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document
Pulsed electromagnetic fields for postmenopausal osteoporosis and concomitant lumbar osteoarthritis in southwest China using proximal femur bone mineral density as the primary endpoint : study protocol for a randomized controlled trial . BACKGROUND Osteoporosis ( OP ) and osteoarthritis ( OA ) are prevalent skeletal disorders among postmenopausal women . Coexistence is common especially that of postmenopausal osteoporosis ( PMO ) and lumbar OA . An hypothesis has been raised that OP and OA might share the same pathogenic mechanism , and pulsed electromagnetic fields ( PEMFs ) were reported to have anti-osteoporosis and anti-osteoarthritis properties , but this suggestion was based primarily on biomarker data . Therefore , whether these two effects could take place simultaneously has not yet been investigated . This randomized controlled trial ( RCT ) is designed to explore the effect of PEMFs for PMO and concomitant lumbar OA . METHODS/DESIGN The study will include PMO patients ( postmenopausal women ; aged between 50 and 70 years ; have been postmenopausal for at least 5 years and diagnosed with OP using proximal femur T-score ) with concomitant lumbar OA ( patients with confounding disorders like diabetes , hypertension , hyperlipidemia , and previous fracture history , etcetera , will be excluded ) will be randomly assigned to two arms : PEMFs group and sham PEMFs group . There will be 25 participants in each arm ( 50 in total ) and the outcome assessment , including the primary endpoint ( proximal femur bone mineral density ) , will be performed at 5 weeks , 3 months and 6 months after enrollment . DISCUSSION PMO and lumbar OA are prominent public health problem , especially for postmenopausal women . We hope this RCT will provide scientific evidence to primary care of the postmenopausal women regarding the use of these nonpharmaceutical , noninvasive modalities , PEMFs , in managing PMO and lumbar OA . TRIAL REGISTRATION Chinese Clinical Trial Registry : ChiCTR-TRC-14005156 ( 28 August 2014 ) .
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Intervention_Physical
Pulsed electromagnetic fields
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Intervention_Physical
pulsed electromagnetic fields ( PEMFs )
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Intervention_Physical
PEMFs
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Intervention_Physical
PEMFs
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Intervention_Control
sham PEMFs group
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Intervention_Physical
PEMFs
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Outcome_Physical
proximal femur bone mineral density
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Outcome_Physical
( proximal femur bone mineral density )
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Participant_Condition
postmenopausal osteoporosis and concomitant lumbar osteoarthritis in southwest China
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Participant_Condition
postmenopausal
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Participant_Sex
women
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Participant_Age
aged between 50 and 70 years
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Participant_Condition
postmenopausal
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Participant_Condition
diagnosed with OP using proximal femur T-score ) with concomitant lumbar
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Participant_Sample-size
25 participants in each arm
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Participant_Sample-size
50 in total
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Participant_Condition
postmenopausal
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Participant_Sex
women