Trial Outcomes & Findings for Reduction of Opioid Dose Using Conditioning & Open-Label Placebo (COLP) in Intensive Rehabilitation (NCT NCT03906721)

Reduction of Opioid Dose Using Conditioning & Open-Label Placebo (COLP) in Intensive Rehabilitation

Morphine Milligram Equivalents (MME) are used to standardize opioid exposure by expressing the analgesic potency of different opioids relative to morphine. MME is calculated by multiplying the prescribed opioid dose by the daily frequency of administration and then by an opioid-specific conversion factor. The resulting value is expressed as milligrams of morphine equivalents (mg MME). Values range from 0 mg MME upward, with higher values indicating greater opioid exposure, which has been associated with an increased risk of adverse clinical outcomes.

The Visual Analog Scale (VAS) is a measurement tool used to quantify pain intensity. It consists of a 10-point anchored by a minimum value of 0, representing "no pain," and a maximum value of 10, representing the "worst pain imaginable." Patients mark their perceived pain level; higher scores indicate a worse outcome, reflecting greater pain severity or distress. For this outcome, we are reporting the difference in VAS from Day 1 to Day 6.

This measurement system was developed to address the shortage of relevant and psychometrically sound patient reported outcome measures available for clinical care and research in spinal cord injury (SCI) rehabilitation. For the purpose of this research, the Pain Behavior subdomain will be the primary component of this scale to be used. This 7-item fixed-length scale measures manifestations of pain. These actions or reactions can be verbal or non-verbal and involuntary or deliberate. They include observable displays, and verbal reports of pain. This scale includes a small subset of the Patient-Reported Outcomes Measurement Information System (PROMIS ) Pain Behavior item bank (i = 4) and three new items.

The Numerical Opioid Side Effect (NOSE) assessment tool is a simple, rapid, self-administered instrument to document and longitudinally follow trends of opioid adverse effects. The NOSE typically assesses 10 common, specific opioid side effects, including nausea, fatigue/drowsiness, constipation, itching, decreased libido, dry mouth, abdominal pain, sweating, dizziness, and urinary retention, with each item rated on this 0-10 scale. Higher values on the NOSE scale represent worst side effects Minimum Score: 0 (indicates no problems with opioid side-effects) Maximum Score: 100 (indicates the worst possible opioids side-effects) The reported outcome is the change in NOSE from Day 1(baseline) to Day 6(post-intervention)

Electroencephalography (EEG) is an electrophysiological monitoring method to record the electrical activity of the brain. Quantitative electroencephalography (qEEG) stands out as a valuable, non-invasive tool because it provides reliable and relevant information about brain functioning during rest, sensory stimulation, and cognitive tasks. Besides, this technique is safe, low-cost, and employs a straightforward methodology, making it an appropriate tool for clinical practice. The EEG recordings will be processed for analytical purposes by the investigators will explore standard EEG metrics (e.g., spectral analysis).

NIRS is a spectroscopic method that uses the near-infrared region of the electromagnetic spectrum. This method is based on near-infrared light absorption fluctuations that depend on concentration changes of the chromophores oxygenated hemoglobin (O2Hb) and deoxygenated hemoglobin (HHb). The values are usually expressed in micromolar units (mM) of concentration change relative to a baseline. The higher the O2Hb value, represents higher cortical activity. Higher HHb represents decreased cortical activity. The outcome is reported as the change O2Hb and HHb from Day 1(baseline) to Day 6 (post-intervention)

Metabolomics is the large-scale study of small molecules. The analysis will focus on pathways associated with cognitive and cellular metabolism. The investigators will collect samples by pinprick system, and analysis will be done using liquid chromatography (LC) technique and by employing Electrochemical Array Detection (ECA). Concentration of metabolites will be reported and used for analysis using the absolute quantification value in (micromolar). This outcome measure data represents the change in metabolite concentration from baseline to post-intervention.