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Clinical Trials/NCT03612843
NCT03612843
Completed
N/A

Clinician-Reported and Patient Reported Incidence of Mild and Significant Adverse Events Associated With Dry Needling by Physical Therapists

Elizabeth Lane1 site in 1 country250 target enrollmentAugust 1, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Muscle Soreness
Sponsor
Elizabeth Lane
Enrollment
250
Locations
1
Primary Endpoint
Adverse event
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

The purpose of this prospective cohort survey study is to further explore the incidence of adverse events with dry needling by physical therapists - as well as any differences or similarities between patient-reported vs therapist-reported incidence of AEs.

Detailed Description

The study design will comprise of an observational study, where practicing clinicians will log data from dry needling sessions and patients will report via online surveys. Clinician logs will be collected weekly via an online REDCap survey . Patients will be instructed to complete an online REDCap survey in the event that an adverse event occurs. Data will be collected for a period of 4 mo. Descriptive statistics will be used to calculate frequencies of various AE's and rates of occurrence per 100 treatments. Adverse events will be classified on how frequently they occur, ranging from very common (\>1/10 treatments) to very rare (\<1/10,000 treatments). The investigators will then examine for differences between patient-reported and clinician-reported incidences and also explore for any correlations between adverse events and other various reported factors.

Registry
clinicaltrials.gov
Start Date
August 1, 2018
End Date
December 30, 2018
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Elizabeth Lane
Responsible Party
Sponsor Investigator
Principal Investigator

Elizabeth Lane

Co-investigator

University of Utah

Eligibility Criteria

Inclusion Criteria

  • Any patient that receives dry needling as a part of their care by a physical therapist and consents to provide information

Exclusion Criteria

  • Does not receive dry needling or does not consent to provide information

Outcomes

Primary Outcomes

Adverse event

Time Frame: 1 week

adverse events are recorded by the patient and therapist

Study Sites (1)

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