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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03728751
Recruitment Status : Completed
First Posted : November 2, 2018
Last Update Posted : November 2, 2018
Sponsor:
Information provided by (Responsible Party):
Florida Gulf Coast University

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

Condition or disease Intervention/treatment Phase
Healthy Procedure: Dry needling Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Single group pre-test post test study design
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Optimal Time for In-situ Dry Needling to Affect the Autonomic Nervous System: A Pilot Study
Actual Study Start Date : September 1, 2018
Actual Primary Completion Date : October 15, 2018
Actual Study Completion Date : October 29, 2018

Arm Intervention/treatment
Experimental: study group
Study group receiving dry needling and pupil diameter will be studied up to 23 minutes after needle placement.
Procedure: Dry needling
Paravertebral dry needling C7-T4. Total of 8 needles.




Primary Outcome Measures :
  1. Pupil diameter [ Time Frame: 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 ]
    Change in pupil diameter measured with automated pupillometry device from Micromedical.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age between 18-65 years old
  2. No pain at all anywhere in the body at the time of testing.
  3. 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:

  1. 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.
  2. Use of blood thinners
  3. History of surgery and or injury within the past six weeks
  4. 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.
  5. Prior surgery to the neck or thoracic spine
  6. Chiropractic, Physical Therapy, Dry needling or Acupuncture treatment for their neck pain in the last 3-months
  7. Inability to follow directions and keep the eye open during the measurement phase of this study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03728751


Locations
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United States, Indiana
Integrated Therapy Practice PC
Hobart, Indiana, United States, 46342
Sponsors and Collaborators
Florida Gulf Coast University
Investigators
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Principal Investigator: Rob Sillevis, PhD Faculty

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Responsible Party: Florida Gulf Coast University
ClinicalTrials.gov Identifier: NCT03728751     History of Changes
Other Study ID Numbers: FGCU IRB 2018-51
First Posted: November 2, 2018    Key Record Dates
Last Update Posted: November 2, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Florida Gulf Coast University:
Dry needling
Autonomic nervous system
pupillometry