Evidence map›Paper›PMID 38286223›Full record

ArticleContemporary clinical trials2024

Improving multimodal physical function in adults with heterogeneous chronic pain; Protocol for a multisite feasibility RCT.

Julia E Hooker, Julie R Brewer, Katherine A McDermott, Millan Kanaya, Tamara J Somers, Francis Keefe, Sarah Kelleher, Hannah M Fisher, John Burns, Rebecca W Jeddi and 6 more

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

Article in Contemporary clinical trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05700383 (The Thrive Study), 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
3.1field-weighted citation impact, top 10% 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.

NCT05700383 nacompletednot on this map

The Thrive Study: Improving Multimodal Physical Function in Adults With Heterogenous Chronic Pain: Multi-site Feasibility RCT

TypeinterventionalSponsorMassachusetts General HospitalRan2023 to 2024Enrolled92ConditionsChronic PainArmsGetActive-Fitbit, Healthy Living for Pain
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 7 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. Article
  5. Article
  6. Review
  7. Article
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 4 institutions in 1 country.

Julia E HookerCenter for Health Outcomes and Interdisciplinary Research, Department of Psychiatry, Massachusetts General Hospital, Boston, MA, United States; Harvard Medical School, Boston, MA, United States.
Julie R BrewerCenter for Health Outcomes and Interdisciplinary Research, Department of Psychiatry, Massachusetts General Hospital, Boston, MA, United States.
Katherine A McDermottCenter for Health Outcomes and Interdisciplinary Research, Department of Psychiatry, Massachusetts General Hospital, Boston, MA, United States; Harvard Medical School, Boston, MA, United States.
Millan KanayaCenter for Health Outcomes and Interdisciplinary Research, Department of Psychiatry, Massachusetts General Hospital, Boston, MA, United States.
Tamara J SomersDuke University School of Medicine, Department of Psychiatry and Behavioral Sciences, Durham, NC, United States.
Francis KeefeDuke University School of Medicine, Department of Psychiatry and Behavioral Sciences, Durham, NC, United States.
Sarah KelleherDuke University School of Medicine, Department of Psychiatry and Behavioral Sciences, Durham, NC, United States.
Hannah M FisherDuke University School of Medicine, Department of Psychiatry and Behavioral Sciences, Durham, NC, United States.
John BurnsRush University, Department of Psychiatry and Behavioral Sciences, Rush University Medical Center, Chicago, IL, United States.
Rebecca W JeddiRush University, Department of Psychiatry and Behavioral Sciences, Rush University Medical Center, Chicago, IL, United States; Rush University, Department of Family and Preventive Medicine, Rush University Medical Center, Chicago, IL, United States.
Ronald KulichHarvard Medical School, Boston, MA, United States; Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Boston, MA, United States.
Gary PolykoffHarvard Medical School, Boston, MA, United States; Department of Physical Medicine and Rehabilitation, Massachusetts General Hospital, Boston, MA, United States.
Robert A ParkerBiostatistics Center, Massachusetts General Hospital, Boston, MA, United States.
THRIVE Study Team
Jonathan GreenbergCenter for Health Outcomes and Interdisciplinary Research, Department of Psychiatry, Massachusetts General Hospital, Boston, MA, United States; Harvard Medical School, Boston, MA, United States.
Ana-Maria VranceanuCenter for Health Outcomes and Interdisciplinary Research, Department of Psychiatry, Massachusetts General Hospital, Boston, MA, United States; Harvard Medical School, Boston, MA, United States.
Massachusetts General Hospital · USDuke University · USHarvard University · USRush University Medical Center · US

Funding

Improving multimodal physical function in adults with heterogeneous chronic pain; Multi-site feasibility RCT (Diversity Supplement)R01AT012069 · NCCIH · MASSACHUSETTS GENERAL HOSPITAL · PI GREENBERG, JONATHAN, VRANCEANU, ANA-MARIA · 2022 to 2024
$1.9M
Bridging the Science-to-Service Gap in Aging Care: Prevention, Optimization and Living Well with Persistent or Serious IllnessesT32AG081327 · NIA · MASSACHUSETTS GENERAL HOSPITAL · PI Christine S Ritchie, Ana-Maria Vranceanu · 2023 to 2026
$1.6M
Mentoring in technology enhanced mind body and lifestyle interventionsK24AT011760 · NCCIH · MASSACHUSETTS GENERAL HOSPITAL · PI Ana-Maria Vranceanu · 2022 to 2026
$911k
NCCIH NIH HHS K24 AT011760NCCIH NIH HHS R01 AT012069NIA NIH HHS T32 AG081327
6 · The paper itself

Abstract

backgroundChronic pain is associated with substantial impairment in physical function, which has been identified as a top concern among persons with pain. GetActive-Fitbit, a mind-body activity program, is feasible, acceptable, and associated with improvement in physical function among primarily White, sedentary individuals with pain. In preparation for a multisite efficacy trial, we must examine feasibility across multiple sites with diverse patient populations. Here we describe the protocol of a multisite, feasibility RCT comparing GetActive-Fitbit with a time- and attention-matched educational comparison (Healthy Living for Pain). We aim to 1) test multisite fidelity of clinician training; 2) evaluate multisite feasibility benchmarks, including recruitment of chronic pain patients taking <5000 steps/day and racial and ethnic minorities; and 3) optimize fidelity and study protocol in preparation for a future multisite efficacy trial.

methodsClinician training fidelity was assessed via roleplays and mock group sessions. Feasibility (i.e., recruitment, acceptability, credibility, adherence, satisfaction), multimodal physical function (e.g., self-report, 6-Minute Walk Test, step-count), and other psychosocial outcomes are assessed at baseline, posttest, and 6 months. Protocol optimization will be assessed using exit interviews and cross-site meetings.

resultsThe trial is ongoing. Clinician training is complete. 87 participants have been recruited. 54 completed baseline assessments and randomization, 44 are mid-intervention, and 9 have completed the intervention and posttest.

conclusionsThis study addresses the critical need for feasible, acceptable mind-body-activity interventions for chronic pain that follow evidence-based guidelines and improve all aspects of physical function across diverse populations. Results will inform a future fully-powered multisite efficacy trial. CLINICAL

trial registrationNCT05700383.

Indexed as

Chronic PainAdultFeasibility StudiesHumansRandomized Controlled Trials as TopicSelf ReportChronic painFeasibilityMind-bodyPhysical functionStep count

Identifiers

PMID38286223
PMCPMC10932927
OpenAlexW4391289152

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.