Identifying Which Adverse Events Associated With Dry Needling Should be Included For Informed Consent: A Modified e-Delphi Study

NCT05300815 | Completed

• 1 other identifier: 2022-117
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Dry Needling

Keywords

informed consent; adverse event; delphi

Outcome Measures

Primary Outcomes (4)

• Demographic Information Form

  Contains questions about the characteristics of the participants

  Baseline

• Round 1 Questionnaire

  Participants list known adverse events associated with dry needling

  Baseline to 3 weeks

• Round 2 Questionnaire

  Participants identify which adverse events they agree should be included during informed consent.

  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.

  6 weeks to 9 weeks

Study Arms (1)

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.

Other: Delphi Questionaire

Interventions

Delphi Questionaire OTHER

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.

Dry Needling Experts

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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)

You may qualify if:

• 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)

You may not qualify if:

• Not a Physical Therapist
• Has less than 7 years experience in dry needling

Sponsors & Collaborators

• Youngstown State University: lead

Study Sites (1)

Youngstown State University

Youngstown, Ohio, 44555, United States

Location

Related Publications (1)

• 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.

  PMID: 34764170 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: March 19, 2022
• First Posted: March 29, 2022
• Study Start: March 2, 2022
• Primary Completion: July 31, 2022
• Study Completion: July 31, 2022
• Last Updated: June 13, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)