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

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.
    

Intervention name(s): Delphi Questionaire
Intervention type(s): Other
Intervention description(s): 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.
Observational model: Cohort
Time perspective: Prospective
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)
      
Keywords: informed consent; adverse event; delphi