This is a randomized controlled trial that studied the effectiveness of acupuncture in reducing pain and bothersomeness in patients with chronic low back pain (CLBP) compared to placebo treatment. Bothersomeness and pain were measured using visual analogue scales (VAS). Disability, health status, and depression were other outcomes measured using various instruments. The study used a sample of 130 adults with CLBP for three months before the trial and recruited from three medical hospitals in Korea. They were randomly allocated to two groups – real acupuncture group and sham acupuncture group. Treatment was given twice a week for six weeks by physicians specializing in rehabilitation medicine which included expertise in acupuncture. Baseline and post-intervention measures were taken. Follow-ups were at three and six months following the last treatment.
Results showed that there were statistically significant between-group differences in VAS bothersomeness and pain intensity scores favoring the real acupuncture group. In addition, the scores on these two measures continuously improved up to three months. There were no significant differences with respect to the other secondary measures. Sixteen participants experienced mild to moderate side-effects through to be arising from the treatments. Thus, the researchers concluded that real acupuncture treatment is effective in reducing pain intensity and bothersomeness among patients with CLBP.
Strengths and Weaknesses
The study’s main strength lies in its attempts to reduce bias. The placebo effect is a known source of bias in pain studies. The use of sham acupuncture as control treatment was meant to counter the placebo effect and therefore lend credibility to study findings. Stringent eligibility criteria were used in recruiting patients to ensure that acupuncture was investigated in cases of uncomplicated CLPB only. Thus, patients experiencing concurrent conditions in other areas of the body that could also be bothersome or painful and could cause disability or general ill health were excluded to minimize confounding variables. Other conditions where the safety of acupuncture is largely unknown such as pregnancy also led to the exclusion of potential participants. Prior and concurrent treatment with acupuncture or other forms of therapy further constituted an exclusion criterion. Randomization to the different arms was conducted using computerized stratified block methods to achieve balance in participant attributes between the two groups. Homogeneity between treatment and control group participants was confirmed using a test. Several medical doctors performed the treatments and to reduce bias in this area, they underwent training to standardize both the true acupuncture and sham acupuncture protocols.
A primary weakness is its sampling method and sampling size. The study used volunteer sampling in that recruitment was via newspaper, hospital website, hospital magazine, and bulletin board advertising. For this reason, not everyone in the population had an equal chance of participation that may have contributed to bias. The sampling size was adequate even at 20% drop out, although the actual drop-out rate was 10%. However, this achieved an 80% statistical power. If the study was to achieve higher levels of power at 90% or 95%, a much larger sample will be required.
The study is a randomized controlled trial that investigated the effectiveness of acupuncture mainly in improving the quality of life of patients suffering from chronic neck myofascial pain syndrome (MPS). The Short Form-36 (SF-36) was employed to assess quality of life. The study also examined the effect of acupuncture on secondary outcomes, namely range of motion of the neck, pain precipitated by movement, and the items in the Short-Form McGill Pain Questionnaire (SF-MPQ). There were two arms in the study – the acupuncture group and the sham acupuncture group to which a sample of 35 patients were assigned using random methods.
Baseline measures were taken before and after treatment that consisted of six acupuncture sessions performed twice a week for three weeks. Follow-up measurements were taken at four weeks and again at 12 weeks from the last treatment session. The study showed that between the two groups, there were no statistically significant differences in neck ROM, pain related to movement, and SF-MPQ outcomes after treatment and during follow-up. However, the acupuncture group had significantly better physical functioning, quality of life at 12 weeks, and role emotion in the SF-36. Three patients experienced minor side-effects that were effectively managed. The researchers concluded that acupuncture may enhance the quality of life of persons diagnosed with MPS.
Strengths and Weaknesses
The strength of the study is its research methodology as well. A randomized controlled trial with random allocation to a treatment and control group and before-after comparison of data ascribes greater reliability to the findings. There were attempts to control for bias. Patients with MPS secondary to another condition such as fracture or cervical root compression were excluded to achieve greater homogeneity in the sample. Other major differences that similarly had implications on patient safety such as substance abuse, pregnancy, and psychiatric disorders also led to the exclusion of potential participants. Patients using other treatments were excluded as well. This ensured that outcomes can only be attributed to acupuncture treatment. MPS was also diagnosed using only one set of criteria. Moreover, the treatment procedure was standardized and acupuncture was provided by only one practitioner. An investigator was assigned to evaluate treatment outcomes and was blinded as to treatment or control groups. The statistical analysis employed methods that analyzed differences in outcomes not only between groups but also within groups.
A weakness is the use of convenience sampling that could have affected the representativeness of the sample. Another is the small sample size at 18 participants in the acupuncture group and 16 in the sham acupuncture group. A sample-size estimation and power analysis were conducted and the sample exceeded the optimum sample size to achieve 90% statistical power. However, a much larger sample is needed to achieve a 95% or higher level of statistical power that would provide greater strength to the study conclusion.
Despite the weaknesses of the study, the researchers were able to establish the effect of acupuncture on the quality of life of persons with MPS in Taiwan at a time when the primary focus of research was on analgesia. Quality of life in this trial included pain as one of eight measures. Using more objective measures in conjunction with the subjective measure of pain enabled the researchers to transcend the placebo effect that is a major source of bias in pain studies. By focusing on quality of life, the study also highlighted the role of alternative therapies such as acupuncture in the delivery of holistic care.
This is a critical review of literature employing the modern view of acupuncture which sees the therapy as having a biological basis. For instance, one theory proposed that acupuncture stimulates neural pathways in muscle and the release of neurotransmitters is responsible for the analgesic effects reported by patients. This was the premise of laboratory, imaging, and neurophysiologic studies. A study of the effects of acupuncture on laboratory-induced pain in humans showed that treatment increased the pain threshold by up to 90%. This effect is gradual beginning at 20 minutes after needle insertion with peak effect at 40 minutes. Morphine and transcutaneous electrical stimulation achieve the same results.
Animal and human models provided evidence of the involvement of cerebrospinal fluid (CSF) and several of the body’s natural opioids in the analgesic mechanisms of acupuncture. These opioids include endorphins, enkephalins, and dynorphins. Further, tolerance has been documented with acupuncture treatments given in close intervals such as every 30 minutes. There is also some evidence that acupuncture can reduce inflammation through its effect on cell receptors. Other studies show that acupuncture induces central nervous system (CNS) responses by stimulating the same nociceptors in skin and muscle that are activated by pain and other noxious stimuli.
Imaging studies using positron emission tomography (PET) showed that the thalamic asymmetry in patients with chronic pain disappeared following treatment with acupuncture. This was validated by SPECT studies showing increased thalamic uptake during the pain experience that was reduced after acupuncture and subsequent pain relief was achieved. Compared to sham acupuncture, PET scans also revealed the activation of six areas in the brain that are similarly stimulated by pain. Acupuncture activated brain areas associated with expectation such as when patients believe that treatment will result in pain relief.
Meanwhile, MRI studies showed the similarities and differences in areas of the brain stimulated by traditional acupuncture, minimal acupuncture, superficial needle pricking, needle manipulation, high and low-frequency acupuncture, and sham acupuncture. Results implied that pain and acupuncture share the same pathways but trigger opposing activities in the CNS. In addition, activities in the hypothalamus and limbic system are uniquely associated with traditional acupuncture. These findings support several assumptions about the mechanisms whereby acupuncture produces analgesia but more research is needed to create an exact picture.
Strengths and Weaknesses
The strength of the study is that it summarized the results of experimental and imaging studies since the theory of the biological basis of acupuncture was first proposed in the late 1970’s. It showed the historical progression of research providing scientific evidence that acupuncture initiates biological processes that relate to pain and inflammation rather than just a placebo effect. However, many questions still need to be answered before a complete picture of the effect of acupuncture at the physiologic level is generated. A weakness of the study is that some of the experiments documented in studies did not employ a control group. There were also variations in the procedures used to perform and report imaging results.
The study summarizes what is currently known about the physiologic basis of acupuncture. It essentially provides a basic science perspective on the treatment modality and information on how this research approach relates to clinical application. The study further highlights how developments in technology enable biophysiologic methods in the investigation of alternative therapy.
Critical Assessment of the Treatment
During new treatment development, researchers first establish the biological basis of the therapy using in-vivo and ex-vivo studies before proceeding to clinical trials wherein the treatment is actually administered. This ensures that researchers have an idea of what goes on in the body during therapy that leads to the observed outcomes. In this manner, there is reduction in potential harm, there is a higher likelihood of benefit/s to patients, and researchers can avoid a waste in time and resources. To a certain extent, scientific research on acupuncture underwent a similar process.
Acupuncture has been part of traditional Chinese medicine for several millennia but has not been scientifically studied until the past century. Following a hypothesis on how the treatment exerts its effects on the human body, i.e. through the nervous system, laboratory experiments using human and animal models were conducted to test the theory (Wang, Kain & White, 2008). More recently, various imaging techniques were also employed as non-invasive means to study the effects of acupuncture. For this reason, the acceptability of the treatment in the Western medical community has grown and especially so when subsequent clinical trials of the impact of acupuncture on pain and other measures in different illnesses among actual patients generated results significantly favoring traditional acupuncture.
The Role of Acupuncture in Patient Care
The need for alternative treatments is greatest among patients with chronic illnesses or conditions where pain, discomfort, bothersomeness, disability, subjective perceptions of ill health, depression, and reduced quality of life are common reports. Two such conditions are chronic low back pain and chronic neck myofascial pain syndrome. Conventional treatments are mainly pharmacologic. For instance, prescriptions are often for pain relievers such as tramadol and non-steroidal anti-inflammatory drugs (NSAIDS), and patients may also be recommended to take tricyclic antidepressants (Sun et al., 2010). Current standards consider alternative therapies such as acupuncture and massage as adjuncts to treatment.
A problem with pharmacologic treatment is the side effects. Long-term use of NSAIDS can lead to gastric ulcer, and tricyclic antidepressants induce sedation, blurred vision, dry mouth, urine retention, and constipation (Lazzaroni & Porro, 2009; Mayo Clinic Staff, 2013). Such side effects range from bothersome to adverse. A potential role of acupuncture is to serve as primary or sole treatment for pain and other manifestations of chronic illness. In one of the trials reviewed above, participants with chronic low back pain in the true acupuncture group reported significantly higher scores on the visual analogue scales for pain and bothersomeness following treatment and at follow-up compared with sham acupuncture (Cho et al., 2013).
Another role of acupuncture is to serve as adjunct treatment to medications by improving the quality of life. In the other clinical trial annotated above, acupuncture significantly improved the physical functioning, general perception of quality of life, and role limitations arising from emotional problems (Sun et al., 2010). A holistic perspective of health considers not only the physiologic manifestations of illness such as pain or inflammation but also the patient’s psychological and sociocultural wellbeing. All these aspects contribute to health or illness. In addition, principles of culturally competent care include the respect for patient preferences and cultural health practices (Schofield et al., 2010). A patient who wishes to receive acupuncture treatment must not be prevented from doing so if there are no known adverse consequences.
The Role of Nurses in Relation to Acupuncture
Nurses can advocate for the patient’s right to have acupuncture as an option for treatment. In some facilities in Canada and the U.S., nurses who are certified experts in administering acupuncture are permitted to provide the treatment to patients (CNO, 2013; Springboard, 2012). Registered nurses can also educate patients about the treatment to facilitate informed consent and advocate for policies and evidence-based guidelines that health care professionals can employ to respond to patients’ queries or needs for complementary and alternative therapies (Nowack & Birck, 2012; Schofield et al., 2010). For example, a consensus document on the evidence-base of acupuncture derived from a review of the literature can be made available as clinical support or reference. The consensus document can include the potential mechanism of action of acupuncture, adverse effects, interactions, and contraindications.
Mechanism of Action
In biophysical and imaging studies, acupuncture is thought to stimulate the production of natural opioids or pain relievers in the body (Wang, Kain & White, 2008). These substances include endorphins that produce analgesic effects similar to opioid medications. Rat and human models and imaging studies also point to acupuncture setting of neural activities that oppose those involved in the experience of pain (Wang, Kain & White, 2008). Although both sham and true acupuncture affect the part of the brain involved in expectation, the effect is greater for acupuncture and may be the mechanism behind its capacity to improve quality of life.
Acupuncture can possibly interact with analgesic medications. In biophysical and imaging experiments, the concurrent administration of an anesthetic and acupuncture rendered the latter ineffective (Wang, Kain & White, 2008). As such, patients should not take anesthetics when they wish to receive acupuncture and vice versa. In addition, the possible interactions of acupuncture with other therapies such as herbal medications, corticosteroids, muscle relaxants, and narcotics have not been studied thoroughly (Cho et al., 2013). The trials ensured that patients have not taken any other treatments for several weeks before participation so that the residual effects will not interfere with study findings. Erring on the side of caution, acupuncture should not be employed together with other treatments.
Further, there are several contraindications to acupuncture. Sessions with close intervals such as 30 minutes induce desensitization to the effects of the treatment so that subsequent treatments are ineffective (Wang, Kain & White, 2008). This is the reason why the trials used a longer time interval such as every two or three days. In general, the trials also showed that acupuncture is effective in patients with uncomplicated chronic low-back pain and primary chronic neck myofascial pain syndrome. As such, it is not known whether acupuncture will work just as well in patients with comorbid conditions such as arthritis, bone fracture, cancer, or infection. The effects are also not known in the event of pregnancy, psychiatric illness, substance abuse, alcoholism, and seizure disorders (Sun et al., 2010; Cho et al., 2013). Again, erring on the side of caution, patients with comorbid conditions should not receive acupuncture. Because the treatment involves the insertion of needles through the skin, there are clear contraindications for patients with clotting or bleeding disorders and those taking anticoagulants (Sun et al., 2010; Cho et al., 2013).
There were several side effects noted in the trials. Sensations of a mild, localized, and dull ache, referred to as deqi actually indicate the achievement of qi or the attainment of vital energy (Wang, Kain & White, 2008; Cho et al., 2013). These symptoms signal successful treatment and must be expected. However, unexpected effects included ecchymosis that can be treated by cold compress and slight dizziness that can be managed by rest and drinking warm water (Sun et al., 2010). Other unexpected side effects were noted in the other clinical trial but were not described in detail except to say that these were mild to moderate in nature, did not lead to adverse outcomes, and lasted for less than a week (Cho et al., 2013).
The results of the two clinical trials and the information contained in the critical review point to the fact that there is still no strong scientific support for the unequivocal decision to recommend acupuncture as treatment for chronic lower back pain and neck myofascial pain syndrome. The trials, despite the rigorous methodologies employed, used small sample sizes and low albeit acceptable levels of statistical power. The critical review pointed to the lack of standardization in imaging protocols but showed initial glimpses of the mechanism of action of the treatment. Clearly, studies employing larger samples and further biophysical research need to be conducted in the future. That there is some research support for the effectiveness of acupuncture should be truthfully communicated to patients. The possible interactions, contraindications, and adverse effects of acupuncture must be discussed with patients as well with emphasis that it is a relatively safe treatment option.
Cho, Y., Song, Y., Cha, Y., Shin, B., Shin, I., Park, H., Song, M. (2013). Acupuncture for chronic low back pain: A multicenter, randomized, patient-assessor blind, sham- controlled clinical trial. Spine, 38(7), 549-557. doi: 10.1097/BRS.0b013e318275e601.
Lazzaroni, M., & Porro, G.B. (2009). Management of NSAID-induced gastrointestinal toxicity: Focus on proton pump inhibitors. Drugs, 69(1), 51-69. doi: 10.2165/00003495-200969010-00004.
Mayo Clinic Staff (2013). Tricyclic antidepressants and tetracyclic antidepressants. Retrieved from http://www.mayoclinic.org/diseases-conditions/depression/in- depth/antidepressants/art-20046983
Nowarck, R., & Birck, R. (2012). Complementary and alternative medicine is popular among chronic renal failure patients – renal teams must increase their competence to advise patients with respect to efficacy and safety. Evidence Based Nursing, 15(1), 29-30. doi: 10.1136/ebnurs-2011-100105.
Schofield, P., Diggens, J., Charleson, C., Marigliani, R., & Jefford, M. (2010). Effectively discussion complementary and alternative medicine in a conventional oncology setting: Communication recommendations for clinicians. Patient Education & Counseling, 79(2), 143-151. doi: 10.1016/j.pec.2009.07.038.
SpringBoard (2012). Career of the week: Acupuncturist nurse. Retrieved from http://blog.springerpub.com/nursing/career-of-the-week-acupuncturist-nurse
Sun, M.Y., Hsieh, C.L., Cheng, Y.Y., Hung, H.C., Li, T.C., Yen, S.M., & Huang, I.S. (2010). The therapeutic effects of acupuncture on patients with chronic neck myofascial pain syndrome: A single blind randomized controlled trial. The American Journal of Chinese Medicine, 38(5), 849–859. doi: 10.1142/S0192415X10008299.
Wang, S.M., Kain, Z.N., & White, P. (2008). Acupuncture analgesia: I. The scientific basis. International Anesthesia Research Society, 106(2), 602–610. doi: 10.1213/01.ane.0000277493.42335.7b.