Sequential and Comparative Evaluation of Pain Treatment Effectiveness Response (SCEPTER), a pragmatic trial for conservative chronic low back pain treatment.

BACKGROUND: Chronic low back pain (cLBP) is a common and highly disabling problem world-wide. Although many treatment options exist, it is unclear how to best sequence the multitude of care options to provide the greatest benefit to patients. METHODS: The Sequential and Comparative Evaluation of Pain Treatment Effectiveness Response (SCEPTER) trial uses a pragmatic, randomized, stepped design. Enrollment targets 2529 participants from 20 Veterans Affairs (VA) medical centers. Participants with chronic low back pain will first be randomized to one of three options: 1) an internet-based self-management program (Pain EASE); 2) a tailored physical therapy program (Enhanced PT); or 3) continued care with active monitoring (CCAM), a form of usual care. Participants not achieving a 30% or 2-point reduction on the study's primary outcome (Brief Pain Inventory Pain Interference (BPI-PI) subscale), 3 months after beginning treatment may undergo re-randomization in a second step to cognitive behavioral therapy for chronic pain, spinal manipulation therapy, or yoga. Secondary outcomes include pain intensity, back pain-related disability, depression, and others. Participants will be assessed every three months until 12 months after initiating their final trial therapy. Companion economic and implementation analyses are also planned. RESULTS: The SCEPTER trial is currently recruiting and enrolling participants. CONCLUSIONS: Trial results will inform treatment decisions for the stepped management of chronic low back pain - a common and disabling condition. Additional analyses will help tailor treatment selection to individual patient characteristics, promote efficient resource use, and identify implementation barriers of interventions. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT04142177.

Olanzapine for the treatment of hemiballismus: A case report.

Hemiballismus is a rare movement disorder characterized by involuntary, large amplitude movements of the limbs of 1 side of the body. We describe the case of a man in his late sixties with slurred speech, agitation, and right-sided hemiballismus resulting from a left thalamic hemorrhagic stroke. Treatment with haloperidol was unsuccessful, but both the hemiballismus and agitation diminished significantly after initiation of olanzapine (Zyprexa). The improvement in the hemiballismus was quantified by recording the number of hemiballistic movements that occurred while the patient performed standardized 30-minute sessions (daily for 5d). With the first task (reaching within the base of support while seated), the average number of hemiballismic movements per session decreased from a baseline of 23.5 to 3.0 in the upper extremity and from 20.5 to 7.0 in the lower extremity. With the second task (catching a ball while seated), the abnormal movements decreased from 52 to 6.3 in the upper extremity and from 34.5 to 2.7 in the lower extremity. This case suggests that olanzapine may be a valuable pharmacologic alternative for patients with hemiballismus.