Medical Vibration Therapy in Osteopenic patients with Galileo900/2000 S.F.E. Praet MD MSc Trainee...
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Medical Vibration Therapy in Osteopenic patients with Galileo900/2000
S.F.E. Praet MD MSc
Trainee Sports Medicine
Movement Scientist
Máxima Medical Centre
Veldhoven (Nl) N. Snelder, BSc
Masters student
Life Science and Technology
TU Delft / RU Leiden (Nl)
H. Mulder, MD PhD
Endocrinologist
Director Osteosupport SMO
Rotterdam (Nl)
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• Introduction• Background• Research Question• Methods• The Galileo™ principle• Results• Discussion• Summary
Overview
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IntroductionIntroduction
Definition of Bone Mineral Density Definition of Bone Mineral Density
(WHO)(WHO)
Healthy Bone = Reference BMD of 25 yrs old female(T-score < -1)(T-score < -1)
Osteopenic = BMD < 1 SD of reference BMD (T-score < -1)(T-score < -1)
Osteoporotic = BMD < 2.5 SD (T-score < -2.5)(T-score < -2.5)
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Introduction
Natural BMD at Hip in Caucasian Females
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• Approximately 30% of postmenopausal females have osteoporosis according to the World Health Organization (WHO) ( Kanis 1994, WHO 1994).
• The excess mortality associated with a hip fracture has been estimated to be at 20% ( Cooper 1993),
• Cumulative lifetime fracture risk for a 50 year-old women may be as high as 60% (Cummings 1989).
Introduction
Epidemiology of Osteoporosis
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Introduction
Bone Mineral Density vs. Risk of Hip fracture
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• The total dollar cost of osteoporosis was estimated at seven to ten billion annually in 1988 (WHO 1994).
• Hip fractures and hospitalization for all types of fracture accounted for most of these costs (Cooper 1993).
• Therefore, the prevention of fractures is the primary goal of intervention.
Introduction
Cost of Osteoporosis
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• Anti-resorptive bone formation agents (e.g. estrogen and biophosphates)
• Bone formation agents (e.g. fluoride and PTH).
• Calcium and Vitamin D supplementation
JAMA 285: 785-795, 2001Chapuy et al. Osteoporos. Int. 2002
Introduction
Prevention of Osteoporosis
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IntroductionOsteoporosis & Calcium
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• “The value of exercise as an intervention for the prevention of postmenopausal bone loss is a controversial subject”
Kanis, WHO Study Group. Osteoporosis Int. 1994
Introduction
Prevention of Osteoporosis
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IntroductionOsteoporosis & Exercise:
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Background
Vibrations and Bone mass
Animal studies (Turkey)
Rubin et al. Nature 2001
Fritton, McLeod, Rubin, J. Biomech. 2000
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Background
Normal Frequency & Microstrain Pattern in Bone
Animal studies (Turkey/Sheep/Dog)
Fritton, McLeod, Rubin, J. Biomech. 2000
Walking Turkey 12 h. Daily activity
1 microstrain is 0.0001% strain (e = dL/L)
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Background
Vibrations and Bone mass
Animal studies (Ewes)
Rubin et al. Bone 2002
Rubin et al. J Bone Miner. Res. 2002
30Hz, 0.3 g, 20min/day5x/wk during 1 year
Femur: 34.2% BMD increaseTibia: 26.7% Strength increase
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Background
Vibrations and Bone mass
Animal studies: Bone Formation (Prox. Tibia) in Rats
Rubin et al. FASEB 2001
28 days follow up period:
LTC=Long term controlMS=Mech. Stim/ @ 90Hz 0.25 g
10 min/day 5x/wkDis= Disuse Hindlimb suspensionWB=Weight Bearing
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Background
Vibrations and Bone mass
Animal studies: Mineralization of Trabuculae
Rubin et al. FASEB 2001
Control Disuse Mech. Stim.
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Research Question
What is the effect of Vibration Therapy
on patients with low bone mass?
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Methods Subjects Selection
Inclusion Criteria:
•Osteopenia: BMD –2.0 < t-value < 1.0 (DEXA)•Able to stand on vibration platform•Motivation to participate
Exclusion Criteria:
•Use of Medication that influences Bone metabolism•History of Deep Venous Thrombosis
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Methods Subjects Selection
January 2001- April 2001
•60 patients visiting Osteoporosis Clinic for DEXA measurement with osteopenia (-2.0 < t < -1.0)
•37 patients included
•23 patients excluded•10 not allowed medication•3 History of DVT•3 Disabled•7 Not interested to participate
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Methods Therapeutical Intervention through Randomization
Group I (n=19 (13 F / 6 M)
Age: 61 yrs ± 7
10 post menopausal
•WBV on Galileo2000
1x/week: 3 x 3 min @16 Hz
Group II (n=18 (13 F / 5 M)
Age: 64 yrs ± 5
8 post menopausal
•WBV on Galileo2000
1x/week: 3 x 3 min @16 Hz
•Vitamin D 400 I.U. / day
•Calcium 500 mg / day
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Galileo ™ 900/2000
Whole Body Vibration Platform
•Amplitude: 0-12 mm
•Frequency 5-30 Hz (continuum)
•Tilting platform
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Whole Body Vibration
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• Downward displacement / Acceleration of leg• Reactive upward force (cf. landing phase)
Dampening through:
• Eccentric muscle contraction:alternating left / right limb +contralateral trunk muscles
• Simultaneous Bone strain
Whole Body Vibration according to Galileo principle
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Methods BMD measurements
Dual Energy X-Ray Absorptiometry (DEXA)
At 0 – 6 – 12 and 24 months
•Lunar DPX-L machine
Hip (Neck) Lumbar spine (L1-L4)
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Methods Marker Bone Growth
Serum Alkaline Phosphatase measurements
At 0 – 12 and 24 months
Statistics
Multiple t-tests within and between the two groups
Confidence interval 99%
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ResultsSerum Alkaline Phosphates
94,0%
96,0%
98,0%
100,0%
102,0%
104,0%
106,0%
108,0%
110,0%
0 12 24
Months
Serum Alkaline Phosphates
Change Alkaline Phosphates I
Change Alkaline Phosphates II
* * * *
* p<0.01
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BMD L1-L4
98,0%
99,0%
100,0%
101,0%
102,0%
103,0%
104,0%
105,0%
106,0%
107,0%
108,0%
0 6 12 24
Months
Change BMD Spine I
Change BMD Spine II
ResultsBMD change Spine
*
*¶ ¶
¶
¶ p<0.01, * p<0.001
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BMD Femoral Neck
98,0%
99,0%
100,0%
101,0%
102,0%
103,0%
104,0%
105,0%
106,0%
107,0%
108,0%
0 6 12 24
Months
Change BMD Hip I
Change BMD Hip II
ResultsBMD change Hip
*
* *
¶ p<0.01, * p<0.001
¶
¶¶
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ResultsPercentual BMD change
Spine group 1 Hip group 1Months
0 100,0% 100,0%6 101,0% 101,7%
12 101,8% 103,3%24 102,1% 103,6%
Spine group 2 Hip group 2Months
0 100,0% 100,0%6 101,3% 102,0%
12 103,1% 104,2%24 104,0% 103,9%
Percental change in bonemass
Percental change in bonemass
I
II**
*
*
¶
*
¶¶
¶¶
¶
¶ p<0.01, * p<0.001
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Results
Percental change in bonemass (spine and femoral neck of the hip) in patients with Osteopenia,
treated with WBV without (group 1) and with calcium-vitamin D supplementation (group 2)
Bone Mineral Density change (DEXA)
100,0%
100,5%
101,0%
101,5%
102,0%
102,5%
103,0%
103,5%
104,0%
104,5%
0 6 12 24months
Spine group 1 Hip group 1 Spine group 2 Hip group 2
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ResultsTherapy compliance
Table IV Group Igroup IINote: Medical Vibraion Therapy each weak = 100%
90%93%94%
Compliance to the Whole Body Vibration protocol104 weeks52 weeks
92%
Reported side effects: none
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Other Literature8 Months of Vertical WBV @ 25-45 Hz
in young healthy adults vs controls (RCT, n=56)
2-5x/wk, 4 min/day
Torvinen et al, J Bone Miner Res 2003 May 18:876-84
•No effect on BMC (DEXA/pQCT)
•No effect on Serum Bone Turnover Markers
•7.8 % net increase in Jump Height
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Other LiteratureStrength training vs. Tilting WBV @ 25 Hz
12 mths, 2x/wk +/- HRT post-menopausal (n=51)
C. Kleinmond, PhD Thesis FU Berlin, 2002 http://darwin.inf.fu-berlin.de/2002/270
SpineSpine
HipHip
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DiscussionWhole Body Vibration and Bone Metabolism
•Catabolic vs Anabolic state of Bone
•Secondary/functional hypoparathyreoidism•Pre vs Post menopausal•Base line BMD / Activity level
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DiscussionWhole Body Vibration and Bone Metabolism
•Synergistic Effect with
•Ca++/Vit D•Hormone Replacement Therapy
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DiscussionWhole Body Vibration and Bone Metabolism
Dose-response relationship ?
•Frequency•Duration•Amplitude•Vertical vs Tilting •Therapy Compliance
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DiscussionWhole Body Vibration and Bone Cell
Theoretical Model of Osteogenesis and Vibration:
Perturbation Intermedullary PressurePerturbation Intermedullary PressureFluid flow through bone canuculi /lacunaeFluid flow through bone canuculi /lacunae
Shear Stress Cell Membrane Shear Stress Cell Membrane (>5 microstrain @ 30 Hz)(>5 microstrain @ 30 Hz)
Mechanotransduction Mechanotransduction Cytoskeletal stressCytoskeletal stress
Expression of mRNAExpression of mRNAOsteoblast Osteoblast
expression /activationexpression /activation Weinbaum et al. J. Biomech. 27, 1993Hsich& Turner J Bone Miner Res 16, 2001Rubin et al Nature 412, 200/ Bone 30, 2002
Qin, Rubin, McLeod J Orth Res 16 1998Cullen et al. J. Appl. Physiol 91, 2001
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WBV and Fall risk
• ADL in Geriatric patients (Balance + chair rising test)(n=34, 67 yrs; 2 mths: 3x/wk 3 x 2 min WBV)
+ 18 % progress in Chair rising test
Runge et al. ; J. Musculoskeletal Interact. 1 (2000)
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Summary Whole Body Vibration in Osteopenia
•Synergistic effect of WBV and Ca++/Vit D Supplementation
•Fast response at Femoral Neck
•Long term response at Lumbar Spine
•Leveling off after 12 months
•Optimal dose response?
•Fall and fracture risk reduction: still undetermined
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Thank you for your attention