Evidence map›Paper›PMID 29480886›Full record

Trial reportClinical orthopaedics and related research2018

Does a Brief Mindfulness Exercise Improve Outcomes in Upper Extremity Patients? A Randomized Controlled Trial.

Ritsaart F Westenberg, Emily L Zale, Tessa J Heinhuis, Sezai Özkan, Adam Nazzal, Sang-Gil Lee, Neal C Chen, Ana-Maria Vranceanu

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Clinical orthopaedics and related research, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03819907 (The Use of Virtual Reality for Lumbar Pain Management in an Outpatient Spine Clinic), which is not on this map. Cited by 21 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 4 pooled it
–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.

NCT03819907 nacompletednot on this mapstarted 2019, after this paper: background citation

The Use of Virtual Reality for Lumbar Pain Management in an Outpatient Spine Clinic: An Exploratory Comparative Randomized Trial

TypeinterventionalSponsorSpaulding Rehabilitation HospitalRan2019 to 2019Enrolled45ConditionsChronic Low Back PainArmsAudiovisual Guided Relaxation, Virtual Reality Guided Relaxation
3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 4 syntheses or guidelines pooled it.

  1. Pain, mindfulness, and placebo: a systematic review.Frontiers in integrative neuroscience · 2024
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  4. Reporting and Analyzing Race and Ethnicity in Orthopaedic Clinical Trials: A Systematic Review.Journal of the American Academy of Orthopaedic Surgeons. Global research & reviews · 2021
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors.

Ritsaart F WestenbergR. F. Westenberg, S. Özkan, A. Nazzal, S.-G. Lee, N. C. Chen, Hand and Upper Extremity Service, Department of Orthopedic Surgery, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA E. L. Zale, T. J. Heinhuis, A.-M. Vranceanu, Integrated Brain Health Clinical and Research Program, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA E. L. Zale, Department of Psychology, Syracuse University, Syracuse, NY, USA S. Özkan, Department of Trauma Surgery, VU University Medical Center, Amsterdam, The Netherlands.
Emily L Zale
Tessa J Heinhuis
Sezai Özkan
Adam Nazzal
Sang-Gil Lee
Neal C Chen
Ana-Maria Vranceanu

Funding

Integrating Mind Body Skills with Physical Activity to Improve Pain Outcomes in Patients with Heterogeneous Chronic Pain ConditionsR34AT009356 · NCCIH · MASSACHUSETTS GENERAL HOSPITAL · PI VRANCEANU, ANA-MARIA · 2017 to 2019
$1.2M
NCCIH NIH HHS R34 AT009356
6 · The paper itself

Abstract

backgroundMindfulness-based interventions are useful in reducing psychologic distress and pain intensity in patients with chronic pain. However, most mindfulness-based interventions are resource-intensive, lengthy, and not feasible for busy orthopaedic surgical practices. QUESTIONS/PURPOSES: The purpose of this study was to determine if a 60-second personalized mindfulness-based video exercise is (1) associated with improved pain intensity, emotional distress, and state anxiety compared with an attention placebo control (a time-matched educational pamphlet about pain and stress); and (2) feasible and acceptable for patients with upper extremity injury in an orthopaedic practice.

methodsThis was a single-center, single-blind randomized controlled trial of the mindfulness-based video exercise (60 seconds duration, free online) versus an attention placebo control (an educational pamphlet about pain and stress presented to patients to read over 60 seconds). One hundred forty-nine patients presenting for a new or followup appointment at the office of one of two orthopaedic hand and upper extremity outpatient surgical practices at an urban academic hospital were invited to participate between September 2016 and December 2016. Of 149 patients screened, 125 patients were randomized and completed a demographic questionnaire, the Numeric Rating Scale to assess pain intensity, the State Anxiety subscale of the State Trait Anxiety Inventory to assess state anxiety, and Emotion Thermometers to assess anxiety, anger, and depression before and after the interventions. Postintervention, patients also completed the Client Satisfaction Questionnaire Scale-3 to assess the acceptability. A mean score of 21 or higher is considered acceptable. Feasibility was determined based on number of patients approached who refused participation. The intervention was defined as feasible if refusal rate was lower than 25%. Analysis of covariance was used to test comparative improved pain intensity on the NRS, psychologic distress on the Emotion Thermometers, and state anxiety on the State Anxiety Subscale of the State Trait Anxiety Index after controlling for respective baseline scores. A 1-point minimal clinically important difference (MCID) was used on the NRS for pain intensity.

resultsAdjusted for the baseline means, compared with patients who received the attention placebo control, patients who participated in the mindfulness-based video exercise demonstrated improved pain intensity (mindfulness-based video exercise: 3.03 ± 0.12; control: 3.49 ± 0.12; mean difference: 0.46 [0.12-0.80]; p = 0.008); state anxiety (mindfulness-based video exercise: 32.35 ± 0.59; control: 35.29 ± 0.59; mean difference: 2.94 [1.29-4.59]; p = 0.001); anxiety symptoms (mindfulness-based video exercise: 1.49 ± 0.19; control: 2.10 ± 0.19; mean difference: 0.61 [0.08-1.14]; p = 0.024); depression (mindfulness-based video exercise: 1.03 ± 0.10; control: 1.47 ± 0.11; mean difference: 0.44 [0.15-0.73]; p = 0.004); and anger (mindfulness-based video exercise: 0.76 ± 0.12; control: 1.36 ± 0.12; mean difference: 0.60 [0.26-0.94]; p = 0.001). However, the observed differences in pain intensity were below 1 point on the NRS, which is the MCID established in patients with chronic pain. No MCID is available for the other measures. The mindfulness-based video exercise was feasible based on a dropout rate of 0%, and acceptability reached the medium range with similar scores in both groups (mindfulness-based video exercise: 20.70 ± 5.48; control: 20.52 ± 6.42).

conclusionsA 60-second mindfulness-based video exercise is feasible to implement and acceptable to patients in busy orthopaedic practices. This video exercise is also effective in improving momentary pain, anxiety, depression, and anger in this population, but it is unclear whether these improved pain and distress levels are meaningful to patients who present with low levels of pain and psychologic distress. Future studies should seek to discern whether the improved pain and distress levels we observed are clinically important or whether the intervention delivers larger effects in subgroups of patients experiencing greater pain intensity and if the improved pain and distress levels are durable. Such studies might also assess cost-effectiveness, because this mindfulness-based tool takes little time and few resources to use, and the effects and durability of multiple sessions of a mindfulness-based video exercise. LEVEL OF EVIDENCE: Level II, therapeutic study.

Indexed as

MindfulnessAdultAgedArm InjuriesBostonEmotionsFeasibility StudiesFemaleHumansMaleMental HealthMiddle AgedMusculoskeletal PainPain ManagementPain MeasurementSingle-Blind Method

Identifiers

PMID29480886
PMCPMC6260083

What OpenQuestion holds

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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.