Treatment for Placebos

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Luana Colloca, Baltimore, MD
Placebos+6 More
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether virtual reality can be used to reduce pain.

See full description

Eligible Conditions

  • Placebos
  • Virtual Reality
  • Temporomandibular Disorders
  • Pain

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Treatment will improve 1 primary outcome and 1 secondary outcome in patients with Placebos. Measurement will happen over the course of one session lasting from 2 to 3 hours.

Hour 3
Ischemic pain endurance
Ischemic pain rating

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Naloxone
1 of 2
Saline
1 of 2
Active Control
Non-Treatment Group

This trial requires 259 total participants across 2 different treatment groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

NaloxoneNARCAN® Naloxone Nasal Spray will be used to determine how the opioid tone shapes VR-induced hypoalgesia. Participants will be stratified for sex and then randomized to naloxone (The dose of naloxone will be 4 mg, so 0.1 mL of 40 mg/ml naloxone solution given intranasally) or saline (0.1 mL 0.9% sodium chloride intranasally), respectively. Investigators, staff, and participants will be blinded to the treatment options.
SalineSaline group, where participants will be given saline solution (4mg) via an identical spray device. Participants will be stratified for sex and then randomized to saline arm (The dose of saline will be (0.1 mL 0.9% sodium chloride intranasally), respectively. Investigators, staff, and participants will be blinded to the treatment options.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: one session lasting from 2 to 3 hours
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly one session lasting from 2 to 3 hours for reporting.

Who is running the study

Principal Investigator
L. C.
Prof. Luana Colloca, Professor
University of Maryland, Baltimore

Closest Location

Luana Colloca - Baltimore, MD

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Age (18-88 years)
English speaker (written and spoken)
Temporal Mandibular Disorder (TMD) for at least 3 months

Patient Q&A Section

What causes chronic pain?

"In many illnesses, [chronic pain](https://www.withpower.com/clinical-trials/chronic-pain) is associated with damage in the peripheral or central parts of the nervous system or both, rather than simple sensitization to pain caused by injury to the joint. Chronic pain has a range of causes, many of which are still to be fully understood." - Anonymous Online Contributor

Unverified Answer

What is chronic pain?

"Although the term 'pain' is ambiguous, it should be understood both in its generic sense of 'a sensation' that usually motivates or motivates motivation, and as a type of sensory experience, specifically the experience of chronic pain. This article examines the role of chronic illness and chronic pain in explaining an illness-associated disability (the illness-associated disability hypothesis, or IAH). Illness-associated disability is a disability that develops because of a person's illness, not because the person wants or expects to have the disability." - Anonymous Online Contributor

Unverified Answer

What are common treatments for chronic pain?

"A variety of treatments have been reported to be effective and well tolerated for chronic pain. Despite this, little evidence and practice guidelines exist to guide physicians in evaluating and treating patients with chronic pain." - Anonymous Online Contributor

Unverified Answer

Can chronic pain be cured?

"The key to ending [chronic pain](https://www.withpower.com/clinical-trials/chronic-pain) is developing and using effective, long-duration pain treatments. Those who are motivated, who accept risk, and who understand when pain medications work for them, will have better outcomes. Those who are not open to working in this area, and/or who lack motivation, or who discount the risks when medications do work for them, are unlikely to be successful with most short-term approaches to managing painful conditions. However, some of those who are open to working in this area might be able to be effectively managed with long-duration treatments." - Anonymous Online Contributor

Unverified Answer

What are the signs of chronic pain?

"Chronic pain patients frequently did not show obvious signs, for which this study offered a simple approach to identification. The most important clinical findings have been explored systematically for the first time. It remains an open question why chronic pain patients and their physicians should keep silent." - Anonymous Online Contributor

Unverified Answer

How many people get chronic pain a year in the United States?

"About 45 million people have chronic pain each year in the United States. The severity of chronic pain is higher in women, in the elderly, in people with multiple chronic illnesses and in people living without insurance." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for chronic pain?

"Clinicians should be cautious about providing clinical trials to patients with chronic pain. Patients need to be motivated and aware of the expected benefits and risks of taking part in studies. Their expectations about the intervention must be carefully considered." - Anonymous Online Contributor

Unverified Answer

Is treatment safe for people?

"The overall frequency of adverse effects experienced by the patients in the group studied was low. The frequency of adverse effects was not affected by the type of treatments. This indicates that the adverse effects did not prevent the use of treatment, which was acceptable to patients. The frequency of the adverse effects was not significantly different in the groups examined, except for nausea and vomiting. There were no serious adverse effects reported during the follow-up." - Anonymous Online Contributor

Unverified Answer

How serious can chronic pain be?

"There is plenty of evidence for the seriousness of chronic back pain. This is important for health care professionals because back pain is often the first symptom of serious disease. A clear understanding of the seriousness of chronic back pain can change the emphasis of treatment from pain management alone to a more comprehensive approach to help relieve symptoms and promote recovery." - Anonymous Online Contributor

Unverified Answer

What is treatment?

"There are many treatment options available, and as an informed patient, you can be proactive, seeking treatment options to help manage your pain and also your functioning. You will decide what’s best for your situation and you will decide how far you want the treatment to go.\nThe patient must have an honest discussion with their doctor and with other healthcare providers. They must also be educated on where they can find many different sources of information from which to make an informed decision, and they should remember to listen to their doctor." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of treatment?

"The common side effects of treatment would be fatigue, drowsiness, numbness, pain, or itching all of which can be caused by the narcotic the person is taking." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in treatment for therapeutic use?

"There are 3 new medications in the treatment of chronic post-traumatic pain. These medications have been approved by the U.K. Medicines Commission but there are currently no evidence-based pharmacological treatments for this condition. Many of our patients may be in great need of these medications, but they do not currently have these treatments available. They are in short supply and therefore are going to stay costly. We need large studies of chronic post-traumatic pain in adults to see if we can make a better world by treating it more efficiently." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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