Optimal Time for In-situ Dry Needling to Affect the Auton... | NCT03728751

Studies
Optimal Time for In-situ Dry Needling to Affect the Autonomic Nervous System

NCT03728751

Sponsor

Florida Gulf Coast University

Status

Completed

Last Update Posted

Nov 2, 2018Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Healthy

Interventions

Dry needling

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2018Actual

Primary Completion Date

Oct 15, 2018Actual

Completion Date

Oct 29, 2018Actual

First Submitted Date

Oct 29, 2018

First Submission Date that Met QC Criteria

Nov 1, 2018

First Posted Date

Nov 2, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 1, 2018

Last Update Posted Date

Nov 2, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Assessing for optimal time dry needles need to remain inside the body to have positive effect on the nervous system

Detailed Description

The purpose of this study is to determine what most optimal dry needling duration effect on the autonomic nervous system.

Design: The researchers will conduct a pilot study to assess the effect of dry needling on the autonomic nervous system

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
study group	Experimental	Study group receiving dry needling and pupil diameter will be studied up to 23 minutes after needle placement.	Procedure: Dry needling

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dry needling	Procedure	Paravertebral dry needling C7-T4. Total of 8 needles.	study group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pupil diameter	Change in pupil diameter measured with automated pupillometry device from Micromedical.	1.) 1 minute measure will be taken after accommodation of 2 minutes to the dark environment, 2.) needle placement and an immediate 1 minute second measure, 3.) every 2 minutes a measure of 1 minute to 8 post needle measures (24 minutes) total

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age between 18-65 years old
No pain at all anywhere in the body at the time of testing.
No caffeine containing products 3 hours before measurement and no use of over the counter Non-Steroidal Anti-Inflammatory Drug (NSAID) before the testing.

Exclusion Criteria:

Red flags identified during the subjects intake. If needling is contraindicated the subjects will be removed from the study and if necessary will be referred to an appropriate health care provider.
Use of blood thinners
History of surgery and or injury within the past six weeks
Evidence of central nervous system involvement, to include hyperreflexia, sensory disturbances in the hand, intrinsic muscle wasting of the hands, unsteadiness during walking, nystagmus, loss of visual acuity, impaired sensation of the face, altered taste, the presence of pathological reflexes (i.e. positive Hoffman's and/or Babinski reflexes), etc.
Prior surgery to the neck or thoracic spine
Chiropractic, Physical Therapy, Dry needling or Acupuncture treatment for their neck pain in the last 3-months
Inability to follow directions and keep the eye open during the measurement phase of this study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Rob Sillevis, PhD	Faculty	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Integrated Therapy Practice PC		Hobart	Indiana	46342	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D000529	Complementary Therapies
D013812	Therapeutics
D026741	Physical Therapy Modalities