Adverse Events in Dry Needling

Completed

• Conditions: Knee Osteoarthritis; Headache; Back Pain; Neck Pain; Shoulder Pain; Muscle Soreness; Needle Stick; Hip Osteoarthritis
• Interventions: Other: Observational dry needle

• Registration Number: NCT03612843
• Lead Sponsor: Elizabeth Lane

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.

Study Timeline

• Study First Submitted: 2018-07-27
• Study First Submitted QC: 2018-07-27
• Study Start: 2018-08-01
• Study First Posted: 2018-08-02
• Primary Completion: 2018-12-30
• Study Completion: 2018-12-30
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-16
• Last Update Posted: 2019-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Dry needle	Observational 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.

Primary Outcome Measures

Name	Time	Method
Adverse event	1 week	adverse events are recorded by the patient and therapist

Trial Locations

Locations (1)

Benchmark Physical Therapy; 🇺🇸 Kingsport, Tennessee, United States