Feasibility and Acceptability of OLP-EXP in Chronic Pain
Evaluating the Feasibility and Acceptability of Expectation-optimized Open-label Placebo as an Adjuvant Treatment for Chronic Pain
The primary objective is to determine the feasibility of delivering OLP-EXP, EXP only, and OLP only over 6 weeks to adults with chronic TMD. The trial will be considered feasible for progression planning when the 6-week retention rate is at least 80% in each arm and average OLP pill adherence is at least 80% of prescribed days in each OLP arm.
Primary hypothesis: Each intervention arm will meet the prespecified 6-week retention benchmark, and each OLP arm will meet the prespecified pill-adherence benchmark.
The secondary objectives are:
- To evaluate acceptability of each intervention using the TFA measurement and semi-structured interviews.
- To assess the feasibility of collecting daily EMA, continuous actigraphy, weekly questionnaires, and 3-, 6-, and 12-month follow-up assessments.
- To identify intervention barriers, facilitators, perceived benefits, burden, ethical concerns, and recommendations for a future fully powered efficacy trial.
- To estimate variability, missingness, and measure reliability needed to select outcomes and design a future trial.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Pain lasting for more than 3 months becomes chronic, and is prevalent across the global population. Among chronic pain conditions, temporomandibular disorders (TMD), a common orofacial pain condition affecting 9 to 30% of the general population, have attracted the attention of clinical providers and researchers. The high incidence and disastrous consequences of TMD underscore the need for effective and safe treatments.
Clinical and mechanistic research has shown substantial placebo responses in pain trials, highlighting the great potential to harness placebo mechanisms in clinical care. For example, a meta-analysis estimated that placebo responses could account for up to 66% of observed improvement in migraine-related outcomes.8 In one efficacy and safety trial of an intravenously eptinezumab, as much as 74% of the apparent benefit was attributed to placebo responses.
In ethically translating placebo mechanisms, open-label placebo (OLP) offers an adjuvant to current pharmacological and psychological treatments for chronic pain. OLP refers to the transparent, honest administration of placebos. Studies have found that people can still experience improvements in symptoms even after receiving OLP.
Previous RCT has demonstrated efficacy of EXPECT in a pilot clinical trial showing a reduction in the length of hospital stay after cardiac surgery. Moreover, participants who received EXPECT showed greater improvements in disability, and reduced pro-inflammatory cytokine concentrations compared to those in the treatment as usual group.
The investigators aim to develop an expectation-optimized OLP intervention (OLP-EXP) that could potentially maximize OLP effects and yield larger improvement in managing chronic pain, and an EXP only intervention that delivers expectations induced analgesia without the negative connotations of "placebo".
The investigators hypothesize that the adapted OLP-EXP and EXP only will be feasible and well-accepted in chronic pain population.
This is a single-site, three-arm, parallel-group, randomized pilot/feasibility clinical trial. Fifty-seven adults with chronic TMD will be randomized 1:1:1 to OLP-EXP, EXP only, or OLP only. All participants will continue treatment as usual. The intervention period is 6 weeks, followed by remote assessments at 3, 6, and 12 months.
The intervention arms are:
- OLP-EXP: Expectation optimization addressing benefit, personal-control, and coping expectations, plus transparent daily OLP pills for 6 weeks and weekly boosters.
- EXP only: Expectation optimization addressing personal-control and coping expectations associated with chronic pain in general, plus weekly boosters.
- OLP only: Standard transparent OLP rationale and daily OLP pills for 6 weeks, with neutral matched study contacts that do not deliver expectation-optimization content.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yang Wang, PhD
- Phone Number: 410-706-7824
- Email: yang.wang@umaryland.edu
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- English speaking (written and spoken)
- Age between 18 and 65 years
- Confirmed TMD for more than 3 months
- Grade II or above on the Graded Chronic Pain Scale
Exclusion Criteria:
- Personal (or family first degree) history of mania, schizophrenia, or other psychoses
- Severe psychiatric conditions require medication (e.g. schizophrenia, bipolar disorders, autism) or hospitalization within the last 3 years.
- Lifetime alcohol/drug dependence and alcohol/drug abuse in past one year
- Pregnancy/Breastfeeding
- Currently participating in another clinical trial
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: OLP-EXP
Expectation optimization addressing benefit, personal-control, and coping expectations, plus transparent daily OLP pills for 6 weeks and weekly boosters.
|
Expectation optimization addressing benefit, personal control, and coping expectations, plus transparent daily OLP pills for 6 weeks and weekly boosters.
Other Names:
|
|
Experimental: EXP
Expectation optimization addressing personal-control and coping expectations associated with chronic pain in general, plus weekly boosters.
|
Expectation optimization addressing personal-control and coping expectations associated with chronic pain in general, plus weekly boosters.
Other Names:
|
|
Active Comparator: OLP
Standard transparent OLP rationale and daily OLP pills for 6 weeks, with neutral matched study contacts that do not deliver expectation-optimization content.
|
Open-label placebo pills.
The placebo pills in this study are empty capsules without any ingredients inside.
The capsules are made of microcrystalline cellulose.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Enrollment rate
Time Frame: At the enrollment
|
Enrollment rate: the proportion (%) of recruited participants who enrolled in the study.
|
At the enrollment
|
|
Retention rate
Time Frame: End of week 6
|
Retention rate: the proportion (%) of enrolled participants who finished the study
|
End of week 6
|
|
Daily survey completion rate
Time Frame: End of week 6
|
Module rate: the proportion (%) of completed daily surveys sent through DockTales and REDCap-based surveys.
|
End of week 6
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HP-00120206
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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