- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04040218
Trigger Point Dry Needling Practice in Colorado: Practitioner and Patient
July 30, 2019 updated by: Regis University
Harms Associated With Dry Needling Provided During Patient Care in Colorado by Physical Therapists
A retrospective analysis of responses following a descriptive survey to investigate the benefits and harms associated with dry needling as provided by a physical therapists in CO
Study Overview
Detailed Description
Two surveys were completed to identify the reported harms by physical therapists in the provision of dry needling in Colorado, and by patients who received dry needling from physical therapists in Colorado in April 2017.
Retrospective analysis of the data (de-identified) was completed to provide a representative reporting on harms associated with the dry needling provided and received for patients.
Study Type
Interventional
Enrollment (Actual)
2607
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Colorado
-
Denver, Colorado, United States, 80221
- Regis University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Physical therapists providing dry needling to patients in Colorado
- Patients who had received dry needling from Physical Therapists in Colorado
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Survey analysis of harm data
Time Frame: As reported during the four week survey time frame
|
Harm - "any ill-effect, no matter how small, that was unintended."
Further delineation was made that minor/insignificant complaints/harms were defined as short term soreness less than 24 hours and more than 24 hours, bruising and light-headedness, and major/significant harm was defined infection or pneumothorax (PTX).
|
As reported during the four week survey time frame
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2017
Primary Completion (Actual)
April 30, 2017
Study Completion (Actual)
April 30, 2017
Study Registration Dates
First Submitted
July 30, 2019
First Submitted That Met QC Criteria
July 30, 2019
First Posted (Actual)
July 31, 2019
Study Record Updates
Last Update Posted (Actual)
July 31, 2019
Last Update Submitted That Met QC Criteria
July 30, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 1069837-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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