Clinical trial NCT05300815: Identifying Which Adverse Events Associated With Dry Needling Should be Included For Informed Consent: A Modified e-Delphi Study
Official title: Identifying Which Adverse Events Associated With Dry Needling Should be Included For Informed Consent: A Modified e-Delphi Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dry Needling
Keywords: informed consent
adverse event
delphi
Lead sponsor: Youngstown State University
Sponsor class: OTHER
First posted: 2022-03-29
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
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)

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.

Eligibility criteria: 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

Primary outcomes:
measure: Demographic Information Form
timeFrame: Baseline
measure: Round 1 Questionnaire
timeFrame: Baseline to 3 weeks
measure: Round 2 Questionnaire
timeFrame: 3 weeks to 6 weeks
measure: Round 3 Questionnaire
timeFrame: 6 weeks to 9 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Youngstown
country: United States
facility: Youngstown State University
state: Ohio
Study officials:
References:
citation: 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.