Placebo Impacts Sleep and Pain Modulation in Chronic Headache

University of Maryland Baltimore (UMB) logo

University of Maryland Baltimore (UMB)

Status

Not yet enrolling

Conditions

Chronic Pain
Headache

Treatments

Dietary Supplement: Open-label placebo pills

Study type

Interventional

Funder types

Other

Identifiers

NCT06225817
HP-00105618

Details and patient eligibility

About

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.

Full 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.

Enrollment

72 estimated patients

Sex

All

Ages

18 to 88 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age ( 18-88 years old)
  • English speaker (written and spoken)
  • Chronic headache 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

72 participants in 2 patient groups

Open label placebo arm
Experimental group
Description:
Participants who are assigned to the OLP group will be given a bottle of OLP pills. They will be asked to take one pill per day for 45 days. They will be introduced to placebo effects and the therapeutic potential of using open-label placebo for chronic pain management and sleep improvement.
Treatment:
Dietary Supplement: Open-label placebo pills
Wait-list arm
No Intervention group
Description:
Participants in the wait-list group will not receive OLP pills until the end of the 45-day monitoring period. Therefore, the 45 days without OLP will serve as an no intervention comparators relative to the OLP group.

Trial contacts and locations

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Central trial contact

Yang Wang, PhD

Data sourced from clinicaltrials.gov

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