Clinical trial NCT03612843: Adverse Events in Dry Needling
Official title: Clinician-Reported and Patient Reported Incidence of Mild and Significant Adverse Events Associated With Dry Needling by Physical Therapists
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Muscle Soreness
Headache
Knee Osteoarthritis
Back Pain
Neck Pain
Needle Stick
Shoulder Pain
Hip Osteoarthritis
Keywords: dry needling
adverse event
physical therapy
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: Brenau University
First posted: 2018-08-02
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patient receiving DN as a regular part of their physical therapy care for any diagnosis.

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.

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

Primary outcomes:
measure: Adverse event
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Acworth
country: United States
facility: Benchmark Physical Therapy
state: Georgia
city: Cartersville
country: United States
facility: Benchmark Physical Therapy
state: Georgia
city: Fort Oglethorpe
country: United States
facility: Benchmark Physical Therapy
state: Georgia
city: Marietta
country: United States
facility: Benchmark Physical Therapy
state: Georgia
city: Roswell
country: United States
facility: Benchmark Physical Therapy
state: Georgia
city: Athens
country: United States
facility: Benchmark Physical Therapy
state: Tennessee
city: Hixson
country: United States
facility: Benchmark Physical Therapy
state: Tennessee
city: Kingsport
country: United States
facility: Benchmark Physical Therapy
state: Tennessee
Study officials:
References: