1 |
Low-intensity pulsed ultrasound (LIPUS) in fresh clavicle fractures: A multi-Centre double blind randomized controlled trial |
Lubert et al. [1212 Lubbert PH, Van der Rijt RH, Hoorntje LE, Van der Werken C. Low-intensity pulsed ultrasound (LIPUS) in fresh clavicle fractures: a multi-centre double blind randomised controlled trial. Injury. 2008;39(12):1444-52. https://dx.doi.org/10.1016/j.injury.2008.04.004 https://doi.org/10.1016/j.injury.2008.04...
], 2008 |
Multi centre double blinded RCT |
Double Blinded |
Randomized (Block randomisation) |
2 months |
Obtained |
Approved by Local medical ethical committee |
Performed |
Fresh clavicle fractue |
Group 1-(control group) placebo transducer without LIPUS stimulation Group 2-(Test group) Active transducer with LIPUS stimulation N = 101 Group 1 = 49 Group 2 = 52 |
SATA intensity;30mW/cm3 Frequency-1.5MHz Puduration-200mico seconds |
Differences between groups were analyzed using the Student’s t-test and the Pearson Chi-square test |
Clinical - Fracture consolidation (healing) according to the patient’s perception, Painkiller usage, VAS score, Adverse events, Resumption of sport, professional and household activities Radiological - Nil Histological – Nil Biomarkers – Nil |
2 |
Low-Intensity Pulsed Ultrasound as a Useful Adjuvant During Distraction Osteogenesis: A Prospective, Randomized Controlled Trial |
Dudda et al. [1313 Liu Y, Wei X, Kuang Y, Zheng Y, Gu X, Zhan H, Shi Y. Ultrasound treatment for accelerating fracture healing of the distal radius. A control study. Acta Cir Bras. 2014;29(11):765-70. https://dx.doi.org/10.1590/S0102-86502014001800012 https://doi.org/10.1590/S0102-8650201400...
], 2011 |
A prospective, Randomised control trial |
No blinding |
Randomized (Method – Not mentioned) |
1-28 months |
Not mentioned |
Not mentioned |
Not mentioned |
Distraction osteogenesis of lower limb |
Group 1–(control group) distraction osteogenesis only Group 2 – (Test group) distraction osteogenesis + LIPUS N = 36 Group 1 = 20 Group 2 = 16 |
SATA intensity;30mW/cm3 Frequency-1.5MHz Pulse duration-200mico seconds |
t test |
Clinical – 1. Fixator gestation period (treatment period) 2. Time to bone healing (Paley index), 3. Distraction consolidation index Radiological - Nil Histological – Nil Biomarkers - Nil |
3 |
Effect of Low-Intensity Pulsed Ultrasound on Bone Healing at Osteotomy Sites After Forearm Bone Shortening |
Urita et al. [1414 Kristiansen TK, Ryaby JP, McCabe J, Frey JJ, Roe LR. Accelerated healing of distal radial fractures with the use of specific, low-intensity ultrasound. A multicenter, prospective, randomized, double-blind, placebo-controlled study. J Bone Joint Surg Am. 1997;79(7):961-73. https://dx.doi.org/10.2106/00004623-199707000-00002 https://doi.org/10.2106/00004623-1997070...
], 2013 |
A prospective Multicentre, Randomized clinical trial |
Investigotor was blinded |
Randomised (Odd-even system) |
6 months |
Obtained |
Approved by local institutional review board |
Performed |
Ulnar shortening osteotomy |
Group 1 – (Control group) only Ulnar or radial shortening osteotomy Group 2 – (Test group) Ulnar or radial shortening osteotomy + LIPUS N= 27 Group 1 = 13, Group 2 = 14 |
SATA intensity;30mW/cm3 Frequency-1.5MHz Pulse duration-200mico seconds |
unpaired t-test |
Clinical – 1. Total Modified Mayo wrist score Radiological– 1.Time to Cortical union 2.Time to Endosteal union Histological – Nil Biomarkers - Nil |
4 |
Ultrasound treatment for accelerating fracture healing of the distal radius. A control study |
Liu et al. [1515 Leung KS, Lee WS, Tsui HF, Liu PP, Cheung WH. Complex tibial fracture outcomes following treatment with low-intensity pulsed ultrasound. Ultrasound Med Biol. 2004;30(3):389-95. https://dx.doi.org/10.1016/j.ultrasmedbio.2003.11.008 https://doi.org/10.1016/j.ultrasmedbio.2...
], 2014 |
Randomized clinical trial |
Investigotor was blinded |
Randomised (With Random number table) |
2 months |
Obtained |
Approved by Ethics committee of Shuguang hospital. |
Not mentioned |
Distal radius fracture |
Group 1 – (Control) Immobilisation with cast only Group 2 – (Test Group) Immobilisation with cast + LIPUS N=81 Group1 = 40 Group 2 = 41 |
SATA intensity;30mW/cm3 Frequency-1.5MHz Pulse duration-200mico seconds |
To compare binary variables – Chi-square test To compare means of continuous variables – student t-test To compare distribution of ordinal variables – Mann Whitney test |
Clinical – 1. Healing time Radiological – 1. Ratio of the grey level , Histological – Nil Biomarkers - Nil |
5 |
Low-intensity pulsed ultrasound does not influence bone healing by distraction osteogenesis |
Simpson et al. [1616 Heckman JD, Ryaby JP, McCabe J, Frey JJ, Kilcoyne RF. Acceleration of tibial fracture-healing by non-invasive, low-intensity pulsed ultrasound. J Bone Joint Surg Am. 1994;76(1):26-34. doi: https://dx.doi.org/10.2106/00004623-199401000-00004 https://doi.org/10.2106/00004623-1994010...
], 2017 |
Multi centre double blinded RCT |
Double blinded |
Randomised (Computer generated randomisation scheme) |
6 months |
Obtained |
Not mentioned |
Performed |
Distraction osteogenesis of limb |
Group 1 - control – Placebo Group 2 - Test – Active LIPUS N= 62 Group 1 = 30 Group 2 = 32 |
SATA intensity;30mW/cm3 Frequency-1.5MHz Pulse duration-200mico seconds |
Mann-Whitney U test to assess linear variables and a chi-squared to assess dichotomous variables between the groups |
Clinical - 1. Distraction length 2. Time to regenerate maturation, 3. Regenerate maturation index 4. Covariates affecting the time to removal of the frame Radiological - Nil Histological – Nil Biomarkers - Nil |
6 |
Histologic evaluation of low-intensity pulsed ultrasound effects on bone regeneration in sinus lift |
Kim et al. [1717 Mayr E, Rudzki MM, Rudzki M, Borchardt B, Häusser H, Rüter A. Beschleunigt niedrig intensiver, gepulster Ultraschall die Heilung von Skaphoidfrakturen? [Does low intensity, pulsed ultrasound speed healing of scaphoid fractures?]. Handchir Mikrochir Plast Chir. 2000;32(2):115-22. German. https://dx.doi.org/10.1055/s-2000-19253 https://doi.org/10.1055/s-2000-19253...
], 2010 |
Randomized contrlled trial |
Not mentioned |
Randomised (Method – Not mentioned) |
8 months |
Not mentioned |
Approved by Institutional Review Board at Dankook UniversityDental Hospital |
Not mentioned |
Sinus lift |
Group 1 - (Control) Only sinus lifting Group 2 - (Test) Sinus lift + LIPUS N = 8 sinus lifting sites Control = 4 Test = 4 |
SATA intensity-240mW Frequency-3 MHz Pulse duration- Not mentioned |
To compare the average new bone volume and grafted material volume for each group - The Wilcoxon signed rank test |
Clinical – Nil Radiological – Nil Histomorphometric analysis – 1. Quantitative analysis of new bone, 2. Remaining grafted material Biomarkers - Nil |
7 |
Improved healing response in delayed unions of the tibia with low-intensity pulsed ultrasound: results of a randomized sham-controlled trial |
Schofer et al. [1818 Busse JW, Bhandari M, Einhorn TA, Schemitsch E, Heckman JD, Tornetta P 3rd, et al. Re-evaluation of low intensity pulsed ultrasound in treatment of tibial fractures (TRUST): randomized clinical trial. BMJ. 2016;355:i5351. https://dx.doi.org/10.1136/bmj.i5351 https://doi.org/10.1136/bmj.i5351...
] 2010 |
Multicentre, Randomized clinical trial |
Blinded |
Randomised (Computer generated randomisation scheme) |
4 months |
Obtained |
Approved |
Not mentioned |
Delayed tibial fractures |
Group 1 – control – Sham LIPUS (Inactive LIPUS) Group 2 – Test – Active LIPUS N = 101 Group 1 = 51 Group 2 = 50 |
SATA intensity;30mW/cm3 Frequency-1.5MHz Pulse duration-200mico seconds |
To compare, proportions - Chi-square test Continuous variables – two sample t-test. |
Clinical - Nil Radiological – 1. Bone Mineral Density, 2. Gap Area at the fracture site Histological – Nil Biomarkers - Nil |
8 |
Accelerated Healing of Distal Radius Fractures with the use of specific, Low-Intensity Ultrasound |
Kristiansen et al. [1919 Schofer MD, Block JE, Aigner J, Schmelz A. Improved healing response in delayed unions of the tibia with low-intensity pulsed ultrasound: results of a randomized sham-controlled trial. BMC Musculoskelet Disord. 2010;11:229. https://dx.doi.org/10.1186/1471-2474-11-229 https://doi.org/10.1186/1471-2474-11-229...
], 1997 |
A prospective Multicentre, double blinded, Randomized clinical trial |
Double Blinded |
Randomised (Computer generated randomisation scheme) |
4 months |
Obtained |
Approved by Institutional Review Board |
Not mentioned |
Distal radial fracture |
Group 1 - control – Placebo Group 2 - Test – Active LIPUS N = 61 Group 1 = 31 Group 2 = 30 |
SATA intensity;30mW/cm3 Frequency-1.5MHz Pulse duration-200mico seconds |
ANOVA |
Clinical – Time to bone healing Radiological – 1. Time after fracture to early trabecular healing 2. Time after fracture to cortical bridging Histological – Nil Biomarkers - Nil |
9 |
Low intensity pulsed ultrasound increases bone volume, osteoid thickness and mineral apposition rate in the area of fracture healing in patients with a delayed union of the osteotomized fibula |
Rutten et al. [2020 Rutten S, Nolte PA, Korstjens CM, van Duin MA, Klein-Nulend J. Low-intensity pulsed ultrasound increases bone volume, osteoid thickness and mineral apposition rate in the area of fracture healing in patients with a delayed union of the osteotomized fibula. Bone. 2008;43(2):348-354. https://dx.doi.org/10.1016/j.bone.2008.04.010 https://doi.org/10.1016/j.bone.2008.04.0...
], 2008 |
A randomised prospective double blind placebo controlled clinical trial |
Double Blinded |
Randomised (Computer generated randomisation scheme) |
5 months |
Obtained |
Approved by Medical Ethical Review Board of the vrije universiteit medical center |
Not mentioned |
Delayed union of osteotomized fibula |
Group 1 - control – Placebo Group 2 - Test – Active LIPUS N = 13 Group 1 = 6 Group 2= 7 |
SATA intensity;30mW/cm3 Frequency-1.5MHz Pulse duration-200mico seconds |
Student’s independant t-test |
Clinical – Nil Radiological – Nil Histomorphometric analysis – 1.Bone Volume of total tissue volume 2. Mineralised volume 3. Absolute osteoid volume 4. Relative osteoid volume 5. Osteoid thickness 6. Mineral apposition rate (µm/day) 7. No. of osteoclasts per mineralised tissue area (mm2) 8. No. of osteocytes per mineralised tissue area (0.01 mm2) Biomarkers - Nil |
10 |
Complex Tibial Fracture outcomes following treatment with Low-Intensity Pulsed Ultrasound |
Leung et al. [2121 Dudda M, Hauser J, Muhr G, Esenwein SA. Low-intensity pulsed ultrasound as a useful adjuvant during distraction osteogenesis: a prospective, randomized controlled trial. J Trauma. 2011;71(5):1376-80. https://dx.doi.org/10.1097/TA.0b013e31821912b2 https://doi.org/10.1097/TA.0b013e3182191...
], 2003 |
Adouble blinded controlled clinical trial |
Double Blinded |
Not mentioned |
9 months |
Obtained |
Approved by Clinical Research ethics committee of the Chinese University of HongKong |
Performed |
Complex Tibial fracture |
Group 1 – control – Sham LIPUS (Inactive LIPUS) Group 2 – Test – Active LIPUS N = 30 Group 1 = 14 Group 2 = 16 |
SATA intensity;30mW/cm3 Frequency-1.5MHz Pulse duration-200mico seconds |
To compare the differences between groups on the clinical and radiological assessments – Student’s t test To compare the differences between groups for bone mineral content and ALP analysis- Mann Whitney U-test |
Clinical – 1. Time to the disappearance of tenderness 2. Time to start partial weight bearing 3. Time to start full weight bearing 4. Time to remove the external fixator Radiological – 1. Time to appearance of first callus 2. Time to appearance of second callus 3. Time to appearance of third callus Histological – Nil Biomarkers – 1. Percentage change in Bone mineral content 2. Percentage change in Plasma bone specific Alkaline phosphatase |
11 |
Low-Intensity Pulsed Ultrasound in lower limb bone stress Injuries: A Randomized Controlled trial |
Gan et al. [2222 Simpson AH, Keenan G, Nayagam S, Atkins RM, Marsh D, Clement ND. Low-intensity pulsed ultrasound does not influence bone healing by distraction osteogenesis: a multicentre double-blind randomised control trial. Bone Joint J. 2017;99-B(4):494-502. https://dx.doi.org/10.1302/0301-620X.99B4.BJJ-2016-0559.R1 https://doi.org/10.1302/0301-620X.99B4.B...
], 2014 |
A prospective, randomised, double blinded, placebo controlled trial |
Double Blinded |
Randomised (Method – not mentioned) |
3 months |
Obtained |
Approved by the University of New South Wales Human Research ethics Advisory Panel |
Not mentioned |
Bone stress injury |
Group 1 - control – Placebo Group 2 - Test – Active LIPUS N = 23 Group 1 = 13 Group 2 = 10 |
SATA intensity;30mW/cm3Frequency-1.5MHz Pulse duration-200mico seconds |
ANOVA |
Clinical – 1. Symptomatic days of Night Pain 2. Symptomatic days of Walking Pain 3. Symptomatic days of Sitting pain 4. Symptomatic days of pain with hopping 5. Symptomatic days of Tenderness 6. Symptomatic days of running pain Radiological – 1. Change in MRI grade 2. Change in edema size Histological – Nil Biomarkers – Nil |
12 |
Acceleration of tibial fracture-healing by non-invasive, low-intensity pulsed ultrasound |
Heckmann et al. [2323 Urita A, Iwasaki N, Kondo M, Nishio Y, Kamishima T, Minami A. Effect of low-intensity pulsed ultrasound on bone healing at osteotomy sites after forearm bone shortening. J Hand Surg Am. 2013;38(3):498-503. https://dx.doi.org/10.1016/j.jhsa.2012.11.032 https://doi.org/10.1016/j.jhsa.2012.11.0...
], 1994 |
A multicenter, prospective, double blinded, placebo controlled, randomised clinical trial |
Double Blinded |
Randomised (Computer generated code) |
13 months |
Obtained |
Not mentioned |
Not mentioned |
Treatment of fracture with closed reduction and immobilisation cast |
Group 1 - control – Placebo Group 2 - Test – Active LIPUS N = 67 Group 1 = 34 Group 2 = 33 |
SATA intensity;30mW/cm3 Frequency-1.5MHz Pulse duration-200mico seconds |
ANOVA |
Clinical – 1. Time to clinical healing 2. Time to discontinuation of the cast Radiological – 1. Cortical bridging 2. Endosteal healing Histological – Nil Biomarkers – Nil |
13 |
Does Low Intensity, pulsed ultrasound speed healing of scaphoid fractures? |
Mayr et al. [2424 Gan TY, Kuah DE, Graham KS, Markson G. Low-intensity pulsed ultrasound in lower limb bone stress injuries: a randomized controlled trial. Clin J Sport Med. 2014;24(6):457-60. https://dx.doi.org/10.1097/JSM.0000000000000084 https://doi.org/10.1097/JSM.000000000000...
] 2000 |
A Randomised controlled trial |
Blinded |
Randomised (Random number generator) |
1-3 months |
Not mentioned |
Not mentioned |
Performed |
Scaphoid fracture |
Group 1 - control Group 2 - Test – Active LIPUS N = 30 Group 1 = 15 Group 2 = 15 |
SATA intensity;30mW/cm3 Frequency-1.5MHz Pulse duration-200mico seconds |
Mann Whitney U test |
Clinical – Time to fracture healing Radiological – Trabecular bridging in % Radiological – Nil Histological - Nil |
14 |
Re-evaluation of low intensity pulsed ultrasound in treatment of tibial fractures (TRUST) : Randomised clinical trial |
Busse et al. [2525 Kim SH, Hong KS. Histologic evaluation of low-intensity pulsed ultrasound effects on bone regeneration in sinus lift. J Periodontal Implant Sci. 2010;40(6):271-5. https://dx.doi.org/10.5051/jpis.2010.40.6.271 https://doi.org/10.5051/jpis.2010.40.6.2...
], 2016 |
A multicenter, randomised, blinded, sham controlled, clinical trial |
Blinded |
Randomised (Block Randomisation) |
13 months |
Obtained |
Approved |
Performed |
Tibial fracture |
Group 1 - control – Placebo Group 2 - Test – Active LIPUS N = 48 Group 1 = 241 Group 2 = 240 |
SATA intensity;30mW/cm3 Frequency-1.5MHz Pulse duration-200mico seconds |
Cox proportional hazards |
Clinical - SF – 36 PCS Health utilities index scores Radiological Nil Histological - Nil |