Conditioning & Open-Label Placebo (COLP) for Opioid Management in Intensive Inpatient Rehabilitation

Launched by SPAULDING REHABILITATION HOSPITAL · Apr 21, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new approach called Conditioning & Open-Label Placebo (COLP) to help manage pain in patients with spinal cord injuries, polytrauma (multiple injuries), and burn injuries, while reducing the need for opioid medications. The goal is to provide effective pain relief without relying heavily on opioids, which can have side effects and lead to the risk of addiction. By using this method, researchers hope to achieve the same level of comfort for patients while using lower doses of opioids.

To participate in this trial, you must be 18 years or older and currently receiving treatment for spinal cord injury, polytrauma, or burn injuries at Spaulding Rehabilitation Hospital. You should also be experiencing moderate to severe pain and currently using narcotics to manage that pain, but not exceeding 120 mg of morphine or its equivalent. Participants can expect to receive care in a supportive environment while being monitored closely for their pain management needs. It's important to note that individuals with a history of substance abuse, certain medical conditions, or those who are pregnant or breastfeeding cannot participate in this study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Men and women aged 18 or older with traumatic and non-traumatic SCI (ASIA A-D), polytrauma, or burn injury patients from the Comprehensive Rehabilitation Program at Spaulding Rehabilitation Hospital,
• • SCI, polytrauma, or burn injury patients from the Comprehensive Rehabilitation Program at Spaulding Rehabilitation Hospital and pain of no more than five years of evolution,
• • Patients admitted to the Spaulding Comprehensive Rehabilitation Unit at Spaulding Rehabilitation Hospital,
• • Who have; above, at, or sub-lesional neuropathic pain and nociceptive pain (musculoskeletal or visceral) that is moderate or severe (average VAS scale score of 4 or greater at time of enrollment),
• • Inpatients with polytrauma (defined as having injuries that affect two or more body systems or organs) or patients with burn injuries, amputations, or post-surgical (e.g., orthopedic surgery)
• • Respiratory and hemodynamically stable,
• • With current narcotic use for pain control,
• • Narcotic usage of no more than 120 mg of morphine equivalent
• Exclusion Criteria:
• • History of alcohol or drug dependence, as self-reported,
• • History of bipolar disorder or psychosis, as self-reported,
• • Any substantial decrease in alertness, language reception, or attention that might interfere with understanding,
• • Current usage of narcotic medication with a dosage higher than 120 mg of morphine equivalent or 80 mg of short-acting oxycodone, or 30 mg of hydromorphone
• • Current use of a ventilator,
• • Compromised medical status due to uncontrolled pathologies such as cancer, heart failure, kidney or liver insufficiency, or any other condition which jeopardizes the patient's participation in the study
• • Pregnancy or breastfeeding. Participants with pregnancy capability will be tested for pregnancy by serum human chorionic gonadotropin (hCG) test.