Related Experiment Video
Updated: Aug 18, 2025
Biomechanical Changes Related to Low Back Pain: An Innovative Tool for Movement Pattern Assessment and Treatment Evaluation in Rehabilitation
Published on: December 13, 2024
Sequential and Comparative Evaluation of Pain Treatment Effectiveness Response (SCEPTER), a pragmatic trial for
J David Clark1, Matthew J Bair2, Ilana Belitskaya-Lévy3
1Anesthesiology Service, VA Palo Alto Health Care System, Palo Alto, CA, USA; Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University, Stanford, CA, USA.
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.
