Adverse Events in Dry Needling

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

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.

Study Overview

• Status: Completed
• Conditions: Back Pain; Knee Osteoarthritis; Neck Pain; Shoulder Pain; Headache; Hip Osteoarthritis; Muscle Soreness; Needle Stick
• Intervention / Treatment: Other: Observational dry needle

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.

• Study Type: Observational
• Enrollment (Actual): 250

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Acworth, Georgia, United States, 30101
      • Benchmark Physical Therapy
    • Cartersville, Georgia, United States, 30101
      • Benchmark Physical Therapy
    • Fort Oglethorpe, Georgia, United States, 30707
      • Benchmark Physical Therapy
    • Marietta, Georgia, United States, 30008
      • Benchmark Physical Therapy
    • Roswell, Georgia, United States, 30009
      • Benchmark Physical Therapy
  • Tennessee
    • Athens, Tennessee, United States, 37371
      • Benchmark Physical Therapy
    • Hixson, Tennessee, United States, 37415
      • Benchmark Physical Therapy
    • Kingsport, Tennessee, United States, 37617
      • Benchmark Physical Therapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Any patient receiving DN as a regular part of their physical therapy care for any diagnosis.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Dry needle; Dry needling is provided as a part of a comprehensive treatment program by a physical therapist. The patient and the therapist will record any adverse events that occur.	Other: Observational dry needle; No intervention provided by the study. Observation of any adverse events that occur surrounding dry needling by a physical therapist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse event	adverse events are recorded by the patient and therapist	1 week

Collaborators and Investigators

• Sponsor: Elizabeth Lane
• Collaborators: Brenau University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2018
• Primary Completion (Actual): December 30, 2018
• Study Completion (Actual): December 30, 2018

Study Registration Dates

• First Submitted: July 27, 2018
• First Submitted That Met QC Criteria: July 27, 2018
• First Posted (Actual): August 2, 2018

Study Record Updates

• Last Update Posted (Actual): April 18, 2019
• Last Update Submitted That Met QC Criteria: April 16, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: physical therapy; dry needling; adverse event
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Muscular Diseases; Neuromuscular Diseases; Musculoskeletal Pain; Arthralgia; Wounds, Stab; Wounds, Penetrating; Osteoarthritis; Myalgia; Osteoarthritis, Knee; Neck Pain; Shoulder Pain; Headache; Osteoarthritis, Hip; Needlestick Injuries
• Other Study ID Numbers: UUtah

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No