Evidence map›Paper›PMID 25885585›Full record

Trial reportBMC pregnancy and childbirth2015

Adherence, tolerance and effectiveness of two different pelvic support belts as a treatment for pregnancy-related symphyseal pain - a pilot randomized trial.

Natasha A M S Flack, E Jean C Hay-Smith, Mark D Stringer, Andrew R Gray, Stephanie J Woodley

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC pregnancy and childbirth, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03518840 (The Predictive Value of the Active Straight Leg Raise on the Efficacy of a Sacroiliac Joint Belt in Posterior Pelvic Girdle Pain During Pregnancy), which is not on this map. Cited by 6 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 3 pooled it
20.5field-weighted citation impact, top 1% 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.

NCT03518840 nacompletednot on this mapstarted 2017, after this paper: background citation

The Predictive Value of the Active Straight Leg Raise on the Efficacy of a Sacroiliac Joint Belt in Posterior Pelvic Girdle Pain During Pregnancy

TypeinterventionalSponsorLoyola UniversityRan2017 to 2019Enrolled63ConditionsPelvic Girdle PainArmsSIJ Belt
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 3 syntheses or guidelines pooled it, 85 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Article
  5. Article
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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

5 authors at 1 institution in 1 country.

Natasha A M S FlackDepartment of Anatomy, University of Otago, Dunedin, New Zealand. natasha.flack@anatomy.otago.ac.nz.
E Jean C Hay-SmithDepartment of Medicine, University of Otago, Wellington, New Zealand. jean.hay-smith@otago.ac.nz.
Mark D StringerDepartment of Anatomy, University of Otago, Dunedin, New Zealand. mark.stringer@anatomy.otago.ac.nz.
Andrew R GrayDepartment of Preventive and Social Medicine, University of Otago, Dunedin, New Zealand. andrew.gray@otago.ac.nz.
Stephanie J WoodleyDepartment of Anatomy, University of Otago, Dunedin, New Zealand. stephanie.woodley@anatomy.otago.ac.nz.
University of Otago · NZ

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPregnancy-related pubic symphysis pain is relatively common and can significantly interfere with daily activities. Physiotherapist-prescribed pelvic support belts are a treatment option, but little evidence exists to support their use. This pilot compared two pelvic belts to determine effectiveness (symptomatic relief), tolerance (comfort) and adherence (frequency, duration of use).

methodsUnblinded, 2-arm, single-center, randomized (1:1) parallel-group trial. Twenty pregnant women recruited from the community (Dunedin, New Zealand), with physiotherapist-diagnosed symphyseal pain, were randomly allocated to wear either a flexible or rigid belt for three weeks. One author, not involved in data collection, randomized the allocation to trial group. The unblinded primary outcome was the Patient Specific Functional Scale (PSFS). Secondary outcomes were pain intensity during the preceding 24 hours and preceding week (visual analogue scale [VAS]), and disability (Modified Oswestry Disability Questionnaire [MODQ]). Duration of use (hours) was recorded daily by text messaging. Participants were assessed at baseline, by weekly phone interviews and at intervention completion (three weeks). To assess comfort, women wore the alternate belt in the fourth week.

resultsTwenty pregnant women (mean ± SD age, 29.4 ± 6.5 years; mean gestation at baseline, 30.8 ± 5.2 weeks) were randomized to treatment groups (flexible = 10, rigid =10) and all were included in analysis. When adjusted for baseline, PSFS scores were not significantly different between groups at follow up (mean difference -0.1; 95% CI: -2.5 to 2.3; p =0.94). Pain in the preceding 24 hours reached statistical significance in favor of the flexible belt (VAS, p = 0.049). Combining both groups' data, function and pain were significantly improved at three weeks (mean difference -2.3; 95% CI: 1.2 to 3.5; p< 0.001). Belts were worn for an average of 4.9 ± 2.9 hours per day; women preferred the flexible belt. No adverse events were reported.

conclusionThese preliminary results suggest the flexible pelvic support belt may be more effective in reducing pain and is potentially better tolerated than a rigid belt. Based on these data, a larger trial is both feasible and clinically useful.

trial registrationAustralian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12614000898651 , 25th August, 2014.

Indexed as

BracesPain ManagementPatient CompliancePatient PreferencePelvic Girdle PainPregnancy ComplicationsActivities of Daily LivingAdultFemaleHumansPain MeasurementPregnancyTreatment Outcome

Identifiers

PMID25885585
PMCPMC4339641
OpenAlexW2070027815

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.