare the effectiveness and safety of these two techniques in reducing pain and opioid use after lumbar spine surgery.

Biologic Injection For Adults With Lumbar Disc Herniation

The goal of this clinical trial is to find out whether adding a bone-marrow aspirate concentrate (BMAC) injection during surgery can improve recovery in adults undergoing lumbar microdiscectomy for a lumbar disc herniation. The main questions it aims to answer are: * Does the BMAC injection lead to better disc tissue health after surgery (as seen on MRI scans)? * Does the BMAC injection lead to greater improvement in pain and disability compared to surgery alone? Participants will be adults aged 18 and older who are scheduled for lumbar microdiscectomy surgery. Researchers will compare one group of participants receiving the standard-of-care surgery plus the BMAC injection with another group receiving the same surgery without the injection to see if the injection offers added benefit. Participants will: * Have surgery (microdiscectomy) with or without the injection. * Complete pain and disability questionnaires at several times over 2 years. * Undergo MRI scans at baseline and follow-up to assess disc structure and tissue health. * Provide samples of leftover disc or bone-marrow tissue (as applicable) from surgery for analysis.