Therapeutic Ultrasound Therapeutic Ultrasound Setting the Stage for - - PowerPoint PPT Presentation

▶
therapeutic ultrasound therapeutic ultrasound
SMART_READER_LITE
LIVE PREVIEW

Therapeutic Ultrasound Therapeutic Ultrasound Setting the Stage for - - PowerPoint PPT Presentation

Jan 15, 2023 329 likes •712 views

Therapeutic Ultrasound Therapeutic Ultrasound Setting the Stage for Evidence Setting the Stage for Evidence Based Clinical Trials Based Clinical Trials Johns LD, Straub SJ, *LeDet LeDet EG, * Howard S and Zaino A: EG, * Howard S and Zaino A:

slide-1
SLIDE 1

Therapeutic Ultrasound Therapeutic Ultrasound

Setting the Stage for Evidence Setting the Stage for Evidence Based Clinical Trials Based Clinical Trials

Johns LD, Straub SJ, * Johns LD, Straub SJ, *LeDet LeDet EG, * Howard S and Zaino A: EG, * Howard S and Zaino A: Quinnipiac University, Hamden Connecticut and Quinnipiac University, Hamden Connecticut and Onda Onda Corporation*, Sunnyvale, California. Corporation*, Sunnyvale, California. Funded by Quinnipiac University, EATA & NATA Funded by Quinnipiac University, EATA & NATA-

  • REF

REF

slide-2
SLIDE 2

Clinical Indications: Inferential

Methods Methods Results Results

Cell Biology Studies: Cell Biology Studies: Strong Support Strong Support Clinical Trials: Clinical Trials: Inconclusive Inconclusive Tissue Heating: Tissue Heating: Conclusive ‘BUT’ Conclusive ‘BUT’

Variable Variable

slide-3
SLIDE 3

Clinical Variability Clinical Variability

Human Human – –vs vs-

  • Technology

Technology

Technique Technique

– – Treatment Area, Coupling Medium Treatment Area, Coupling Medium

Differences between manufacturers Differences between manufacturers

– – Ultrasound field produced Ultrasound field produced – – BNR, ERA, crystals, Technology, etc BNR, ERA, crystals, Technology, etc – – Calibrations Calibrations + + 15 15-

  • 20 % of baseline

20 % of baseline

30 30-

  • 40% difference between heads

40% difference between heads

Or….more fundamental issues? Or….more fundamental issues?

slide-4
SLIDE 4

Clinical Assumption Clinical Assumption

Equality Between: Equality Between:

1.

  • 1. Manufacturers

Manufacturers 2.

  • 2. Various Heads within a Manufacturer

Various Heads within a Manufacturer

BNR and ERA are Predictive BNR and ERA are Predictive

True True or

  • r False

False

slide-5
SLIDE 5

0.63 3.8 oC 1.6 cm 6 1.5 <6.0 ` Dynatron 0.62 3.7 oC 1.6 cm 6 1.5 <4.0 ` Excel 1.00 6.0 oC 1.6 cm 6 1.5 3.9 ` Omnisound 0.39 3.9 oC 1.2 cm 10 1.0 2.3 " Forte 0.58 5.8 oC 1.2 cm 10 1.0 3.7 " Omnisound

  • C/min

Temp Depth Min W/cm2 BNR

“Holcomb etal 2003, JAT 38(1):24-27. 49% difference in heating rate ` Merrick etal 2003, JOSPT 33:379-385. 59 & 61% difference in heating rate

Variability Between Manufacturers Variability Between Manufacturers

3 MHz 3 MHz N=1 Head N=1 Head

slide-6
SLIDE 6

Variability Between Heads??? Variability Between Heads???

^ Draper, etal. JOSPT. 21(3) 1995, page 153-157 ~ Rose,etal., JAT, 31(2) 1996, pages 139-143 Difference Difference in heating in heating rate rate 39% 39% 1 MHz 1 MHz 0.39 3.9 oC 5.0 cm 10.0 1.5 2.2 ^Omnisound 0.28 3.5 oC 5.0 cm 12.3 1.5 1.8 ~Omnisound

  • C/min

Temp Depth Min W/cm2 BNR

slide-7
SLIDE 7

Clinical Assumption Clinical Assumption

Equality Between: Equality Between:

1.

  • 1. Manufacturers

Manufacturers

2.

  • 2. Various Heads within a Manufacturer

Various Heads within a Manufacturer

BNR and ERA are Predictive BNR and ERA are Predictive

Appear to be False Appear to be False

slide-8
SLIDE 8

2 Possible Factors Leading to Variability in 2 Possible Factors Leading to Variability in Clinical Outcom Clinical Outcomes

1) Determination of SAI 1) Determination of SAI W/cm W/cm2

2

– – Total Power Total Power

Display of total power Display of total power – –vs vs-

  • actual total power produced

actual total power produced SAI variability ( SAI variability (+ + 20%) 20%)

– – ERA ERA

group means in the software to determine SAI group means in the software to determine SAI SAI variability ( SAI variability (+ + 20 20-

  • 25%)

25%)

2) Distribution of acoustical amplitudes 2) Distribution of acoustical amplitudes

– – Variability in tissue heating Variability in tissue heating

slide-9
SLIDE 9

Range of Potential SAI Values Range of Potential SAI Values While Staying Within Manufacturer Limits While Staying Within Manufacturer Limits

1.4 2.00* 1.67 1.33 3.0 0.75 0.75 1.50 1.25* 1.00 4.0 0.5 1.20 1.00 0.80* 5.0 Rate 6.0 5.0 4.0 ERA cm2 *Heating Watts + 20%

Digital indicator on machines reads 1.25 W/cm2 3 MHz Heating Rate oC/min in muscle (based upon Draper) 150% difference between high and low SAI

slide-10
SLIDE 10

Field Testing of Clinical Units Field Testing of Clinical Units

44% Failed Calibration or Electrical Safety (N=45) 44% Failed Calibration or Electrical Safety (N=45)

Daniel & Rupert, Daniel & Rupert, J.Man.Phys.Ther J.Man.Phys.Ther 26(3):171 26(3):171-

  • 175, 2003

175, 2003

39% Failed Calibration Standard (N=32) 39% Failed Calibration Standard (N=32)

Artho Artho, , etal etal, Physical Therapy82(3):257 , Physical Therapy82(3):257-

  • 263, 2002

263, 2002

69% Failed Calibration Standard (N=85) 69% Failed Calibration Standard (N=85)

Pye Pye & Milford, Ultrasound, Med Biol. 23:347 & Milford, Ultrasound, Med Biol. 23:347-

  • 359, 1994

359, 1994

56% Failed Calibration Standard (N=43) 56% Failed Calibration Standard (N=43)

Lloyd & Evans, Physiotherapy, 74:56 Lloyd & Evans, Physiotherapy, 74:56-

  • 61, 1988

61, 1988

81% Failed Calibration Standard (N=26) 81% Failed Calibration Standard (N=26)

Snow, Physiotherapy Canada, 34:185 Snow, Physiotherapy Canada, 34:185-

  • 189, 1982

189, 1982

85% Failed Calibration Standard (N=58) 85% Failed Calibration Standard (N=58)

Stewart, Stewart, etal etal, Phys , Phys Ther Ther, 54:707 , 54:707-

  • 715, 1974

715, 1974

slide-11
SLIDE 11

Clinical Assumption Clinical Assumption

New transducers are more accurate? New transducers are more accurate? Buy new transducers and test Buy new transducers and test

slide-12
SLIDE 12

Experimental Design Experimental Design

Chattanooga Chattanooga Intellect Intellect Model # Model # 78047 78047 Frequency: Frequency: 1 & 3 MHz 1 & 3 MHz Head size: Head size: 5 cm 5 cm2

2

N= N= 7 Heads 7 Heads Manufacturer Reported Manufacturer Reported

– – BNR: BNR: 4:1 Max 4:1 Max – – ERA: ERA: 4.0 cm 4.0 cm2

2

slide-13
SLIDE 13

Independent Analysis of Independent Analysis of Ultrasound Transducers at 1.0 MHz Ultrasound Transducers at 1.0 MHz

4.18 + 1.14 1.3 + 0.10 5.30 + 0.23 4.03 + 0.27 Mean 5.85 1.4 5.4 3.85 37954 4.48 1.3 5.5 4.34 37953 5.09 1.2 5.0 4.13 37952 4.51 1.3 5.1 4.04 35986 2.87 1.2 5.4 4.38 35664 2.79 1.4 5.6 3.88 35663 3.65 1.4 5.1 3.62 35661 Planar BNR SAI in W/cm2 Watts ERA in cm2 Transducer

Manufacturer reported ERA 4.00 + 1.0 Watts calibrated to 5.0 + 0.75 or 15% SAI, digital indicator on machines reads 1.2 W/cm2

slide-14
SLIDE 14

0.83 + 0.06^ 4.42 + 0.20 5.35 + 0.28 5.00 + 1.00 Dynatronics 0.99 + 0.16 4.95 + 0.38 5.03 + 0.58 4.45 + 0.67 Omnisound 1.09 + 0.13 4.28 + 0.43 3.97 + 0.25 4.00 + 1.00 Chattanooga 1.12 + 0.15 5.14 + 0.23 4.61 + 0.49 5.00 + 0.75 Xltek 1.19 + 0.07 4.57 + 0.23 3.83 + 0.21 5.00 + 1.00 Rich-Mar 1.36 + 0.11 1.26 + 0.44 5.45 + 0.20 3.97 + 0.41 4.01 + 0.34 3.16 + 0.66 5.00 + 1.00 4.00 + 1.00 Mettler Chatt.New Measured Measured Measured Reported SAI Total Power ERA ERA 1 MHz

Dynatronics Dynatronics ERA was larger than all others ( ERA was larger than all others (P P<0.05) <0.05) Xltek Xltek and and Omnisound Omnisound ERA was larger than ERA was larger than Mettler Mettler, Chattanooga and Rich , Chattanooga and Rich-

  • Mar (

Mar (P P<0.05) <0.05) Overall ERA at 1MHz was smaller than at 3MHz ( Overall ERA at 1MHz was smaller than at 3MHz (P P<0.005) <0.005)

ERA in cm2, Total Power in Watts and SAI in W/cm2 *SAI when the ultrasound generator reads 1.0 Watts/cm2

Transducer Profiling of ERA and Generation of Watts at 1 MHz

slide-15
SLIDE 15

0.83 + 0.06^ 4.42 + 0.20 5.35 + 0.28 5.00 + 1.00 Dynatronics 0.99 + 0.16 4.95 + 0.38 5.03 + 0.58 4.45 + 0.67 Omnisound 1.09 + 0.13 4.28 + 0.43 3.97 + 0.25 4.00 + 1.00 Chattanooga 1.12 + 0.15 5.14 + 0.23 4.61 + 0.49 5.00 + 0.75 Xltek 1.19 + 0.07 4.57 + 0.23 3.83 + 0.21 5.00 + 1.00 Rich-Mar 1.36 + 0.11 1.26 + 0.44 5.45 + 0.20 3.97 + 0.41 4.01 + 0.34 3.16 + 0.66 5.00 + 1.00 4.00 + 1.00 Mettler Chatt.New Measured Measured Measured Reported SAI Total Power ERA ERA 1 MHz

* *Mettler Mettler SAI was higher than all others ( SAI was higher than all others (P P<0.05) <0.05) ^ ^Dynatronics Dynatronics SAI was lower than all others ( SAI was lower than all others (P P<0.05). <0.05). SAI range across all 66 transducers at 1 MHz was SAI range across all 66 transducers at 1 MHz was 0.76 to 1.56 0.76 to 1.56

ERA in cm2, Total Power in Watts and SAI in W/cm2 *SAI when the ultrasound generator reads 1.0 Watts/cm2

Transducer Profiling of ERA and Generation of Watts at 1 MHz

slide-16
SLIDE 16

% Difference in Mean SAI: 1 MHz % Difference in Mean SAI: 1 MHz

0% 0.83 Dynatronics 19% 0% 0.99 Omnisound 31% 10% 0% 1.09 Chattanooga 35% 13% 3% 0% 1.12 Xltek 43% 20% 9% 6% 0% 1.19 Richmar 64% 37% 25% 21% 14% 0% 1.36 Mettler 0.83 0.99 1.09 1.12 1.19 1.36 Dynatronics Omnisound Chattanooga Xltek Richmar Mettler SAI = W/cm2 SAI = W/cm2

slide-17
SLIDE 17

%Difference Between High and Low SAI, 1 MHz

SAI = W/cm2 SAI = W/cm2

24% 7% 9%

  • 3%
  • 14%
  • 20%

0.94 Dynatronics 50% 30% 33% 18% 5%

  • 3%

1.14 Omnisound 71% 48% 51% 34% 19% 11% 1.30 Chattanooga 86% 60% 64% 45% 29% 21% 1.41 XlTeck 71% 48% 51% 34% 19% 11% 1.30 Rich-Mar 105% 77% 81% 61% 43% 33% 1.56 Mettler 0.76 0.88 0.86 0.97 1.09 1.17 Dynatronics Omnisound Chattanooga XlTek Rich-Mar Mettler

slide-18
SLIDE 18

Independent Analysis of Ultrasound Independent Analysis of Ultrasound Transducers at 3.3 MHz Transducers at 3.3 MHz

3.42 + 0.73 1.3 + 0.16 5.4 + 0.44 4.22 + 0.35 Mean 2.85 1.2 4.8 3.91 37954 3.13 1.3 5.7 4.34 37953 3.04 1.3 5.7 4.44 37952 4.56 1.5 5.6 3.74 35986 4.06 1.4 5.6 4.04 35664 2.51 1.3 5.6 4.31 35663 3.81 1.0 4.7 4.76 35661 Planar BNR SAI in W/cm2 Watts ERA in cm2 Transducer

Manufacturer reported ERA 4.00 + 1.0 SAI of 1.0 = 0.6 oC/min >> 6.6 min >> 55% Watts calibrated to 5.0 + 0.75 or 15% SAI of 1.5 = 1.0 oC/min >> 4.0 min SAI, digital indicator on machines reads 1.2 W/cm2

slide-19
SLIDE 19

Transducer Profiling of ERA and Transducer Profiling of ERA and Generation of Watts at 3 MHz Generation of Watts at 3 MHz

0.81 + 0.06 3.94 + 0.29 4.64 + 0.44 4.00 + 1.00 Chattanooga 0.93 + 0.04 5.16 + 0.22 5.56 + 0.15 5.00 + 0.75 Xltek 0.97 + 0.07 5.49 + 0.19 5.64 + 0.30 5.00 + 1.00 Mettler 1.02 + 0.09 4.95 + 0.41 4.56 + 0.62 4.46 + 0.39 Omnisound 1.04 + 0.07 4.72 + 0.20 4.55 + 0.33 5.00 + 1.00 Rich-Mar 1.08 + 0.24 1.06 + 0.10 4.09 + 0.36 5.11 + 0.44 3.79 + 0.72 4.83 + 0.11 4.00 + 1.00 5.00 + 1.00 Chatt.New Dynatronics Measured Measured Measured Reported *SAI Total Power ERA ERA 3 MHz Mettler Mettler and and Xltek Xltek ERA, were larger than ERA, were larger than Chattanooga, Chattanooga, Dynatronics Dynatronics, , Omnisound Omnisound and Rich and Rich-

  • Mar

Mar ( (P P<0.001) <0.001)

ERA in cm2, Total Power in Watts and SAI in W/cm2 *SAI when the ultrasound generator reads 1.0 Watts/cm2

slide-20
SLIDE 20

Transducer Profiling of ERA and Transducer Profiling of ERA and Generation of Watts at 3 MHz Generation of Watts at 3 MHz

0.81 + 0.06 3.94 + 0.29 4.64 + 0.44 4.00 + 1.00 Chattanooga 0.93 + 0.04 5.16 + 0.22 5.56 + 0.15 5.00 + 0.75 Xltek 0.97 + 0.07 5.49 + 0.19 5.64 + 0.30 5.00 + 1.00 Mettler 1.02 + 0.09 4.95 + 0.41 4.56 + 0.62 4.46 + 0.39 Omnisound 1.04 + 0.07 4.72 + 0.20 4.55 + 0.33 5.00 + 1.00 Rich-Mar 1.08 + 0.24 1.06 + 0.10 4.09 + 0.36 5.11 + 0.44 3.79 + 0.72 4.83 + 0.11 4.00 + 1.00 5.00 + 1.00 Chatt.New Dynatronics Measured Measured Measured Reported *SAI Total Power ERA ERA 3 MHz

SAI of Chattanooga was lower than all other SAI of Chattanooga was lower than all other SAI range across all 77 transducers at 3 MHz was SAI range across all 77 transducers at 3 MHz was 0.69 to 1.68

ERA in cm2, Total Power in Watts and SAI in W/cm2 *SAI when the ultrasound generator reads 1.0 Watts/cm2

slide-21
SLIDE 21

% Difference in Mean SAI: 3 MHz % Difference in Mean SAI: 3 MHz

SAI = W/cm SAI = W/cm2

2

0% 0.81 Chattanooga 15% 0% 0.93 Xltek 20% 4% 0% 0.97 Mettler 26% 10% 5% 0% 1.02 Omnisound 28% 12% 7% 2% 0% 1.04 Rich-Mar 31% 14% 9% 4% 2% 0% 1.06 Dynatronics 0.81 0.93 0.97 1.02 1.04 1.06 Chattanooga Xltek Mettler Omnisound Rich-Mar Dynatronics

slide-22
SLIDE 22

%Difference Between %Difference Between High and Low SAI, 3 MHz High and Low SAI, 3 MHz

Comparative analysis depends on which ultrasound heads we compar Comparative analysis depends on which ultrasound heads we compare e SAI = W/cm SAI = W/cm2

2

29% 1% 3% 0%

  • 6%

1% 0.89 Chattanooga 48% 16% 19% 15% 7% 16% 1.02 Xltek 58% 24% 27% 22% 15% 24% 1.09 Mettler 68% 32% 35% 30% 22% 32% 1.16 Omnisound 68% 32% 35% 30% 22% 32% 1.16 Rich-Mar 72% 35% 38% 34% 25% 35% 1.19 Dynatronics 0.69 0.88 0.86 0.89 0.95 0.88 Chattanooga Xltek Mettler Omnisound Rich-Mar Dynatronics

slide-23
SLIDE 23

Conclusions Conclusions

Significant variability in SAI exists Significant variability in SAI exists

– – Within manufacturer Within manufacturer – – Between manufacturers Between manufacturers

Two factors contribute to wide variability Two factors contribute to wide variability

– – Utilization of Group mean ERA in the calculation of Utilization of Group mean ERA in the calculation of SAI SAI – – + + 20% power calibrations 20% power calibrations

slide-24
SLIDE 24

Recommendations Recommendations

ERA should be reported ERA should be reported

– – Transducer specific Transducer specific – – Frequency specific Frequency specific

Improved accuracy of power measurement Improved accuracy of power measurement

– – Incorporation into SAI calculations Incorporation into SAI calculations

Incorporation of these finding by manufacturers Incorporation of these finding by manufacturers and clinicians may increase consistency in and clinicians may increase consistency in applied treatments applied treatments

slide-25
SLIDE 25

2 Possible Factors Leading to Variability in 2 Possible Factors Leading to Variability in Clinical Outcom Clinical Outcomes

1) Determination of SAI 1) Determination of SAI W/cm W/cm2

2

– – Total Power Total Power

Display of total power Display of total power – –vs vs-

  • actual total power produced

actual total power produced SAI variability ( SAI variability (+ + 20%) 20%)

– – ERA ERA

group means in the software to determine SAI group means in the software to determine SAI SAI variability ( SAI variability (+ + 20 20-

  • 25%)

25%)

2) Distribution of acoustical amplitudes 2) Distribution of acoustical amplitudes

– – Variability in tissue heating Variability in tissue heating

slide-26
SLIDE 26

Primary Objective Primary Objective

1.

  • 1. Develop Novel Method

Develop Novel Method

WHOLE FIELD characterization WHOLE FIELD characterization Not dependent on BNR and ERA Not dependent on BNR and ERA

2.

  • 2. Establish a General Beam Profile of a

Establish a General Beam Profile of a Single Manufacturer Single Manufacturer

slide-27
SLIDE 27

Schlieren Schlieren Image Image

Describes the interaction of light and sound Describes the interaction of light and sound

– – Optical index of refraction Optical index of refraction – – Shows field variations Shows field variations

slide-28
SLIDE 28

High Intensity Focused High Intensity Focused Ultrasound Ultrasound

slide-29
SLIDE 29

Experimental Set up for Experimental Set up for Schlieren Schlieren Measurements Measurements

slide-30
SLIDE 30

0.00 0.40 0.80 1.20 1.60 2.00 1 cm 2 cm 3 cm 4 cm 5 cm 6 cm 7 cm Distance from Transducer Beam W idth in cm 80% 40%

Schlieren Schlieren Image and Image and Data Analysis Data Analysis

slide-31
SLIDE 31

3 MHz: General Images 3 MHz: General Images

UL – Chattanooga & Richmar UR – Dynatronics, Mettler & Xltek LL - Omnisound

slide-32
SLIDE 32

1 MHz: General Images 1 MHz: General Images

UL – Dynatronics UR – Xltek, Rich-Mar, Omnisound, Chattanooga LL - Mettler

slide-33
SLIDE 33

1 MHz Images 1 MHz Images

slide-34
SLIDE 34

3 MHz Images 3 MHz Images

slide-35
SLIDE 35

Take Home Message Take Home Message

Utilized a Novel Method for Therapeutic Ultrasound Whole Utilized a Novel Method for Therapeutic Ultrasound Whole Field Characterization Field Characterization

ERA & BNR are a component of beam profiling ERA & BNR are a component of beam profiling But appear to be insufficient But appear to be insufficient

Demonstrated variability within manufacturer Demonstrated variability within manufacturer

– – Variability between heads (3 profiles) Variability between heads (3 profiles)

3.3 MHz is significantly wider than 1.0 MHz 3.3 MHz is significantly wider than 1.0 MHz

– – Clinical effects of this are unknown Clinical effects of this are unknown

Limitations Limitations

– – Beams in water Beams in water – – Effects of Tissue on profile Effects of Tissue on profile

Refraction & Reflection Refraction & Reflection Preliminary studies underway Preliminary studies underway

slide-36
SLIDE 36

Therapeutic Ultrasound Therapeutic Ultrasound

Setting the Stage for Evidence Setting the Stage for Evidence Based Clinical Trials Based Clinical Trials

Johns LD, Straub SJ, * Johns LD, Straub SJ, *LeDet LeDet EG, * Howard S and Zaino A: EG, * Howard S and Zaino A: Quinnipiac University, Hamden Connecticut and Quinnipiac University, Hamden Connecticut and Onda Onda Corporation*, Sunnyvale, California. Corporation*, Sunnyvale, California. Funded by Quinnipiac University, EATA & NATA Funded by Quinnipiac University, EATA & NATA-

  • REF

REF