Trials / Completed
CompletedNCT03612843
Adverse Events in Dry Needling
Clinician-Reported and Patient Reported Incidence of Mild and Significant Adverse Events Associated With Dry Needling by Physical Therapists
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 250 (actual)
- Sponsor
- Elizabeth Lane · Academic / Other
- Sex
- All
- Age
- 18 Years – 100 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Muscle Soreness
- Headache
- Knee Osteoarthritis
- Back Pain
- Neck Pain
- Needle Stick
- Shoulder Pain
- Hip Osteoarthritis
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Observational dry needle | No intervention provided by the study. Observation of any adverse events that occur surrounding dry needling by a physical therapist. |
Timeline
- Start date
- 2018-08-01
- Primary completion
- 2018-12-30
- Completion
- 2018-12-30
- First posted
- 2018-08-02
- Last updated
- 2019-04-18
Locations
8 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT03612843. Inclusion in this directory is not an endorsement.