NCT04040218

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,607

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2017

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2017

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

July 30, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 31, 2019

Completed
Last Updated

July 31, 2019

Status Verified

July 1, 2019

Enrollment Period

29 days

First QC Date

July 30, 2019

Last Update Submit

July 30, 2019

Conditions

Keywords

dry needlingphysical therapy

Outcome Measures

Primary Outcomes (1)

  • Survey analysis of harm data

    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

Interventions

Dry NeedlingPROCEDURE

Dry needling is utilized by multiple practitioners to address impairments in neuromusculoskeletal function, often related to pain and loss of mobility. Dry needling, according the American Physical Therapy Association (APTA), is defined as a skilled intervention that uses a thin filiform needle to penetrate the skin and stimulate underlying myofascial trigger points, muscular, and connective tissues for the management of neuromusculoskeletal pain and movement impairments

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Physical therapists providing dry needling to patients in Colorado
  • Patients who had received dry needling from Physical Therapists in Colorado

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Regis University

Denver, Colorado, 80221, United States

Location

MeSH Terms

Interventions

Dry Needling

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: The target population for this study was a representative sample of PT providers that administer and patients that receive dry needling as a treatment modality in the state of Colorado. 440 PT's licensed in Colorado and 2167 patients were recruited for this study. Purposive sampling was implemented through convenience sampling methods; by which PT respondents were included through their association to APTA CO or Kinetacore@ (an education provider in DN) and patients through their PT provider. The PT survey was sent out to APTA CO members and via a Kinetacore email list; which included approximately 900 individuals trained by Kinetacore in CO. All respondents to the PT survey were requested to provide patients with a direct link to the patient survey. Invitation was promoted by APTA CO outside of their member portal to non-members and word of mouth was encouraged.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2019

First Posted

July 31, 2019

Study Start

April 1, 2017

Primary Completion

April 30, 2017

Study Completion

April 30, 2017

Last Updated

July 31, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations