HOnest Placebos With Explanations: Evaluating Open-Label Placebos for Chronic Pain

Not Applicable

Recruiting

• Conditions: Chronic Low-back Pain; Chronic Pain
• Interventions: Drug: Open-label Placebo; Behavioral: Standard Rationale; Behavioral: Mindfulness; Behavioral: Control Rationale

• Registration Number: NCT06931158
• Lead Sponsor: Rhode Island Hospital

Brief Summary

The goal of this clinical trial is to examine the effect of rationale condition when taking open-label placebos on pain by 1) comparing each rationale to the no rationale control condition and the no treatment control condition; and 2) comparing the rationale conditions to each other. We also aim to examine the effect of rationale condition on prescription opioid use by 1) comparing each rationale to the no rationale control condition and the no treatment control condition; and 2) comparing the rationale conditions to each other.

This study will include patients with chronic low back pain. The main question it aims to answer is:

How do rationales influence the effects of open-label placebos?

Researchers will compare different rationales given when taking an open-label placebo and a no-treatment group and a no rationale group taking OLPs.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-03-01
• Status Verified: 2025-04
• Study First Submitted: 2025-04-01
• Study First Submitted QC: 2025-04-08
• Study First Posted: 2025-04-17
• Last Update Submitted: 2025-04-23
• Last Update Posted: 2025-04-27
• Primary Completion: 2027-01
• Study Completion: 2027-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 340

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OLP + Standard Rationale	Open-label Placebo	Participants in this group will receive an open-label placebo along with information based on the standard rationales used in other OLP studies.
OLP + Standard Rationale	Standard Rationale	Participants in this group will receive an open-label placebo along with information based on the standard rationales used in other OLP studies.
OLP + Mindfulness Rationale	Open-label Placebo	Participants in this group will receive an open-label placebo along with information with mindfulness information.
OLP + Mindfulness Rationale	Mindfulness	Participants in this group will receive an open-label placebo along with information with mindfulness information.
OLP + Control Rationale	Open-label Placebo	Participants in this group will receive an open-label placebo along with no information on the placebo effect.. They will receive basic epidemiological information on chronic pain to guarantee structural equivalence of the trial design.
OLP + Control Rationale	Control Rationale	Participants in this group will receive an open-label placebo along with no information on the placebo effect.. They will receive basic epidemiological information on chronic pain to guarantee structural equivalence of the trial design.
No Treatment + Control Rationale	Control Rationale	Participants in this group will receive no treatment. They will receive basic epidemiological information on chronic pain to guarantee structural equivalence of the trial design.

Primary Outcome Measures

Name	Time	Method
Pain intensity	across 42 days	Single-item assessing current pain level from 0 (min value) to 10 (max value). Higher scores indicate more pain intensity

Secondary Outcome Measures

Name	Time	Method
Pain interference	across 42 days	Pain Interference subscale from Brief Pain Inventory Pain interference is measured for general activity, mood, walking ability, work, relationships, sleep, and enjoyment of life on a 0-10 NRS with 0 = "does not interfere" and 10 = "completely interferes" Higher scores indicated greater pain intensity or greater interference with function.
Pain catastrophizing	across 42 days	Single item assessing how much the patient catastrophizes about their pain from 0 (minimum) to 10 (maximum). Higher scores indicate more catastrophizing.; 13 items rated on 5-point Likert scales, from (0) not at all to (4) all the time Higher score indicates higher level of catastrophizing; Item scores are summed into a total score (PCS-T) and three subscale scores: * Rumination (PCS-R): Items 8, 9, 10, and 11; * Magnification (PCS-M): Items 6, 7, 13; * Helplessness (PCS-H): Items 1, 2, 3, 4, 5, and 12 Minimum total score = 0, maximum total score = 52 Subscale score ranges: PCS-R: 0-16; PCS-M: 0-12; PCS-H: 0-24 A total score above 30 indicates clinically relevant level of catastrophizing
Prescription Medication use (including opioids)	across 42 days

Trial Locations

Locations (1)

Rhode Island Hospital; 🇺🇸 Providence, Rhode Island, United States