Ultrasound in Muscle Biopsy

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2015-10-31

Brief Summary

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The objective of the proposed study is to evaluate the clinical utility of muscle ultrasonography for improving the diagnostic yield and safety of core muscle biopsy. Our facility currently uses core (needle) biopsy to obtain muscle samples in patients 18 years old or older. Currently, there is no imaging tool used to guide the actual biopsy. As muscle biopsy is an invasive and potentially painful procedure, improving the diagnostic yield of this test is important.

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Detailed Description

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Conditions

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Myopathy Myositis Muscular Dystrophy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Ultrasound Guided Biopsy

Ultrasound guided biopsy will be used in all patients.

Group Type EXPERIMENTAL

Ultrasound

Intervention Type PROCEDURE

The ultrasound guided group will have an ultrasound to identify the optimal site for biopsy and guide the procedure for safety purposes.

Non-Ultrasound Guided Group

The control group will have non-ultrasound guided biopsies performed, which is the current standard of care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Ultrasound

The ultrasound guided group will have an ultrasound to identify the optimal site for biopsy and guide the procedure for safety purposes.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Consecutive subjects scheduled for a biopsy at our EMG laboratory will be asked if they would like to participate until a total of 40 participants are obtained.