Treatment Trials

17 Clinical Trials for Various Conditions

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COMPLETED
Spinal Cord Stimulation Research Study
Description

The purpose of this study is to characterize a patient's activity levels before and after spinal cord stimulation therapy.

COMPLETED
Spinal Cord Stimulation Research Study
Description

The purpose of this study is to characterize subjects' response to spinal cord stimulation with postural changes.

COMPLETED
SCS as an Option for Chronic Low Back and/or Leg Pain Instead of Surgery
Description

To evaluate the safety and effectiveness of Spinal Cord Stimulation (SCS) with multiple modalities compared to Conventional Medical Management (CMM) in patients with chronic low back and/or leg pain who have not undergone spinal surgery when using the Boston Scientific WaveWriter SCS Systems.

Conditions
COMPLETED
Treatment of Chronic Low Back and Lower Extremity Pain
Description

1. To demonstrate clinically significant improvements in patients undergoing lumbar interlaminar epidurals. Improvement will be assessed in relation to the clinical outcome measures of pain and function. 2. To evaluate and compare the adverse event profile in all patients.

Conditions
COMPLETED
Effectiveness of Caudal Epidural Injections in Treatment of Chronic Low Back and Lower Extremity Pain
Description

To demonstrate clinically significant improvements or lack thereof in the caudal epidural patients with our without steroids. To evaluate differences in outcomes in patients receiving steroids compared to those patients randomized to the local anesthetic group who did not receive steroids. To assess improvements among patients and compare steroid groups with each other and local anesthetic group. To evaluate and compare the adverse event profile in all patients

Conditions
COMPLETED
Prospective Randomized Feasibility Study Comparing Manual vs. Automatic Position-Adaptive Spinal Cord Stimulation With Surgical Leads
Description

The main purpose of this study is to establish the extent that chronic pain patients implanted with surgical, laminectomy-type, leads experience position-related variation in spinal cord stimulation therapy and to investigate the effects of manual versus automatic position-adaptive spinal cord stimulation on clinical outcome.

COMPLETED
MIS MiLIF Versus Open
Description

This study is being undertaken to compare the clinical outcomes of patients that have unilateral posterolateral lumbar interbody fusion using a traditional open approach versus the MiLIF procedure based on the MiCOR Precision Bone Allograft, specialized Atavi instrumentation, and minimally invasive visualization capabilities.

COMPLETED
The Feasibility of Using Neuroscience Education in Adults Over 65 Years Old With Chronic Low Back and/or Lower Extremity Pain
Description

This is a pilot study to determine if neuroscience education is acceptable to adults over 65 and if it can have an impact on pain, pain beliefs and gait speed

UNKNOWN
Effect of Spinal Cord Stimulation on Gait and Balance in Chronic Low Back Pain Patients
Description

Spinal Cord Stimulation (SCS) uses electrical signals to disrupt noxious signals arising from painful areas, thereby reducing pain perception. Successful SCS implants lead to a broad range of positive outcomes: 1) long-term pain can be expected to be reduced by at least by 50%; 2) quality of life as assessed by subjective measurements improves substantially; 3) patients can significantly reduce opioid medication intake.1 However, the impacts of SCS intervention on neuromuscular and biomechanical outcomes including gait and balance have not been fully explored. Fifty subjects with symptomatic leg pain and/or low back pain (LBP) who are deemed appropriate SCS candidates and are scheduled for surgery will undergo gait and balance analyses preoperatively as well as 6 weeks and 3 months post operatively. In addition, 50 control subjects having no pain will undergo 1 session of gait and balance assessment. Objective spine and lower extremity motion and neuromuscular control will be evaluated using dynamic surface EMG and a video motion capture system during functional evaluation. Also, explored will be the relationship of changes in gait and balance to psychosocial factors that have previously been shown to be correlated with SCS outcomes.

COMPLETED
Comparison of the Effects of Two Spinal Cord Stimulation (SCS) Therapies on Subject Reported Pain (BENEFIT-02)
Description

A BIOTRONIK wearable stimulator will be utilized in order to investigate the effects of two study spinal cord stimulation (SCS) therapies on subject reported pain and paresthesia perception observed over 12 days of study stimulation testing following the conclusion of a successful SCS commercial trial.

TERMINATED
Percutaneous Neuromodulation Therapy (PNT) With Chronic Low Back Pain Patients
Description

The purpose of this study is to assess the benefits of Percutaneous Neuromodulation Therapy when compared to a reference sham treatment in the treatment of patients who have undergone surgical intervention for chronic low back pain with or without a radiating lower extremity pain component.

Conditions
COMPLETED
Role of Steroids and 10% Hypertonic Sodium Chloride in Adhesiolysis in Post Lumbar Surgery Syndrome Patients
Description

To evaluate the effectiveness of steroids and/or 10% hypertonic sodium chloride in percutaneous adhesiolysis in managing chronic low back and/or lower extremity pain in patients with post lumbar surgery syndrome. To evaluate and compare the adverse event profile in all groups.

Conditions
COMPLETED
Evaluation of the Effectiveness of Transforaminal Epidural Injections in Lumbar Disc Herniation or Radiculitis
Description

To evaluate differences in outcomes in patients receiving steroids compared to those patients randomized to the local anesthetic group who did not receive steroids. To evaluate and compare the adverse event profile in all patients.

Conditions
COMPLETED
Integrated Supported Biopsychosocial Self-Management for Back Related Leg Pain
Description

Guidelines advocate several complementary modalities as alternatives to drugs and other invasive treatments for chronic low back pain (LBP) conditions. However, there is little high-quality research investigating treatments for back-related leg pain, one of the more severe and disabling presentations of LBP. The investigators are conducting a pilot study to assess the feasibility of a future phase II multi-site randomized clinical trial (RCT). The future trial will assess the comparative effectiveness of a novel supported biopsychosocial self-management (SBSM) intervention versus Medical Care (MC).

COMPLETED
Manual Therapy as a Form of Sensory Discrimination in Chronic Low Back Pain
Description

This study evaluates whether different explanations given to patients with long lasting back pain influence a physical therapy treatment technique. Half of the patients will receive an explanation of the proposed treatment technique focusing on how their joints are moving and not moving. The second half of the group will receive the same treatment technique as the first group, but their explanation of the technique's purpose will focus on how their brain interprets the information. The study aims to determine if patients have a different response to the treatment based on the words chosen to explain the technique.

Conditions
COMPLETED
Making Better Lives: Patient-Focused Care for Low Back Pain (LBP)
Description

Back pain is a huge problem for millions of Americans, including nearly 11 million Veterans. Our older Veterans suffer the most. Citizens spend billions of dollars, yet consistently get poor results. Primary Care Providers are often tasked with diagnosing and treating Chronic Low Back Pain, even though they are often undereducated in the field. These PCPs often use advanced imaging, usually MRIs to guide care. These images often show degenerative disc disease and other common pathologies in older adults, even those who are pain free, which can lead to misdiagnosis and treatment. The investigators believe that Chronic Low Back Pain is a syndrome, a final common pathway for the expression of multiple contributors that often lie outside the spine itself. For example, hip osteoarthritis, knee pain, and even anxiety could all lessen back pain if addressed and treated probably. Investigators will measure participants' low back pain-associated disability with the well-validated RMDQ. Data will be collected at baseline and monthly via telephone. The investigators hypothesize that veterans who receive PCCET will experience significantly greater reduction in low back pain-associated disability than those who receive IAUC at six months. Investigators will also measure participants' low back pain with the 0-10 Numeric Rating Scale for Pain. Data will be collected at baseline and monthly via telephone. The investigators hypothesize that veterans who receive PCCET will experience significantly greater reduction in low back pain than those who receive IAUC at six months. The goal of this study is to compare patients treated with usual care, which usually starts with imaging, versus patients who are treated by trained geriatricians who know how to recognize and address 11 key conditions that commonly drive pain and disability in older adults. The investigators believe that older patients who receive care tailored to their needs by educated PCPs will ultimately have less back pain and, more importantly, better quality of life.

COMPLETED
Cost Effectiveness of OMT for Chronic Low Back Pain
Description

The specific aim of this study is to conduct a prospective, multicenter cohort study over four months to compare the cost of standard of allopathic care (control group, N=90) versus standard of care plus osteopathic manipulative treatment (experimental group, N=90) in a cohort of 180 consecutive patients seeking treatment for chronic low back pain at three osteopathic clinics and three allopathic medical clinics (offering only standard care) located in three different regions of the United States.