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.
Further information about study design and hypothesis is provided in the following citation. Study start date refers to the date the first participant completed baseline assessment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
327
Open-label placebo pill for 21 days at 2 per day
Scientific rationale about the placebo effect
Mindfulness based rationale
Basic epidemiological information about chronic pain to achieve structural equivalence for the control groups
Rhode Island Hospital
Providence, Rhode Island, United States
Pain intensity
Single-item assessing current pain level from 0 (min value) to 10 (max value). Higher scores indicate more pain intensity
Time frame: across 42 days
Pain interference
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.
Time frame: across 42 days
Pain catastrophizing
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
Time frame: across 42 days
Prescription Medication use (including opioids)
Time frame: across 42 days
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