Chronic Low-back Pain, Chronic Pain
Conditions
Keywords
open-label placebo, rationales, placebo effect
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
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.
Interventions
Open-label placebo pill for 21 days at 2 per day
BEHAVIORALStandard Rationale
Scientific rationale about the placebo effect
BEHAVIORALMindfulness
Mindfulness based rationale
BEHAVIORALControl Rationale
Basic epidemiological information about chronic pain to achieve structural equivalence for the control groups
Sponsors
Rhode Island Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Participants are blind to the research hypothesis but not to treatment allocation that are by definition open.
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
are: * chronic pain (pain lasting at least 3 months, pain intensity 4/10 or over and interference 3/10 or over) * at least 18 years old * English speaking * have a smartphone or computer with video access * the chronic pain is concentrated into the patient's lower back (tentative criteria based on recruitment rate)
Exclusion criteria
* Have chronic pain because of a cancer diagnosis * Over 89 years of age * Suspect an allergy to any placebo ingredient * Currently receiving worker's compensation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
United States
Outcome results
None listed