Using open-label placebo to improve sleep and pain in chronic pain patients
The Impact of Open-label Placebo on Sleep and Pain Modulation
This study is testing if a special type of placebo treatment can help people with chronic jaw pain sleep better and feel less pain.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 111 (estimated) |
| Ages | 18 Years to 88 Years |
| Sex | All |
| Sponsor | University of Maryland, Baltimore Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT06225817 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of open-label placebo (OLP) on chronic pain and sleep quality in individuals with temporomandibular disorders (TMD) lasting over three months. Participants will undergo a two-day phenotyping phase to assess their pain and sleep patterns before being randomly assigned to one of three groups: OLP with expectation management, OLP only, or standard care. The study aims to determine if OLP, combined with expectation management, can enhance pain relief and improve sleep quality. The trial is voluntary, allowing participants to withdraw at any time without consequences.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-88 who have been diagnosed with temporomandibular disorders for at least three months.
Not a fit: Patients with severe psychiatric conditions, degenerative neuromuscular diseases, or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a non-invasive and cost-effective method to alleviate chronic pain and improve sleep quality for patients with TMD.
How similar studies have performed: While the use of open-label placebo is a novel approach, preliminary studies have shown promising results in similar contexts, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Baltimore, Maryland
- University of Maryland Baltimore School of Nursing — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Study coordinator: Yang Wang, PhD
- Email: yang.wang@umaryland.edu
- Phone: 4107067824
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.