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

Optimal Time for In-situ Dry Needling to Affect the Autonomic Nervous System: A Pilot Study

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Procedure: Dry needling

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

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Hobart, Indiana, United States, 46342
      • Integrated therapy Practice PC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Florida Gulf Coast University
• Investigators: Principal Investigator: Rob Sillevis, PhD, Faculty

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Actual): October 15, 2018
• Study Completion (Actual): October 29, 2018

Study Registration Dates

• First Submitted: October 29, 2018
• First Submitted That Met QC Criteria: November 1, 2018
• First Posted (Actual): November 2, 2018

Study Record Updates

• Last Update Posted (Actual): November 2, 2018
• Last Update Submitted That Met QC Criteria: November 1, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Autonomic nervous system; Dry needling; pupillometry
• Other Study ID Numbers: FGCU IRB 2018-51

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