Identifying Which Adverse Events Associated With Dry Needling Should be Included For Informed Consent: A Modified e-Delphi Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Demographic Information Form
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •Not a Physical Therapist
- •Has less than 7 years experience in dry needling
- •Does not meet the secondary criteria established in the inclusion criteria
结局指标
主要结局
Demographic Information Form
时间窗: Baseline
Contains questions about the characteristics of the participants
Round 2 Questionnaire
时间窗: 3 weeks to 6 weeks
Participants identify which adverse events they agree should be included during informed consent.
Round 1 Questionnaire
时间窗: Baseline to 3 weeks
Participants list known adverse events associated with dry needling
Round 3 Questionnaire
时间窗: 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.
次要结局
未报告次要终点
研究者
Edmund Ickert
Primary Investigator
Youngstown State University