Adverse Events in Dry Needling

NCT ID: NCT03612843

Last Updated: 2019-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-01

Study Completion Date

2018-12-30

Brief Summary

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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

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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.

Conditions

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Muscle Soreness Headache Knee Osteoarthritis Back Pain Neck Pain Needle Stick Shoulder Pain Hip Osteoarthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Observational dry needle

Intervention Type OTHER

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

Interventions

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Observational dry needle

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brenau University

OTHER

Sponsor Role collaborator

Elizabeth Lane

OTHER

Sponsor Role lead

Responsible Party

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Elizabeth Lane

Co-investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Benchmark Physical Therapy

Acworth, Georgia, United States

Site Status

Benchmark Physical Therapy

Cartersville, Georgia, United States

Site Status

Benchmark Physical Therapy

Fort Oglethorpe, Georgia, United States

Site Status

Benchmark Physical Therapy

Marietta, Georgia, United States

Site Status

Benchmark Physical Therapy

Roswell, Georgia, United States

Site Status

Benchmark Physical Therapy

Athens, Tennessee, United States

Site Status

Benchmark Physical Therapy

Hixson, Tennessee, United States

Site Status

Benchmark Physical Therapy

Kingsport, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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UUtah

Identifier Type: -

Identifier Source: org_study_id

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