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

NCT03728751 | Completed

• 1 other identifier: FGCU IRB 2018-51
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

Dry needling; Autonomic nervous system; pupillometry

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Dry needling PROCEDURE

Paravertebral dry needling C7-T4. Total of 8 needles.

study group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Florida Gulf Coast University: lead

Study Sites (1)

Integrated Therapy Practice PC

Hobart, Indiana, 46342, United States

Location

MeSH Terms

Interventions

Dry Needling

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities

Study Officials

• Rob Sillevis, PhD

  Faculty

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single group pre-test post test study design

Study Record Dates

• First Submitted: October 29, 2018
• First Posted: November 2, 2018
• Study Start: September 1, 2018
• Primary Completion: October 15, 2018
• Study Completion: October 29, 2018
• Last Updated: November 2, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)