Dry NeedlingDNICNGTNCT05560100
Development of an Informed Consent Statement Which Communicates the Risk of Adverse Events Associated With Dry Needling
An observational study of Dry Needling, run by Youngstown State University at 1 site in United States.
Trial summary
As Dry Needling (DN) continues to see increased use in the clinic, there is a need to establish adverse events that could occur as a result of DN intervention. The adverse events are important to consider when an individual needs to make an informed decision regarding their care. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Needling
- What is being tested?
- Nominal Group Technique - 2 to 3 hour virtual meeting
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Sep 2022to 31 Oct 2022
- Phase
- Observational
- 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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Dry Needling Experts, Legal Experts, Policy Experts, and Patients (Defined with inclusion criteria above).
Who may be able to join
- Participants must be 18 years old or above and be able to read/write in English Participants must provide informed consent Participants must meet the criteria of one of the previously defined cohort groups used in the study
- Dry Needling Experts
- Must have >= 5 years of clinical practice performing dry needling and at least ONE of the following secondary criteria:
- Certification in Dry Needling
- Completion of a manual therapy fellowship that included dry needling training
- >= 1 total scholarly product (poster presentation, author of a peer-reviewed publication) involving the use of dry needling
Show all 19Show fewer
- Legal Expert
- An individual who is an attorney and who has had training in health law as evidenced by at least ONE of the following criteria:
- Training in health law as evidenced by ONE of the following:
- Concentration/Certification in Health Law
- L.L.M in health or medical law
- SJD in health law
- Experience in litigating medical malpractice cases involving failure to obtain informed consent
- Published scholarship on informed consent in an academic journal (>= 1) Policy Expert
- An individual who has a degree in bioethics with at least ONE of the following criteria:
- >= 5 years of experience in obtaining informed consent or an advanced graduate degree in bioethics
- Has served on ethics related committee in a healthcare institution or healthcare society/professional association
- Is or has been a member of a state licensing board
- Patient Must have participated in >= 1 session of dry needling treatment and not be a healthcare provider
Who cannot join
- Participants who did not provide informed consent Participants who did not meet the inclusion criteria of one of the four cohort groups defined in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of an Informed Consent Statement Which Communicates the Risk of Adverse Events Associated With Dry Needling Using an Online Nominal Group
As Dry Needling (DN) continues to see increased use in the clinic, there is a need to establish adverse events that could occur as a result of DN intervention. The adverse events are important to consider when an individual needs to make an informed decision regarding their care. It is important to consider how such information should be presented during the informed consent process to improve an individual's ability to make a sound decision regarding their own personal care.
Read the detailed description
Dry Needling (DN) has been defined by a Task Force organized by the Federation of State Boards of Physical Therapy (FSBPT) as "a skilled intervention performed by a physical therapist using filiform needles to penetrate the skin and/or underlying tissues to affect change in body structures and functions for the evaluation and management of neuromusculoskeletal conditions, pain, movement impairments, and disability". As DN interest continues to expand and studies continue to show the feasibility of applying DN to a wider range of pathological conditions, there is a need to understand the risks related to the use of DN. Understanding the risks associated with DN will allow for improvements in clinical decision making regarding it's application in the clinic.
Enhancing patient choice is a central theme of medical ethics and law. Informed consent (IC) is the legal process used to promote patient autonomy while concepts of shared decision making (SDM) is a widely promoted ethical approach. IC is a means of respecting the autonomous preferences of persons seeking health care or participation in research. Empowerment of the patient is important in healthcare and can lead to improvements in overall quality of patient care and outcomes.
To date, there has been little research conducted that explored the topic of how risks should be presented during the IC process. The purpose of this study will be to utilize expert consensus to establish a risk statement for adverse events associated with DN that an be used during IC.
- Conditions
- Dry Needling
- Being tested
- Nominal Group Technique - 2 to 3 hour virtual meeting
- Keywords
- informed consent, adverse event, nominal group technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nominal Group Technique - 2 to 3 hour virtual meetingOther
Participants will be invited to a 2-3 online virtual online meeting with the goal of constructing and defining elements for producing a risk statement for dry needling that can be used for informed consent.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Must have participated in >= 1 session of dry needling treatment and not be a healthcare provider. Receives: Other: Nominal Group Technique - 2 to 3 hour virtual meeting | |
| Dry Needling Experts | (1) Must have >= 5 years of clinical practice performing dry needling and at least ONE of the following secondary criteria:
1. Certification in Dry Needling
2. Completion of a manual therapy fellowship that included dry needling training
3. >= 1 total scholarly product (poster presentation, author of a peer-reviewed publication) involving the use of dry needling Receives: Other: Nominal Group Technique - 2 to 3 hour virtual meeting | |
| Policy Experts | An individual who has a degree in bioethics with at least ONE of the following criteria:
1. >= 5 years of experience in obtaining informed consent or an advanced graduate degree in bioethics
2. Has served on ethics related committee in a healthcare institution or healthcare society/professional association
3. Is or has been a member of a state licensing board Receives: Other: Nominal Group Technique - 2 to 3 hour virtual meeting | |
| Legal Experts | An individual who is an attorney and who has had training in health law as evidenced by at least ONE of the following criteria:
1. Evidence of training based on ONE of the follow:
1. Concentration/Certification in Health Law
2. L.L.M in health or medical law
3. SJD in health law
2. Experience in litigating medical malpractice cases involving failure to obtain informed consent
3. Published scholarship on informed consent in an academic journal (>= 1) Receives: Other: Nominal Group Technique - 2 to 3 hour virtual meeting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographic Information Form
Contains questions about the characteristics of the participants
Measured: Up to 2 hours
Ranking of Statements
Participants will rank statements generated during the meeting to determine which statement best meets consensus within the group
Measured: A 2 hour virtual meeting for participants to rank statements
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2022
- Study start19 Sep 2022
- Primary completion31 Oct 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dry NeedlingStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Youngstown State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edmund C Ickert, PhD, Principal investigator, Youngstown State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05560100
- Sponsor's protocol ID
- 2022-173
- Acronym
- DNICNGT
- Status last verified
- Jun 2023
- First submitted
- 21 Sep 2022
- Last updated
- 13 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Whitney SN, McGuire AL, McCullough LB. A typology of shared decision making, informed consent, and simple consent. Ann Intern Med. 2004 Jan 6;140(1):54-9. doi: 10.7326/0003-4819-140-1-200401060-00012.
PubMed 14706973Ickert EC, Griswold D, Learman K, Cook C. Creation of a risk of harms informed consent form for dry needling: A nominal group technique. Musculoskelet Sci Pract. 2023 Aug;66:102778. doi: 10.1016/j.msksp.2023.102778. Epub 2023 May 24.
PubMed 37290346
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an Informed Consent Statement Which Communicates the Risk of Adverse Events Associated With Dry Needling Using an Online Nominal Group
- ClinicalTrials.gov ID
- NCT05560100
- Acronym / sponsor ID
- DNICNGT / 2022-173
- Conditions
- Dry Needling
- Keywords
- informed consent, adverse event, nominal group technique
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Youngstown State UniversityUniversity, hospital or other
- Study start
- 19 Sep 2022 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 29 Sep 2022 (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.
As Dry Needling (DN) continues to see increased use in the clinic, there is a need to establish adverse events that could occur as a result of DN intervention. The adverse events are important to consider when an individual needs to make an informed decision regarding their care. It is important to consider how such information should be presented during the informed consent process to improve an individual's ability to make a sound decision regarding their own personal care.
Detailed description
Dry Needling (DN) has been defined by a Task Force organized by the Federation of State Boards of Physical Therapy (FSBPT) as "a skilled intervention performed by a physical therapist using filiform needles to penetrate the skin and/or underlying tissues to affect change in body structures and functions for the evaluation and management of neuromusculoskeletal conditions, pain, movement impairments, and disability". As DN interest continues to expand and studies continue to show the feasibility of applying DN to a wider range of pathological conditions, there is a need to understand the risks related to the use of DN. Understanding the risks associated with DN will allow for improvements in clinical decision making regarding it's application in the clinic.
Enhancing patient choice is a central theme of medical ethics and law. Informed consent (IC) is the legal process used to promote patient autonomy while concepts of shared decision making (SDM) is a widely promoted ethical approach. IC is a means of respecting the autonomous preferences of persons seeking health care or participation in research. Empowerment of the patient is important in healthcare and can lead to improvements in overall quality of patient care and outcomes.
To date, there has been little research conducted that explored the topic of how risks should be presented during the IC process. The purpose of this study will be to utilize expert consensus to establish a risk statement for adverse events associated with DN that an be used during IC.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: Nominal Group Technique - 2 to 3 hour virtual meetingMust have participated in >= 1 session of dry needling treatment and not be a healthcare provider. |
| Dry Needling Experts | – | Other: Nominal Group Technique - 2 to 3 hour virtual meeting(1) Must have >= 5 years of clinical practice performing dry needling and at least ONE of the following secondary criteria: 1. Certification in Dry Needling 2. Completion of a manual therapy fellowship that included dry needling training 3. >= 1 total scholarly product (poster presentation, author of a peer-reviewed publication) involving the use of dry needling |
| Policy Experts | – | Other: Nominal Group Technique - 2 to 3 hour virtual meetingAn individual who has a degree in bioethics with at least ONE of the following criteria: 1. >= 5 years of experience in obtaining informed consent or an advanced graduate degree in bioethics 2. Has served on ethics related committee in a healthcare institution or healthcare society/professional association 3. Is or has been a member of a state licensing board |
| Legal Experts | – | Other: Nominal Group Technique - 2 to 3 hour virtual meetingAn individual who is an attorney and who has had training in health law as evidenced by at least ONE of the following criteria: 1. Evidence of training based on ONE of the follow: 1. Concentration/Certification in Health Law 2. L.L.M in health or medical law 3. SJD in health law 2. Experience in litigating medical malpractice cases involving failure to obtain informed consent 3. Published scholarship on informed consent in an academic journal (>= 1) |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Dry Needling Experts, Legal Experts, Policy Experts, and Patients (Defined with inclusion criteria above).
Key inclusion criteria (19 listed)
- Participants must be 18 years old or above and be able to read/write in English Participants must provide informed consent Participants must meet the criteria of one of the previously defined cohort groups used in the study
- Dry Needling Experts
- Must have >= 5 years of clinical practice performing dry needling and at least ONE of the following secondary criteria:
- Certification in Dry Needling
- Completion of a manual therapy fellowship that included dry needling training
Key exclusion criteria (1 listed)
- Participants who did not provide informed consent Participants who did not meet the inclusion criteria of one of the four cohort groups defined in the study.
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 |
|---|---|---|
| Nominal Group Technique - 2 to 3 hour virtual meetingParticipants will be invited to a 2-3 online virtual online meeting with the goal of constructing and defining elements for producing a risk statement for dry needling that can be used for informed consent. | Other | Dry Needling Experts, Legal Experts, Patients, Policy Experts |
Primary outcome
Demographic Information Form
Time frame: Up to 2 hours
Contains questions about the characteristics of the participants
Ranking of Statements
Time frame: A 2 hour virtual meeting for participants to rank statements
Participants will rank statements generated during the meeting to determine which statement best meets consensus within the group
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 13 Jun 2023.
- Background: PubMed 14706973Whitney SN, McGuire AL, McCullough LB. A typology of shared decision making, informed consent, and simple consent. Ann Intern Med. 2004 Jan 6;140(1):54-9. doi: 10.7326/0003-4819-140-1-200401060-00012.
- Derived from this study: PubMed 37290346Ickert EC, Griswold D, Learman K, Cook C. Creation of a risk of harms informed consent form for dry needling: A nominal group technique. Musculoskelet Sci Pract. 2023 Aug;66:102778. doi: 10.1016/j.msksp.2023.102778. Epub 2023 May 24.
- 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.
Edmund C Ickert, PhD principal investigator
Youngstown State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dry Needling, run by Youngstown State 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 19 inclusion and 1 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 13 Jun 2023. 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?
Demographic Information Form (time frame: Up to 2 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05560100, which also lists 2 linked publications.
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 13 Jun 2023.