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

Study Overview

• Status: Completed
• Conditions: Dry Needling
• Intervention / Treatment: Other: Delphi Questionaire

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 Type: Observational
• Enrollment (Actual): 39

Contacts and Locations

• Study Contact: Name: David Griswold, PhD; Phone Number: 330-941-1898; Email: dwgriswold@ysu.edu
• Study Contact Backup: Name: Edmund C Ickert, DPT; Phone Number: 3309411326; Email: ecickert@ysu.edu

Study Locations

• United States
  • Ohio
    • Youngstown, Ohio, United States, 44555
      • Youngstown State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• 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)

Description

Inclusion Criteria:

Physical Therapists who:

Have >= 7 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)

Exclusion Criteria:

• Not a Physical Therapist
• Has less than 7 years experience in dry needling
• Does not meet the secondary criteria established in the inclusion criteria

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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: 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 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Youngstown State University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2022
• Primary Completion (Actual): July 31, 2022
• Study Completion (Actual): July 31, 2022

Study Registration Dates

• First Submitted: March 19, 2022
• First Submitted That Met QC Criteria: March 19, 2022
• First Posted (Actual): March 29, 2022

Study Record Updates

• Last Update Posted (Estimated): June 13, 2023
• Last Update Submitted That Met QC Criteria: June 10, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: informed consent; adverse event; delphi
• Other Study ID Numbers: 2022-117

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No