Chapter 5 The author would like to acknowledge the authors and reviewers for the Irish Guidelines for Safe Dry Needling Practice for Chartered Physiotherapists (McEvoy et al., 2012). Dry needling (DN) is an invasive procedure that poses certain risks, in part, not generally associated with other physical therapy or chiropractic treatments. The focal point of this chapter is on safety issues associated with DN. DN can be divided into superficial dry needling (SDN) and trigger point dry needling (TrP-DN). Ultimately, the health and welfare of the patient should be the first consideration (World Health Association, 2006), but the welfare of healthcare workers (HCWs) and third parties should not be overlooked. Guidelines and checklists have been employed to improve the quality and safety of complex systems and practices in, for example, aviation, engineering, medicine, and surgery (Gawande, 2009). A practice guideline is a formal statement about a defined task or function in clinical practice (Barlow-Pugh, 2000). DN practice guidelines have been developed in Australia (ASAP, 2007), Canada (CPTA, 2007), and Ireland (McEvoy et al., 2012), among others. The main focus of this chapter is on patient safety, but HCWs and third party risks are also recognised. DN is the use of a solid filament needle for the treatment of pain and dysfunction of various body tissues. DN is an invasive technique within the scope of practice of multiple disciplines such as physical therapy, chiropractic, medicine, dentistry, and acupuncture. There are a variety of conceptual models as outlined in other chapters of this book, including TrP-DN and SDN, which are commonly employed to treat pain and dysfunction associated with myofascial TrPs as described by Travell and Simons (Travell & Simons, 1983, 1992; Simons et al., 1999). Clinicians may employ one or a combination of conceptual models in clinical practice. TrP-DN is practiced by physical therapists in many countries, including Australia, Canada, Ireland, the Netherlands, South Africa, Spain, Switzerland, the UK, and the US (Dommerholt et al., 2006). An increasing number of states in the US, the American Physical Therapy Association, and the American Academy of Orthopaedic Manual Physical Therapists have ruled DN to be under the scope of physical therapy practice (APTA, 2012). Other disciplines also employ TrP-DN such as chiropractors in the UK and in several US states, myotherapists in Australia, and dentists in various countries, among others. With the increase in DN among clinicians internationally, it is important to focus on safety, which must be considered the number one priority. In this chapter, DN is approached from a physical therapy perspective, but the safety precautions are of course applicable to all HCWs. Acronyms used throughout this chapter are listed in Box 5.1. TrP-DN poses potential risks to patients, HCWs, and third parties. Many of these risks are not associated with traditional noninvasive physical therapy treatments and may include bruising, pneumothorax, infection, internal tissue damage, and bleeding. The term adverse event (AE) is used to describe any ill effect of a treatment, no matter how small, that is unintended and nontherapeutic (White et al., 1997). The severity of AEs can be graded as mild (minor), significant, and serious (White et al., 2001, 2008). A mild AE is considered of short duration, reversible, and does not particularly inconvenience the patient; a significant AE requires medical attention or interferes with the patient’s activities; a serious AE requires hospital admission with potential persistent or significant disability or death (White et al., 2008). Quantification and qualification grading of AEs has been proposed to objectify risk, and this is invaluable for patient education and informed consent. AEs can be categorised into very common, common, uncommon, rare, and very rare with corresponding quantification (Table 5.1) (Witt et al., 2009). This grading is helpful when reviewing AE studies. Safety of DN is of significant importance. Individual cases of significant injury have been reported, including cervical spine haematoma (Lee et al., 2011), pneumothorax (Cummings et al., 2014), hemiplegia (Ji et al., 2015), and infection (Callan et al., 2016; Steentjes et al., 2016). Despite this, significant TrP-DN AEs are rare. Nevertheless, there is a need for more high quality TrP-DN AE studies to quantify risk in different settings, among clinicians with different levels of experience, for example. A prospective TrP-DN AE study among physiotherapists was carried out in Ireland (Brady et al., 2014). The study was adapted from a previous study on AE in acupuncture by healthcare clinicians (White et al., 2001). Thirty-nine physiotherapists who had undertaken 63 hours of TrP-DN training completed the study over a 10-month period, totaling 7629 treatments. No significant AEs were reported. Common minor AEs included bruising (7.55%), bleeding (4.65%), pain during treatment (3.01%), and pain after treatment (2.19%). Uncommon minor AEs included aggravation of symptoms (0.88%), drowsiness (0.26%), headache (0.14%), and nausea (0.13%). Reported rare minor AEs were fatigue (0.04%), altered emotions (0.04%), shaking, itching, claustrophobia, and numbness, all 0.01%. Minor AEs were common (19.18%). Although no significant AEs were recorded, utilising Hanley’s rule of three (Hanley & Lippman-Hand, 1983), the upper risk rate for significant AEs was estimated at less than or equal to 0.04%. The authors concluded that the sample size may limit the results for more rare occurrences such as pneumothorax or infection. For pneumothorax and infection, larger scale acupuncture studies may assist in quantifying risk (see later in this chapter). Although TrP-DN and acupuncture differ in terms of historical, philosophical, indicative, and practical contexts, similarities do exist in terms of solid filament needle skin penetration to varying depths within the body. In this context, acupuncture AE studies assist in identifying TrP-DN risks. Notwithstanding the differences between traditional acupuncture and TrP-DN, clinicians practicing TrP-DN should familiarise themselves with acupuncture AE studies to optimise safe practice and also for patient informed consent. Acupuncture is considered one of the safer forms of medical treatment (Vincent, 2001; White et al., 2008). Despite this safety statement, AEs do occur. Peuker and Gronemeyer (2001) grouped acupuncture AEs into five categories including delayed or missed diagnosis, deterioration of disorder under treatment, autonomic reactions, infections, and trauma to tissues or organs (Table 5.2). Table 5.2 Categories adapted from: Peuker E, Gronemeyer D (2001). Rare but serious complication of acupuncture: traumatic lesions. Acupunct Med, 19, 103–108. A significant number of acupuncture safety and AE studies have been published. Three studies are of particular interest to TrP-DN as they were carried out on physiotherapists and medical doctors and may best reflect clinicians with Western medical training. A summary of the main AEs is presented in Table 5.3. Table 5.3 See these references for further information: White et al. (2001), Melchart et al. (2004), and Witt et al. (2009). White and colleagues (2001) reported AEs related to acupuncture in a prospective clinician survey of 32,000 treatments of 78 British physiotherapists and medical doctors. Common minor AEs included bleeding and needling pain; uncommon minor AEs included aggravation of symptoms, faintness, drowsiness, a stuck or bent needle, and headache. Significant AEs were rare or very rare (n = 43) and included administrative problems (forgotten needle, forgotten patient), issues at the application site (cellulitis, needle allergy, needle site pain), cardiovascular problem (fainting), gastrointestinal problem (nausea, vomiting), neurological and psychiatric problem (anxiety, panic, euphoria, hyperesthesia, headache, slurred speech), or exacerbation of symptoms (back pain, fibromyalgia, shoulder pain, vomiting, migraine). No serious AE was reported in the 32,000 treatments surveyed. It was concluded that acupuncture in skilled hands is one of the safer forms of medical intervention (White et al., 2001). Witt and associates (2009) reported AEs related to acupuncture in a prospective 229,230 patient based survey consisting of 2.2 million treatments delivered by German physician acupuncturists. AEs were reported per patient (n = 229,230) and not per treatment (n = 2.2 million); this should be taken into account when comparing with White et al. (2001), who reported AE per treatment (n = 32,000). A noteworthy 8.6% of patients reported at least one AE, in which 2.2% of patients required medical treatment (significant or serious AE). Common side effects included bleeding and haem-atoma (n = 14,083; 6.1%) and pain (n = 4681; 2%). Uncommon side effects included strong pain during needling (n = 490; 0.2%), autonomic symptoms (n = 1663; 0.7%), and nerve irritation and injury (n = 601; 0.26%). Rare and very rare side effects included local infection (n = 31; 0.014%), systemic infection (n = 5; 0.002%), and pneumothorax (n = 2; 0.001%). As this is arguably the most comprehensive AE acupuncture study, clinicians should familiarise themselves with this study and the expansive quantification of side effects. Melchart and associates (2004) reported AE after acupuncture in a prospective clinician-based survey of 97,733 patients (760,000 treatments) delivered by German physician acupuncturists. Again, similar to the results of Witt et al. (2009), the incidence of AE was reported per patient and not per treatment. Nonserious AEs were seen in 7.10% of patients and included needling pain (3.28%), haematoma (3.19%), and bleeding (1.3%). Serious AE were reported in 6 of 97,733 patients, including exacerbation of depression, acute hypertensive crisis, vasovagal reaction, asthma attack with hypertension, angina, and pneumothorax in two cases. Despite the generally good safety of acupuncture, a review of acupuncture systematic reviews from 2000 onwards identified 95 cases of severe AEs including five fatalities (Ernst et al., 2011). Peuker and Gronemeyer (2001) reported on rare but serious complications of acupuncture due to traumatic lesions in a review of the literature from 1965 onwards. According to the authors, all traumatic lesions described could be avoided if clinicians had better anatomical knowledge or applied existing knowledge. DN is an invasive procedure that poses infection risks to patients, clinicians, and third parties, which are not normally associated with manual treatments. In 2002 US healthcare-associated infections (HAI) amounted to 1.7 million recorded incidents with 98,987 deaths (Klevens et al., 2007). As many as 1 in 10 patients acquire a HAI (HSE, 2009). Infectious agents include bacteria (e.g., Staphylococcus, E. coli), viruses (e.g., hepatitis B and C, human immunodeficiency virus [HIV]), fungi (e.g., tinea pedis, Candida albicans), protozoa (e.g., toxoplasmosis), and prions (e.g., Creutzfeldt–Jakob disease). The chain of infection is a six-element way of describing infectious disease transmission (HSE, 2009) and consists of an infectious agent, a reservoir (infectious agent area), a portal of exit (from infected person), a means of transmission, a portal of entry (to target person), and a susceptible host. Standard Precautions are clinical guidelines to prevent transmission of infectious agents and are published by the United States Centers for Disease Control and Prevention (USCDC) (Siegel et al., 2007; HSE, 2009). The purpose of Standard Precautions is to break the chain of infection by focusing particularly, but not exclusively, on the mode of transmission, portal of entry, and susceptible hosts (HSE, 2009). Standard precautions require HCWs to assume that every person is potentially infected or colonised with an organism that could be transmitted in the healthcare setting and apply a set of work practices to minimise the risk of contamination (HSE, 2009). Work practices relevant to DN include attention to hand hygiene, glove usage, skin preparation, management of needles and medical waste, and needlestick injuries (NSI) (Dommerholt, 2011). Hand hygiene is considered the single most important intervention to prevent transmission of infection (SARI, 2005). Hand hygiene activity recommendations have been evidenced-categorised. For hand hygiene preparation, nails should be kept short and cut smoothly (II) with the avoidance of false nails or extenders (I) and nail polish (III). All wrist and hand jewelry except plain wedding bands should be removed (II), and sleeves should be short or turned up (III). Hand decontamination should be carried out with suitable soap and water or, if hands are visibly clean of contaminant, with appropriate alcohol-based hand rub or gel. Hand decontamination is recommended for these situations. Hand hygiene and decontamination is a learned skill and should be a quality standard in all healthcare institutions (SARI, 2005). It may appear rudimentary, but attention to hand decontamination technique is important and often practiced poorly by HCWs. Handwashing with regular soap can remove dirt but is generally ineffective in preventing antimicrobial activity, whereas alcohol-based hand rub is generally effective (Ehrenkranz & Alfonso, 1991). Antimicrobial soap is somewhat more efficient than nonantimicrobial soap and produces a statistically significant reduction in microbial activity compared with nonantimicrobial soap (Montville & Schaffner, 2011). However, the use of alcohol in either soap or gel is more effective than antimicrobial or bland soap without alcohol (Paulson et al., 1999). Multiple-use cloth towel, either roll type or hanging style are not appropriate for the healthcare setting (Boyce & Pittet, 2002). Hands can be decontaminated with suitable alcohol- based hand rub or gel once the hands are visibly clean. Alcohol-based hand rub can be inactivated by organic material and therefore if hands are visibly soiled, they should be washed per the previous recommendations. Alcohol-based hand sanitiser is usually recommended at a 70% concentration by weight of isopropanol, ethanol, or n-propanol. Higher concentrations may increase the risk of skin dryness and dermatitis. The US Centers for Disease Control and Prevention recommend handwashing with soap after every 5 to 10 applications of alcohol-based hand gel due to build-up of emollients on the hands (Boyce & Pittet, 2002). Manufacturer’s instructions of such products should be noted. As HCWs wash and decontaminate their hands up to 30 times per shift (Boyce & Pittet, 2002), there is a significant risk of skin irritation and dermatitis. Irritant dermatitis is a nonimmunological inflammatory skin response to an external agent and may leave the skin more prone to harbor microorganisms (SARI, 2005). Prevention and management of all forms of dermatitis is important for the safety of patients and HCWs. The USCDC recommends the addition of 1% to 3% glycerol to alcohol-based hand gel as this can reduce or eliminate the drying effect of the alcohol (Boyce & Pittet, 2002). Advice for the prevention of occupational dermatitis in the healthcare setting includes (SARI, 2005): Gloves are the main protective equipment employed during DN. Gloves should be worn without exception at least on the palpating hand or, if so preferred or legally required, on both hands. Guidelines vary in different countries and jurisdictions. There are potential arguments against the use of gloves that may include the effect on kinesthetic feedback, awkwardness, time consuming, or lack of evidence for reducing NSI. These objections are muted, however, by the requirements of Standard Precautions that require gloves to be worn for all activities when it can be reasonably anticipated to have hand contact with blood, bodily fluids, or other potentially infectious materials, mucous membranes, and nonintact skin (HSE, 2009). According to regulations (Standards 29 CFR) published by the United States Occupational Safety and Health Administration (OSHA, 2011): ‘Gloves shall be worn when it can be reasonably anticipated that the employee may have hand contact with blood, other potentially infectious materials, mucous membranes, and non-intact skin….’ Due to the fact that clinicians need to compress the needle site after removal of the needle and that bleeding is the most common side effect of DN, the use of gloves is consistent with OSHA regulations. Nevertheless, some physician and acupuncture organisations, including the American Academy of Medical Acupuncture, do not recommend using gloves with needling procedures. Gloves should be single use, disposable, and conform to international community standards. Latex-free gloves should be available for clinicians and used with patients with known latex allergies. Latex-free surgical gloves are being used more frequently due to latex hypersensitivity in HCWs and patients; however, some may not offer the same protection as latex gloves (Boyce & Pittet, 2002; Aldlyami et al., 2010). The Food and Drug Administration has approved several powdered and powdered-free latex gloves with reduced protein contents and synthetic gloves for latex- sensitive HCWs (Boyce & Pittet, 2002). Nitrile gloves are usually preferable, especially for individuals with latex allergy concerns. Gloves should be donned immediately before and removed immediately after the DN procedure is completed and, if contaminated with blood or body fluids, should be disposed of in appropriate healthcare waste. Wearing gloves provides an ideal environment for bacterial growth, and hands should be washed after removal of gloves. Patient skin disinfection is not usually required before DN if the skin is visibly clean, which is in line with the World Health Organization’s (WHO) best practice for intradermal, subcutaneous, and intramuscular needle injections (Hoffman, 2001; Hutin et al., 2003; Baldry, 2005; BAC, 2006; ASAP, 2007; White et al., 2008). Resident skin bacteria are unlikely to lead to infection if host immunity is not compromised (Hoffman, 2001). Many countries do not have formal regulations regarding skin disinfection for needling procedures, but it is required in some jurisdictions (Dommerholt, 2011). The National Acupuncture Foundation recommends disinfecting the skin with 70% isopropyl alcohol before needling (Given, 2009). The British Acupuncture Council Code of Safe Practice recommends using 70% isopropyl alcohol or products that contain 0.5% chlorhexidine before needling in ‘areas of the body where moisture or exudates may collect, such as the groin and genital area, ears, feet, under arms and the area below the breasts, near the mouth, nose, scalp and other hair covered areas’. In contrast, Dutch guidelines (WIP, 2008; Dommerholt, 2011) in line with WHO do not recommend disinfecting the skin, except when using semipermanent needling or performing ear acupuncture. If the skin is visibly soiled it should be washed with warm water and soap and dried accordingly before DN. Clinicians should not needle into joints or bursae. During DN the clinicians should only touch the needle at the handle and should avoid touching the needle shaft. If this occurs the needle should be removed, disposed of, and replaced with a fresh sterile needle. Multipack needles are not recommended for DN as their use increases the likelihood of touching the needle shaft. Immunocompromised patients may not be suitable for DN and special consideration is required. If DN is considered suitable, skin preparation with a sterilising solution such as 2% iodine in 70% alcohol should be used and left on the skin to dry for a minimum time of 2 minutes (ASAP, 2007). Needle and medical waste disposal should be done in accordance with local jurisdictional policies and procedures. Clinicians should be knowledgeable with local laws and regulations as standards differ internationally. In the US, regulated medical waste is material derived from animal or human sources or from biomedical research as described by UN-3291 (USDA, 2009). All sharps and blood or bodily fluid soiled waste from DN needs to be disposed of in suitable waste disposal per local jurisdictional policies. Used needles are disposed of in a regulated ‘sharps container’ meeting regulatory standards such as UN-3291. Medical waste such as soiled gloves or blood swabs (but no sharps objects) is placed in a suitable clinical waste bag. Both sharps containers and clinical waste bags should be disposed in accordance with local laws and procedures, which may entail the use of a licensed medical waste company. Workstations should be designed to ensure sharps containers and medical waste bags are within easy reach. Follow the instructions in relation to sharps containers and do not fill above the permitted ‘fill line’ as this may pose a risk of NSI. Ensure such items are kept out of reach of children. NSI is a common occupational injury among HCWs. In the UK 37% of nurses reported a prevalence of NSI (Yang & Mullan, 2011). In Ireland medical interns reported a 26% incidence of NSI in the first 8 months of work with only 26% commonly using gloves in phlebotomy-like tasks (O’Sullivan et al., 2011). Medical students based in the US reported a 59% NSI rate during their training (Sharma et al., 2009). It has been estimated that over 20 bloodborne pathogens can be transmitted from contaminated needles, including hepatitis B (HBV), hepatitis C (HCV), and human immunodeficiency virus (HIV) (Yang & Mullan, 2011), and therefore NSI creates a serious risk for HCWs. Surprisingly, NSIs commonly go unreported. In one study, only 17.5% of incidences were reported (Hettiaratchy et al., 1998). The associated risk of infection transmission of HIV after a hollow needle NSI is about 0.3%, compared with 3% for HCV and 30% for HBV (Parsons, 2000). Exposure risk increases with a larger quantity of blood, for example, when the needle is visibly contaminated with the patient’s blood (Rodts & Benson, 1992). Furthermore, hepatitis B virus can survive for 1 week in dried blood, which underpins the importance of good hygiene techniques and needle and waste disposal (Bond et al., 1981). Other factors that increase NSI infection transmission include piercing deeply or directly into an artery or vein with the contaminated needle (CDC, 1995). The risk of NSI infection with a solid filament needle would be expected to be less than a hollow needle; however, NSI risk should be taken seriously. If a NSI occurs, the USCDC recommends immediately washing the punctured area with soap and water, reporting the incident to the appropriate line manager, and seeking medical assessment as soon as possible (CDC, 2011). HCWs should have hepatitis A and B vaccinations as required. To prevent NSI related to DN practice, clinicians should account for all needles and ensure adequate disposal into the sharps container. Keep the sharps container within easy reach of the treatment area and do not overfill the box. Avoid rushing and interruptions, and do not needle when tired. Gloves should be worn—although they may not fully protect against an NSI, they may offer some level of protection, especially from contact with blood and bodily fluids. The risk of NSI may extend to patients, patient family members, visitors, and other staff from a lost or forgotten needle. Clinicians should ensure that all needles are accounted for and safely discarded and that workstation design and access minimises risk to third parties. It is important to recognise contraindications, relative contraindications, and special precautions for safe DN practice (WHO, 1999; Batavia, 2006; ASAP, 2007; White et al., 2008). Patients should be routinely screened for current or historical presence of contraindications or precautions. Special attention should be paid to medical diagnoses and comorbidities (e.g., a patient with low immune function and history of diabetes). Further, when a contraindication is present, it is important that the clinician is not persuaded to needle by an enthusiastic patient (White et al., 2008). DN therapy is contraindicated and should be avoided in patients under these circumstances (ASAP, 2007; White et al., 2008). When absolute contraindications have been ruled out, clinicians should consider the relative contraindications and precautions for patient selection. This should be done in relation to the patient’s characteristics and medical history, clinical reasoning, likely benefits of treatment, and whether the goals can be met with noninvasive treatments. It is the clinician’s responsibility to discuss the relative risks and benefits of DN therapy with patients (White et al., 2008). Bleeding and bruising are among the most common side effects of needling therapies. Therefore caution should be noted with patients with thrombocytopenia for any reason (e.g., haemophilia, blood thinning medication, chemotherapy, etc.). These patients may not be suitable for DN other than by experienced clinicians, or light needling technique may be advisable initially as a trial. As mentioned previously, severe thrombocytopenia is an absolute contraindication. It is essential to apply pressure hemostasis after needling. Patients with a compromised immune system for any reason may be more susceptible to infection and therefore be at a greater risk of local or systemic infection from DN (ASAP, 2007; White et al., 2008). Patients who may be vulnerable to infection include: Patients with vascular disease may be more susceptible to haematoma, bleeding, tissue trauma, infection, among other conditions. Patients with diabetes may have compromised tissue healing capabilities, sensory deficits, and poor peripheral circulation. Patients with diabetes may be more susceptible to cellulitis (Goodman et al., 2003). The presence of diabetes may influence the decision to needle or which needling techniques to use (e.g., SDN versus TrP-DN) and may determine the intensity of the treatment. The use of DN therapy during pregnancy needs to be discussed thoroughly with the patient and should be used with caution especially in the first trimester (ASAP, 2007). Clinicians should be aware that 20% to 25% of pregnancies may naturally terminate in the first trimester (ASAP, 2007) and therefore erroneous connections between such occurrences and DN are possible. There is conflicting opinion of the ability of acupuncture to induce labour or spontaneous abortion (WHO, 1999; ASAP, 2007; White et al., 2008). In a controlled trial of women with pregnancy-related nausea (n = 593), acupuncture in early pregnancy did not alter the pregnancy outcomes or health of the child (Smith et al., 2002). Carr provided an excellent summary of 15 clinical studies and concluded that there is a well-supported lack of evidence of harm (Carr, 2015). The rates of miscarriage, preterm birth and labour, and other possible complications of pregnancy were comparable with untreated controls or consistent with their anticipated incidence (Carr, 2015). The European Guidelines for the Diagnosis and Treatment of Pelvic Girdle Pain consider the use of acupuncture for low back and pelvic pain during pregnancy (Vleeming et al., 2008). In addition to gaining informed consent from persons under 18 years old, parental or guardian consent must be sought when treating children under the age of 18. Follow local laws in regard to consent issues. Ensure that younger patients do not have a needle phobia and are cooperative to the procedure. It would be judicious to avoid deep DN with children under the age of 13 to 15, dependent on the maturity of the child, due to the ability to understand and follow the procedure. Infirm or frail patients may not tolerate DN therapy well. This includes anorexic and bulimic patients (Steinberg, 2014). In patients with epilepsy, caution should be taken due to tolerance of strong sensory stimulation. Patients with epilepsy should not be left unattended when needles are in situ. Some patients with psychological disorders or distress may not be optimal candidates for DN. Anxiety and emotional distress may affect the ability to safely apply DN and for patients to rationally understand, tolerate treatment, or follow treatment instructions. High stress may reduce the likelihood of response to treatment (Huang et al., 2011) and may increase risk of adverse psychological or physical response to DN. Patients allergic to metals may react to metals used in monofilament needles, particularly to nickel and chromium (Romaguera & Grimalt, 1979; Fisher, 1986; Castelain et al., 1987). A typical monofilament needle contains approximately 8% to 10% nickel and 11% chromium. Relevant risks should be discussed with the patient before treatment. Allergic reactions to needles are very rare. DN treatments can still be administered by using silver- or gold-plated needles. DN should be discontinued if allergic reactions still occur. Allergies to latex, as found in latex gloves, are possible, and alternative gloves should be used for these patients. Latex allergies can be severe. Nitrile gloves are generally better tolerated, but some patients and HCWs may still have allergic reactions. Clinicians should be aware of a patient’s medical and medication history. Medications may alert the clinician to relative contraindications and may include immune suppressive drugs, psychotropic or mood altering medication, and blood thinning agents, among others. The clinician is privy to the overall patient characteristics and should identify other potential contraindications or safety precautions that may affect the suitability of DN. Patient characteristics may change and clinicians need to remain cognisant of this. If there is a specific reason to suggest a patient is unsuitable for DN therapy, then DN should be avoided and reconsidered as appropriate. Dry needling poses potential risks to anatomical structures including organs, such as the lungs, nerves, and blood vessels. Clinicians require excellent academic and practical knowledge of anatomy. All serious needling related traumatic complications, described by Peuker and Gronemeyer (2001), could have been avoided if clinicians had better anatomical knowledge or had applied existing anatomical knowledge better. It is imperative that practical anatomy skills are applied as part of routine DN practice. Clinicians should ensure they limit DN to anatomical regions they are familiar with and have been trained in. Furthermore, it may be wise to limit treatment to one side of the thorax only to prevent the unlikely but serious effect of bilateral pneumothorax. Anatomical considerations include: Pneumothorax is a rare but serious complication of DN and has been reported in the acupuncture literature (Peuker & Gronemeyer, 2001; Melchart et al., 2004; Peuker, 2004; Witt et al., 2009) and DN (Cummings et al., 2014). The risk of pneumothorax is very small if proper consideration of practical anatomy and application of needling techniques are employed. Consideration of pleural and lung anatomy is essential and clinicians should remain aware of anatomical landmarks (Standring & Gray, 2008). DN should be performed in such a manner to avoid needling towards the lung or intercostal space. When able, a pincher grip should be used such as with needling TrPs in the upper and lower trapezius, pectoral muscles, levator scapulae, and latissimus dorsi muscles. A second consideration is to needle towards bone such as the rib or scapula to avoid needling into the pleural space. With this technique it is vitally important to ensure the hand placement over the bone to avoid inadvertently entering the pleura. Clinicians should remain aware of anatomical anomalies. When a pincher grip and needling over bony structures is not feasible, a third option is to block the intercostal space with the fingers of the palpating hand, for example, when needling TrPs in the serratus anterior or rhomboid muscles. The risk of pneumothorax is very rare when needling is practiced by well-trained clinicians skillfully applying practical anatomy. Anatomical knowledge of the vascular system is important as there is a potential to puncture blood vessels during needling. Application of practical anatomical knowledge is important. Clinicians should inspect for location of superficial veins and avoid needling these. Palpating for a pulse, where accessible, may be helpful to locate an artery. Haemostasis is important after withdrawing the needle. Special attention and caution should be paid to those with thrombocytopenia (see previous section). Anatomical knowledge of the nervous system is important as there is a potential for injury to nerves. Needling should be performed slowly and carefully and, when not sure, should be avoided in the vicinity of nerves. If a sharp electrical-type pain is felt distally from the needling site, the needle may have encountered a nerve. Special attention needs to be given in relation to the spinal cord (Yazawa et al., 1998; Lee et al., 2011) and the posterior suboccipital area due to potential brainstem access through the foramen magnum (Nelson & Hoffman, 1998). Several case studies described acute cervical and thoracic epidural haematomae as a complication of DN (Chen et al., 2006; Lee et al., 2011). Anatomical knowledge of internal organs is important. There is potential for internal organ penetration such as the kidney with needling of TrPs in the psoas major and quadratus lumborum muscles or organs within the peritoneal cavity with needling of TrPs in the abdominal muscles or pelvic floor muscles such as the coccygeus and iliococcygeus muscles. Anatomical knowledge of joint anatomy, including capsule and bursa, is important to avoid needling into joints through the joint capsule or bursae. Although needling the capsule or bursae would not necessarily be problematic, it is not the objective of dry needling. Some physicians feel that needling should be avoided into or close to joint or limb prosthetics, including internal and external fixation devices to avoid any kind of infection (Steentjes, 2016; Callan et al., 2016); however, there is no evidence that needling would increase the risk of infection. As a side note, both case reports by Steentjes (2015) and Callan and associates (2016) erroneously blamed a physical therapist for causing a postsurgical infection, even though the infection was with a high degree of medical probability a delayed surgical site complication (Lewkonia et al., 2016). By definition, surgical site infections are infections occurring within 30 days of surgery or 90 days if a prosthesis is involved (Mockford & O’Grady, 2017); delayed infections are a rare, but very serious complication (Lewkonia et al., 2016). Clinicians should avoid needling in the vicinity of implanted devices, including catheters, drug delivery systems, cosmetic breast, buttocks, calves, and other implants, electrical devices and wires associated with such devices as spinal cord stimulators, pacemakers, and defibrillators. Clinicians should avoid needling into pathological sites such as areas with acute inflammation or infected sites, varicose veins, cysts, tumours, and skin lesions, among others. As DN is an invasive procedure, it raises the potential for procedural adverse events. Recognising the potential for these adverse events is important. Patient education and communication are central to good needling practice. Patient education is carried out before, during, and after DN. Although obvious, it is worth stressing that patients should not carry out DN on themselves. Postneedling soreness (PNS) from DN is common for 1 to 2 days after treatment. On occasion this may prolong to 3 to 4 days. This is common with TrPDN and unlikely with SDN. PNS is usually felt in the vicinity of the needled site and may at times be felt in the referral zone of the muscle. It may feel similar to delayed onset of muscle soreness after exercise. Patients should be educated on PNS and be prepared to avoid unnecessary distress and worry. DN should be carried out to the patient’s tolerance and ability by monitoring the response by verbal and nonverbal communication. Do not encourage patients to tolerate pain during DN. Also, consider limiting the number of muscles treated initially to test the patient’s response. Timing of treatment should suit patient’s lifestyle, work, and social commitments. As an example, consider the issues surrounding the application of DN to a ‘needle-naïve’ athlete before a sporting event or a musician before a recital. On the initial insertion of the needle under the skin, if the patient experiences sharp continuing pain the needle should be withdrawn and inserted again slightly away from the original site. It is likely that the needle is in close vicinity of a free nerve ending and provides an Aδ sensory nerve stimulus. If the patient feels a sharp, burning electrical or lancing pain, penetration of a nerve or blood vessel may have occurred. The needle should be withdrawn immediately and haemostasis by manual pressure should be applied for at least 10 seconds. This may attenuate muscle bleeding and therefore PNS. Consider the use of thermal modalities, active pain free range of motion, stretching, muscle reeducation, and posture training after treatment as DN is usually part of a multimodal plan of care. Bruising is a common side effect of DN, which patients should be made aware of. Care should be taken to avoid penetrating blood vessels. Haemostasis by manual pressure is important after DN, and this may assist in reducing bruising and PNS. If bleeding occurs on the skin site, pressure with a cotton swab until stopped and discard the swab in medical waste disposal as appropriate. An ice application can be used over the site. Fainting during or after DN treatment is possible and may occur for a variety of reasons such as pain, psychological stress, needle averse or phobic patients, or autonomic lability. Therefore it is important to treat the patient in a recumbent position. In patients with needle aversion, DN is contraindicated, unless the patient can be educated and coached into tolerating needling. If DN is experienced as a threatening stimulus, it is no longer therapeutic. SDN may be the initial choice of treatment. Avoid aggressive DN technique and maintain verbal and nonverbal communication with the patient to assess response. Watch for autonomic signs including clamminess, sweating, dizziness, increased tension, and light-headedness, among others. If these symptoms occur or the patient faints, remove the needle(s) and consider raising the patient’s legs. Offer reassurance. Symptoms should abate after resting. If symptoms were to persist or if there is any concern about the patient, driving a car should be delayed, and the patient may require medical assessment. Such responses will influence the decision to carry out DN in the future. Needles should be of good quality and used before the printed expiration date. Needles may bend, break, or be forgotten about. These adverse procedural issues can easily be avoided. Needles should be of suitable thickness and length to suit the patient and area being treated. Bending of the needle may occur from contacting harder tissue such as bone, fascia, or a stiffened TrP zone or from a nonoptimal needling technique by curving the needle. Patients should be needled in a relaxed and optimal position. Avoid curving the needle during dynamic DN techniques. If a needle bends, it should be removed, discarded, and replaced with a new needle. Needle breakage is rare, but may occur with poor quality needles or from repeated bending due to poor needling technique. In the past, when needles were sterilised repeatedly with autoclaving, needle breakage may have been more common due to metal fatigue. Therefore DN should be performed only with good quality single use sterile needles. It is recommended to avoid inserting the needle to the handle so that in the event of a breakage at the hub, the needle can be removed by tweezers. In the unlikely event of needle breakage, inform the patient to stay still and remove the needle with fingers or tweezers if accessible. If not visible, press the surrounding tissues gently to see if the needle exposes through the tissue, and if so, then remove with tweezers. If not, mark around the site of insertion with a marker or pen to locate the needle site and seek medical attention as the needle may require surgical removal. Clinicians should account for all needles used. A forgotten needle could cause tissue damage, such as a pneumothorax. This is more likely with static needling techniques and especially if treating several body areas simultaneously. It is advisable not to rush to avoid time pressure mistakes. Consider using a ‘count them in, count them out’ policy aloud, which is useful to the clinician and reassuring to the patient. Tally needle packets with needles withdrawn. There is differing opinion on whether a needle may be used more than once on the same patient in a treatment session (Dommerholt, 2011). The US National Acupuncture Foundation recommends never reusing a needle on the same patient in the same treatment session to avoid autogenous infection (Given, 2009). In contrast, the British Acupuncture Council Code of Safe Practice advises to ‘use a fresh needle for every point needled during a treatment, or if reusing the same needle, only do so where all of the sites to be needled have been swabbed before needling and where the needle (and guide tube, if used) is not placed on any other surface in between separate insertions’ (BAC, 2006). In this regard, clinicians should be guided by local jurisdictional rules and regulations. If using a static needling technique and leaving the patient alone in a treatment room or cubicle, it is important not to forget the patient. Patients with needles in situ are unable to move and therefore are vulnerable. Be sure that the patient has the ability to alert the clinician verbally or with the use of a call bell. Clinicians should delineate procedures to avoid this stressful and embarrassing situation. DN involves a marginal risk of infection. There are no valid studies or case reports of infections as a result of DN. Every time a needle is entered through the skin, the body will respond with an inflammatory reaction; however, in patients with a functional immune response, this should not lead to any noticeable signs of inflammation. Nevertheless, clinicians should follow hygiene guidelines as outlined previously and appropriately select the patient. Before DN, the area and skin should be inspected for any signs of infection before initial and follow-up treatments. Infection signs may include pain, swelling, redness, heat, and tenderness and may be associated with fever and malaise. DN should be avoided with any suggestion of local or systemic infection and medical assessment sought immediately. When needling in the vicinity of the thorax and lung fields, it is important to be aware of the rare but potential risk of pneumothorax. This has been discussed in the previous section under anatomical considerations. The symptoms of a pneumothorax may include shortness of breath, chest pain, coughing, and decreased breath sounds on auscultation or percussion. Pneumothorax symptoms may not occur for several hours after treatment. Should a pneumothorax be suspected, the patient should urgently be sent to the nearest emergency department. A small percentage of patients may report feeling tired, fatigued, or sleepy after DN. Should this occur the patient should be advised not to drive or operate machinery until this feeling has subsided. In individual patients, if there is a history of DN-related drowsiness or fatigue, it may be best to avoid DN or, when appropriate, to time treatment around the patient’s lifestyle. It would be important for the patient to be driven home. This section presents general guidelines for principles of practice. There are many factors relating to safe needling practice. Individual jurisdictional rules and regulations may have specific requirements and these should be taken into account when drafting local DN guidelines. The following guidelines are therefore offered as a general outline. Ultimately the responsibility of patient care solely rests with the individual clinician. These general recommendations are advised (McEvoy et al., 2012). Choosing the correct patient for TrP-DN is a skill based upon balancing the benefits of treatment with the patient’s characteristics and presentation. The selection criteria may vary from patient to patient and in various situations and contexts. One of the fundamental safety principles is the understanding of the patient’s contraindications and precautions to particular treatments and understanding the potential risks (Batavia, 2006). Healthcare clinicians such as physical therapists routinely use patient selection and clinical reasoning skills in practice to enhance safe practice. As an example, consider the selection criteria for the use of neck traction, manipulation, and use of electrophysical agents such as ultrasound, among others. Many of these skills are developed throughout the physical therapist’s training program and further enhanced from experience in clinical practice. Patient selection criteria for TrP-DN have been recommended by the College of Physical Therapists of Alberta (CPTA), Canada (CPTA, 2007). Appropriate patient selection should involve consideration of the following. Furthermore the CPTA recommends consideration of patient characteristics, including the patient’s cultural background, functional and physical abilities, language and communication skills, psychological profile (e.g., fear of needles, stress response), and age (CPTA, 2007). As an example of the importance of patients’ disease characteristics and demographic profile, a study for TrP-DN for myofascial pain syndrome, demonstrated that negative prognostic predictors included long duration of pain, high intensity of pain, poor quality of sleep, and repetitive stress (Huang et al., 2011). DN is a learned skill and standards and safety are promoted by routine approach to practice. This section outlines principles to promote a rational and uniform approach to practice. These principles can be modified to develop guidelines, policies, and procedures. It is assumed that the clinician has selected the patient appropriately and determined that DN is appropriate. The principles of DN application include patient education and consent, procedural education, and practical application such as positioning, palpation, technique, and aftercare (McEvoy et al., 2012). Before the application of DN, it is important to educate the patient on the rationale for the procedure and what to expect. The clinician should ascertain whether the patient has undergone DN therapy in the past, and if so, what was their personal experience. Informed consent should be sought from each patient. This is an excellent time for the clinician to make the patient feel at ease by demonstrating knowledge and confidence. Clinician confidence is important to reduce patient anxiety. The clinician can also gauge the patient’s comfort level and answer patient’s questions. Appropriate education should include elements of the following. DN requires an optimum interaction between the patient and clinician and communication should be encouraged during the procedure. Before any DN application these steps are recommended. Skilled palpation is the key element for identifying TrPs and for the application of safe DN. Clinicians should have excellent knowledge of practical anatomy including: muscle attachments, bony landmarks, muscle fibre directions, muscles layers, neurovascular structures, organs (e.g., pleura and lungs), joints and capsules, among others. There are various DN conceptual models and techniques and clinicians may use a combination of techniques during clinical practice. Equipment required includes needles, gloves, hand sanitiser, alcohol wipes (as required), needle disposal box, cotton swabs for bleeds, and a waste disposal bag or can. General guidelines for technique are as follows. The following are recommended for DN aftercare. Electrotherapy, such as transcutaneous electrical nerve stimulation (TENS), percutaneous electrical nerve stimulation (PENS), and neuromuscular electrical stimulation (NMES) can be delivered via solid filament needles for the treatment of pain, abnormal muscle tone or strengthening. Techniques have been described by Gunn (1997), Baldry (2005), Dommerholt and associates (2006), and White and colleagues (2008). In acupuncture, delivery of electrical currents through needles is termed electro-acupuncture (ASAP, 2007). Extra care should be noted with patients who have bleeding disorders as DN TENS or NMES related muscle contraction may lead to a greater susceptibility to bleeding. The following considerations should be taken into account (ASAP, 2007; White et al., 2008). Contraindications and relative contraindications to electrical stimulation via DN include: TrP-DN is an evolving and expanding treatment (Fig. 5.1). Safety must be considered the number one priority. Clinicians should familiarise themselves with important aspects of DN safety including hygiene, contraindications, precautions, anatomical considerations, and procedural safety issues. Guidelines have been proposed to improve safe DN treatment. Patient selection and practical DN skills are required to ensure safe standardise treatment. Clinicians should encourage local jurisdictional guidelines to improve safety and standards.
Trigger Point Dry Needling: Safety Guidelines
Acknowledgement
Safety considerations
Introduction
Trigger point dry needling: safety
Adverse Event Category
Example
Delayed or missed diagnosis
Cancer
Deterioration of disorder under treatment
Increased pain
Vegetative reactions
Autonomic type reaction, nausea etc.
Bacterial and viral infections
Hepatitis B
Trauma of tissue and organs
Pneumothorax, nerve lesion
Very Common
Common
Uncommon
Rare
Very Rare
≥ 10%
≥ 1–10%
≥ 0.1%–1%
≥ 0.01%–0.1%
< 0.01%
> 1–10
1–10/100
1–10/1000
1–10/10 000
< 1/10 000
Bleeding
Hematoma
Needling site pain
Inflammation
Swelling
Strong pain during treatment
Nerve irritation
Nerve injury
Headache
Fatigue
Vertigo
Nausea
Local infection
Redness
Itching
Sweating
Blood pressure changes
Unconsciousness
Tachycardia
Breathing difficulties
Vomiting
Pneumothorax
Broken needle
Forgotten needle
Systemic infection
Affected speech
Disorientation
Hygiene
Hand Hygiene
Handwashing with soap
Hand decontamination with alcohol-based hand rub
Gloves
Patient Skin Preparation
Needle and Medical Waste Disposal
Needlestick Injury
Contraindications and precautions
Absolute Contraindications
Relative Contraindications
Abnormal bleeding tendency
Compromised immune system
Vascular disease
Diabetes
Pregnancy
Children
Frail patients
Patients with epilepsy
Psychological status
Patient allergies
Patient medication
Unsuitable patient for any reason
Anatomical considerations
Pleura and lung
Blood vessels
Nerves
Organs
Joints
Prosthetic implants
Implanted devices
Other
Procedural safety issues
Painful treatment
Bruising and bleeding
Fainting and autonomic responses
Needle issues
Forgotten patient
Infection
Pneumothorax
Drowsiness and fatigue
General guidelines for principles of practice
Patient selection
Principles of dry needling application
Patient Education and Consent
Procedural Education
Practical Application
Positioning
Palpation
Technique
Aftercare
Electrical stimulation via dry needles
Summary