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29 Idiopathic Scoliosis Trials Near You
Power is an online platform that helps thousands of Idiopathic Scoliosis patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.
Learn More About PowerHypertonic Saline for Brain Disorders
Columbus, Ohio
This is a prospective, randomized study in patients greater than or equal to 10 years of age scheduled for an posterior spinal fusion that requires invasive monitoring of arterial blood pressure. Subjects will be randomized to receive either standard of care Normosol-R or buffered 2% hypertonic saline for intraoperative fluid resuscitation.
The primary objective of this study is to compare intraoperative changes in acid-base status and electrolytes based on the type of fluid administered intraoperatively.
The secondary objective is to compare the volume of fluid required and use of adjunctive volume resuscitation with 5% albumin for intraoperative resuscitation when using standard Normosol-R or a novel buffered 2% saline solution.
Stay on current meds
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 2, 3
Age:10 - 25
Key Eligibility Criteria
Disqualifiers:Arterial Cannula Not Indicated, Others
75 Participants Needed
MID-C System for Adolescent Idiopathic Scoliosis
Dayton, Ohio
The ApiFix MID-C System is a unidirectional expandable rod, designed to be connected unilaterally to the spine via 2 anchor points on the concave side of a scoliotic deformity above and below the apex of the major curvature to treat adolescent idiopathic scoliosis. The MID-C System is designed to act as an internal brace. Patients implanted with the device in the US within 2 years of FDA's approval of H17001 should be enrolled in the study. A minimum number of 200 patients will be enrolled in this study.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:10+
Key Eligibility Criteria
Disqualifiers:Non-idiopathic Scoliosis, Malignancy, Neurological Deficit, Others
200 Participants Needed
Spinal Tethering for Scoliosis
Cincinnati, Ohio
Anterior vertebral body tethering (AVBT) is a novel, minimally invasive, growth modulation technique that was recently approved by the FDA under a Humanitarian Device Exemption (HDE). The goal of AVBT is to control curve progression by applying compression on the convex side of the spine deformity. While there has been great initial enthusiasm about the technique as an alternate treatment option to spinal fusion for skeletally immature children with scoliosis, there is a need to better understand the long-term outcomes.
The purpose of this study is to report the long-term clinical outcomes of skeletally immature patients treated with AVBT, specifically:
1. The effect on three-dimensional spine growth as compared to normal controls
2. Maintenance of major Cobb angle less than or equal to 50 degrees at skeletal maturity
3. Complications associated with both the procedure and the device
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:< 18
Key Eligibility Criteria
Disqualifiers:Infections, Prior Spinal Surgery, Others
106 Participants Needed
Meditation for Postoperative Pain
Cincinnati, Ohio
This will be a prospective study to determine the association between specific genotypes, epigenetics, behavioral, social and biological factors, with the phenotypes, defined by pain perception, postoperative pain, analgesic effects, side effects to perioperative analgesics, chronic postoperative pain, and gene expression in patients following pectus excavatum repair.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:8+
Key Eligibility Criteria
Disqualifiers:Renal Disease, Liver Disease, Cardiac Conditions, Seizures, Others
Must Not Be Taking:Paroxetine, Fluoxetine, Cimetidine, Duloxetine
600 Participants Needed
Methadone-Based Analgesia for Scoliosis Surgery
Pittsburgh, Pennsylvania
The purpose of this study is to look at a standardized methadone-based enhanced recovery after surgery protocol following pediatric spinal surgery. This study will consist of randomly assigning children to receive the methadone-based recovery procedures or to receive current standard of care recovery procedures. Randomly assigning means that there is a 50/50 chance, like a coin flip, of being assigned to either research group.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 3
Age:10 - 18
Key Eligibility Criteria
Disqualifiers:Adults, Pregnancy, Severe Sleep Apnea, Others
Must Not Be Taking:Opioids
500 Participants Needed
Casting vs Bracing for Scoliosis
Pittsburgh, Pennsylvania
Comparison of casting and bracing for the treatment of idiopathic early onset scoliosis
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:12 - 36
Key Eligibility Criteria
Disqualifiers:Previous Treatment, Developmental Delay, Others
71 Participants Needed
Braive™ GMS for Scoliosis
Washington, District of Columbia
This trial aims to test the benefits and safety of the Braive™ GMS device in children with worsening scoliosis. The device helps straighten their spine and prevent further curvature.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Non-idiopathic Scoliosis, Pregnancy, Infection, Others
10 Participants Needed
Yoga for Scoliosis
Baltimore, Maryland
The Problem: Adolescent Idiopathic Scoliosis (AIS), the pre-eminent spinal pathology affecting over 5% of children and adolescents, presents a pronounced spinal curvature exceeding 10 degrees, with prevalence amongst female adolescents at a ratio of 3:1 compared to males. A significant portion of these patients are not immediate candidates for surgical intervention. The acute shortage of viable non-operative management strategies, which is becoming increasingly imperative given the current barriers to physical therapy access and the growing opioid crisis. The investigator's research intends to explore the addition of a structured yoga protocol to standard of care. This research will thus explore the potential for improved relief and quality-of-life improvements for AIS patients not ready for surgery.
Significance: AIS is a pervasive condition which correlates with chronic and episodic lower back pain, diminished sleep quality, and depressive symptoms. This extensive comorbid association coupled with the financial pressure to patients and the healthcare system cannot be understated.
Needs Statement: There is a lack of sufficient non-operative management options for AIS. Many patients face limited access and require supplementary management strategies to address the patient's conditions effectively, creating a significant unmet need for non-pharmacological pain management interventions. This need is further highlighted in the context of the escalating opioid crisis, a leading cause of death among adolescents and young adults.
Hypothesis: The introduction of a structured yoga protocol can serve as a non-inferior or even superior alternative to traditional standard of care i management of AIS, addressing both the physical and psychosocial aspects intertwined with the condition.
IMPACT: Change in Problem Significance: This research trial aims to enhance current standard of care for patients grappling with AIS. If the trial demonstrates superiority of yoga, it will delineate a paradigm shift in the current care standards for AIS patients, fostering a move towards a more cost-effective and holistic approach. Yoga could help alleviate the burdens on the healthcare system by reducing costs and enhancing accessibility for patients.
Improvement in Pediatric Orthopedics Practice: By paving the way for non-pharmacological interventions, the trial aspires to mitigate the reliance on opioids for pain management in the pediatric demographic, therefore promoting overall well-being. This project not only seeks to develop alternative pain management strategies amidst a growing opioid epidemic but also champions the cause of improving the quality of life for the pediatric population battling chronic conditions like AIS. It echoes the urgent call to innovate and expand upon the current strategies in place, steering the medical community towards a future where integrative approaches are not the exception but the norm. Ultimately, this research aspires to guide the trajectory of pediatric orthopedics towards a healthcare system that is more inclusive, accessible, and holistically oriented, thereby enhancing the quality of life for pediatric patients grappling with conditions like AIS.
2. Objectives (include all primary and secondary objectives) Goals/Objectives: To create a randomized clinical trial aimed to evaluate the efficacy of yoga in conjunction with standard of care treatments for AIS patients.
SPECIFIC AIMS Aim 1: Evaluate the feasibility and challenges of implementing a yoga protocol for AIS patients.
Methodology: Online class attendance, survey completions, and follow-up appointments.
Anticipated Results: Adequate participant adherence and data reliability.
Aim 2: Compare clinical outcomes between patients who receive traditional care modalities versus those who added yoga to treatment plan.
Methodology: Utilize validated tools such as the SRS-22 questionnaire and monitor outcomes including depression scale, sleep quality, analgesic usage, activity levels, and Cobb angle.
Anticipated Results: Significant physical and psychological improvements in the yoga group.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:10 - 20
Key Eligibility Criteria
Disqualifiers:Non-AIS Scoliosis, Surgery, Age, Others
500 Participants Needed
Dysport® + Bracing for Adolescent Idiopathic Scoliosis
Baltimore, Maryland
This study evaluates the combined effect of botulinum toxin A (administered as Dysport® (Ipsen Pharmaceuticals)) and bracing in children with adolescent idiopathic scoliosis. Two thirds of patients will be treated with Dysport® and bracing, while the remaining patients will be treated with placebo and bracing.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Age:10 - 16
Key Eligibility Criteria
Disqualifiers:Congenital Scoliosis, Neuromuscular Scoliosis, Surgery, Others
Must Not Be Taking:Neuromuscular Drugs
90 Participants Needed
Opioid-Free Pain Management for Scoliosis
Charlotte, North Carolina
The purpose of this study is to compare the efficacy of a multimodal opioid-free (OF) pain management protocol with a traditional opioid-containing (OC) protocol in pediatric patients undergoing instrumented PSF for idiopathic scoliosis.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 4
Age:10 - 20
Key Eligibility Criteria
Disqualifiers:Non-idiopathic Scoliosis, Others
58 Participants Needed
Postoperative Dexamethasone for Scoliosis
Atlanta, Georgia
The objective of this study is to perform a prospective, randomized controlled trial investigating the clinical usage of perioperative dexamethasone usage on APR activation, postoperative morphine usage, postoperative nausea, and hospital length of stay.
There will be a control control and a Dexamethasone cohort. Participants will be randomized into one of the two cohorts. Patients in the control group will receive one 8mg dose of dexamethasone intraoperatively as per standard of care anesthesia protocols. Patients randomized to the dexamethasone cohort will be administered 8 mg of dexamethasone with 3 additional doses administered at 8-hour intervals following surgery for a total of 4 doses. All study activities will tale place at Egleston during the patient's planned inpatient stay for their posterior spinal fusion.
This project has the potential to validate the utility of dexamethasone as a way to optimize postoperative care following PSF for AIS by minimizing the need for opioid medications and enhancing mobility and recovery.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Age:10 - 18
Key Eligibility Criteria
Disqualifiers:Congenital Scoliosis, Pregnant, Prisoners, Others
50 Participants Needed
Brace Monitoring for Adolescent Idiopathic Scoliosis
New York, New York
The overall aim of the study is to utilize a novel device and smartphone application in order to improve measurement of patient compliance with at-home bracing for scoliosis as well as create a more accurate assessment of brace fit via continuous and objective measures of tension. These ground-breaking metrics will provide analyzable data to more accurately reflect and predict actual patient compliance as well as allow for further exploration of how to increase compliance, and thus, efficacy of bracing; it will additionally allow both physicians and patients to have a more reliable measure for brace fit by providing them with continuous data of fit via tension, and provide built-in feedback mechanisms to the patient to ensure proper tightness of the brace.
Additionally, the study will investigate whether providing the wearer's own brace-wear compliance information directly to the patient and their caregiver(s) via the mobile app will further improve rates of compliance as compared to those who do not receive the same feedback mechanism.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:8 - 17
Sex:Female
Key Eligibility Criteria
Disqualifiers:Prior Spine Surgery
87 Participants Needed
Botulinum Toxin + Isometric Exercises for Scoliosis
Manhattan, New York
This trial uses a specific yoga pose to treat adolescents with curved spines. The yoga pose strengthens weaker back muscles and helps relax stronger ones. It targets teens aged 12-18 with moderate scoliosis who may not benefit from other treatments.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:14 - 18
Key Eligibility Criteria
Disqualifiers:Neuromuscular Disease, Genetic Abnormalities, Pregnancy, Others
42 Participants Needed
Iron Supplementation for Scoliosis
New York, New York
This study is a randomized controlled trial of preoperative oral iron supplementation, to identify whether iron deficiency is a modifiable risk factor for adverse surgical outcomes such as red blood cell transfusion and diminished postoperative cognitive and physical capacity in adolescents undergoing scoliosis surgery.
Research Question(s)/Hypothesis(es):
Primary
* Iron supplementation will reduce the incidence of perioperative RBC transfusion in iron deficient scoliosis patients undergoing spinal fusion.
Secondary
* Iron supplementation will reduce postoperative neurocognitive functional declines in iron deficient scoliosis patients undergoing spinal fusion.
* Iron supplementation will improve patient-reported physical functioning in iron deficient scoliosis patients undergoing spinal fusion.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:10 - 26
Key Eligibility Criteria
Disqualifiers:Iron Disorder, Pregnancy, Prisoners, Others
Must Not Be Taking:Iron Supplements
275 Participants Needed
Cognitive Behavioral Therapy for Scoliosis
Bronx, New York
Working in partnership with Montefiore-Einstein's Department of Translational Psychiatry, the study team investigators have designed a prospective randomized clinical trial (2:1) study for 45 AIS patients (10-19 yrs.). This protocol includes a baseline assessment of mental health, pain, and function in AIS patients utilizing validated patient reported outcome measures. The investigators will implement and test a structured perioperative psychological intervention program, based on the Aim to Decrease Anxiety and Pain Treatment (ADAPT), which was developed based on evidence-based cognitive behavioral therapy (CBT) protocols for the management of pediatric pain and childhood anxiety disorders
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:10 - 19
Key Eligibility Criteria
Disqualifiers:Cognitive Impairment, Pregnancy, Liver Disease, Others
Must Not Be Taking:Opioids
120 Participants Needed
Virtual Reality for Post-Operative Recovery in Pediatric Scoliosis
Hartford, Connecticut
The purpose of this study is to assess the effect of virtual reality on subjective post-operative pain, total inpatient narcotic administration, and mobilization with physical therapy in pediatric patients who have undergone surgical correction for idiopathic scoliosis.
No Placebo Group
Trial Details
Trial Status:Recruiting
Age:13 - 18
Key Eligibility Criteria
Disqualifiers:Not Listed
60 Participants Needed
REFLECT System for Idiopathic Scoliosis
Rochester, Minnesota
The purpose of this multi-center, prospective, single-arm registry Post-Approval Study (PAS) is to evaluate the radiographic and clinical outcomes of 100 patients with idiopathic scoliosis treated with the REFLECT™ Scoliosis Correction System, as a condition of HDE approval
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Prior Spinal Surgery, Poor Bone Quality, Infections, Others
100 Participants Needed
Intrathecal Hydromorphone for Pain Management in Scoliosis Repair
Rochester, Minnesota
The purpose of this study is to identify a dose of intrathecal hydromorphone (opioid pain medicine) that optimizes pain control but minimizes side effects historically seen with this class of pain medications.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Age:10 - 17
Key Eligibility Criteria
Disqualifiers:Chronic Pain, Spinal Abnormalities, Others
Must Not Be Taking:Opioids
40 Participants Needed
Postural Re-education for Adolescent Scoliosis
Montréal, Quebec
This trial aims to see if GPR, a type of physical therapy focusing on posture and muscle exercises, can help adolescents with scoliosis. The goal is to improve their spine alignment, reduce pain, and enhance their overall physical health.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:10 - 16
Key Eligibility Criteria
Disqualifiers:Non-AIS Diagnosis, Planned Surgery, Others
47 Participants Needed
Optimized Nighttime Brace for Scoliosis
Montreal, Quebec
Adolescent Idiopathic Scoliosis affects 3-4% of the Canadian population, of which about 10% will need a brace treatment during pubertal growth spurt. Our team has developed an innovative conception method for brace design by optimizing for the immediate in-brace correction. The model is customized to each patient. In this project, the investigators will evaluate the effectiveness of this platform's customized treatment and validate its clinical application.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Age:10 - 16
Key Eligibility Criteria
Disqualifiers:Not Listed
58 Participants Needed
Why Other Patients Applied
"I have dealt with voice and vocal fold issues related to paralysis for over 12 years. This problem has negatively impacted virtually every facet of my life. I am an otherwise healthy 48 year old married father of 3 living. My youngest daughter is 12 and has never heard my real voice. I am now having breathing issues related to the paralysis as well as trouble swallowing some liquids. In my research I have seen some recent trials focused on helping people like me."
AG
Paralysis PatientAge: 50
"I was diagnosed with stage 4 pancreatic cancer three months ago, metastatic to my liver, and I have been receiving and responding well to chemotherapy. My blood work revealed that my tumor markers have gone from 2600 in the beginning to 173 as of now, even with the delay in treatment, they are not going up. CT Scans reveal they have been shrinking as well. However, chemo is seriously deteriorating my body. I have 4 more treatments to go in this 12 treatment cycle. I am just interested in learning about my other options, if any are available to me."
ID
Pancreatic Cancer PatientAge: 40
"I've been struggling with ADHD and anxiety since I was 9 years old. I'm currently 30. I really don't like how numb the medications make me feel. And especially now, that I've lost my grandma and my aunt 8 days apart, my anxiety has been even worse. So I'm trying to find something new."
FF
ADHD PatientAge: 31
"As a healthy volunteer, I like to participate in as many trials as I'm able to. It's a good way to help research and earn money."
IZ
Healthy Volunteer PatientAge: 38
"I've tried several different SSRIs over the past 23 years with no luck. Some of these new treatments seem interesting... haven't tried anything like them before. I really hope that one could work."
ZS
Depression PatientAge: 51
Low-Dose Dexmedetomidine for Postoperative Pain in Scoliosis
Kansas City, Missouri
This randomized controlled trial examines whether the addition of a low-dose dexmedetomidine infusion to our current multimodal pain management plan decreases narcotic consumption and reduces side effects in adolescent patients undergoing posterior spinal fusion for idiopathic scoliosis.
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Phase 4
Age:10 - 21
Key Eligibility Criteria
Disqualifiers:Chronic Pain, Unstable Cardiac, Moya Moya, Others
Must Not Be Taking:Opioids, TCA's, Gabapentinoids, Digoxin
160 Participants Needed
Massage Therapy for Scoliosis
Fort Worth, Texas
The purpose of this research is to look at the effect of massage therapy on the pain, anxiety, and quality of life that pediatric patients have after undergoing spinal fusion surgery. This is a single-site, prospective, randomized, interventional study design that will involve post-thoracic and post-lumbar spinal fusion surgeries of pediatric patients from 7 to 19 years of age that present to Cook Children's Medical Center in Fort Worth, Texas. These patients will be identified prior to their scheduled spinal fusion surgery and recruited to enroll in the study. The planned spinal fusion surgeries are not considered part of this research project, but rather considered standard of care and would occur whether the patient is enrolled in this project or not. Enrolled participants will be followed during their inpatient stay and through their subsequent follow-up visits at weeks 2, 6, and 12. Participants will be randomly assigned to either a massage therapy group or a group that receives the standard (normal) care for recovery after surgery. The final study involvement will occur at week 16 (post-hospital discharge) where a study team member will administer a quality of life (PedsQL) questionnaire via phone or mail with the subject. Data will be collected after study related procedures are completed.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:7 - 19
Key Eligibility Criteria
Disqualifiers:Chronic Pain, Psychosis, Paralysis, Others
Must Not Be Taking:Opioids, Illicit Drugs
100 Participants Needed
3D-Printed Brace for Scoliosis
The Woodlands, Texas
Scoliosis bracing is an effective treatment method for idiopathic scoliosis, but only if worn consistently for many hours a day. Unsurprisingly, brace discomfort is a significant deterrent against treatment adherence. For decades, custom braces for idiopathic scoliosis have been fabricated using one of three materials - copolymer, polypropylene, or polyethylene. The application of the biomechanical principles behind bracing have improved over the years, but the materials have not. The investigators' goal is to expand fabrication options by testing a 3D-printed scoliosis brace with variable flexibility. The aim is to improve patients' perceived brace comfort.
After optimizing the brace design, the investigators will collect patient feedback about the design from currently braced participants. These participants understand what a standard brace feels like and will provide impactful feedback.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:8 - 18
Key Eligibility Criteria
Disqualifiers:Other Scoliosis, Cobb Angle, Others
5 Participants Needed
Medrol for Postoperative Pain
Salt Lake City, Utah
The investigators primary purpose of this study is to determine if the addition of a short course use of steroids following surgery for Adolescent Idiopathic Scoliosis (AIS) will improve post-operative pain management and shorten hospital length of stay.
Trial Details
Trial Status:Enrolling By Invitation
Age:10 - 21
Key Eligibility Criteria
Disqualifiers:Not Listed
90 Participants Needed
Postoperative Steroids for Scoliosis
Los Angeles, California
The goal of this randomized clinical trial is to compare the immediate use of steroids after surgery for accelerated discharge in adolescent idiopathic scoliosis and neuromuscular scoliosis after a posterior spinal fusion.
The main question it aims to answer are:
* What are the effects of using steroids immediately after surgery in decreasing opioid use and helping early mobilization(movement)?
* Does post-operative steroid use affect the incidence of wound complications and are there any long-term impacts on scar formation?
Participants will:
* Fill out a Patient-Reported Outcomes Measurement Information System (PROMIS) survey specifically for pain interference and physical activity observing health related quality of life at enrollment, 3 months, 1 year, and 2 years
* Have clinical photos of their incision at 3 months, 1 year, and 2 years
* Their photos will be assessed using the stony book scar evaluation scale
* For treatment of their scoliosis, patients will undergo a posterior spinal fusion (PSF) per standard of care, however whether the participant receives or does not receive steroids is what the investigators are trying to understand.
* Researchers will compare no immediate postoperative steroid (NS) to the group with immediate postoperative steroid (WS) group to see if there are changes in opioid use, wound complications, scar formation, and facilitation in early mobilization.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 4
Age:9 - 18
Key Eligibility Criteria
Disqualifiers:Prior Spine Surgery, Spina Bifida, Allergies, Drug Or Alcohol Use, Others
100 Participants Needed
Anesthesia Combinations for Scoliosis Surgery
Los Angeles, California
Patients with Adolescent Idiopathic Scoliosis may need surgery to correct their scoliosis. General anesthesia is required for this surgery, and a multimodal analgesic regimen using combinations of opioid and non-opioid medications is the standard of care. The purpose of this study is to compare two combinations of total intravenous anesthetic medications in children with Adolescent Idiopathic Scoliosis having posterior spinal fusion surgery.
Participants in the study will be randomly selected to receive either Propofol and Remifentanil or Propofol and Dexmedetomidine as their total intravenous anesthesia (TIVA). TIVA is favored over gas anesthesia because gas anesthesia can affect the neurological monitoring necessary for this surgery.
The first combination (Propofol + Remifentanil) is the most common one used for this surgery at our institution, and the second combination (Propofol + Dexmedetomidine) is more commonly used in adult spine surgery. Though Dexmedetomidine is not approved for pediatric use by the FDA, it is widely used in pediatric patients for procedural sedation and surgical anesthesia in the US and worldwide. Both anesthetic combinations are used safely in adult and pediatric patients at our institution.
Although remifentanil works fast and is an excellent pain medication during surgery, there are reports that it's use can cause increased pain sensitivity and greater need for narcotic pain medication after surgery. This phenomenon is known as opioid-induced hyperalgesia. The investigators hypothesize that avoiding the use of remifentanil in the TIVA by using dexmedetomidine could avoid OIH and thus result in superior postop pain control.
Our study's primary goal is to measure the total opioid consumption on postoperative days (POD)# 0 and 1. Our secondary goals are to measure the pain scores on a visual analog scale (VAS) on POD# 0 and 1, measure the time it takes for participants to move their feet to command when surgery is done, and measure the time it takes for participants to be extubated when surgery is done. By comparing these measurements, the investigators hope to find out if there is any significant difference between the two TIVAs in terms of postop opioid requirements, pain scores, and time to wake up from anesthesia.
The investigators hope that our study gives us more knowledge on how to better treat postoperative pain in children who have spine surgery to correct their
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:12 - 18
Key Eligibility Criteria
Disqualifiers:Neuromuscular Scoliosis, Drug Allergies, Others
Must Not Be Taking:Serotonergic Drugs, MAOIs
120 Participants Needed
Digital CBT for Scoliosis Recovery
Seattle, Washington
This is a randomized controlled trial to test effectiveness of the SurgeryPal intervention vs. education control to improve acute and chronic pain and health outcomes in youth undergoing major musculoskeletal surgery. Youth will be randomized on an individual level using a factorial design to SurgeryPal or Education during 2 phases of intervention: 1) pre-operative phase (4 week duration delivered over the 4 weeks leading up to surgery), and 2) post-operative phase (4 week duration following surgery). Thus there will be 4 treatment arms. Participants will undergo 4 assessments, independent of their treatment assignment: T1: Baseline (pre-randomization); T2: acute post-surgery outcomes (daily assessment of acute outcomes beginning day 1 through day 14 after hospital discharge from surgery); T3: Post-surgery follow-up (assessment of outcomes at 3-months post-surgery); T4: Final post-surgery follow-up (assessment of outcomes at 6-months post-surgery).
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:12 - 18
Key Eligibility Criteria
Disqualifiers:Not Listed
433 Participants Needed
Melatonin for Post-Surgery Recovery in Teens with Scoliosis
Palo Alto, California
The goal of this feasibility clinical trial is to learn if melatonin can help teens having major musculoskeletal surgery by promoting healthy sleep. Melatonin is available as a dietary supplement that may be effective in promoting longer, higher quality sleep. This study will assess the feasibility and acceptability of melatonin for teens undergoing major musculoskeletal surgery, as well as determine optimal measured outcomes (sleep, pain, health-related quality of life) at short- and long-term follow-up.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:12 - 18
Key Eligibility Criteria
Disqualifiers:Cognitive Impairment, Severe Chronic Condition, Others
Must Not Be Taking:Prescription Insomnia Medication
45 Participants Needed
Open-Label Placebo for Adolescent Idiopathic Scoliosis
San Francisco, California
This study aims to investigate the effects of conditioning with open-label placebos on standard postoperative treatment for patients undergoing surgery for idiopathic scoliosis in a randomized controlled, 6-week trial with 64 AIS patients randomly assigned to one of two arms: Open-label Placebo (COLP) + treatment as usual TAU / TAU control. The study involves collecting data from your child's medical record. At each regular clinic visit, the patient clinical data will be collected by the research coordinator. Surveys will be collected including:• PROMIS for the age group 10 to 18 years.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2, 3
Age:10 - 18
Key Eligibility Criteria
Disqualifiers:Non-idiopathic Scoliosis, Pregnancy, Drug Abuse, Others
Must Not Be Taking:Opioids
64 Participants Needed
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We started Power when my dad was diagnosed with multiple myeloma, and I struggled to help him access the latest immunotherapy. Hopefully Power makes it simpler for you to explore promising new treatments, during what is probably a difficult time.
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Frequently Asked Questions
How much do Idiopathic Scoliosis clinical trials pay?
Each trial will compensate patients a different amount, but $50-100 for each visit is a fairly common range for Phase 2–4 trials (Phase 1 trials often pay substantially more). Further, most trials will cover the costs of a travel to-and-from the clinic.
How do Idiopathic Scoliosis clinical trials work?
After a researcher reviews your profile, they may choose to invite you in to a screening appointment, where they'll determine if you meet 100% of the eligibility requirements. If you do, you'll be sorted into one of the treatment groups, and receive your study drug. For some trials, there is a chance you'll receive a placebo. Across Idiopathic Scoliosis trials 30% of clinical trials have a placebo. Typically, you'll be required to check-in with the clinic every month or so. The average trial length for Idiopathic Scoliosis is 12 months.
How do I participate in a study as a "healthy volunteer"?
Not all studies recruit healthy volunteers: usually, Phase 1 studies do. Participating as a healthy volunteer means you will go to a research facility several times over a few days or weeks to receive a dose of either the test treatment or a "placebo," which is a harmless substance that helps researchers compare results. You will have routine tests during these visits, and you'll be compensated for your time and travel, with the number of appointments and details varying by study.
What does the "phase" of a clinical trial mean?
The phase of a trial reveals what stage the drug is in to get approval for a specific condition. Phase 1 trials are the trials to collect safety data in humans. Phase 2 trials are those where the drug has some data showing safety in humans, but where further human data is needed on drug effectiveness. Phase 3 trials are in the final step before approval. The drug already has data showing both safety and effectiveness. As a general rule, Phase 3 trials are more promising than Phase 2, and Phase 2 trials are more promising than phase 1.
Do I need to be insured to participate in a Idiopathic Scoliosis medical study?
Clinical trials are almost always free to participants, and so do not require insurance. The only exception here are trials focused on cancer, because only a small part of the typical treatment plan is actually experimental. For these cancer trials, participants typically need insurance to cover all the non-experimental components.
What are the newest Idiopathic Scoliosis clinical trials?
Most recently, we added Postoperative Steroids for Scoliosis, Methadone-Based Analgesia for Scoliosis Surgery and Hypertonic Saline for Brain Disorders to the Power online platform.
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