Treatment Trials

11 Clinical Trials for Various Conditions

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ENROLLING_BY_INVITATION
SCHF Post-Op Study Between Opioid and Non-Opioid Pain Management
Description

This purpose of this study is to determine the efficacy of nonopioid versus opioid analgesic regimens following surgical fixation of Gartland Type III Supracondylar Humoral Fractures (SCHFs) to assist in the development of a standard outpatient pain management regimen in the treatment of these injuries.

TERMINATED
Evaluating Postoperative Non-Opioid Pain Management Utilizing Local Anesthetics Coupled With Modulated Coagulation
Description

This study is a prospective randomized trial examining the effect of topically combined antifibrinolytics (Tranexamic acid) with local anesthetics in all electively created surgical wound beds in hand surgery to provide long term pain relief and decrease the use of postoperative narcotics.

COMPLETED
Immersive Virtual Reality Intervention for Non-Opioid Pain Management: A Randomized Controlled Trial
Description

The study is a randomized controlled trial (RCT) of VR non-opioid management vs. a control "sham" intervention for a broad and representative group of medical and surgical patients with pain. Hospitalized patients will receive specialized VR interventions, administered via portable VR headsets, to manage breakthrough pain. Control patients will view content on the in-room Health and Wellness television channel. Investigators will follow patients throughout the course of their hospitalization and monitor outcomes during and after their stays, including pain levels, medication requests, and quality of life.

TERMINATED
Virtual Reality After Breast Reconstruction Surgery
Description

This is a pilot study of virtual reality (VR) non-opioid management for women undergoing mastectomy and implant-based reconstruction. Study participants will receive specialized VR interventions, administered via VR headsets, to manage pain.

COMPLETED
By Potentially Adding a Century Old Therapeutic Measure to Pain Treatment Regimens Called Osteopathic Manipulative Treatment, Can Help Decrease Muscle and Bone Pain and the Usage of Opioid Pain Medication.
Description

Osteopathic Manipulative Treatment (OMT) has been used to successfully treat patients for over a hundred years. Even though there have been many subjective clinical results, there is still little research measuring the actual mechanical change to a spinal segment produced by OMT or the actual palpatory changes that one is able to detect or elicit. The Ultralign SA201System (also called a Spineliner internationally) is an advanced technical instrument commercially used for spinal analysis and treatment. It was originally designed to assist chiropractors in locating and correcting "subluxations" or "fixations", which may share many characteristics in common with "somatic dysfunction" or perhaps be identical in all but name. This system can analyze selected regions of the spine for comparison to adjacent tissues as well as pre and post treatment changes using computer graphics and actual digital numbers to describe the changes around a spinal segment. In this study, only the analysis part of the SA201 will be used. The analytical function of the SA201 allows the user to place a force transducer (small, smooth, rubber-like rod) against the skin overlaying a subject's spine and release an impulse (gentle tap) into the somatic tissues of the underlying spinal segment. The force impulse is transmitted through the sensor to the underlying area, soft tissues and articular elements of the subject which results in the formation of a waveform that is characteristic of the ratio of tissue resistance and force dissipation. Interpretation of the waveform measured by the SA201's force sensor provides an indication of the "stiffness" or "compliance" of each spinal segment as well as its "hysteresis" (the lagging of an effect behind its cause or how quickly the tissues tested return towards their original condition). The shape of the wave may be analyzed and further interpreted to reflect muscle spasm or other underlying tissue conditions. In this research study the investigators will obtain hysteresis measurements before and after treatment of spinal areas diagnosed by palpation to contain somatic dysfunction (SD). Hysteresis is the time it takes for the tissues to recoil after a deforming force has been introduced. Measurements of hysteresis will be taken using the SA201 before and after use of two OMT techniques used to relieve SD, High Velocity Low Amplitude (HVLA), Muscle Energy (ME) and Counterstrain (CS). Selection of these three techniques shall be randomized. The investigators will note if the SA201 is able to detect a difference in the hysteresis characteristics of a given SD and document whether OMT is capable of changing this objective parameter related to tissue texture; furthermore, a difference (if there is one) may be detected and quantified to determine if there is a different outcome between the different treatment modalities. The investigators also used a pressure sensor system called the IsoTOUCH during the diagnosis/treatment in the study to gain a better understanding of the amount of pressure that the SA201uses to diagnose a SD compared to the diagnostic pressure the Palpator uses. The IsoTouch were a pair of gloves worn by the physician administering OMT. No sensation other than palpation with gloved fingers were felt by the patient. At preset pressures, the SA201will document hysteresis characteristics of segments considered to have somatic dysfunction or not. This permits comparison of the dysfunctional, normal and corrected sites diagnosed by hand and the sites independently determined by the technology. It should also be able to graphically illustrate the change in the dysfunctional segment's response to the SA201 stimulus pre and post treatment, as well as to document if there is a difference between the various OMT treatment modalities. This machine also allows for the testing of more than one element simultaneously without compromising other aspects of the study. While the SA201 and the IsoTouch palpation monitors are able to diagnosis all segments of the spine this study will limit diagnosis and treatment to the cervical spine only at this time. Later studies can potentially expand to the other areas of the spine and body.

TERMINATED
Randomized, Double-Blind, Placebo-Controlled Pilot Study on the Safety and Effectiveness of LUCEMYRA During an Opioid Taper in Treatment of Withdrawal
Description

Stopping prescription opioid pain medications can be difficult due to withdrawal symptoms. This study will test if LUCEMYRA helps reduce withdrawal symptoms and helps more people reduce their opioid dose compared to placebo.

TERMINATED
Search to Advance Limited Use of Opioids Pilot: Optimization of Non-Opioid Therapy With a Steroid
Description

To provide health care professionals, including dentists, with the best possible evidence for clinical decision making when deciding upon analgesics and use of corticosteroid for acute post-surgical pain management; a pilot double blind randomized clinical trial will be conducted to test the hypothesis that use of preemptive dose of corticosteroid will reduce the need for opioid rescue. The impacted 3rd molar extraction model will be used due to the predictable severity of the post-operative pain and generalizability of results, as well as the fact that dentists write about one third of opioid prescriptions for adolescents.

Conditions
COMPLETED
Neurofeedback-EEG-VR System for Non-opioid Pain Therapy
Description

This study will assess the feasibility of developing the Neurofeedback-EEG-VR (NEVR) system for non-opioid pain therapy. Subjects suffering from pain will undergo sessions involving VR and Neurofeedback training and their pain will be assessed.

Conditions
RECRUITING
Initial Pain Management in Pediatric Pancreatitis: Opioid vs. Non-Opioid
Description

This will be a phase 2, single-center, unblinded randomized controlled pilot trial of two arms comparing opioid-sparing analgesia to the current Boston Children's Hospital institutional practice which has been reported to predominantly include administration of opioids as a first-line analgesic to pediatric patients who present to the emergency department with a diagnosis of acute pancreatitis (AP). This is a pilot trial for which many outcomes have not previously been studied in the pediatric AP population. The focus of this investigation will be to investigate the magnitude and variability of effect sizes for designing a future multi-center, double-blinded randomized controlled trial.

TERMINATED
A Pilot Clinical Trial of Oral Ketamine for Acute Pain Management After Amputation Surgery
Description

The purpose of this pilot study is to test the safety of oral ketamine to treat acute pain after amputation surgery. The objective of the proposed research is to conclusively determine if oral ketamine is a safe alternative analgesic to opioid for acute pain in subjects undergoing elective amputation of the lower extremity. All participants will receive oral ketamine.

NOT_YET_RECRUITING
Comparing the Difference in Pain Control in the Pediatric General Surgery Population: to Alternate or Combine Acetaminophen and Ibuprofen?
Description

To examine the difference in pain control in the pediatric general surgery population alternating acetaminophen and Ibuprofen q 3 hours vs giving them simultaneous combination therapy around the clock.