The Effect of Cold Therapy on Peripheral Neuropathy
An estimated 400 000 children and adolescents ages 0-19 years old are diagnosed with cancer each year (WHO, 2021a). More than 80% of children with cancer are cured in high-income countries, where comprehensive care is generally available; whereas in some low- and middle-income countries less than 30% of patients survive (WHO, 2021b; Lam et al., 2019). Considering the global increase in childhood cancer incidence (Bhakta et al., 2019; Ward et al., 2019), it is critical to characterize the long-lasting side effects of treatment for childhood cancer and accurately assess, monitor, and ultimately develop management strategies to prevent treatment-related side effects (Kandula et al., 2016). Many chemotherapy agents used in cancer treatment can cause acute and chronic peripheral nervous system injury and dysfunction, termed chemotherapy-induced peripheral neuropathy (CIPN) (Rodwin et al., 2021; Kandula et al., 2016). CIPN is a significant problem becoming more prevalent as oncological therapies that use potentially neurotoxic chemotherapy enhance cancer cure and survival (Cavaletti et al., 2019). Peripheral neuropathy is a severe side effect of chemotherapeutic agents, and it can damage the sensory-motor-autonomic regions of the peripheral nervous system (Park et al., 2013; Kandula et al., 2016). Peripheral nerve toxicity has been described with vinca alkaloids, platinum compounds, taxanes, epothilones, bortezomib, and thalidomide (Kandula et al., 2016; Kandula et al., 2018; Cavaletti et al., 2019). Acute CIPN can develop during chemotherapy, necessitating dosage reduction or discontinuation and reducing survival (Colvin, 2019). In a recent systematic review of 42 publications (2009-2020) the reported CIPN incidence ranges from 2.8% to 100%, depending on risk variables. Sensory, motor, autonomic CIPN, and pain had incidence rates of 2-28%, 50-72%, 0.8-83%, and 5.7-44%, respectively (Smith et al., 2021). According to another review, although not life-threatening, CIPN threatens function in children and adolescents treated for cancer both during and following treatment (Bjornard et al., 2018). Smith et al. (2021) noted, "...sensory and motor neuropathy, pain, and functional impairments..." are not uncommon and appear to continue into adulthood. The most common CIPN symptoms in children and adolescents are numbness, tingling, neuropathic pain in the upper and lower limbs, weakness, loss of ankle dorsiflexion range of motion (foot drop), and impaired balance (van de Velde et al., 2017; Kandula et al., 2016; Schouten et al., 2020; van de Velde et al., 2021) VCR is one of the most commonly used vinca alkaloids in pediatric cancer patients and is included in a variety of multiple chemotherapy treatments for acute lymphoblastic leukemia, lymphomas, neuroblastoma, sarcomas, and central nervous system tumors (Mora et al., 2016; Schouten et al., 2020). Neurotoxicity as a prominent side effect of VCR, defined by autonomic and peripheral sensory-motor neuropathy, has been documented in three studies to be as low as 12% and as high as 87% of VCR-exposed children (Gilchrist et al., 2014; van de Velde et al., 2017; van de Velde et al., 2021). The fact that the prevalence of VIPN is so wide is due to the difference in the measurement tools used (van de Velde et al., 2017). VIPN symptoms generally arise after only a few VCR injections, and symptoms often fade a few months after VCR medication is stopped. Paresthesia, constipation, muscular weakness, areflexia, neuropathic pain, and lack of sensation symptoms commonly relate to VIPN (van de Velde et al., 2021). VIPN treatment addresses symptoms and involves analgesics like gabapentin and amitriptyline (van de Velde et al., 2021). However, the only successful therapy option for VIPN is VCR dosage reduction, even though this limits optimal treatment (Mora et al., 2016). The limited treatment options for VIPN and the symptoms it causes in children have been linked to reducing the quality of life (QoL) both during and after treatment (Mora et al., 2016). Furthermore, it is known that peripheral neuropathy pain affects QoL during cancer therapy. However, it is uncertain how much VIPN affects the QoL in children with cancer during therapy (Bjornard et al., 2018; van de Velde et al., 2021). Many pharmacological and non-pharmacological methods are used in the management of peripheral neuropathy. However, the neurotoxicity mechanisms of peripheral neuropathy are not well known, which a significant limitation in discovering effective treatments to prevent VIPN among pediatric oncology patients. A systematic review focusing on the efficacy and safety of cryotherapy for preventing VIPN in adults, reported that cryotherapy is a reasonable option to prevent VIPN (Bailey et al., 2021). The primary mechanism of benefit from cryotherapy has been hypothesized to be via vasoconstriction that decreases blood flow (and therefore, chemotherapy delivery) to treated areas (Loprinzi et al., 2020). Unfortunately, the following factors prevent the use of cryotherapy to prevent CIPN: (i) rare reports of frostbite, (ii) patient irritation, (iii) administrative difficulties (for patients, parents, and care professionals alike), and (iv) the lack of conclusive evidence that this approach reduces CIPN (Loprinzi et al., 2020). Nevertheless, many cryotherapy studies have shown the effectiveness of cryotherapy on peripheral neuropathy in adults (Beijers et al., 2020; Ng et al., 2020), we were unable to identify any studies in children and adolescents with cancer. There is a need for studies to evaluate the effectiveness of cryotherapy in reducing peripheral neuropathy in pediatric oncology patients. This study aims to evaluate the effectiveness, tolerability, and acceptability of cold therapy on VIPN among pediatric oncology patients in Turkey.
Phase
N/ASpan
103 weeksSponsor
Koç UniversityIstanbul
Recruiting
Investigation of Musculoskeletal System Disorders Seen in Automotive Industry Workers
This study will be conducted as a face-to-face survey. Surveys will be created with Google Forms and will be filled out by the physiotherapist according to the participant's response.
Phase
N/ASpan
13 weeksSponsor
Uskudar UniversityIstanbul
Recruiting
Healthy Volunteers
Association of EASIX in Sepsis
Sepsis is a life-threatening condition characterized by a dysregulated host response to infection, leading to organ dysfunction. Despite advancements in medicine, sepsis remains a significant cause of death worldwide. An international study showed that 48.9 million sepsis cases were diagnosed in 195 countries between 1990 and 2017, resulting in 11 million deaths. Recent studies have demonstrated that early diagnosis and treatment reduce sepsis mortality. Therefore, research has focused on identifying biomarkers that aid in early diagnosis and prognosis. The Endothelial Activation and Stress Index (EASIX) was first defined by Luft et al. as a biomarker reflecting endothelial damage. Calculated using readily available laboratory parameters-serum lactate dehydrogenase (LDH) level (U/L) x creatinine level (mg/dL) / platelet count (10⁹/L)-it has been commonly used to predict mortality and prognosis in hematological malignancies. Recently, its application in predicting sepsis mortality and prognosis has gained attention, although only limited retrospective studies have been published.
Phase
N/ASpan
70 weeksSponsor
Sisli Hamidiye Etfal Training and Research HospitalIstanbul
Recruiting
Effect of Vibration Massager Therapy on Non-Specific Low Back Pain
This study will be conducted using a randomized controlled design. Volunteers between the ages of 18-65 with non-specific low back pain will be included in the study. Inclusion criteria are that participants do not have structural pathologies and agree to participate in the study voluntarily. Exclusion criteria include spinal deformities and exercise intolerance. Participants will be randomly divided into two groups. Individuals in the first group will receive vibratory massage therapy, while the second group will be evaluated with standard treatment methods as a control. Both groups will receive treatment 3 times a week for 8 weeks. Participants' quality of life, pain levels, range of motion, and muscle activity will be evaluated before and after treatment. Data will be collected using tools such as SF-36, Oswestry Low Back Pain Index, and VAS (Visual Analog Scale).
Phase
N/ASpan
14 weeksSponsor
Uskudar UniversityIstanbul
Recruiting
Healthy Volunteers
Effects of Hydrotherapy on Unilateral Lower Extremity Lymphedema
This study included patients, with in the control group and in the intervention group, who applied to the lymphedema outpatient clinic at Health Sciences University Gaziosmanpasa Training and Research Hospital, Department of Physical Therapy and Rehabilitation. The demographic and clinical data of the patients were recorded. Before treatment, limb volume was assessed using the circumference measurement method, quality of life was evaluated with the Lymphedema Quality of Life Questionnaire (LYMQOL), lower extremity functionality was assessed with the Lower Extremity Functional Scale (LEFS), and exercise capacity was measured using the 10-Meter Walk Test. Patients in the control group followed only a home exercise program for 6 weeks, while the intervention group received hydrotherapy combined with a home exercise program for the same period. Hydrotherapy was conducted as 30-minute aquatic exercise sessions in groups of 5-7 participants, in a hydrotherapy pool with a depth of 130 cm and a temperature of 30-31°C, under the supervision of a trained physiotherapist. At the end of the treatment, patients were re-evaluated in terms of volume, functionality, quality of life, and exercise capacity. The two groups were compared regarding volume measurement, functionality, and quality of life
Phase
N/ASpan
53 weeksSponsor
Gaziosmanpasa Research and Education HospitalIstanbul
Recruiting
A Comparative Study of Erector Spinae Plane Block and Serratus Posterior Superior Intercostal Plane Block on Postoperative Opioid Consumption Following Breast and Axillary Dissection Surgery
Introduction Breast surgery is one of the most commonly performed surgical procedures worldwide. Postoperative pain is a significant issue as it impacts recovery and mobilization. Additionally, postoperative pain increases the risk of respiratory complications. Although opioid analgesics are effective in controlling pain, their side effects, such as nausea, vomiting, and respiratory depression, can lead to undesirable outcomes. Reducing opioid use is critical for both patient safety and improving the quality of recovery. For managing postoperative pain following breast surgery, the erector spinae plane block (ESPB) and the more recently introduced serratus posterior superior intercostal plane block (SPSIP) have been utilized. Both techniques have been effectively used for analgesia in patients undergoing breast surgery. However, there is insufficient evidence in the literature comparing the efficacy of these two techniques in this context. Aim of the Study The primary aim of this study is to evaluate the effect of ultrasound-guided ESPB and SPSIP blocks on postoperative opioid consumption following breast surgery. Additionally, the secondary aim is to compare opioid-related side effects (e.g., nausea, vomiting, respiratory depression) and postoperative NRS (Numerical Rating Scale) pain scores between the groups. Materials and Methods This prospective, randomized controlled trial will be conducted at Medipol Mega University Hospital on patients undergoing breast surgery and axillary lymph node dissection. The study aims to evaluate the effects of ESPB and SPSIP applications on postoperative opioid consumption and pain management. Written and verbal informed consent will be obtained from all participants prior to the study. Patient Selection Patients aged 18-80 years, classified as ASA (American Society of Anesthesiologists) physical status I-III, and scheduled for breast surgery with axillary lymph node dissection will be included. Patients with a history of allergies, known allergy to local anesthetics, pregnancy, or psychiatric or neurological disorders will be excluded. Group Allocation Patients will be randomized into three groups: Group 1 (Control group): Patients will not receive any nerve block. Group 2 (ESPB group): Patients will receive an erector spinae plane block. Group 3 (SPSIP group): Patients will receive a serratus posterior superior intercostal plane block. Anesthesia Management All patients will receive routine anesthesia protocols. After entering the operating room, patients will be monitored with electrocardiography, peripheral oxygen saturation (SpO₂), and non-invasive blood pressure. Premedication with 2 mg intravenous midazolam will be administered. Anesthesia induction will include 2-2.5 mg/kg IV propofol, 1-1.5 µg/kg IV fentanyl, and 0.6 mg/kg IV rocuronium, followed by intubation. Patients will be ventilated with a 50% oxygen-air mixture. Maintenance of anesthesia will be achieved with intermittent doses of midazolam, fentanyl, and rocuronium. Ventilator settings will include a tidal volume of 6-8 mL/kg and an end-tidal CO₂ of 30-35 mmHg. All patients will receive 1 g intravenous paracetamol and 100 mg intravenous tramadol 30 minutes before the end of surgery. To prevent postoperative nausea and vomiting, 4 mg intravenous ondansetron will be administered. Erector Spinae Plane Block Procedure In Group 2, ESPB will be performed following the surgical procedure but before the patient is awakened. The block will be performed under sterile conditions using ultrasound guidance. Patient Positioning and Preparation: The patient will be positioned laterally with the surgical side up. A sterile ultrasound probe cover will be used. Ultrasound Imaging: A high-frequency (11-12 MHz) linear ultrasound probe will be placed transversely over the T5 thoracic vertebra. Identification of Anatomy: The erector spinae muscle and transverse processes will be identified. Needle Insertion: Using an in-plane technique, the block needle will be advanced to the transverse process. Injection Confirmation: After confirming the needle position with a 1-2 mL saline injection, 30 mL of 0.25% bupivacaine will be injected between the erector spinae muscle and the transverse process. Spread of the local anesthetic will be monitored via ultrasound. Serratus Posterior Superior Intercostal Plane Block Procedure In Group 3, SPSIPB will also be performed following the surgical procedure but before the patient is awakened. The block will be performed under sterile conditions using ultrasound guidance. Patient Positioning and Preparation: The patient will be positioned laterally with the surgical side up. A sterile ultrasound probe cover will be used. Ultrasound Imaging: A high-frequency (11-12 MHz) linear ultrasound probe will be placed sagittally at the upper corner of the scapula. The rhomboid major, trapezius, serratus posterior superior muscles, and the third rib will be visualized. Identification of Anatomy: The third rib and serratus posterior superior muscle will be identified. Needle Insertion: Using an in-plane technique, the block needle will be advanced between the serratus posterior superior muscle and the third rib. Injection Confirmation: After confirming the needle position with a 1-2 mL saline injection, 30 mL of 0.25% bupivacaine will be injected into the space between the serratus posterior superior muscle and the third rib. Spread of the local anesthetic will be monitored via ultrasound. Postoperative Assessment Pain levels will be assessed during the first 24 hours postoperatively. Patients will routinely receive 1,000 mg paracetamol three times daily. Pain scores will be evaluated using the Numerical Rating Scale (NRS), where 0 indicates "no pain" and 10 indicates "worst pain imaginable." Pain scores at rest and during mobilization will be recorded at the recovery unit, as well as at 3, 6, 12, 18, and 24 hours postoperatively. If the NRS score is ≥4, 1 mg/kg IV tramadol will be administered as rescue analgesia. The total amount of rescue analgesic used, postoperative opioid consumption, and side effects such as nausea, vomiting, itching, and complications like hematoma will be documented.
Phase
N/ASpan
31 weeksSponsor
Medipol UniversityIstanbul
Recruiting
The Relationship Between Ergonomic Knowledge of Healthcare Professionals and Musculoskeletal Disorders
The present study is planned to be online. Personal information such as age, gender, and occupation will be collected from participants. Ergonomics information will be questioned. The Nordic musculoskeletal disorders questionnaire will be applied for the musculoskeletal disorders of the participants. Occupational burnout caused by musculoskeletal disorders will be investigated with the Maslach Burnout Scale. The degree to which musculoskeletal disorders affect sleep quality will be investigated with the Pittsburgh Sleep Quality Questionnaire.
Phase
N/ASpan
3 weeksSponsor
Uskudar UniversityIstanbul
Recruiting
Healthy Volunteers
Comparison of the Effectiveness of Two Different Squat Exercises in Healthy Individuals
A total of 60 volunteer participants between the ages of 18-30, who are in the active category of the International Physical Activity Assessment Questionnaire Short Form, are planned to be included in the study. Individuals participating in the study will be divided into 3 groups using a computer randomization system and a closed envelope method. Group I (n=20); squatting with the knees passing the toes (PI), Group II (n=20); squatting with the knees not passing the toes (PG) and Group III (n=20); control group (CG). Squatting with the knees passing the toes (PI); squatting with the knees not passing the toes (PG) will be applied to the study groups as a home program for 4 weeks and will be checked with an exercise diary. Participants will be re-evaluated at the end of the exercise program. No training program will be applied to the control group and they will be asked to continue their daily lives and participants will be evaluated at 4-week intervals. The training program of 1 set; 20 repetitions; 30 seconds active contraction/30 seconds rest is applied to the PI and PG groups 3 days a week, every other day for 6 weeks. The training program of the groups is monitored by a physiotherapist for 6 weeks via telerehabilitation technologies. All participants will be evaluated for back pain, knee pain, muscle thickness, muscle strength, function and balance before and at the end of the program and the data obtained will be recorded.
Phase
N/ASpan
11 weeksSponsor
Uskudar UniversityIstanbul
Recruiting
Healthy Volunteers
Investigation of the Relationship Between Digital Game Addiction and Musculoskeletal System Disorders
This study will be conducted with a cross-sectional design in order to examine the relationship between digital game addiction and musculoskeletal disorders. The methods to be used in the research are as follows: Participant Information: The study will include adults aged 18-39 who play digital games in internet cafes for at least 3 hours a day, 4-5 days a week. Participants will be asked to fill out a form to collect demographic information. This form will include information such as age, gender, weekly game playing frequency (by hour and day), and physical activity levels. Scales to be Used: The following measurement tools will be used in the study to evaluate the effects of digital game addiction on the musculoskeletal system. Digital Game Addiction Scale, Arm, Shoulder and Hand Problems Questionnaire, Pittsburgh Sleep Quality, Cornell Musculoskeletal Disorder Questionnaire.
Phase
N/ASpan
22 weeksSponsor
Uskudar UniversityIstanbul
Recruiting
Healthy Volunteers
Effectiveness of Pilates Exercises Applied to Violinists With Nonspecific Neck Pain
This study is planned as a randomized controlled study. Participants will be divided into two groups, mat pilates and reformer pilates, between the ages of 18-50. Participants will be asked to do the specified exercises for 6 weeks, 2 days a week and 45 minutes each session. Individuals with psychological and physical disabilities to do regular exercise will not be included in the study. The researcher will prepare a personal information form to collect the sociodemographic characteristics of the participants. A visual analog scale will be used to measure pain intensity and recovery process, a neck pain and disability scale to evaluate neck function and disability status, and a neck disability questionnaire to determine the effect of neck pain on daily life activities. These questionnaires will be repeated at the beginning and end of the study.
Phase
N/ASpan
18 weeksSponsor
Uskudar UniversityIstanbul
Recruiting
Healthy Volunteers