Adverse Events in Dry Needling

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03612843
• Other study ID #: UUtah
• Status: Completed
• Start date: August 1, 2018
• Est. completion date: December 30, 2018

Study information

• Verified date: April 2019
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: December 30, 2018
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Headache
• Hip Osteoarthritis
• Knee Osteoarthritis
• Muscle Soreness
• Myalgia
• Neck Pain
• Needle Stick
• Needlestick Injuries
• Osteoarthritis
• Osteoarthritis, Hip
• Osteoarthritis, Knee
• Shoulder Pain

Intervention

Other:
• Observational dry needle
No intervention provided by the study. Observation of any adverse events that occur surrounding dry needling by a physical therapist.

Locations

Country	Name	City	State
United States	Benchmark Physical Therapy	Acworth	Georgia
United States	Benchmark Physical Therapy	Athens	Tennessee
United States	Benchmark Physical Therapy	Cartersville	Georgia
United States	Benchmark Physical Therapy	Fort Oglethorpe	Georgia
United States	Benchmark Physical Therapy	Hixson	Tennessee
United States	Benchmark Physical Therapy	Kingsport	Tennessee
United States	Benchmark Physical Therapy	Marietta	Georgia
United States	Benchmark Physical Therapy	Roswell	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Elizabeth Lane	Brenau University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse event	adverse events are recorded by the patient and therapist	1 week