HealthyNCT03728751
Optimal Time for In-situ Dry Needling to Affect the Autonomic Nervous System
A study testing Dry needling in people with Healthy, run by Florida Gulf Coast University at 1 site in United States.
Trial summary
Assessing for optimal time dry needles need to remain inside the body to have positive effect on the nervous system Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Healthy
- What is being tested?
- Dry needling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2018to 29 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Integrated Therapy Practice PC
Hobart, Indiana, 46342
About this study
Official title: 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
Read the 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
- Conditions
- Healthy
- Being tested
- Dry needling
- Keywords
- Dry needling, Autonomic nervous system, pupillometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry needlingProcedure or surgery
Paravertebral dry needling C7-T4. Total of 8 needles.
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | Study group receiving dry needling and pupil diameter will be studied up to 23 minutes after needle placement. Receives: Procedure: Dry needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pupil diameter
Change in pupil diameter measured with automated pupillometry device from Micromedical.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2018
- Study start1 Sep 2018
- Primary completion15 Oct 2018
- Study completion29 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group pre-test post test study design
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida Gulf Coast University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rob Sillevis, PhD, Principal investigator, Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03728751
- Sponsor's protocol ID
- FGCU IRB 2018-51
- Status last verified
- Oct 2018
- First submitted
- 29 Oct 2018
- Last updated
- 2 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Time for In-situ Dry Needling to Affect the Autonomic Nervous System: A Pilot Study
- ClinicalTrials.gov ID
- NCT03728751
- Acronym / sponsor ID
- FGCU IRB 2018-51
- Conditions
- Healthy
- Keywords
- Dry needling, Autonomic nervous system, pupillometry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Florida Gulf Coast UniversityUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 15 Oct 2018 (actual)
- Study completion
- 29 Oct 2018 (actual)
- First posted
- 2 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group pre-test post test study design
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Procedure: Dry needlingStudy group receiving dry needling and pupil diameter will be studied up to 23 minutes after needle placement. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dry needlingParavertebral dry needling C7-T4. Total of 8 needles. | Procedure or surgery | study group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rob Sillevis, PhD principal investigator
Faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dry needling in people with Healthy, run by Florida Gulf Coast University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2018.