Evidence map›Paper›PMID 31768768›Full record

Trial reportArchives of osteoporosis2019

Effect of unfocused extracorporeal shockwave therapy on bone mineral content of twelve distal forearms of postmenopausal women: a clinical pilot study.

Marianne K E Koolen, Moyo C Kruyt, Fetullah C Öner, Wolfgang Schaden, Harrie Weinans, Olav P van der Jagt

Open access · hybridAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Archives of osteoporosis, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.6field-weighted citation impact, top 32% 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.

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

5 citing papers in PubMed, 5 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. Effect of External Mechanical Stimuli on Human Bone: a narrative review.Progress in biomedical engineering (Bristol, England) · 2022
    Article
  5. 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

6 authors at 3 institutions in 2 countries.

Marianne K E KoolenDepartment of Orthopaedics, University Medical Centre Utrecht, Utrecht, The Netherlands. m.k.e.koolen@umcutrecht.nl.ORCID http://orcid.org/0000-0003-1743-7690
Moyo C KruytDepartment of Orthopaedics, University Medical Centre Utrecht, Utrecht, The Netherlands.
Fetullah C ÖnerDepartment of Orthopaedics, University Medical Centre Utrecht, Utrecht, The Netherlands.
Wolfgang SchadenDepartment of Traumatology, AUVA Trauma Center Meidling, Vienna, Austria.
Harrie WeinansDepartment of Orthopaedics, University Medical Centre Utrecht, Utrecht, The Netherlands.
Olav P van der JagtDepartment of Orthopaedics, Elisabeth-TweeSteden Hospital, Tilburg, The Netherlands.
University Medical Center Utrecht · NLElisabeth-TweeSteden Ziekenhuis · NLUnfallkrankenhaus Meidling · AT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Extracorporeal shockwave therapy showed a pronounced effect on bone mass in previous animal studies. We showed in this pilot study that a single treatment with unfocused shockwave therapy in unselected patients does not show side effects. Although our study did not show any effect of shockwave on BMD, the limited sample size does not definitively exclude this and a study with 174 subjects per group would be needed to show an effect size of 0.3 with a power of 80%. PURPOSE: Unfocused extracorporeal shockwave therapy might stimulate bone formation to reduce the fracture risk. In this study, we assessed the safety of unfocused extracorporeal shockwave therapy and its effects on bone mass.

methodsA clinical pilot study with twelve female patients free of bone disease undergoing elective surgery of the lower extremity or elective spinal surgery under general anesthesia received 3.000 electrohydraulic-generated unfocused extracorporeal shockwaves (energy flux density 0.3 mJ/mm

resultsNo difference in bone mineral content and density was measured 6 and 12 weeks after therapy. shockwave therapy occasionally caused transient erythema or mild hematoma, but no discomfort in daily life or (late) adverse events.

conclusionsUnfocused extracorporeal shockwave therapy is a safe treatment, but no increase in bone mass on the forearm was found at 0.3 mJ/mm

Indexed as

Absorptiometry, PhotonAgedAged, 80 and overBone DensityExtracorporeal Shockwave TherapyFemaleForearmHumansMiddle AgedOsteoporotic FracturesPainPilot ProjectsPostmenopauseRadiographySingle-Blind MethodBone densityHigh-energy shockwavesOsteoporosis

Identifiers

PMID31768768
PMCPMC6877705
OpenAlexW2991636083

What OpenQuestion holds

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Registered trials

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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.