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Completed

NCT Number: NCT03612843

Adverse Events in Dry Needling

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.

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Key information

Conditions

Muscle Soreness Arthralgia Arthritis Back Pain Headache Hip Osteoarthritis Joint Diseases Knee Osteoarthritis Muscular Diseases Musculoskeletal Diseases Musculoskeletal Pain Myalgia Neck Pain Needle Stick Needlestick Injuries Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Osteoarthritis Osteoarthritis, Hip Osteoarthritis, Knee Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Shoulder Pain Signs and Symptoms Wounds and Injuries Wounds, Penetrating Wounds, Stab

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Benchmark Physical Therapy, Acworth, Georgia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Observational dry needle

Other

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

Primary outcomes

  1. Adverse event

    Time frame: 1 week

    adverse events are recorded by the patient and therapist

Sponsors and collaborators

Lead sponsor

Elizabeth Lane

Other

Collaborators

  • Brenau University

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 2, 2018
Registry last updated
Apr 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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