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

Completed

• Conditions: Dry Needling

• Registration Number: NCT05300815
• Lead Sponsor: Youngstown State University

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.

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 Timeline

• Study Start: 2022-03-02
• Study First Submitted: 2022-03-19
• Study First Submitted QC: 2022-03-19
• Study First Posted: 2022-03-29
• Primary Completion: 2022-07-31
• Study Completion: 2022-07-31
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-10
• Last Update Posted: 2023-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Demographic Information Form	Baseline	Contains questions about the characteristics of the participants
Round 2 Questionnaire	3 weeks to 6 weeks	Participants identify which adverse events they agree should be included during informed consent.
Round 1 Questionnaire	Baseline to 3 weeks	Participants list known adverse events associated with dry needling
Round 3 Questionnaire	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.

Trial Locations

Locations (1)

Youngstown State University; 🇺🇸 Youngstown, Ohio, United States