Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06225817 |
| Other study ID # |
HP-00105618 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 28, 2024 |
| Est. completion date |
July 30, 2026 |
Study information
| Verified date |
April 2024 |
| Source |
University of Maryland, Baltimore |
| Contact |
Yang Wang, PhD |
| Phone |
4107067824 |
| Email |
yang.wang[@]umaryland.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The goal of this free-choice parallel design clinical trial is to examine the potential
beneficial effects of using open-label placebo (OLP) in improving chronic headache related
outcomes and sleep quality. This study will enroll a cohort of participants with chronic
headache which lasts for more than 3 months. The main questions it aims to answer are:
1. Will participants with chronic headache be more likely to take open-label placebo pills
if they are introduced to the effects of placebo?
2. Will taking open-label placebo improve chronic pain related outcomes, such as chronic
pain intensity, interference, levels of anxiety and depression, in the cohort of chronic
headache?
3. Will open-label placebo improve sleep quality in participants suffering from chronic
headache?
To answer the above questions, participants with chronic headache will be randomly assigned
to two groups: 1. Open-label placebo group where participants will be asked to take
open-label placebo pills, one pill per day, for a total of 45 days. 2) wait-list group where
participants will maintain their usual care without introducing open-label placebo to them
during the 45 days monitoring. Researchers will compare the chronic pain intensity,
interference, mood, anxiety, and sleep quality between the open-label placebo group and the
wait-list group. Daily chronic pain will be measured using visual analog scale (VAS) ranging
from 0=no pain at all to 100=maximum tolerable pain. Chronic pain interference using
Patient-Reported Outcomes Measurement Information System (PROMIS) pain interference and pain
behavior. Anxiety and depression will be measured using PROMIS-anxiety, and PROMIS-depression
scales respectively. Finally, sleep quality will be quantified using the objective
measurement Motion Watch during the 45 days intervention and monitoring. In order to have a
rigorous measurement of the baseline pain and sleep fluctuation, this study will include a
7-day phenotyping period before the starting of the 45-day intervention and monitoring.
During the 7-day phenotyping period, participants will record their daily chronic pain and
sleep quality using polysomnography.
Description:
This is a longitudinal parallel randomized clinical trial with chronic headache participants
randomly assigned to either 1) the open-label placebo (OLP) group, or 2) the wait-list group.
To examine how baseline chronic pain and sleep patterns could have impacted the effects of
OLP, we will deep-phenotype participants based on their sleep profiles and fluctuations in
their chronic pain characteristics via a 7-day phenotyping phase. Following the 7-day
phenotyping phase, participants will enter a 45-day intervention phase. The nature of the
participation will be voluntary. Namely, participants can withdraw during trial from the
study without any consequences.
Phenotyping phase (7-day) The phenotyping phase includes an in-person visit and a 7-day
at-home monitoring period. During the in-person visit, after signing the informed consent
form with the trained staff, participants will complete a heat pain sensitivity test using a
30mmx30mm Advanced Thermal Stimulator (ATS) via the Medoc Pathway system (Medoc Advanced
Medical Systems, Medoc Ltd., Israel). Painful and non-painful stimuli will be delivered to
the ventral forearm of the non-dominant hand.
After the in-person visit, participants will enter a 7-day daily monitoring period, where
their daily pain expectations, pain experience fluctuations, and sleep diaries will be
assessed in real time and in their natural environment using the Ecological Momentary
Assessment (EMA) method. Sleep profiles will be assessed using polysomnography to obtain
natural sleep architectures, including the duration of different sleep stages, sleep
efficiency, breathing, and body movement during sleep.
Free-choice OLP intervention Immediately following the phenotyping phase, participants will
return to the laboratory before entering the 45-day intervention phase. Participants will be
randomized to either the OLP group or the wait-list group. Participants in the OLP group will
receive a bottle of 45 OLP pills. According to the free-choice paradigm, participants in the
OLP group are allowed to choose whether to take the pills each day during the intervention.
This paradigm maximizes participant benefit because it provides the option of "not" taking
the placebo pills. Participants in the wait-list group will not receive OLP pills until the
end of the 45-day monitoring period.
