NCT03612843

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2018

Shorter than P25 for all trials

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

August 1, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 2, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2018

Completed
Last Updated

April 18, 2019

Status Verified

April 1, 2019

Enrollment Period

5 months

First QC Date

July 27, 2018

Last Update Submit

April 16, 2019

Conditions

Keywords

dry needlingadverse eventphysical therapy

Outcome Measures

Primary Outcomes (1)

  • Adverse event

    adverse events are recorded by the patient and therapist

    1 week

Study Arms (1)

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

Interventions

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

Dry needle

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Any patient receiving DN as a regular part of their physical therapy care for any diagnosis.

You may qualify if:

  • Any patient that receives dry needling as a part of their care by a physical therapist and consents to provide information

You may not qualify if:

  • Does not receive dry needling or does not consent to provide information

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Benchmark Physical Therapy

Acworth, Georgia, 30101, United States

Location

Benchmark Physical Therapy

Cartersville, Georgia, 30101, United States

Location

Benchmark Physical Therapy

Fort Oglethorpe, Georgia, 30707, United States

Location

Benchmark Physical Therapy

Marietta, Georgia, 30008, United States

Location

Benchmark Physical Therapy

Roswell, Georgia, 30009, United States

Location

Benchmark Physical Therapy

Athens, Tennessee, 37371, United States

Location

Benchmark Physical Therapy

Hixson, Tennessee, 37415, United States

Location

Benchmark Physical Therapy

Kingsport, Tennessee, 37617, United States

Location

MeSH Terms

Conditions

MyalgiaHeadacheOsteoarthritis, KneeBack PainNeck PainNeedlestick InjuriesShoulder PainOsteoarthritis, Hip

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesMusculoskeletal PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsOsteoarthritisArthritisJoint DiseasesRheumatic DiseasesWounds, StabWounds, PenetratingWounds and InjuriesArthralgia

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Co-investigator

Study Record Dates

First Submitted

July 27, 2018

First Posted

August 2, 2018

Study Start

August 1, 2018

Primary Completion

December 30, 2018

Study Completion

December 30, 2018

Last Updated

April 18, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations