Evidence map›Paper›PMID 36715655›Full record

ArticlePain medicine (Malden, Mass.)2023

Back Pain Consortium (BACPAC): Protocol and Pilot Study Results for a Randomized Comparative-Effectiveness Trial of Antidepressants, Fear Avoidance Rehabilitation, or the Combination for Chronic Low Back Pain and Comorbid High Negative Affect.

Ajay D Wasan, Robert R Edwards, Kevin L Kraemer, Jong Jeong, Megan Kenney, Kevin Luong, Marise C Cornelius, Caitlin Mickles, Bhagya Dharmaraj, Essa Sharif and 6 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial Protocol
In one paragraph

Article in Pain medicine (Malden, Mass.), 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04747314 (Proof of Concept Study to Treat Negative Affect in Chronic Low Back Pain), which is not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
0.5field-weighted citation impact, top 35% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04747314 phase2completednot on this map

Proof of Concept Study to Treat Negative Affect in Chronic Low Back Pain

TypeinterventionalSponsorAjay Wasan, MD, MscRan2021 to 2024Enrolled308ConditionsChronic Low Back Pain, Negative AffectivityArmsAntidepressant, Enhanced Fear Avoidance Rehabilitation
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 2 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors at 6 institutions in 1 country.

Ajay D WasanDepartment of Anesthesiology and Perioperative Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA 15206, United States.ORCID 0000-0002-6394-6077
Robert R EdwardsDepartment of Anesthesiology, Perioperative, and Pain Medicine, Brigham and Women's Hospital, Boston, MA 02467, United States.
Kevin L KraemerDepartment of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA 15261, United States.
Jong JeongDepartment of Biostatistics, University of Pittsburgh School of Public Health, Pittsburgh, PA 15261, United States.
Megan KenneyDepartment of Occupational Therapy, School of Health and Rehabilitation Sciences, University of Pittsburgh, Pittsburgh, PA 15261, United States.
Kevin LuongDepartment of Anesthesiology and Perioperative Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA 15206, United States.
Marise C CorneliusDepartment of Anesthesiology, Perioperative, and Pain Medicine, Brigham and Women's Hospital, Boston, MA 02467, United States.
Caitlin MicklesDepartment of Anesthesiology and Perioperative Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA 15206, United States.
Bhagya DharmarajDepartment of Anesthesiology and Perioperative Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA 15206, United States.
Essa SharifDepartment of Anesthesiology, Mayo Medical School, Rochester, MA 55905, United States.
Anita StoltenbergDepartment of Anesthesiology, Mayo Medical School, Rochester, MA 55905, United States.
Trent EmerickDepartment of Anesthesiology and Perioperative Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA 15206, United States.ORCID 0000-0002-3802-5946
Jordan F KarpDepartment of Psychiatry, University of Arizona College of Medicine, Tucson, AZ 85007, United States.
Matt J BairCenter for Health Information and Communication (CHIC), Health Services Research & Development (HSRD), Richard L Roudebush Veterans Affairs Medical Center, Indianapolis, IN 46202, United States.
Steven Z GeorgeDepartment of Orthopaedics, Duke University, Durham, NC 27710, United States.ORCID 0000-0003-4988-9421
William M HootenDepartment of Anesthesiology, Mayo Medical School, Rochester, MA 55905, United States.ORCID 0000-0001-5645-6355
University of Pittsburgh · USMayo Clinic in Arizona · USBrigham and Women's Hospital · USDuke University · USHealth Services Research & Development · USUniversity of Arizona · US

Funding

Proof of concept study to treat negative affect in chronic low back painUG3AR076568 · NIAMS · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI WASAN, AJAY D · 2019 to 2019
$304k
NIAMS NIH HHS UG3 AR076568
6 · The paper itself

Abstract

objectivePatients with chronic low back pain (CLBP) and comorbid depression or anxiety disorders are highly prevalent. Negative affect (NA) refers to a combination of negative thoughts, emotions, and behaviors. Patients with CLBP with high NA have greater pain, worse treatment outcomes, and greater prescription opioid misuse. We present the protocol for SYNNAPTIC (SYNergizing Negative Affect & Pain Treatment In Chronic pain).

designA randomized comparative-effectiveness study of antidepressants, fear-avoidance rehabilitation, or their combination in 300 patients with CLBP with high NA. In the antidepressant- or rehabilitation-only arms, SYNNAPTIC includes an adaptive design of re-randomization after 4 months for nonresponders.

settingA multisite trial conducted in routine pain clinical treatment settings: pain clinics and physical and occupational therapy treatment centers.

methodsInclusion criteria include CLBP with elevated depression and anxiety symptoms. Antidepressant and rehabilitation treatments follow validated and effective protocols for musculoskeletal pain in patients with high NA. Power and sample size are based on superior outcomes of combination therapy with these same treatments in a 71-subject 4-arm pilot randomized controlled trial.

conclusionsSYNNAPTIC addresses the lack of evidence-based protocols for the treatment of the vulnerable subgroup of patients with CLBP and high NA. We hypothesize that combination therapy of antidepressants plus fear-avoidance rehabilitation will be more effective than each treatment alone.

trial registrationClinicalTrials.gov ID: NCT04747314.

Indexed as

Chronic PainLow Back PainAffectAntidepressive AgentsBack PainComparative Effectiveness ResearchFearHumansPain MeasurementPilot ProjectsRandomized Controlled Trials as TopicTreatment OutcomeAntidepressive Agentschronic low back paincomparative effectivenessnegative affectrandomized trial

Identifiers

PMID36715655
PMCPMC10403304
OpenAlexW4318541249

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.