Adverse Events in Dry Needling

Sponsor

Elizabeth Lane (Other)

Overall Status

Completed

CT.gov ID

NCT03612843

Collaborator

Brenau University (Other)

250

Enrollment

Locations

Actual Duration (Months)

31.3

Patients Per Site

6.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Muscle Soreness Headache Knee Osteoarthritis Back Pain Neck Pain Needle Stick Shoulder Pain Hip Osteoarthritis	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 Design

Study Type:

Observational

Actual Enrollment :

250 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Aug 1, 2018

Actual Primary Completion Date :

Dec 30, 2018

Actual Study Completion Date :

Dec 30, 2018

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Adverse event [1 week]
adverse events are recorded by the patient and therapist

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Benchmark Physical Therapy	Acworth	Georgia	United States	30101
2	Benchmark Physical Therapy	Cartersville	Georgia	United States	30101
3	Benchmark Physical Therapy	Fort Oglethorpe	Georgia	United States	30707
4	Benchmark Physical Therapy	Marietta	Georgia	United States	30008
5	Benchmark Physical Therapy	Roswell	Georgia	United States	30009
6	Benchmark Physical Therapy	Athens	Tennessee	United States	37371
7	Benchmark Physical Therapy	Hixson	Tennessee	United States	37415
8	Benchmark Physical Therapy	Kingsport	Tennessee	United States	37617