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Research

Low intensity pulsed ultrasound for bone healing: systematic review of randomized controlled trials

BMJ 2017; 356 doi: https://doi.org/10.1136/bmj.j656 (Published 22 February 2017) Cite this as: BMJ 2017;356:j656
  1. Stefan Schandelmaier, methodologist1 2,
  2. Alka Kaushal, physician1 3,
  3. Lyubov Lytvyn, methodologist4,
  4. Diane Heels-Ansdell, biostatistician1,
  5. Reed A C Siemieniuk, methodologist1 5,
  6. Thomas Agoritsas, assistant professor1 6,
  7. Gordon H Guyatt, distinguished professor1 7,
  8. Per O Vandvik, associate professor8 9,
  9. Rachel Couban, medical librarian3,
  10. Brent Mollon, orthopedic surgeon10,
  11. Jason W Busse, associate professor1 3 11
  1. 1Department of Clinical Epidemiology and Biostatistics, McMaster University, 1280 Main St West, Hamilton, ON L8S 4L8, Canada
  2. 2Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel, Spitalstrasse 12, CH-4031 Basel, Switzerland
  3. 3Michael G. DeGroote Institute for Pain Research and Care, McMaster University, Hamilton, ON L8S 4K1, Canada
  4. 4Oslo University Hospital, Forskningsveien 2b, Postboks 1089, Blindern 0317 Oslo, Norway
  5. 5Department of Medicine, University of Toronto, 200 Elizabeth Street, Toronto, ON, M5G 2C4, Canada
  6. 6Division General Internal Medicine and Division of Clinical Epidemiology, University Hospitals of Geneva, Rue Gabrielle-Perret-Gentil 4, CH-1211, Geneva, Switzerland
  7. 7Department of Medicine, McMaster University, 1280 Main St West, Hamilton, ON L8S 4L8, Canada
  8. 8Institute of Health and Society, Faculty of Medicine, University of Oslo, 0318 Oslo, Norway
  9. 9Department of Medicine, Innlandet Hospital Trust-division, Gjøvik, Norway
  10. 10Orillia Soldiers’ Memorial Hospital, 41 Frederick Street, Orillia, ON L3V 5W6, Canada
  11. 11Department of Anesthesia, McMaster University, Hamilton, ON L8S 4K1, Canada
  1. Correspondence to: S Schandelmaier, Department of Clinical Epidemiology and Biostatistics, McMaster University, 1280 Main St W, Hamilton, ON L8S 4L8, Canada schandes{at}mcmaster.ca
  • Accepted 1 February 2017

Abstract

Objective To determine the efficacy of low intensity pulsed ultrasound (LIPUS) for healing of fracture or osteotomy.

Design Systematic review and meta-analysis.

Data sources Medline, Embase, CINAHL, Cochrane Central Register of Controlled Trials, and trial registries up to November 2016.

Study selection Randomized controlled trials of LIPUS compared with sham device or no device in patients with any kind of fracture or osteotomy.

Review methods Two independent reviewers identified studies, extracted data, and assessed risk of bias. A parallel guideline committee (BMJ Rapid Recommendation) provided input on the design and interpretation of the systematic review, including selection of outcomes important to patients. The GRADE system was used to assess the quality of evidence.

Results 26 randomized controlled trials with a median sample size of 30 (range 8-501) were included. The most trustworthy evidence came from four trials at low risk of bias that included patients with tibia or clavicle fractures. Compared with control, LIPUS did not reduce time to return to work (percentage difference: 2.7% later with LIPUS, 95% confidence interval 7.7% earlier to 14.3% later; moderate certainty) or the number of subsequent operations (risk ratio 0.80, 95% confidence interval 0.55 to 1.16; moderate certainty). For pain, days to weight bearing, and radiographic healing, effects varied substantially among studies. For all three outcomes, trials at low risk of bias failed to show a benefit with LIPUS, while trials at high risk of bias suggested a benefit (interaction P<0.001). When only trials at low risk of bias trials were considered, LIPUS did not reduce days to weight bearing (4.8% later, 4.0% earlier to 14.4% later; high certainty), pain at four to six weeks (mean difference on 0-100 visual analogue scale: 0.93 lower, 2.51 lower to 0.64 higher; high certainty), and days to radiographic healing (1.7% earlier, 11.2% earlier to 8.8% later; moderate certainty).

Conclusions Based on moderate to high quality evidence from studies in patients with fresh fracture, LIPUS does not improve outcomes important to patients and probably has no effect on radiographic bone healing. The applicability to other types of fracture or osteotomy is open to debate.

Systematic review registration PROSPERO CRD42016050965

Footnotes

  • We thank members of the Rapid Recommendations panel for critical feedback on outcome and subgroup selection, GRADE judgments, and manuscript feedback, including Rudolf Poolman (chair and orthopedic surgeon), Ian Harris (orthopedic and trauma surgeon), Inger Schipper (trauma surgeon), Maureen Smith (patient representative), Alexandra Albin (patient representative), Sally Nador (patient representative), William Sasges (patient representative), Ton Kuijpers (methodologist), Loes van Beers (physiotherapist), and Michael Verhofstad (trauma surgeon).

  • Contributors: JWB, RACS, GHG, and POV conceived the study idea. SS and JWB coordinated the systematic review. SS wrote the first draft of the manuscript. RC designed the search strategy. LL, AK, RC, and SS screened abstracts and full texts. LL, AK, RACS, TA, and SS acquired the data and judged risk of bias in the studies. SS, JWB, and DHA performed the data analysis. DHA and GHG provided statistical advice. SS, RACS, BM, POV, JWB, and GHG interpreted the data analysis. All authors critically revised the manuscript. SS had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. SS is guarantor.

  • Funding: This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.

  • Competing interest: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare that JWB, DHA, and GHG were co-authors of the TRUST trial, which was supported in part by an industry grant from Smith & Nephew, a manufacturer of LIPUS devices.

  • Ethical approval: Not required.

  • Data sharing: No additional data available.

  • Transparency: The lead author (the manuscript’s guarantor) affirms that this manuscript is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as planned (and, if relevant, registered) have been explained.

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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