Dry NeedlingNCT05300815
Identifying Which Adverse Events Associated With Dry Needling Should be Included For Informed Consent: A Modified e-Delphi Study
An observational study of Dry Needling, run by Youngstown State University at 1 site in United States.
Trial summary
Dry Needling is an intervention that continues to gain widespread interest as a treatment adjunct for various pathological conditions. With the increased use of dry needling in the clinic, there comes a need for additional research to investigate the adverse events associated with the use of dry needling. 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?
- Delphi Questionaire
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Mar 2022to 31 Jul 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: Physical Therapists who have >= 7 years of experience 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)
Who may be able to join
- Physical Therapists who:
- Have >= 7 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)
Who cannot join
- Not a Physical Therapist
- Has less than 7 years experience in dry needling
- Does not meet the secondary criteria established in the inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Dry Needling is an intervention that continues to gain widespread interest as a treatment adjunct for various pathological conditions. With the increased use of dry needling in the clinic, there comes a need for additional research to investigate the adverse events associated with the use of dry needling. Informed Consent is a process that is legally required in many states prior to the performance of a treatment intervention like dry needling. It is important therefore to identify which of these adverse events should be included in an informed consent process.
Read the detailed description
Over the past 10 years, there have been a great deal of studies that examined the application of DN to varying pathological conditions. Some of the more recent studies involving the application of DN for various conditions include: temporomandibular joint dysfunction (TMD), post-stroke, plantar heel pain or plantar fasciitis, osteoarthritis, headache, fibromyalgia, neck and shoulder pain, lateral epicondylagia, back pain, and hallux valgus. In addition to studies that applied DN to specific pathological conditions, the effects of DN have also been studied. DN has been shown to: improve spasticity and range of motion (ROM), improve flexibility of muscles, myofascial trigger point pain, scar tissue, and neuromuscular control.
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 whether DN is an appropriate choice for the patient. Informed Consent (IC) is a means of respecting the autonomous preferences of persons seeking health care or participation in research. One of the important elements of IC is the need to be explicit and descriptive about the risks of treatment which include: the nature of the risk, the probability the risk will occur, the severity of the risk, and the proximity of the risk. These are important elements that would allow the patient to be able to consider the risks to benefit ratio of a given intervention and will lead to making a better informed decision regarding their own care. Without the risks being properly identified for the intervention, the IC process could not be adhered to and the patient would not be able to make a well-informed decision regarding their own care.
There have been no studies that have described how the risks associated with DN should be incorporated during the IC process to drive patient-centered care and autonomy in decision making. The purpose of this study will be to utilize a Modified Delphi framework to identify expert consensus on which risks should be included in the IC process.
- Conditions
- Dry Needling
- Being tested
- Delphi Questionaire
- Keywords
- informed consent, adverse event, delphi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delphi QuestionaireOther
This study involves the use of questionnaires across 3 rounds as follows:
The objectives of round 1 are to collect participant demographic information and generate a list of adverse events. Round 1 will be open for 3 weeks with email reminders being provided at weeks 1 and 2.
The objectives of round 2 will be to share a list of adverse events generated from round 1 (with the addition of adverse events identified in literature if not generated in round 1) and allow participants to rate from 1-4 how important each item is for inclusion on informed consent. As per round 1, the round 2 questionnaire will remain active for 3 weeks with email reminders sent at weeks 1 and 2.
The objective of round 3 is to further gain consensus on adverse events from the results of round 2 where agreement was not reached. Round 3 remains active for 3 weeks with email reminders sent at weeks 1 and 2.
| Study group | Role | What they receive |
|---|---|---|
| Dry Needling Experts | Experts will be defined as adult individuals with a high level of knowledge within the area of patient safety and adverse events related to dry needling which will be confirmed using the following eligibility criteria:
(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
Eligible participants will be identified through existing professional networks and social media/internet-based searching. They will be recruited worldwide and be aged 18 or above, able to read and write in English, and willing to provide signed informed consent. Receives: Other: Delphi Questionaire |
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: Baseline
Round 1 Questionnaire
Participants list known adverse events associated with dry needling
Measured: Baseline to 3 weeks
Round 2 Questionnaire
Participants identify which adverse events they agree should be included during informed consent.
Measured: 3 weeks to 6 weeks
Round 3 Questionnaire
Participants will see the results from round 2 and further identify which adverse events should be included for informed consent.
Measured: 6 weeks to 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start2 Mar 2022
- Primary completion31 Jul 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Youngstown State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edmund Ickert, Youngstown State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05300815
- Sponsor's protocol ID
- 2022-117
- Status last verified
- Jun 2023
- First submitted
- 19 Mar 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
Funabashi M, Pohlman KA, Gorrell LM, Salsbury SA, Bergna A, Heneghan NR. Expert consensus on a standardised definition and severity classification for adverse events associated with spinal and peripheral joint manipulation and mobilisation: protocol for an international e-Delphi study. BMJ Open. 2021 Nov 11;11(11):e050219. doi: 10.1136/bmjopen-2021-050219.
PubMed 34764170
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
- Identifying Which Adverse Events Associated With Dry Needling Should be Included For Informed Consent: A Modified e-Delphi Study
- ClinicalTrials.gov ID
- NCT05300815
- Acronym / sponsor ID
- 2022-117
- Conditions
- Dry Needling
- Keywords
- informed consent, adverse event, delphi
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Youngstown State UniversityUniversity, hospital or other
- Study start
- 2 Mar 2022 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 29 Mar 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.
Dry Needling is an intervention that continues to gain widespread interest as a treatment adjunct for various pathological conditions. With the increased use of dry needling in the clinic, there comes a need for additional research to investigate the adverse events associated with the use of dry needling. Informed Consent is a process that is legally required in many states prior to the performance of a treatment intervention like dry needling. It is important therefore to identify which of these adverse events should be included in an informed consent process.
Detailed description
Over the past 10 years, there have been a great deal of studies that examined the application of DN to varying pathological conditions. Some of the more recent studies involving the application of DN for various conditions include: temporomandibular joint dysfunction (TMD), post-stroke, plantar heel pain or plantar fasciitis, osteoarthritis, headache, fibromyalgia, neck and shoulder pain, lateral epicondylagia, back pain, and hallux valgus. In addition to studies that applied DN to specific pathological conditions, the effects of DN have also been studied. DN has been shown to: improve spasticity and range of motion (ROM), improve flexibility of muscles, myofascial trigger point pain, scar tissue, and neuromuscular control.
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 whether DN is an appropriate choice for the patient. Informed Consent (IC) is a means of respecting the autonomous preferences of persons seeking health care or participation in research. One of the important elements of IC is the need to be explicit and descriptive about the risks of treatment which include: the nature of the risk, the probability the risk will occur, the severity of the risk, and the proximity of the risk. These are important elements that would allow the patient to be able to consider the risks to benefit ratio of a given intervention and will lead to making a better informed decision regarding their own care. Without the risks being properly identified for the intervention, the IC process could not be adhered to and the patient would not be able to make a well-informed decision regarding their own care.
There have been no studies that have described how the risks associated with DN should be incorporated during the IC process to drive patient-centered care and autonomy in decision making. The purpose of this study will be to utilize a Modified Delphi framework to identify expert consensus on which risks should be included in the IC process.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dry Needling Experts | – | Other: Delphi QuestionaireExperts will be defined as adult individuals with a high level of knowledge within the area of patient safety and adverse events related to dry needling which will be confirmed using the following eligibility criteria: (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 Eligible participants will be identified through existing professional networks and social media/internet-based searching. They will be recruited worldwide and be aged 18 or above, able to read and write in English, and willing to provide signed informed consent. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Physical Therapists who have >= 7 years of experience 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)
Key inclusion criteria (5 listed)
- Have >= 7 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)
Key exclusion criteria (3 listed)
- Not a Physical Therapist
- Has less than 7 years experience in dry needling
- Does not meet the secondary criteria established in the inclusion criteria
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 |
|---|---|---|
| Delphi QuestionaireThis study involves the use of questionnaires across 3 rounds as follows: The objectives of round 1 are to collect participant demographic information and generate a list of adverse events. Round 1 will be open for 3 weeks with email reminders being provided at weeks 1 and 2. The objectives of round 2 will be to share a list of adverse events generated from round 1 (with the addition of adverse events identified in literature if not generated in round 1) and allow participants to rate from 1-4 how important each item is for inclusion on informed consent. As per round 1, the round 2 questionnaire will remain active for 3 weeks with email reminders sent at weeks 1 and 2. The objective of round 3 is to further gain consensus on adverse events from the results of round 2 where agreement was not reached. Round 3 remains active for 3 weeks with email reminders sent at weeks 1 and 2. | Other | Dry Needling Experts |
Primary outcome
Demographic Information Form
Time frame: Baseline
Contains questions about the characteristics of the participants
Round 1 Questionnaire
Time frame: Baseline to 3 weeks
Participants list known adverse events associated with dry needling
Round 2 Questionnaire
Time frame: 3 weeks to 6 weeks
Participants identify which adverse events they agree should be included during informed consent.
Round 3 Questionnaire
Time frame: 6 weeks to 9 weeks
Participants will see the results from round 2 and further identify which adverse events should be included for informed consent.
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 34764170Funabashi M, Pohlman KA, Gorrell LM, Salsbury SA, Bergna A, Heneghan NR. Expert consensus on a standardised definition and severity classification for adverse events associated with spinal and peripheral joint manipulation and mobilisation: protocol for an international e-Delphi study. BMJ Open. 2021 Nov 11;11(11):e050219. doi: 10.1136/bmjopen-2021-050219.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 5 inclusion and 3 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: Baseline). The study lists 4 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 NCT05300815, which also lists 1 linked publication.
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.