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

J David Clark; Matthew J Bair; Ilana Belitskaya-Lévy; Colleen Fitzsimmons; Lisa M Zehm; Paul E Dougherty; Karleen F Giannitrapani; Erik J Groessl; Diana M Higgins; Jennifer L Murphy; Daniel L Riddle; Grant D Huang; Mei-Chiung Shih

doi:10.1016/j.cct.2022.107041

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

Contemp Clin Trials. 2023 Feb:125:107041. doi: 10.1016/j.cct.2022.107041. Epub 2022 Dec 7.

Affiliations

¹ Anesthesiology Service, VA Palo Alto Health Care System, Palo Alto, CA, USA; Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University, Stanford, CA, USA.
² VA HSR&D Center for Health Information and Communication, Roudebush VA Medical Center, Indianapolis, IN, USA; Indiana University School of Medicine, Department of Medicine, Indianapolis, IN, USA; Regenstrief Institute, Inc., Indianapolis, IN, USA. Electronic address: mbair@iu.edu.
³ VA Cooperative Studies Program Coordinating Center, VA Palo Alto Health Care System, Mountain View, CA, USA.
⁴ Anesthesiology Service, VA Palo Alto Health Care System, Palo Alto, CA, USA.
⁵ VA Finger Lakes Health Care System, Canandaigua, NY, USA; Northeast College of Health Sciences, Seneca Falls, NY, USA.
⁶ Center for Innovation to Implementation (Ci2i), VA Palo Alto Health Care System, Menlo Park, CA, USA; Division of Primary Care and Population Health, Stanford University School of Medicine, Stanford, CA, USA.
⁷ Research Service, VA San Diego Healthcare System, San Diego, CA, USA; Herbert Wertheim School of Public Health, University of California San Diego, La Jolla, CA, USA.
⁸ Durham VA Healthcare System Duram, NC, USA; Boston University School of Medicine, Boston, MA, USA.
⁹ Department of Veterans Affairs (VA), Specialty Care Program Office, Director of Pain Management, Washington, DC, USA.
¹⁰ Departments of Physical Therapy, Orthopedic Surgery and Rheumatology, Virginia Commonwealth University, Richmond, VA, USA.
¹¹ Office of Research and Development, U.S. Department of Veterans Affairs, Washington, DC, USA.

PMID: 36496154
DOI: 10.1016/j.cct.2022.107041

Abstract

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.

Keywords: Cognitive behavioral Therapy; Low Back pain; Physical Therapy; Randomized trial; Spinal manipulation; Yoga.

Publication types

Pragmatic Clinical Trial
Randomized Controlled Trial
Research Support, U.S. Gov't, Non-P.H.S.

MeSH terms

Back Pain
Chronic Pain* / psychology
Chronic Pain* / therapy
Cognitive Behavioral Therapy* / methods
Humans
Low Back Pain* / psychology
Low Back Pain* / therapy
Treatment Outcome

Associated data

ClinicalTrials.gov/NCT04142177