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119 Back Pain Trials Near You
Power is an online platform that helps thousands of Back Pain 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 PowerPeripheral Nerve Stimulation for Back Pain
Columbus, Ohio
The purpose of this study is to compare standard of care treatments for back pain to electrical stimulation. Stimulation is delivering small amounts of electricity to the nerves in your low back. This study will use a device called the SPRINT Peripheral Nerve Stimulation (PNS) System. The device is cleared by the FDA for up to 60 days of use for the relief of chronic or acute pain (including back pain)
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:21 - 75
Key Eligibility Criteria
Disqualifiers:Bmi > 40, Prior Lumbar Surgery, Others
230 Participants Needed
Immediate Physical Therapy for Spondylolysis
Columbus, Ohio
Spondylolysis, a stress fracture in the pars interarticularis of a lumbar vertebra, is the most common identifiable cause of low back pain (LBP) in adolescent athletes, occurring in 14-30% of athletes who experience LBP. Spondylolysis can cause significant pain and disability and months of exclusion from sports or an active lifestyle. Standard care of spondylolysis in adolescent athletes is primarily based on expert opinion, with dramatic variations in clinical practice, including restrictive bracing, extended rest periods before the intervention, long durations out of sport and activity, and suboptimal long-term clinical outcomes. As the next step towards our research goal, the overall objective of this pilot study is to perform a pilot randomized controlled trial to assess a novel rehabilitation strategy, the immediate functional progression program (IFPP), for treating active spondylolysis in adolescent athletes. Participants randomized to the IFPP group will begin physical therapy immediately (\<1 week) after diagnosis. In contrast, those in the standard care group (control) will not start physical therapy until their pain has resolved. Aim 1 will evaluate the effects of the IFPP on outcomes (Function, Pain, Quality of Life, and Edema on MRI) among adolescent athletes with an active spondylolysis. Aim 2 will assess the feasibility of performing a full randomized trial using the novel IFPP to treat athletes ages 10-19 with an active spondylolysis. Aim 3 will compare the tolerability of the IFPP to standard care. This pilot study will lay the necessary groundwork to perform a larger hypothesis-driven randomized controlled trial.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:10 - 19
Key Eligibility Criteria
Disqualifiers:Previous Rest >4 Weeks, Numbness, Other Injury, Surgery, Others
60 Participants Needed
CLE-400 Gel for Chronic Itching
Dublin, Ohio
This is a Phase 2, randomized, double-blind, vehicle-controlled study to assess the efficacy and safety of CLE-400 topical gel for the treatment of chronic pruritus in adult subjects with Notalgia Paresthetica (NP).
Trial Details
Trial Status:Recruiting
Key Eligibility Criteria
Disqualifiers:Not Listed
54 Participants Needed
Multiple Treatments for Chronic Pain
Dayton, Ohio
This trial is testing different treatments for chronic pain in patients with knee osteoarthritis, chronic low back pain, and diabetic nerve pain. It aims to find effective ways to reduce their chronic pain.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Heart Block, Cancer, Fibromyalgia, Substance Use, Others
10000 Participants Needed
Rexlemestrocel-L + HA for Lower Back Pain
Dayton, Ohio
The primary purpose of this study is to evaluate the efficacy of rexlemestrocel-L+HA compared to control in reducing low back pain at 12 months post-treatment and safety of a single injection of rexlemestrocel-L+HA injected into a lumbar intervertebral disc compared to control through 12 months post-treatment.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Osteoporosis, Substance Abuse, Severe Depression, Others
Must Not Be Taking:Immunosuppressants
300 Participants Needed
Interspinous Fusion for Lower Back Pain
Loveland, Ohio
The purpose of this study is to evaluate the effectiveness and safety of the use of Aurora Spine ZIP™ MIS Interspinous Fusion System and bone graft material in fusion in patients with chronic low back pain that present with degenerative disc disease with concurrent neurogenic claudication.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Previous Lumbar Surgery, Osteoporosis, Pregnancy, Others
100 Participants Needed
Two-Point Discrimination Training for Chronic Pain
Cincinnati, Ohio
SPECIFIC AIMS
Pain in both youth and adults is a complex, subjective and personal experience, and remains poorly understood. One particularly perplexing dimension of some forms of pain is the tendency of pain to spread outside of an affected body site to adjacent location, and then to unaffected body sites. Such widespread pain may reflect an altered spatial tuning of somatosensory processing, such that lateral inhibition is diminished, thereby allowing pain to spread. To date, no therapies exist which are designed specifically to diminish or even reverse the spatial spread of pain. However, training in two-point discrimination holds the potential to retune spatial aspects of somatosensory processing and may represent a novel therapy for widespread pain. Thus, the present investigation will test the following aims:
Aim 1. Do youth with chronic pain have disrupted spatial tuning of somatosensory processing? Deficits in two point tactile discrimination have long been noted in adults with chronic pain, but such deficits remain poorly documented in pediatric chronic pain patients. In order to determine if such deficits exist, youth with both chronic pain and healthy youth will undergo assessment of two point discrimination thresholds.
Aim 2. Does two-point discrimination training result in diminished pain and disability in youth with somatic pain? After initial characterization of tactile discrimination thresholds, youth with chronic pain will participate in multiple sessions of either two-point discrimination training or a single-point spatially-directed attentional control condition. Training will involve up to 9 additional sessions. Efficacy of training will be assessed by 1) reductions in the spatial extent of pain, 2) reductions in pain intensity and unpleasantness, and 3) reductions in pain-related disability.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Early Phase 1
Age:10 - 17
Key Eligibility Criteria
Disqualifiers:Mental Health Disorders, Drug Dependence, Developmental Delays, Others
60 Participants Needed
VIA Disc NP Allograft for Degenerative Disc Disease
Cleveland, Ohio
This trial tests VIA Disc NP, an injection to repair damaged spinal discs, in adults aged 65+ with back pain not relieved by other treatments. The injection adds material to the damaged discs to improve function and reduce pain.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Age:65 - 80
Key Eligibility Criteria
Disqualifiers:Not Listed
21 Participants Needed
ReActiv8 Therapy for Chronic Lower Back Pain
Cleveland, Ohio
This study is a prospective, randomized study comparing ReActiv8 Therapy to Optimal Medical Management (OMM).
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:21+
Key Eligibility Criteria
Disqualifiers:BMI > 35, Scoliosis, Others
Must Be Taking:Optimal Medical Management
203 Participants Needed
MMG vs EMG for Cortical Breach Detection in Low Back Pain
Lexington, Kentucky
The purpose of this study is to determine how well mechanomyography (MMG) and electromyography (EMG) prevent cortical bone breaches, or the pinching of a nerve from screw placement, in patients having lower back surgery requiring hardware. Both MMG and EMG are devices approved by the FDA to detect the location of nerves during surgery so they can be avoided. The results from both tests will be compared to one another to determine if one is better at accurately locating nerves than the other.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Key Eligibility Criteria
Disqualifiers:Not Listed
65 Participants Needed
Spinal Cord Stimulation for Pain
Sewickley, Pennsylvania
To characterize the effects of stimulation parameters on pain relief and other cohort specific outcomes.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Age:22+
Key Eligibility Criteria
Disqualifiers:Not Listed
360 Participants Needed
Auriculotherapy for Low Back Pain
Pittsburgh, Pennsylvania
This is a clinical study of patients who have low back pain (for at least 6 months). The goal is to understand, with brain imaging, how auriculotherapy (an acupuncture-like stimulation of the ear) may work to relieve pain. There are 4 total study visits, divided into two pairs of visits that occur before and 5-7 days after receiving either a real or sham auriculotherapy treatment. The cryo-IQ device will be used, to stimulate 7 small areas on both ears with a focused jet of cold as a small amount of compressed gas is released. This is generally not painful, and less invasive, compared to using needles for auriculotherapy.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Ear Neuropathy, Recent Surgery, Cold Diseases, Others
Must Not Be Taking:Marijuana, Opioids, Antidepressants, Others
60 Participants Needed
Self-Administered Acupressure for Chronic Back Pain
Ann Arbor, Michigan
Many Veterans experience chronic pain, with back pain the most commonly reported condition. The Veterans Health Administration (VHA) is moving from reliance on medications to an approach in which non-medication interventions, including complementary and integrative health treatments, are now a first line of care. Acupressure, a Traditional Chinese Medicine technique derived from acupuncture, is emerging as a potentially effective approach for treating several chronic pain conditions and could prove beneficial in helping Veterans manage their chronic low back pain.
This study will determine the effectiveness of self-administered acupressure to treat chronic low back pain. 300 Veterans will be invited to participate in the study. All participants will be asked to attend an introduction to acupressure class and complete a survey when they join the study and again at 6 weeks and 10 weeks. The survey measures assess important outcomes, such as how pain interferes with daily function, as well as other areas that can be affected by pain such as fatigue and sleep quality. After completing the first survey, half of the participants will receive a tablet computer with an app that shows them how to self-administer acupressure for low back pain and will be asked to do daily acupressure sessions for the next 6 weeks. The other half of the participants will receive the tablet computer with the app approximately 10 weeks after completing the final survey based assessment. The investigators anticipate that outcomes will be improved after 6 weeks of acupressure practice, and these improvements will persist for the following 4 weeks.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Pregnant, Recent Back Surgery, Cognitive Impairment, Others
300 Participants Needed
Physical Therapy + Antidepressant for Chronic Lower Back Pain with Depression
Pittsburgh, Pennsylvania
This study will examine how the use of antidepressant, physical therapy, and combination of both affects pain, function, and depression outcomes in chronic low back pain patients.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2, 3
Key Eligibility Criteria
Disqualifiers:Back Surgery, Worker’s Compensation, Pregnancy, Others
Must Be Taking:Opioids
330 Participants Needed
Pain Reprocessing Therapy for Chronic Lower Back Pain
Ann Arbor, Michigan
This research is studying whether a Zoom-based behavioral intervention may have an impact as a treatment for Veterans with Chronic Low Back Pain (CLBP).
The study will examine:
* The acceptability of the Brief Pain Reprocessing Therapy (BPRT) intervention
* The feasibility of the BPRT intervention
* The safety of the BPRT intervention
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Rheumatoid Arthritis, Dementia, Cancer, Others
40 Participants Needed
Tailored PainGuide for Chronic Lower Back Pain
Ann Arbor, Michigan
This research is studying whether changing an individual's behaviors may have an impact as a treatment or outcome for chronic low back pain. This research will try to understand how much an electronic, self-management website like PainGuide can help participants.
The study hypothesizes that tailored digital interventions (plus using PainGuide) will demonstrate greater improvement in pain interference.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Cancer Pain, Autoimmune Disease, Pregnancy, Others
550 Participants Needed
Patient Education for Chronic Low Back Pain
Pittsburgh, Pennsylvania
The goal of this pilot single-arm study is to examine the potential of personalized patient education materials to improve self-efficacy and perceived functional disability in patients with chronic low back pain. The main questions it aims to answer are:
1. What is the feasibility of delivering a personalized patient education program for individuals with chronic low back pain?
2. What is the impact of personalized patient education materials on disease-specific self-efficacy and patient-reported function in a small sample of individuals with chronic low back pain?
Participants will be asked to:
* access and complete online baseline questionnaires
* access and follow online patient materials on chronic low back pain on days 5, 8, 11, 14, and 17
* access and complete online follow-up responses to baseline questionnaires and a post-study survey
No Placebo Group
Trial Details
Trial Status:Recruiting
Key Eligibility Criteria
Disqualifiers:Not Listed
20 Participants Needed
Ketamine for Chronic Lower Back Pain and Depression
Ann Arbor, Michigan
This is a pilot study to evaluate the feasibility, acceptability, and safety of ketamine infusions followed by a brief behavioral intervention in Veterans with chronic low back pain and depression.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Psychotic Disorders, Uncontrolled Hypertension, Cardiac Condition, Others
44 Participants Needed
Psychosocial Treatments for Chronic Pain
Detroit, Michigan
Chronic musculoskeletal pain (CP) is a major public health concern. Psychosocial treatments have been shown to be efficacious when compared to largely inert control conditions, but they are characterized by modest effects on primary outcomes. One strategy to boost efficacy is to increase our understanding of treatment mediators. Studies of mediators that directly compare different treatments with each other are needed to determine which mediators are treatment-specific, which are shared across treatments, and which contribute the most to clinical outcomes. Another strategy is to identify the patient characteristics that moderate treatment responses. Research is needed that is guided by theoretical models and that tests moderators across multiple treatments. Identifying subgroups of patients more likely to respond to one or another treatment can advance precision medicine by informing a priori patient-treatment matches that can optimize treatment effects. To accomplish these goals, the authors will conduct a randomized clinical trial to compare the mediators and moderators of the clinical effects of Cognitive-Behavioral Therapy (CBT), Acceptance and Commitment Therapy (ACT), and Emotional Awareness and Expression Therapy (EAET) on adults with chronic spinal (axial) pain. Following baseline assessment of outcome variables as well as potential mediators and moderators, 460 participants will be randomized to CBT, ACT, EAET, or treatment-as-usual control (TAU). The three treatments will be conducted as individual therapy provided weekly for 8 weeks via telehealth. The researchers will conduct weekly assessments of both potential mediators and outcomes, as well as post-treatment and 6-month follow-up assessments. The goal of the study is to identify the most powerful treatment mechanisms - specific and shared -- and reveal for whom the mediator-outcome pathways are strongest.This project can increase the effects of our psychosocial chronic pain treatments by identifying the most effective treatment mechanisms and by informing patient-treatment matches that can optimize treatment effects.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Epilepsy, Autoimmune, Cancer, Heart, Others
460 Participants Needed
Online Pain Management Program for Chronic Back/Neck Pain
New York, New York
This trial tests if an online educational session about brain and emotions, combined with a writing exercise about trauma, can help adults aged 18-75 with chronic back or neck pain. The goal is to see if these activities can change how they think about their pain and reduce their emotional distress, leading to better pain management.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Cancer, Systemic Infection, Rheumatoid Arthritis, Others
120 Participants Needed
Why Other Patients Applied
"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
"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
"My orthopedist recommended a half replacement of my right knee. I have had both hips replaced. Currently have arthritis in knee, shoulder, and thumb. I want to avoid surgery, and I'm open-minded about trying a trial before using surgery as a last resort."
HZ
Arthritis PatientAge: 78
"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 changed my diet in 2020 and I’ve lost 95 pounds from my highest weight (283). I am 5’3”, female, and now 188. I still have a 33 BMI. I've been doing research on alternative approaches to continue my progress, which brought me here to consider clinical trials."
WR
Obesity PatientAge: 58
Burst-SCS for Chronic Pain
Ann Arbor, Michigan
Recently a new form of spinal cord stimulation therapy called burst spinal cord stimulation (Burst-SCS) is available to treat chronic pain. The goal of this study is to learn more about how Burst-SCS works to reduce chronic pain. The study will examine chronic pain patients who have been deemed candidates for Burst-SCS therapy, and who have already been selected to receive a temporary externalized trial of Burst-SCS from their own doctors as part of their standard clinical care for chronic pain management. During the study, participants will be asked to complete a variety of evaluations at certain time points. In addition, there will be a randomized, double blind, crossover phase, where the particular effects of Burst-SCS and sham SCS will be evaluated. The device used to deliver Burst-SCS and sham SCS is the St. Jude Medical Invisible Trial System.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Pregnancy, Artificial Nails, Uncooperative, Others
20 Participants Needed
Enhanced Physical Therapy for Chronic Lower Back Pain
Indianapolis, Indiana
This trial aims to find the best non-drug treatments for chronic low back pain in U.S. Veterans. It compares regular care, online programs, and physical therapy first. If needed, patients can then try yoga, spinal adjustments, or mental health therapy to manage their pain.
Stay on current meds
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Uncontrolled Hypertension, Recent Myocardial Infarction, Severe Psychiatric Illness, Others
2529 Participants Needed
Multimodal Treatments for Chronic Lower Back Pain
Ann Arbor, Michigan
This study is being completed to better understand who benefits from different chronic pain treatments and how these treatments work.
This study will include a four week run-in period for all cLBP participants. After completing the PainGuide (online or smart phone accessible website) run-in period, participants will be assessed using either the light or light plus deep phenotyping assessment battery and those who minimal or modest improvement in their pain (based on PGIC) will be randomized to one of four 8-week treatments (mindfulness-based stress reduction (MBSR), physical therapy (PT) and exercise, acupressure self-management, or duloxetine).
In addition, participants will complete study visits including physical exams, complete surveys, provide samples (blood,saliva, etc.), wear an electronic wrist device at certain times, and have Magnetic resonance imaging (MRIs) during the study.
Following one of the 4 treatments (8 weeks) if participants have a certain level of pain (that meets eligibility for more treatment) they will be then randomized to complete one of the 3 treatments that was not already assigned to them.
The study hypothesizes the following:
that this interventional response phenotyping can identify individuals with different underlying mechanisms for their pain who thus respond differentially to evidence-based interventions for chronic lower back pain (cLBP).
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Age:25 - 70
Key Eligibility Criteria
Disqualifiers:Not Listed
494 Participants Needed
MagnetOs Putty for Spinal Fusion
Detroit, Michigan
This is a phase IV post-marketing study for MagnetOs Easypack Putty. MagnetOs Easypack Putty is a synthetic bone graft extender product that is routinely used by surgeons as a treatment for patients with degenerative disc disease or spinal trauma undergoing spinal fusion surgery.
In this study, MagnetOs Easypack Putty will be used according to the latest U.S. Instructions For Use, standalone in the posterolateral spine.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Pregnancy, Bone Disorders, Infections, Others
Must Not Be Taking:Calcium Metabolism Drugs
60 Participants Needed
MagnetOs Flex Matrix for Degenerative Disc Disease
Bloomfield Hills, Michigan
This is a phase IV post-marketing study for MagnetOs Flex Matrix. MagnetOs Flex Matrix is a synthetic bone graft extender product that is routinely used by surgeons as a treatment for patients with degenerative disc disease and undergoing spinal fusion surgery.
In this study, MagnetOs Flex Matrix will be used according to the latest U.S. Instructions For Use, specifically as a bone graft extender mixed with autograft in a 1:1 vol.% in the posterolateral spine.
Trinity Elite will also be used according to its latest IFU approved in the US. Specifically, this cellular based allograft is an allograft intended for the treatment of musculoskeletal defects.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Pregnancy, Bone Disorders, Infections, Others
Must Not Be Taking:Calcium Metabolism Drugs
100 Participants Needed
Haloperidol for Back Pain
Kalamazoo, Michigan
Single center, double-blind, randomized, controlled trial in patients who present to the emergency department (ED) with a chief complaint of back pain. A total of 150 patients age 18-65 presenting to the emergency department with chief complaint of backpain will be enrolled from April 2024 - April 2025. Patients will be randomized and symptom levels will be recorded at 30, 60, 90, minutes. Follow-up will be performed by telephone at 24 hours.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Traumatic Injury, Saddle Anesthesia, Bowel Dysfunction, Others
75 Participants Needed
rTMS + Facet Joint Injections for Chronic Back Pain
London, Ontario
Chronic spinal pain (CSP) is one of the most common chronic pain conditions globally. Steroid joint injections (SJI) are a routine treatment option for patients with CLBP that is recalcitrant to other treatments. However, SJI has been shown to have limited long-term efficacy with patients often requiring another injection within months to adequately control pain. One option to prolong the analgesic effects of SJI is to use a type of noninvasive brain stimulation called repetitive transcranial magnetic stimulation (rTMS). Previous studies have shown rTMS may be capable of providing long-term pain relief in patients with chronic back pain. However, the literature on rTMS in patients with CSP is limited and no study has explored rTMS in patients receiving recurrent SJI for pain control.
In this pilot randomized controlled trial study, we'll be investigating if combining rTMS with SJI in CSP individuals will enhance or prolong the analgesic effects of SJI alone.
The investigators hypothesize that a combined rTMS and SJI intervention will be feasible, tolerable, and safe and will have larger and longer-lasting effects on CSP than a sham rTMS and SJI intervention.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Serious Spinal Pathology, Spinal Surgery, Others
Must Be Taking:Steroid Injections
40 Participants Needed
Osteopathic Treatment for Low Back Pain
Blacksburg, Virginia
This Study is for our continued study of the Thoracolumbar Fascia (TFL) in patients with and without low back pain by our experienced multidisciplinary team:
Vincent Wang PhD, VT Biomedical Engineering \& Mechanics (BEAM). Albert J Kozar DO, FAOASM, R-MSK. P. Gunnar Brolinson, DO, FAOASM, FAOCFP. David T. Redden PhD, VCOM Research Biostatistician. Matthew Chung DO, VCOM and Team Physician at Virginia Tech. Edward Magalhaes, PhD, LPC, Psychiatry and Neuro- Behavioral Sciences, VCOM.
This listing is specifically for our renewed efforts via two, Department of Defense (DoD) and American Osteopathic Association (AOA), extramurally, simultaneously funded grants for similar but distinct projects. Both funding sources are aware of each other's funding and have approved their grant study moving forward simultaneously with some integration.
DoD: Machine Learning Analysis of Ultrasound Images for the Investigation of Thoracolumbar Myofascial Pain and Therapeutic Efficacy of Hydrodissection.
The primary objectives of the proposed project are to:
1. develop reliable, quantitative image analysis approaches to objectively distinguish images from subjects with acute or chronic TLF pain from those without pain and
2. to assess the preliminary clinical efficacy of hydrodissection of the TLF as a novel therapeutic treatment for chronic LBP.
AOA: Assessment of the Therapeutic Efficacy of OMT on Chronic Low Back Pain: An Integrated Sonographic and Machine Learning Analysis of Thoracolumbar Fascia Glide Impairment.
The primary objectives of the proposed project are to:
1. assess the preliminary clinical efficacy of OMT as a therapeutic treatment for CLBP of TLF origin and
2. develop reliable, quantitative image analysis approaches to objectively distinguish images from subjects with TLF pain from those without pain.
These projects will share 50 no LBP subjects as controls. The DOD study will include 50 acute LBP and 50 CLBP. The AOA study will include 50 CLBP.
This project uses standard surveys, physical exam, functional tests, and ultrasound imaging to obtain both static images of the TLF at multiple transition zones. It further uses ultrasound to evaluate the dynamic gliding motion, via cine loops, of this fascia in 2 different body movements in subjects with acute low back pain (ALBP), with chronic low back pain (CLBP), and without low back pain (WLBP). All images will be clinically analyzed and further assessed by textural and machine learning analysis. Patients with CLBP (only) will choose to enter one of the two studies (DoD vs AOA) at the time of consent.
All images will be clinically analyzed and further assessed by textural and machine learning analysis. Patients with CLBP (only) that are found to have TLF glide impairment or positive physical exam maneuvers suggesting TLF as etiology will enter the treatment arm of the chosen study at the time of consent, either ultrasound guided hydrodissection (USGH), or Osteopathic Manipulative Therapy (OMT). After receiving 3 treatments utilizing one of these modalities, the CLBP participants will have repeat standard surveys, physical exam, functional tests, and ultrasound imaging assessments at 2,4,6,12, and 24 weeks post-treatment.
At the conclusion of this project, the investigators expect to have developed, refined, and implemented robust and feasible experimental and computational approaches which can be further expanded in larger-scale studies. The development of our data-driven computer models for the objective analysis of sonographic images of the TLF has high potential impact as it seeks to transform the assessment of TLF integrity, injury and healing via establishment of reliable US imaging biomarkers. The investigators anticipate that the tools developed will have broad utility to assess a variety of clinical treatments for the TLF. The investigators also hope to validate physical exam maneuvers that may predict TLF mediated LBP and have preliminary evidence of the efficacy of hydrodissection and OMT in TLF mediated LBP.
In pursuit of these objectives, the investigators will adopt an innovative approach featuring a robust integration of clinical imaging, physical exam, pain and functional outcomes, quantitative image analysis, and machine learning analyses.
Specific Aim 1: Compare sonographic TLF imaging characteristics in individuals with acute versus chronic pain to those without low back pain.
Specific Aim 2: Develop a machine learning (ML) classification algorithm to reliably distinguish abnormal myofascial tissue in acute versus chronic pain stages from healthy tissue.
Specific Aim 3:
DoD Study: Assess the preliminary therapeutic efficacy of hydrodissection as a novel treatment for TLF pain using quantitative US imaging and ML tools.
AOA Study: Assess the preliminary therapeutic efficacy of OMT as a treatment for CLBP using quantitative US imaging and ML tools.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 50
Key Eligibility Criteria
Disqualifiers:BMI > 30, Pregnancy, Spinal Surgery, Others
Must Not Be Taking:Corticosteroids, Anticoagulants, Muscle Relaxants
200 Participants Needed
PIPE-791 for Osteoarthritis and Low Back Pain
Duncansville, Pennsylvania
The primary goal of this clinical trial is to learn if PIPE-791 is safe and well-tolerated in adults with chronic osteoarthritis pain (COAP) or chronic low back pain (CLBP). The study will also explore whether PIPE-791 lowers pain in people with COAP or CLBP.
Subjects will:
* Complete a washout period to stop their current pain medications.
* Take a daily dose of PIPE-791 or placebo for 4 weeks, then reverse treatment assignment for another 4 weeks.
* Record pain levels and track dosing in a daily e-diary.
* Visit the clinic for checkups and lab tests throughout the study.
* Complete phone assessments during the treatment periods.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Sex:Male
Key Eligibility Criteria
Disqualifiers:Fibromyalgia, Rheumatoid Arthritis, Others
Must Not Be Taking:Capsaicin
40 Participants Needed
coflex® Interlaminar Stabilization for Spinal Stenosis
Munster, Indiana
This trial evaluates the safety and effectiveness of the coflex® device for patients with spinal stenosis and low back pain. The device is a small implant that helps stabilize the spine and relieve nerve pressure. The study aims to see how well it works over an extended period. The Coflex device has been studied extensively for its effectiveness in treating lumbar spinal stenosis and degenerative lumbar diseases, with multiple studies showing its long-term efficacy and safety.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Osteoporosis, Morbid Obesity, Infection, Others
300 Participants Needed
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Frequently Asked Questions
How much do Back Pain 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 Back Pain 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 Back Pain 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 Back Pain 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 Back Pain 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 Back Pain clinical trials?
Most recently, we added Ketamine for Chronic Lower Back Pain and Depression, Pregnenolone + DHEA for Lower Back Pain and Chiropractic Care for Back Pain to the Power online platform.
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