Needling Therapies in the Outpatient Care: Adverse Effects

The invasive techniques have been used for many years. There is a lot of literature on the advances that have been made, as well as the adverse effects or possible complications that have occurred during the performance of these treatments. Acupuncture and injections (saline, anesthetics, corticosteroids or botulinum toxin) have reported several cases of complications. Dry needling is also beginning to have several publications of this type. The objective of this chapter is to summarize the articles published in relation to adverse effects of needling therapies to promote a good practice and knowledge. Original articles in form of randomized controlled trials, case reports and reviews relating adverse effects and possible complications due to invasive/needling techniques: acupuncture, injections and dry needling have been included. 102 articles met the inclusion criteria between January 2000 and January 2020. The first limitation found in the literature was the huge variety of cases, therapists and incidents to generalize. As a conclusion we can stated the importance of a good knowledge of the anatomy and its variants, the correct application of these techniques and a continuous training of these therapists must be essential.


Introduction
Muscular pain is a very common pathology in the physiotherapy treatment of outpatient care. The invasive techniques for treating these patients have aroused great interest, there are many reviews made in recent years about its effectiveness but none with conclusive results [1][2][3][4][5][6]. Articles about post-needling pain [7,8] and adverse side effects that may occur due to dry needling are being published until this day.
Dry needling is a minimally invasive technique into the most hypersensitive area/point of a tense band in a skeletal muscle (called myofascial trigger point), without the addition of any drug (Figure 1). It can be classified as deep or superficial [9]. There is not much evidence about which of the two options is better, it seems that deep dry needling has shown greater effectiveness due to penetrating the myofascial trigger point while the superficial dry needling penetrates the skin and the subcutaneous cellular tissue [10,11]. In the same way, the appearance of local twitch response would guarantee its effectiveness [12,13].
These myofascial trigger points present a high equivalence with the ashi points of acupuncture, corresponding to approximately 71% as Melzack introduced [14]. Acupuncture is based on a traditional and invasive Chinese technique of thousand years of age based on metaphysical concepts of "Ch'i" (Qi), the body energy flows through channels called "meridians" that has hypersensitive areas called ashi points  Needling Therapies in the Outpatient Care: Adverse Effects DOI: http://dx.doi.org/10.5772/intechopen.94774 (Figure 2). Its treatment also consists in the insertion of a needle in these points without any type of drugs [15].
On the other hand, injections have also been the subject of many reviews, [16,17] they have combined the effects of needling with the effect of local anesthetics. However, in 1943 Lewit [18] demonstrated that the true effectiveness of the infiltrations was due to the mechanical effect generated by the insertion of the needle itself and not the anesthetic.
The objective of this study is to summarize the articles published in relation to adverse effects of needling therapies to promote a good practice and knowledge.

Data sources and searches
A review of the literature was carried out in Pubmed, Web of Science, Medline and PEDro databases. The search was limited to studies on adverse effects and possible complications due to invasive/needling techniques: acupuncture, injections and dry needling in English and Spanish.
The search fields were title/abstract of the keywords of the studies publishes by the journals indexed in Pubmed during the period between 2000 (January) AND 2020 (January). In Web of Science the search fields were TS (theme)/TI (title). In Medline search field was TI (title) and in PEDro a simple search was done. The manuscripts selected for this systematic review met the following inclusion criteria: (i) articles that report the adverse effects and/or complications of invasive/needling techniques; (ii) reviews of such complications; (iii) articles in English and Spanish and (iv) articles with protocols or recommendations on the safe practice of these techniques. We excluded theoretical articles on the application of these techniques and articles that were not published in English or Spanish.

Study selection and data extraction
Type of articles: randomized clinical trials, case reports and reviews were included in this review. Letters to editor, commentaries to other articles and practical application of these techniques were excluded.
Type of participants: participants of all ages/nationalities/sex/gender/education level/socioeconomic status which has been treated with needling therapies.
Type of interventions and outcomes: articles which have reported adverse effects (mild-severe) due to acupuncture, dry needling and injection were selected.
Type of publications: full text articles published in English or Spanish. Once the articles were found, randomized clinical trials, case reports and reviews were selected. Once duplicates were removed, 2 reviewers analyzed the abstracts in a first screening and then carried out an exhaustive reading of the preselected ones until obtaining the final sample of articles reviewed and included in this study. If there was disagreement among the independent reviewers, a third reviewer decided. The data were extracted independently by the reviewers.
Outpatient Care 4 Data extraction: tables summarize the different adverse effects in chronological order classified in relation of the type of intervention.
Quality assessment: both authors selected, reviewed and assessed the quality of studies included in this review. Discrepancies were resolved by consensus.

Data synthesis and analysis
A summary of the findings of the included studies was performed, structured in the incidence/frequency of adverse effects, most prevalent adverse effects, type of intervention, type of population and other associated diseases which could influence the results (Tables 1-3). Each article was named by the author and date; they have a brief description of the intervention, the type of the adverse effect and the conclusion/resolution of the inconvenience.

Selection of the studies
The initial search provided 4.034 potential reports, after applying the inclusion and exclusion criteria, the sample consisted of 2.169 articles from Pubmed, 814 articles from Web of Science, 781 articles from Medline, 270 from PEDro and 9  found manually through preselected references from the Google Scholar database (Figure 3). After duplicated were excluded, 1.881 articles were selected. Both reviewers screened abstracts in a first time. In a second time, articles selected had a more detailed evaluation and 46 articles were excluded by the language, being letters to the editor or comments on other articles. Finally, 102 articles considered valid (93 from the initial search and 9 found manually). Detailed characteristics of the included studies are described in Tables 1-3 in relation to acupuncture, injection or dry needling respectively.

Author/year Description
Tandon, S. (1998) [19] 48-year-old male suffering from bronchial asthma. Pneumothorax following acupuncture with electrical stimulation in the third and fourth intercostal spaces.
Peuker, ET. (1999) [20] To review the traumatic injuries after acupuncture and discuss how to avoid these adverse effects.

Characteristics of the reviewed articles
102 articles met the inclusion criteria of the research in the period between 2000 (January) and 2020 (January) in form of original articles, case reports and reviews.
From these 102 articles selected, 23 refer to pneumothorax including more than 120 cases (19 of acupuncture, 3 of injection and 2 of dry needling); 4 articles refer to cardiac tamponade with more than 25 cases (both of acupuncture), 21 in relation to infections, abscesses or hemorrhages (14 of acupuncture, 6 of injection and 1 of dry needling) and other 7 articles refer to adverse effects such as syncope and cardiogenic shock (acupuncture), 3 pneumoperitoneo (acupuncture), 9 hematoma (6 of acupuncture, 1 of injection, 2 of dry needling), hemiplegia (acupuncture), cardiac perforation (acupuncture), hypokalemic paralysis (injection), 6 neuropathies (injection), 1 neuroapraxia (dry needling) and 12 cutaneous lesions/Nicolau syndrome/necrosis (3 of acupuncture, 9 of injection). In 11 articles there already was an existing disease, in other 4 the needle was broken and unfortunately in 4 articles the consequences were fatal. It has also collected 21 review articles of these needling therapies (more than 21.000 adverse effects described). Finally, 6 articles have synthetized information about benefits, risks, perception of security and even modifications of the application of these techniques (Figure 4)

Discussion
Considering the outpatient care treatment, adverse effects are possible complications that can occur during or even after the application of these techniques. In more cases there has little importance such as pain, a slight bleeding or a small bruise that disappears quickly. However, other adverse effects without a clear cause can suppose a serious risk for the patient.
These risks have always been present, but in recent years publications have increased considerably. There is no consensus about the classification of these adverse effects. Some authors [111] categorized them into four groups: delayed or missed diagnosis, adverse effects during treatment, bacterial or viral infections, or tissue or organ trauma.

Incidence/frequency of adverse effects
The incidence/frequency of these adverse effects is not clear. Acupuncture seems to have an incidence of 2/125.000 cases [30]; White et al. [58] estimated the risk of a serious adverse event with acupuncture at 0.05 per 10.000 treatments, and 0.55 per 10.000 individual patients, Lin et al. [70] reported a pneumothorax incidence of 0.87 per 1.000.000 acupuncture treatments and 1.75 per 1.000.000 in anatomical risk areas; these authors also showed a cellulitis incidence [72] about 64.4 per 100.000 treatments.
In relation to injections, Anderson et al. [97] explained an incidence of 5.8% of adverse effects. Kim et al. [93] introduced the incidence separately in relation with the case: 0.84% and 1.63% in relation to the patient; on the other hand, the procedure had an incidence of 0.07% and the administrated drug 0.15%. Finally, the unknown etiology had a 0.63% for this author [93] and for other authors it is unknown [121].
Data about incidence of dry needling procedures has not been found. The most reviewed articles refer isolated cases and not a periodicity, but other authors have published several reviews that try to synthesize this information. Considering these 3 needling techniques, acupuncture leaves a clear superiority in relation to the number of publications with adverse effects.
Peuker et al. [20] investigated the traumatic wounds caused by acupuncture and discuss how these complications could be avoided. Lao et al. [22] reviewed 98 publications (1965-1999) and they found 202 complications (infections, tissue/ organ damage and nerve injury). Cutaneous disorders, hypotension, fainting and vomiting were some adverse effects described. Chauffe et al. [29] found 9 cases of pneumothorax since 1985. Witt et al. [36] reviewed acupuncture studies in chronic osteoarthritis pain of the knee or hip, lumbar, cervical, head, allergic rhinitis, dysmenorrhea and asthma. Out of 229.230, 19.726 reported at least 1 adverse effect (bleeding, pain, vegetative symptoms). The longest duration of these adverse effects was 180 days (nerve injury). Ernst et al. [39] conducted a review of cardiac tamponade after acupuncture: 26 cases were found and 14 with fatal complications. He et al. [43] reviewed 167 articles with 1.038 cases (35 deaths) from Chinese literature. 468 cases were syncope, 307 pneumothorax, and 64 subarachnoid hemorrhage. Xu et al. [44] checked the frequency and severity of these effects (2000)(2001)(2002)(2003)(2004)(2005)(2006)(2007)(2008)(2009)(2010)(2011): 117 articles with 308 adverse effects in 25 countries (294 for acupuncture, 4 moxibustion and 10 cupping). Peuker et al. [52] reviewed the traumatic lesions after acupuncture. Wu et al. [53] performed a review in China (1980-2013), finding 182 incidents in 133 papers (internal organ, tissue and nerve injury are the major complications). The adverse effects included were syncope, infection, hemorrhage, allergy, burn, aphonia, hysteria, cough, thirst, fever, somnolence and broken needles. White et al. [58] found 715 incidents in their review: 90 reports of trauma and 12 reports of death. In Taiwan, Lin et al. [70,72] published 2 reviews (1997-2012) about pneumothorax and cellulitis incidence respectively. They evaluated 411.734 patients with 5.407.378 treatments of acupuncture [70] and 407.802 patients with 6.207.378 acupuncture treatments [72]. In both articles the authors emphasized the importance of the previous medical history. Ullah (1955)(1956)(1957)(1958)(1959), finding 71 cases of pneumothorax and Cheng et al. [81] performed a review  explaining the complications of this technique: "infections, spinal cord injury and peripheral nerve injuries, pneumothorax, air embolism, pain or swelling at the site of injection, chemical meningism, granulomatous inflammation of the synovium, aseptic acute arthritis, embolia cutis medicamentosa, skeletal muscle toxicity, and tendon and fascial ruptures". De la Torre et al. [87] introduced a review about the adverse effects caused by botulinum toxin A in masticatory muscles. They used 436 citations and concluded with 16:7 were myofascial pain and 9 were trigeminal neuralgia. The most frequent adverse effects were "temporary regional weakness, tenderness over the injection sites and minor discomfort during chewing". Most of them had a spontaneous resolution. Marcus et al. [91] found a very rare complication due to injections (diclofenac, dexamethasone and benzathine penicilin): Nicolau Syndrome. They found 4 cases (2016-2018). Park et al. [93] investigates an association between steroid injection and calcification in lateral epicondylitis. They evaluated 110 patients (February 2016-October 2018) and concluded that the injections history and the number of them has a significative association with soft tissue calcifications. A review (January 2000-April 2016) about adverse events due to intra-articular corticosteroid injections was made by Anderson et al. [97] 1.708 patients from 3 regional hospital participated: 99 patients had 104 adverse effects within 90 days post-injection. The most prevalent symptom was flare (78 patients) and 10 patients had skin reactions. There were no infections. Years before, Kim et al. [98] had reviewed 11.980 injections in 6.066 patients (January 2007-December 2017). There were 101 facet-joint injections and 99 patients developed adverse effects. 7 patients had an infectious spondylitis, 1 patient died of an uncontrolled infection and 2 patients had partial recovery of their neurological condition. Finally, Desai et al. [107] published a review of 17 years where reflected the iatrogenic peripheral nerve injuries due to injections. They included "intramuscular injections, brachial nerves procedures, subclavian and jugular venous cannulation and routine intravenous injections". The most frequents symptoms were pain, paresthesia and sensory-motor deficits. 190 patients needed surgical intervention, 164 had any sequel or no recovery and 9 had neurological deterioration with weakness.
There is not standard data on the incidence of these events. Unfortunately, the huge diversity of pathologies, interventions, therapists… makes difficult a generalization.

Most prevalent adverse effects
There is no consensus about the most frequent adverse effect in the literature. Some of them are pneumothorax, cardiac tamponade, air embolism, spinal epidural haematoma/abscess, abdominal visceral injury, median and fibular nerve injury and infection [20,36,75,77,81,87,111].
Some authors reflected that pneumothorax is the most cited adverse effect, [50,63] while for others is infection [44]. White et al. [58] agree with both theories being the most common complication pneumothorax and injury to the central nervous system and infection will be in second place. Ullah et al. [77] concluded that cardiac tamponade is the most frequent complication.

Special considerations
There are several aspects must be considered when carrying out these techniques in the treatment of muscular pain in outpatients. These incidents, even taking caution may occur; therefore, it is important to obtain a complete clinical history highlighting possible underlying pathologies [70][71][72]. Several articles have found patients with asthma [19], diabetes [25,85], anemia [42], herpes zoster [47], cancer [51], miastenia gravis [55] and scoliosis [57] and sclerosis [89]. These pathologies could influence the appearance or greater probability of developing a complication.

Type of population
The age of the patients is other aspect to discuss. A review performed in children (acupuncture to prevent postoperative nausea) has been published without conclusion about its effectiveness [34]. Quincer et al. [96] showed the case of a 5-year-old boy who developed a Nicolau Syndrome after an intramuscular injection in deltoid. Besides, cases of elderly people who have suffered syncope's due to acupuncture have also been described [28]. These patients (the most prevalent population in the outpatient) may be more debilitated and suffer more adverse effects even taking precautions.
There are some types of population could be considered "at risk" when using these needling techniques, like pregnant women. We have found an article that exposes a retrosternal abscess due to sternoclavicular joint injection with resolution [82]. McDowell et al. have developed a review on the safety of acupuncture and dry needling in pregnant women in New Zealand. They conclude that of 124 responses obtained, only 60 therapists needle pregnant women and only 66% of them express safety. More training is needed in this field, particularly on dry needling [120].
In relation to sex, only one article showed major incidence in men than in woman [70].

Other applications of needling therapies
It seems that the most frequent application of these techniques is analgesia, including analgesic blocks [40], but there are other applications such hyaluronic acid in eyebrow [102], botulinum toxin A for axilar hiperhidrosis [105] and aesthetics for rejuvenation have also presented adverse effects [122,123].

Reviews about safety
Among all reviews a meta-analysis of 33 randomized controlled trials was found. The authors conclude that acupuncture and dry needling are effective techniques, but more research on the safety of them is needed [65]. McCutcheon et al. [112] also reviewed the safety of acupuncture and dry needling, suggesting modifications of these techniques to avoid pleura and the lung. However, there are no conclusive results.
Considering the severity of these techniques, Brady et al. [113] conducted a study to check the adverse effects of dry needling. They filled in 2 questionnaires for 10 months to 39 physiotherapists and regrouped 1.463 adverse effects (common/less common/rare). They showed that it was a safe technique. Similarly, Halle et al. have published 2 articles [114,115]. They assessed the risk/benefit of these techniques to minimize them, proposed an adequate education, knowledge of anatomy, training and to inform the patient via informed consent.
Guided techniques should be an interesting option to reduce these complications, but several articles do not support this affirmation [92,110]. More investigation in this line is needed. On the other side, if dry needling seems to be safe, maybe it would be chosen instead injections to avoid the possible events effects derivate to the administered drugs like Kim et al. [93] exposed.

Limitations
Language was the first limitation, several articles have been found in France [124,125], Portugal [126], Russia [127], Germany [128], Italy [129], Denmark [130], and Iceland [131] that have not been included in the revision due to its original language. 3 reviews in Chinese [132], German [128] and Danish [133] respectively were excluded for the same reason. The first two expose a synthesis or classification of adverse effects and the third, is a review on acupuncture in children in Denmark. Letters and comments were also excluded; however, we highlight the case of acupuncture in the disease of behgets [134]; a letter to editor where they expose a case of pneumothorax during a demonstration of dry needling in the thoracic iliocostal [135] and a needle broken as a complication of acupuncture [136]. Neither has been taken into account articles on practical applications, effectiveness of such techniques or superiority of some over others.

Future investigations
Acupuncture seems to have the most adverse effects reported throughout the literature, while injections and dry needling are increasing their publications, probably due to the increase in popularity especially of the second [114,115]. Nowadays adverse effects seem to be common, but complications are rare. All authors of these articles agree in some tips to take in consideration: • The anatomy of the area to treat should be familiar to the healthcare professionals before undertaking the procedure.
• Communication with the patient via informed consent is needed.
• Aseptic conditions during the procedure are necessary.
• The appropriate time to apply the treatments correctly becomes essential for a good practice and an adequate achievement of the results.
• A correct training and continuous formation of healthcare practitioners are necessary.

Conclusion
This is a brief summary of the adverse effects found in the literature. There is no clear consensus about incidence, the most prevalent adverse effect, the intervention protocols, or experience of the therapist… As a conclusion, needling therapies are usual techniques in the outpatient care and complications are possible even considering all the precautions. Therapists have to know how to react, recognize the adverse effects and correct them as far as possible or refer the patient to the corresponding service, being always updated to new advances and familiar to the normal and variants of anatomy of the patients to avoid complications as much as possible. Caring the aseptic conditions and the communication with the patient to inform them about all the parts of the treatment with needling therapies are essential.

Conflict of interest
None declared. © 2020 The Author(s). Licensee IntechOpen. This chapter is distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/ by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.