Adverse Events in Dry Needling

Study Purpose

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.#46;therapist-reported incidence of AEs.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03612843
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Elizabeth Lane
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

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

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Benchmark Physical Therapy, Acworth, Georgia

Status

Recruiting

Address

Benchmark Physical Therapy

Acworth, Georgia, 30101

Site Contact

Daniel Maddox

[email protected]

423-238-7217

Benchmark Physical Therapy, Cartersville, Georgia

Status

Recruiting

Address

Benchmark Physical Therapy

Cartersville, Georgia, 30101

Site Contact

Daniel Maddox

[email protected]

423-238-7217

Benchmark Physical Therapy, Fort Oglethorpe, Georgia

Status

Recruiting

Address

Benchmark Physical Therapy

Fort Oglethorpe, Georgia, 30707

Site Contact

Daniel Maddox

[email protected]

423-238-7217

Benchmark Physical Therapy, Marietta, Georgia

Status

Recruiting

Address

Benchmark Physical Therapy

Marietta, Georgia, 30008

Site Contact

Daniel Maddox

[email protected]

423-238-7217

Benchmark Physical Therapy, Roswell, Georgia

Status

Recruiting

Address

Benchmark Physical Therapy

Roswell, Georgia, 30009

Site Contact

Daniel Maddox

[email protected]

423-238-7217

Benchmark Physical Therapy, Athens, Tennessee

Status

Recruiting

Address

Benchmark Physical Therapy

Athens, Tennessee, 37371

Site Contact

Daniel Maddox

[email protected]

423-238-7217

Benchmark Physical Therapy, Hixson, Tennessee

Status

Recruiting

Address

Benchmark Physical Therapy

Hixson, Tennessee, 37415

Site Contact

Daniel Maddox

[email protected]

423-238-7217

Benchmark Physical Therapy, Kingsport, Tennessee

Status

Recruiting

Address

Benchmark Physical Therapy

Kingsport, Tennessee, 37617

Site Contact

Daniel Maddox

[email protected]

423-238-7217