Evidence map›Paper›PMID 28315479›Full record

Trial reportContemporary clinical trials2017

Biopsychosocial influence on shoulder pain: Rationale and protocol for a pre-clinical trial.

Steven Z George, Roland Staud, Paul A Borsa, Samuel S Wu, Margaret R Wallace, Warren H Greenfield, Lauren N Mackie, Roger B Fillingim

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Contemporary clinical trials, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02620579 (Biopsychosocial Influence on Shoulder Pain), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–field-weighted citation impact
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.

NCT02620579 phase2completednot on this map

Biopsychosocial Influence on Shoulder Pain: a Randomized, Pre-clinical Trial

TypeinterventionalSponsorDuke UniversityRan2016 to 2021Enrolled264ConditionsShoulder PainArmsPropranolol LA (60 mg), Placebo, Shoulder Anatomy Education, Pain Processing Education
3 · Its place in the literature

Who cites it

7 citing papers in PubMed.

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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

8 authors.

Steven Z GeorgeDuke Clinical Research Institute, Department of Orthopaedic Surgery, Duke University, Durham, NC 27715, USA. Electronic address: steven.george@duke.edu.
Roland StaudDepartment of Medicine, Univ. of Florida, Gainesville, FL 32610, USA. Electronic address: staudr@ufl.edu.
Paul A BorsaApplied Physiology and Kinesiology, Univ. of Florida, Gainesville, FL 32611, USA. Electronic address: pborsa@hhp.ufl.edu.
Samuel S WuBiostatistics, Univ. of Florida, Gainesville, FL 32610, USA. Electronic address: samwu@biostat.ufl.edu.
Margaret R WallaceMolecular Genetics and Microbiology, UF Genetics Institute, Univ. of Florida, Gainesville, FL 32610, USA. Electronic address: PhDpeggyw@mgm.ufl.edu.
Warren H GreenfieldDepartment of Physical Therapy, Univ. of Florida, Gainesville, FL 32610, USA. Electronic address: whgiii@phhp.ufl.edu.
Lauren N MackieSchool of Medicine, Saint Louis University, St. Louis, MO 63104, USA. Electronic address: mackieln@slu.edu.
Roger B FillingimPain Research & Intervention Center of Excellence, Univ. of Florida, Gainesville, FL 32610, USA. Electronic address: rfillingim@dental.ufl.edu.

Funding

University of Florida Older Americans Independence Center (OAIC)P30AG028740 · NIA · UNIVERSITY OF FLORIDA · PI Peihua Qiu · 2007 to 2026
$22.8M
Biopsychosocial Influence on Shoulder PainR01AR055899 · NIAMS · UNIVERSITY OF FLORIDA · PI GEORGE, STEVEN Z · 2008 to 2020
$5.5M
NIAMS NIH HHS R01 AR055899NIA NIH HHS P30 AG028740
6 · The paper itself

Abstract

backgroundChronic musculoskeletal pain conditions are a prevalent and disabling problem. Preventing chronic musculoskeletal pain requires multifactorial treatment approaches that address its complex etiology. Prior cohort studies identified a high risk subgroup comprised of variation in COMT genotype and pain catastrophizing. This subgroup had increased chance of heightened pain responses (in a pre-clinical model) and higher 12month post-operatives pain intensity ratings (in a clinical model). This pre-clinical trial will test mechanisms and efficacy of personalized pain interventions matched to the genetic and psychological characteristics of the high-risk subgroup.

methodsPotential participants will be screened for high risk subgroup membership, appropriateness for exercise-induced muscle injury protocol, and appropriateness for propranolol administration. Eligible participants that consent to the study will then be randomized into one of four treatment groups; 1) personalized pharmaceutical and psychological education; 2) personalized pharmaceutical and general education; 3) placebo pharmaceutical and psychological education; 4) placebo pharmaceutical and psychological education. Over the 5-day study period participants will complete an exercise-induced muscle injury protocol and receive study interventions. Pain and disability assessments will be completed daily, with primary outcomes being duration of shoulder pain (number of days until recovery), peak shoulder pain intensity, and peak shoulder disability. Secondary outcomes include inflammatory markers, psychological mediators, and measures of pain sensitivity regulation.

conclusionThis pre-clinical trial builds on prior cohort studies and its completion will provide foundational data supporting efficacy and mechanisms of personalized interventions for individuals that may be at increased risk for developing chronic shoulder pain.

trial registrationClinicalTrials.gov registry, NCT02620579 (Registered on November 13, 2015).

Indexed as

AdolescentAdrenergic beta-AntagonistsAdultAgedCatastrophizationCatechol O-MethyltransferaseChronic PainExerciseFemaleGenotypeHumansInflammation MediatorsMaleMiddle AgedPain MeasurementPatient Education as TopicAdrenergic beta-AntagonistsCatechol O-MethyltransferaseCOMT protein, humanInflammation MediatorsPropranolol

Identifiers

PMID28315479
PMCPMC5484407

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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.