Evidence map›Paper›PMID 38860445›Full record

Trial reportLiver international : official journal of the International Association for the Study of the Liver2024

The RELAX randomized controlled trial: Stretching versus meditation for nocturnal muscle cramps.

Elliot B Tapper, Hirsh Trivedi, Douglas A Simonetto, Vilas Patwardhan, Erin Ospina, Beanna Martinez, Xi Chen, Susan Walker, Samantha Nikirk

Abstract readRandomized Controlled TrialComparative Study
In one paragraph

Trial report in Liver international : official journal of the International Association for the Study of the Liver, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Article
  3. Symptom burden in chronic liver disease.Gastroenterology report · 2024
    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

9 authors.

Elliot B TapperDivision of Gastroenterology and Hepatology, University of Michigan, Ann Arbor, Michigan, USA.ORCID 0000-0002-0839-1515
Hirsh TrivediDivision of Gastroenterology, Cedars Sinai, Los Angeles, California, USA.
Douglas A SimonettoDivision of Gastroenterology and Hepatology, Mayo Clinic, Rochester, New York, USA.
Vilas PatwardhanDivision of Gastroenterology, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.
Erin OspinaDivision of Gastroenterology and Hepatology, University of Michigan, Ann Arbor, Michigan, USA.
Beanna MartinezDivision of Gastroenterology and Hepatology, University of Michigan, Ann Arbor, Michigan, USA.
Xi ChenDivision of Gastroenterology and Hepatology, University of Michigan, Ann Arbor, Michigan, USA.
Susan WalkerHolistic Integrated Massage and Meditation, Poland, Ohio, USA.
Samantha NikirkDivision of Gastroenterology and Hepatology, University of Michigan, Ann Arbor, Michigan, USA.

Funding

Statin Therapy for patients with compensated CirrhosisU01DK130113 · NIDDK · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI Neehar Dilip Parikh, Elliot Tapper · 2021 to 2026
$3.4M
Optimizing Measures for Clinical Trials in Covert Hepatic EncephalopathyK23DK117055 · NIDDK · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI TAPPER, ELLIOT · 2019 to 2022
$776k
NIDDK NIH HHS K23 DK117055NIDDK NIH HHS U01 DK130113
6 · The paper itself

Abstract

backgroundMuscle cramps are common among persons with cirrhosis and are associated with poor health-related quality of life (HRQOL). Treatment options are limited. We compared stretching or meditation in a randomized-controlled trial (RCT). PATIENTS: We enrolled 98 patients with a history of >4 muscle cramps in the prior month from 7/22-7/23. We randomized patients 1:1 to stretching versus meditation for 35 days. Our primary outcome was the change in cramp severity measured by the visual analogue scale for cramps (VAS-cramps, scaled 0-10). Secondary outcomes included a patient global impression of change (PGIC), change in sleep quality and global HRQOL measured using the EQ-5D and VAS-global HRQOL.

resultsOverall, 48% of patients had cirrhosis, 40% had diabetes, 16% the median age was 63, most were women (67%) and 81% were college educated. Both arms experienced a reduction in cramp severity-a median of 1.44 (.58-2.29) points for stretching and 1.97 (1.01-2.93) points for meditation. These changes were significant changes from baseline (p = .001 for stretching, p < .0001 for meditation) but these changes were equivalent between arms (p = .4). The PGIC was improved: 1.33 (1.02-1.65) for stretching, 1.05 (.70-1.41) for meditation, p-difference .2. Sleep was also improved for both. HRQOL did not change according to the Eq5D; according to the VAS, HRQOL rose for meditation by 6 (.1-11.8) points but not for stretching. More patients recommended stretching than meditation (79.2% vs. 55.3%, p = .02).

conclusionIn a randomized trial, stretching and meditation both reduced cramp severity and improved sleep quality and global impression of change. While patients preferred stretching, there was no difference in effect between arms.

Indexed as

MeditationMuscle CrampMuscle Stretching ExercisesQuality of LifeAgedFemaleHumansMaleMiddle AgedSeverity of Illness IndexSleep QualityTreatment Outcomeliver diseasepatient‐reported outcomesquality of lifesleep

Identifiers

PMID38860445
PMCPMC11369850

What Socratic holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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 Socratic graph.