Placebo Impacts Sleep and Pain Modulation in Chronic Pain

Launched by UNIVERSITY OF MARYLAND, BALTIMORE · Jan 16, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how an open-label placebo (OLP) might help improve sleep and reduce pain in people with temporomandibular disorders (TMD), which are painful conditions affecting the jaw. In this study, participants will be divided into three groups: one will take an OLP along with a session to discuss their expectations about the treatment; another group will take the OLP without any additional discussion; and the third group will continue with their usual care without the placebo. Researchers want to see if taking the OLP helps reduce pain, anxiety, and depression, and improves sleep quality for those suffering from TMD.

To participate, individuals must be between 18 and 88 years old, speak English, and have had TMD for at least three months. Participants will need to have a smartphone for communication and should be able to record their pain and sleep patterns during the study. It's important to note that people with certain health conditions or psychiatric histories will not be eligible for this trial. Over the course of 45 days, participants will report on their pain levels and sleep quality, helping researchers understand the potential benefits of the open-label placebo approach.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ( 18-88 years old)
• • English speaker (written and spoken)
• • TMD for at least 3 months
• • Grade Chronic Pain Scale (GCPS) ≥1
• • Smartphone/text messaging capability
• Exclusion Criteria:
• • Present or past degenerative neuromuscular disease
• • Cardiovascular, neurological diseases, pulmonary abnormalities, kidney disease, liver disease, history of cancer within past 3 years
• • Any personal (or family first degree) history of mania, schizophrenia, or other psychoses
• • Severe psychiatric condition (e.g. schizophrenia, bipolar disorders, autism) leading to hospitalization within the last 3 years.
• • Lifetime alcohol/drug dependence or alcohol/drug abuse in past 3 months
• • Pregnancy or breast feeding
• • Impaired or uncorrected hearing