THE EFFECTIVENESS OF ACUPUNCTURE FOR ACUTE LOW BACK PAIN By William F. Wittman, RN, BSN, CEN Submitted in Partial Fulfillment of the Requirements for the Master of Science in Nursing Degree Edinboro University of Pennsylvania Effectiveness of acupuncture for acute low back pain by William F. U i t tman. Thesis Nurs. 1999 W832m c .2 Approved by: a------- - o - - Judith Schilling PhD, CRN^ Committee Chairperson Alice Conway PhD/y Committee Member rp Dat< aL./ JqrieU0eisel PhD, RN ✓Committee Member c/ V Abstract The Effectiveness of Acupuncture for Acute Low Back Pain The purpose of this research was to assess the effectiveness of acupuncture for adults aged 20 to 50 with acute low back pain. Very little research has been conducted in this area, but case studies indicate that acupuncture has the potential to shorten disability, decrease medical costs, and hasten pain relief. This retrospective study examined the difference in perception of pain experienced by subjects before and after a single acupuncture treatment. Acute low back pain was defined in this study as pain of less than 3 months duration in the absence of a serious underlying pathology. The subjects were between 20 an 50 years of age. This convenient sample of 12 patients completed a 0 to 10 pain scale prior to a single acupuncture treatment and again the day after the treatment. Treatments were administered by two certified acupuncturists. The results were analyzed using a one- tailed dependant t-test and revealed that there was a significant decrease in the perception of pain 24 hours after acupuncture treatment. This study will enhance the knowledge of the health care community, as well as encourage additional research into acupuncture as a way of easing pain and decreasing medical costs. Recommendations for further research are made. ii Acknowledgments I would like to thank all of those individuals who helped me complete this thesis. A special thank you to my parents John and Maureen who were instrumental in this whole process. I would also like to thank my wonderful committee members: Dr. Judith Schilling, Dr. Alice Conway, and Dr. Janet Geisel. Finally, to John, Hally, Jeff, Jason, Jake, Paul, Jo Rae and the rest of the gang, I thank you guys for the laughs along the way. iii Table of Contents Content Page Chapter I. Introduction 1 Background of the Problem 1 Purpose of the Study 4 Theoretical Framework 4 Research Question 6 Assumptions 6 Limitations 6 Definition of Terms ,7 Summary 8 9 Chapter II. Review of Literature 9 Acupuncture Types of Acupuncture 10 How Acupuncture is Performed 11 Western View of Acupuncture 13 Complications of Acupuncture 14 Licensing and Education 14 Role of the Nurse Practitioner 16 Identifying Red Flags 16 iv Referring to an Acupuncturist Studies of Acupuncture 18 19 Studies of Acute Low Back Pain 20 Studies of Chronic Low Back Pain 21 Summary 24 Chapter III. Methodology 25 Hypothesis 25 Operational Definitions 25 Research Design 26 Setting and Procedures 26 Sample Informed Consent. 27 Instrumentation 27 Data Analysis 27 Summary 29 Chapter IV. Analysis of Data. Sample Group 29 Results Summary Chapter V. Discussion.. Summary v Conclusions 35 Recommendations for Future Research. 36 Summary. 36 References 37 Appendices 41 A. Pain Scale. 42 B. Mathematics for t-Test Calculations .43 vi List of Tables Table Page 1. Subject Information 30 2. Mean Gender Differeences 31 Vll 1 Chapter 1 Introduction This chapter presents a brief summary of acupuncture and acute low back pain. The Theory of Qi was the theoretical framework used for this research. Assumptions, limitations, statement of the purpose, and definition of terms are included. Background of the problem Low back pain is a health concern that has increased dramatically in recent decades (Breakstone, 1995). It is one of the most common reasons for patients with a work-related injury to visit a primary care provider (Daniels, 1997). For persons under the age of 45 years, low back problems are the most common cause of disability (Daniels, 1997) and are second only to upper respiratory disease as a cause of temporary disability in people of all ages (Della-Giustina, 1998). Between 1970 and 1981, the increased incidence of low back pain was an astounding 1400% (Breakstone, 1995). In the general adult population, approximately 85% will have low back pain at some point during their lifetime that is severe enough to seek medical attention (Daniels, 1997); it is estimated that 25% of adults experience low back pain in any given year (Suarez -Almazor, Belseck, & Russell, 1997). It is the second leading cause of visits to clinicians, the third most common reason for surgical procedures, and the fifth leading reason for hospitalizations (Rubin, 1995). With the increase in cases of low back pain, comes an increased cost both in 2 quality of life and financial losses. Back pain is responsible for more than $24 billion yearly in medical costs (Rubin, 1995). According to Breakstone (1995), the societal cost to Americans is approximately $20 billion yearly. Back pain is a very common problem which not only causes discomfort, but adds to the high indirect costs by increasing disability and absenteeism (Suarez-Almazar et al., 1997). One study concluded that 2% of the industrial workforce encounter back pain that qualifies for workers’ compensation each year (Taylor, Deyo, Ciol, & Kreuter, 1996). The total annual costs, which included both direct and indirect costs, were in excess of $50 billion a year (Taylor et al., 1996). Fortunately, most cases of low back pain resolve spontaneously. According to Daniels (1997), approximately 60% improve in 1 week, 70% are asymptomatic after 2 weeks, and 90% are relieved at 6 weeks. However, 3% of patients with a diagnosis of low back pain account for 80% of the total cost to society to treat this condition (Daniels, 1997). Traditional treatment of low back pain is controversial (Daniels, 1997). In general no single treatment is preferred (“Acute Low Back Problems,” 1995). The most common medications used in acute low back pain are tylenol, nonsteroidal anti- inflammatory drugs (NSAIDs), opioids, and muscle relaxants. The safest drug is tylenol and some patients find it helpful, but in many instances NSAIDs are more effective (“Acute Low Back Problems,” 1995). According to Daniels (1997), NSAIDs are helpful, but often not sufficient. Drawbacks in using NSAIDs include gastrointestinal irritation or ulceration, renal problems, and allergic reactions (“Acute 3 Low Back Problems”, 1995). Opioids appear to be no more effective than safer analgesics for managing low back symptoms and up to 35% of patients develop drowsiness, decreased reaction time, clouded judgement, and potential misuse/dependance (“Acute Low Back Problems", 1995). Muscle relaxants are no more effective than NSAIDs, and when combined with NSAIDs have no demonstrated benefit. Side effects similar to opioids are reported in up to 30% of patients taking muscle relaxants. There are also nonphannacological ways of treating acute low back pain in traditional medicine. Spinal manipulation is frequently utilized and it is often effective when used within the first month of symptoms (“Acute Low Back Problems”, 1995). However, efficacy is unproven after that period of time. Bed rest was once recommended widely for the treatment of acute low back pain (Borenstein, D., Deyo, R., Marcus, N., 1998). Prolonged bed rest, more than 4 days, has potentially debilitating effects and is reserved for those patients with severe limitations (“Acute Low Back Problems”, 1995). Regardless of the chosen treatment, the goal is to return to normal activities as soon as possible. Several back exercises are very helpful for patients but vigorous exercising should wait until symptoms are gone (Borenstein et al. 1998). Other treatments such as message, dithermy, ultrasound, biofeedback, and transcutaneous electrical nerve stimulation (TENS) have no proven efficacy in the treatment of acute low back pain (“Acute Low Back Problems”, 1995). However, ibj ect of much discussion recently because of its potential acupuncture has been the sul 4 for pain control (Borenstein et al., 1995). According to the National Institute of Health Consensus Panel on Acupuncture (“Acpuncture”,1998), ample clinical experience supported by some research data, suggests that acupuncture may be a reasonable option for a number of clinical conditions including low back pain. Purpose of the Study The purpose of this study was to assess the effectiveness of acupuncture for subjects aged 20 through 50 with acute low back pain. There are many studies that evaluate acupuncture’s effectiveness in several illnesses, but few that address acute low back pain. This study will enhance the knowledge of the health care providers, as well as encourage further research into acupuncture as a way of easing pain and decreasing costs. Theoretical Framework The Chinese theory of Qi is the framework of this research. The balance of Qi is the goal of acupuncture, and it is almost 5,000 years old. Qi is the existence of a vital life force that travels in channels, known as meridians, throughout the body. There are 12 major meridians, along with minor meridians, that connect the organ systems (Nurses Handbook of Alternative & Complementary Therapies, 1998). According to the theory of Qi, if an organ is experiencing an energy imbalance or disease state, the forces of yin and yang are disturbed (Dold, 1998). Peterson (1996) added that yin and yang are the sum of Chinese cosmology and that they are both complementary and contradictory. The balance between these forces is necessary in order for wholeness and harmony to exist. Certain symptoms appear 5 once the two forces are disturbed (Dold, 1998). A problem of deficiency or underactivity is of a yin character, whereas a problem of excess or overactivity is of a yang character (Helms, 1995). A fever, red face, agitation, erythema, and tachycardia are all the results of an excess Qi or yang. Depression, cold extremities, bradycardia, and a pale face are a result from a lack of Qi or yin (Dold, 1998). The acupuncturist can locate specific points along a meridian that correlate with a particular organ system. These points are then stimulated with needles to balance, release, or enhance the flow of Qi (Nurses Handbook of Alternative & Complementary Therapies, 1998). What is the nurse practitioners’ role in this care? Nurse practitioners need to be able to identify signs and symptoms of diseases that require immediate intervention, through a careful history and physical examination. If any of the following warning signs are noted, further investigation is warranted and the option of acupuncture must be delayed. “Red flags” for acute low back pain are as follows: pain that is worse when lying down, pain associated with a fever and/or weight loss, focal tenderness of the vertebrae, ecchymosis, history of trauma, saddle anesthesia, numbness/tingling in the lower extremities, weakness with ambulation, decreased or absent reflexes in the lower extremities, new onset of bowel and/or bladder problems, and poor anal sphincter tone (U.S. Department of Health and Human Services, 1994). The nurse practitioner must also be aware that other organ systems may refer pain to the lower back. Some examples of this may be renal colic, abdominal aortic aneurysm, pelvic inflammatory disease, pregnancy, pancreatitis, and a perforating 6 duodenal ulcer (Rubin, 1995). Once the practitioner is satisfied that the patient’s back pain is not caused by an underlying serious disease, acupuncture can be presented as an option. If certified, the nurse practitioner can perform this or refer the patient to an acupuncturist. Research Question Does acupuncture decrease adult patient’s perception of acute low back pain? Assumptions The following five assumptions were made for this research study: 1. Pain is whatever subjects say it is. 2. Subjects understand how to rate pain accurately on the pain intensity scale used in this study. 3. Subjects answered all study questions accurately and honestly. 4. The acupuncturist was competent and skilled. 5. Subjects had no serious underlying disease that was causing their acute low back pain. Limitations The following were limitations for this research study: 1. Subj ects have different perceptions of pain. 2. The research sample size is small and limited to subjects from two practices in northwestern Pennsylvania. This affects the application of research findings to other medical populations. 3. The subjects were all Caucasian. 7 4. Traditional Chinese acupuncture treatments are very individualized. Definition of Terms The following terms were defined for this research study: 1. Cauda equina syndrome is characterized by a dull aching pain of the perineum, bladder, and sacrum which radiates, and is associated with paraesthesias and paralysis, due to compression of nerve roots (American Heritage Stedman’s Medical Dictionary, 1995). 2. Endorphins are any group of peptide hormones that bind to opiate receptors and are found mainly in the brain. Endorphins reduce the sensation of pain and affect emotions (American Heritage Stedman’s Medical Dictionary, 1995). 3. Gamma globulins are a protein fraction of the blood serum containing numerous antibodies, used in the prevention and treatment of certain diseases, such as measles, poliomyelitis, and viral hepatitis (American Heritage Stedman’s Medical Dictionary, 1995). 4. Osteomyelitis is inflammation of bone and bone marrow (American Heritage Stedman’s Medical Dictionary, 1995). 5. Prostaglandins are a group of hormone-like substances produced in various tissues that are derived from amino acids and mediate a range of physiological functions, such as metabolism and nerve transmission (American Heritage Stedman’s Medical Dictionary, 1995). 6. Sciatica is pain along the sciatic nerve that radiates from the lower back to the buttocks and back of the thigh, and is usually caused by ahentiated disk of the 8 lumbar region of the spine (American Heritage Stedman’s Medical Dictionary, 1995). Summary The purpose of this research was to assess the effectiveness of acupuncture for the treatment of acute low back pain. The Chinese theory of Qi is the theoretical framework for this research. The role of the nurse practitioner was discussed as well as the assumptions and limitations of the study. Many Americans suffer from acute back pain yearly. The majority of them recover spontaneously. Studies show that symptoms often take several weeks to resolve (Connelly, 1996). During this time, pain often inhibits the individual’s ability to perform as before. Often patients have expensive imaging studies performed, are given expensive prescriptions, and are unable to function optimally at work. Expenses are even higher in those patients who continue to have pain after several weeks (Longworth & McCarthy, 1997). The direct and indirect costs of either situation are significant. If acupuncture is shown to be efficacious in treating acute low back pain, nurse practitioners can play a key role in decreasing disability, absenteeism, and medical costs. 9 Chapter II Review of the Literature The use of alternative medicine has increased dramatically over the past several years. A 1990 survey showed that 34% of Americans had used at least one type of alternative therapy (Eisenberg et al., 1993). It also showed that patients visited alternative practitioners 425 million times, 40 million more times than they visited their medical primary care providers. Approximately $13.7 billion was spent on this care with $10.3 billion coming out of the patient’s own pocket (Eisenberg et al., 1993). In a study by Borkan, Nehler, Anson, and Smoker (1994), it was noted that 60% of conventional physicians had made at least one referral for alternative treatment in the previous year. Approximately one million Americans use acupuncture yearly, and almost $500 million is spent annually for these treatments (Nurses Handbook of Alternative and Complementary Therapies, 1998). The purpose of this chapter is to describe the various types of acupuncture, how it is performed, western views of acupuncture, complications of treatments, as well as the licensing and educational requirements to become an acupuncturist. It also includes the role of the nurse practitioner, identifying “red flags” in acute low back pain, what patients should know when they are referred to an acupuncturist, and research studies of acute and chronic back pain utilizing acupuncture. Acupuncture Acupuncture is an ancient art that has been in existence tor thousands of years. There is documentation that dates back to 200 BC in Th, Yellow Emperor's 10 Classic of Internal Medicine (Peterson, 1996). Types of Acupuncture . There are several types of acupuncture recognized in the United States (Peterson, 1996). The following types will be discussed in this study. Traditional Chinese medicine acupuncture, French energetics, Korean hand acupuncture, auricular acupuncture, myofascially based acupuncture, scalp acupuncture, and oral mucous membrane acupuncture. All types of acupuncture are intended to correct energy flow of Qi within the body. Traditional Chinese medicine acupuncture concentrates on the patient’s history, speech qualities, appearance, pulse, and odor to formulate a diagnosis (Peterson, 1996). In addition, the radial pulses are evaluated extensively in this type of acupuncture. Various disease states are detected by the quality of six pulsations at each radial artery. The proper acupuncture points are stimulated with needles along with any local tender points, called ah shi points. In French energetic acupuncture, the body is considered to be an “electrolytic milieu in dynamic equilibrium” (Peterson 1996, p.24). It is based on principles of bioenergetics. A decrease in the circulating electrolytes of a meridian is correctable with the placement of a needle that serves as an electrode. Korean hand acupuncture is based on the idea that energy originates in the hands and feet (Peterson,1996). Similar to the other principals of acupuncture, needling the appropriate points can treat a variety of illnesses by restoring the flow of energy. Auricular acupuncture is needling of only the ear (Peterson,1996). This is 11 relatively new in comparison to the other types of acupuncture. There are over 200 ear points that correlate with anatomical sites of the body and are documented for therapeutic needling. Myofascial acupuncture begins with assessing which meridian may be responsible for the patient’s symptoms (Peterson, 1996). The meridian is then palpated both locally and distally for tender points. Treatment by inserting needles at tender points restores the energy flow by releasing the myofascial holding pattern. The sixth and seventh types of acupuncture discussed here are scalp acupuncture and oral mucous membrane acupuncture (Nissel, 1993). Both of these are relatively new. The former was developed by Zeiter at the Vienna Institute and deals with the idea of meridians on the scalp. These meridians are correlated with specific anatomical sites of the body and, when stimulated, can release and restore the flow of Qi. Oral mucous membrane acupuncture is based on the same principle but the meridians are located within the oral cavity. In this type of acupuncture, needles are not utilized; rather, a laser or microinjections of local anesthetic is used. How Acupuncture is Performed. Since the Traditional Chinese medicine acupuncture is the most widely used, the following is an overview of how it is typically carried out. It is important to realize, however, that treatments often vary for patients with the same ailment. The acupuncturist asks questions about the presenting problem, and also about sleep, digestion, elimination, emotions, sexual drive, menstrual patterns, and energy rue is examined for size, shape, and coating. level (Schulte, 1996). In addition, the tong 12 The radial pulse is also of great importance. It is assessed for different qualities while the patient changes positions to formulate a pattern of disharmony. The patient then lies on a padded table (Galant, 1997). Although classical acupuncture notes approximately 365 points on the body’s meridians, a typical practitioner utilizes about 150 points (Johnson, 1996). The designated points are then cleaned with an antiseptic solution and stimulated by needles (Breakstone, 1998). Often, low frequency electrical currents, heat, and moxibustion are concurrently utilized (Breakstone, 1998). If moxibustion is used, a small piece of herb called Mugwart is burned within close proximity of the exposed needle to warm it slightly. The Mugwart may also be burned on another substance such as a piece of ginger, and placed over the designated areas (Nurses Handbook of Alternative and Complementary Therapies, 1998). The needles used are solid metal and most often made of surgical steel; sometimes gold or silver is utilized (Nurses Handbook of Alternative and Complementary Therapies, 1998). New standards are advocating the use of disposable needles. The needle length varies from 1.25 centimeters to 15 centimeters and the width can be anywhere from a 26 to 36 gauge (Peterson, 1996). Typically, eight to 20 needles are used in a treatment (Galant, 1997). They are left in place just under the skin for 20 to 30 minutes (Breakstone, 1998). Pain is rare, but a dull ache or electric shock called a “deqi” is often experienced (Galant, 1997). junction with acupuncture (Palmieri, 1999). A lowOften TENS is used in conjunct voltage electrical current is produced by a hand held controller and passed through 13 wires that are connected to the acupuncture needles after placement in the proper areas. TENS stimulates fast conducting nerves that connect to the spinal cord and, in doing so, slow conducting pain-carrying nerves are prevented from delivering the pain message to the spinal cord. TENS is continued for approximately 20 minutes to 60 minutes after pain relief is achieved. Western View of Acupuncture. There are several theories that attempt to “westernize” the eastern view of Qi (Nurses Handbook od Alternative and Complementary Therapies, 1998). The neurotransmitter theory proposes that acupuncture decreases certain neurotransmitters necessary for the transmission nerve impulses. The electrical conductance theory states that since acupuncture points have a higher level of electrical conductance than other areas, these areas amplify minute electrical signals and acupuncture needles stop or inhibit that flow. A third theory, called the enhanced immunity theory, postulates that acupuncture raises the white blood count as well as prostaglandin, gamma globulins, and overall antibody levels. The circulation control theory concludes that acupuncture works by constricting or dilating blood vessels. The final theory, which is called the endorphin theory, is the most popular theory mentioned in the articles and studies reviewed for this research. According to Nissel (1993) at the Ludwig Boltzman Acupuncture Institute in Vienna, the numbness or De-Qui feeling, which develops after needle insertion, is a result of the stimulation of small type II nerve fibers. The sensation of heaviness is a result of small type III nerve fibers. Activation of these fibers causes the release of enkephalin and 14 dynorphin at the spinal level and the afferent pain pathways are blocked. In the midbrain, the enkephalin activates the descending raphe system, which inhibits the pam s pathway by the interaction of seritonin and noradrenalin. The hypothalamus also secretes hypophyseal beta endorphin that promotes distal analgesia. In addition, the hypothalamus innervates the midbrain, which activates the descending analgesia system via the b-endorphin. There is evidence that supports the endorphin theory. According to Nissel (1992), nalaxone, an opioid antagonist, can immediately interrupt the analgesic effects of acupuncture. This effect was shown by two University of Toronto investigators in 1989 (Schulte, 1996). Complications of Acupuncture. There have been only 125 cases of complications reported in the world medical literature abstracted in English since 1958 (Helms, 1995). Minor bruising and muscle soreness are relatively common and are not considered to be complications. The following make up most of the reported complications: contact dermatitis to stainless steel, compartment syndrome, organ puncture, infections, retained needle, pneumothorax, pneumoperitoneum, hemothorax, cardiac tamponade, abscesses, chondritis, deep vein thrombophlebitis, osteomyelitis, endocarditis, and viral hepatitis. There were no reports of human immunodeficiency virus transmission found in the literature. Licensing and Education. Educational requirements and licensing of acupuncturists vary from state to state (Nurses Handbook of Alternative and Complementary Therapies, 1993). Most states have laws that specify licensing but the 15 scope of practice vanes widely. Some states recognize the Doctor of Oriental Medicine as a pnmary care provider, whereas others only allow a medical doctor to practice acupuncture. Some states allow an acupuncturist to practice only under the supervision of a medical doctor. In older to earn a National Certification Commission for Acupuncture and Oriental Medicine (NCCAOM) certificate, one must be 18 years old, pass all portions of the NCCAOM examination, subscribe to the NCCAOM’s National Code of Ethics, be of good moral character, and meet the eligibility criteria. The NCCAOM exam includes an acupuncture portion, clean needle technique course, and a practical examination of point location skills (National Certification Commission for Acupuncture and Oriental Medicine, 1998). Applicants for NCCAOM certification must be graduates of a full-time acupuncture program with at least 3 years of a comprehensive curriculum consisting of a minimum of 1,350 hours of entry level acupuncture education including at least 500 clinical hours (National Certification Commission for Acupuncture and Oriental Medicine, 1998). The third or fourth year student status is the second category. These students must have completed 1,000 hours of schooling in no less than 18 academic months, which includes 250 clinical hours. The third and final educational option is the apprenticeship. These individuals need at least 4,000 contact hours during a 3 to 6 year period. The apprentice’s preceptor needs to have had at least 5 years experience, must have treated a minimum of 100 different patients, and must have 500 patient visits yearly. 16 The Amen can Association of Acupuncture and Oriental Medicine (AAOM) (1998) recommends that physicians who practice acupuncture have a minimum of 200 hours of training and that nonphysician practitioners have 2 or more years of training at a recognized acupuncture school. Nonphysicians should also be licensed or registered in their state or should be certified by the National Certification Commission for Acupuncturists. Acupuncturists with the most extensive training generally have graduated from one of the nation’s 37 acupuncture colleges (Breakstone, 1995). Role of the Nurse Practitioner The nurse practitioner’s role in managing patients with acute low back pain, with regard to acupuncture, has two aspects. The first is the identification of underlying causes of the back pain through the patient history and physical examination. When “red flags” are noted, the nurse practitioner understands that further testing is necessary, and that acupuncture is not an option at that time. The second role is the teaching that goes along with referring a patient to an acupuncturist. Nurse practitioners can become a certified acupuncturist as well, but they do not qualify for the 200 hours of training available to physicians. Practitioners must be educated like any other nonphysician, as explained previously. Identifying Red Flags. Approximately 16% of all cases of backpam warrant further studies (Gillette, 1996). Of this 16%, 2% require immediate attention. Although only a minority of patients have serious underlying pathology causing their low back pain, it is vety important to detect these ailments. Certain diseases are more 17 common at specific ages. Since this research deals with acute low back pain in subjects between the ages of 20 and 50 years, the most common serious diseases in this age group will be discussed. Mengel and Schwiebert (1996) described five main categories of ailments that are most common for patients under 50 years of age. Of these categories, three include conditions that warrant immediate referral. They are cauda equina syndrome, lumbosacral infections, and inflammatory rheumatic diseases. Cauda equina syndrome is a very rare condition that is associated with herniated lumbar disks. It is characterized by acute urinary or rectal incontinence, with or without paraplegia, usually caused by a large disk herniation (Mengel & Schwiebert, 1996). Other symptoms that should direct one to suspect possible cauda equina syndrome are impotence, perineal saddle anesthesia, sphincter problems, major motor weakness in the lower extremities, or progressive neurological dysfunction in the legs (US Department of Health and Human Services, 1994). The second serious cause of low back pain in younger adults is lumbosacral infections. According to Mengel and Schwiebert (1996), these are more common among those who are immunocompromised such as persons with diabetes melhtis, recent surgery, septicemia, human immunodeficiency virus, and intravenous drug users. Two examples of lumbosacral infections are spinal abscesses and osteomyelitis. Symptoms for these illnesses include fever, chills, weight loss, pain that is worse at night, and pain that is worse when lying supine (US Department of Health and Human Services, 1994). 18 The third and final category of serious concern is inflammatory diseases. The diagnoses that affect the lower back and require referral are ankylosing spondylitis and Reiter’s syndrome. Ankylosing spondylitis is a chronic and progressive disease that geneially begins at the sacroiliac joints and progresses up the spine (Professional Guide to Diseases, 1995). Fibrous tissue forms as bone and cartilage deteriorate and fusion of the spine ensues. Symptoms of this disease are prolonged stiffness, limited motion of the spine, fatigue, fever, anorexia, weight loss, and uveitis. Unlike ankylosing spondylitis, Reiter syndrome is a self-limiting disease that is associated with polyarthritis, urethritis, balanitis, conjunctivitis, and mucocutaneous lesions. It is related to venereal and enteric infections and can be accompanied by fever, weight loss, and anorexia (Professional Guide to Diseases, 1995). Referring to an Acupuncturist. If the nurse practitioner and the patient have decided that acupuncture is an option, there are several points that need to be discussed. First, the patient and the nurse practitioner will check the credentials of the acupuncturist (Weiss, 1995). Even a state liscense does not necessarily mean that the acupuncturist is competent. In states that do not require a license, look for an acupuncturist who is certified by the National Commission for the Certification of Acupuncturists. This commission certifies nonphysician acupuncturists, while the American Academy of Medical Acupuncture is the certifying body for physicians. Next, the patient should understand that iatrogenic problems are rare but possible. These risks can be further reduced by insisting that disposable needles be used. Also, patients need to be educated to ask what kind of treatment is used by that particular 19 acupuncturist, since there are several different types. Cost is an additional concern. Charges can vary from $30 to $100 per session. According to Breakstone (1995), approximately 10% of US health plans pay for acupuncture treatments. Studies of Acupuncture In 1995, Helms published a meta-analysis that reviewed and evaluated all acupuncture i elated literature pertaining to human clinical research studies and anecdotal reports published in western European languages since 1960. A total of 3,425 articles were examined and categorized by the illness studied. Approximately 25% of the articles addressed pain issues. Of that 25%, 67% specifically analyzed musculoskeletal problems. When the variables of randomized, controlled, and prospective investigations were applied to all 3,425 articles, only 150 were considered for further evaluation. Thirteen of these studies addressed low back pain. Of the thirteen studies, all published between 1976 and 1989, seven concluded that acupuncture was superior to controls, one showed favorable results that were not significant, two revealed that acupuncture treatments were equally as effective as controls, and two concluded that acupuncture was equal to or inferior to the control (Helms, 1995). According to the National Institute of Health Consensus Development Panel on Acupuncture (1998), there have been many studies of acupuncture’s potential usefulness, but very few are high quality randomized controlled trials. Most of this literature consists of case reports, case series, or interventional studies with inadequate designs. 20 Studies of AcuteLowBackPain. The first of two studies that examined the effectiveness of acupuncture in acute low back pain were done by Shugai (1992). He performed acupuncture on 100 patients with acute lumbar strain between 1978 and 1992. The duration of the patients’ ailments ranged between 5 hours and 3 days. In sixteen of the cases, the subjects were between the ages of 51 and 62. Shugai’s report did not indicate how the patients were selected, did not reveal how the patients’ pain was evaluated, nor did it give the time frame in which the study took place. One session of acupuncture treatment generally markedly reduced the amount of pain, or even cured the patient. Shugai went on to write that in severe cases, a treatment was given daily for 3 to 5 days. These resulted in a cure, but Shugai did not reveal how many patients required more than one session. Overall, the author reported that 60% of the patients were cured, 26% markedly improved, 10% were helped, and 4% did not respond to treatment. The method of evaluating treatment outcomes was not given. The second study examining the effectiveness of acupuncture for low back pain was similar. Runshu (1993), an acupuncturist, treated 135 cases of acute lumbar sprain beginning in 1982. The article detailed how the treatment was earned out and what meridian points were used. Results were then given in a single sentence, a follows: 115 patients were cured, 18 were markedly improved, and 2 patients were not helped. The total effectiveness rate in this study was 98%. The article went give an example ease and discuss the acupoints used. The author did not indicate how long the patients had suffered horn back pain, how the subjects were chosen, how the 21 pain was evaluated, the ages of the patients, nor the duration of the study. The article also failed to divulge how many treatments were given over what kind of a time frame. Studies of Chrome Low Back Pain. Unlike acute low back pain studies, there are several research studies that examine the effectiveness of acupuncture in treating chronic low back pain. The studies of Coan et al. (1980), Mendelson et al.(1983), Leung (1979), and Macdonald, Macrea, Master, & Rubin (1983), are discussed below. Coan et al. (1980) studied 50 patients with low back pain for at least 6 months. The subjects were told that they would receive ten or more acupuncture treatments. They were divided into two groups. The first group of 25 patients, called the Immediate Treatment Group, began treatments on the day of their initial examination. The second group of 25, called the Delayed Treatment Group, began treatments 8 weeks after the initial examination to create a control. Patients rated their pain on a 0 to 10 pain scale, with 10 representing the most most severe pain. Patients identified their limitation of activity on a 0 to 3 scale with 3 representing severe limitation. The first group was re-examined 10 weeks after the initiation of treatments, while the second group was re-examined 15 weeks after enrollment and before the treatments began. Both groups were then sent mail surveys 40 weeks after enrollment. In evaluating the results, 83% of the Immediate Group reported improvement .nd none wem worse at an average of 10.3 weeks into the study. Significant decreases in pain hours, pain scores, limitation of activity, an g 22 pain pills were also noted. The Delayed Treatment Group reported only a 31% improvement and 25% of these patients' conditions worsened at 15 weeks into the study. At the 40 week mark, 58% of the Immediate Treatment Group were still doing well as opposed to only 11% of the Delayed Treatment Group. The study by Mendelson et al. (1983) was a double-blind placebo-controlled trial that enrolled 77 patients with chronic low back pain. This study also looked extensively at psychosocial factors. A detailed history was elicited from all patients including a personal history, social history, and illness history. All of the subjects took tests to measure neuroticism, extraversion, aggressiveness, hostility, hypochondriasis, anxiety, depression, phobias, and bodily preoccupation. The patient’s expectation of pain relief was recorded using a five-point scale, ranging from “not at all” to “certain”. Three different pain scales were utilized including the Visual Analog Scale of Pain, the McGill Pain questionaire, and a 100 millimeter pain scale. Patients in the placebo group received injections of 2% Lidocaine given at nonacupuncture and nontender sites in the lumbar area. The traditional Chinese technique of acupuncture was used for the treatment group. All patients were treated for 4 weeks, rested for the next 4 weeks, and then crossed over and received the alternate treatment for another 4 weeks. The results of the research showed that the overall reduction of pain in the acupuncture group was 26% compared to a 22% reduction in the placebo group, which was not statistically significant. Leung (1979) extttnmed 20 subjects who had faded conservative treatment for low back pain. Ages varied fttrn 23 to 69, but most fell between 40 and 60 years of 23 age. The duration of acupuncture treatments also varied from 1 month to 10 years, with the average being slightly over a year. No patients had neurological deficits, but 18 had sciatica with straight leg extension. Acupuncture treatment was given along with electrical stimulation daily for 15 minutes and continued until either the pain disappeared, stabilized, or until the patient declined further treatments because of a good response. Pain was determined subjectively by the patient as severe, moderate, or mild. All patients were followed for 12 months. Of the 20 patients treated, four considered themselves cured, ten had a backache which they considered mild and required no analgesics, three had occasional pain that did not require analgesics, and three continued to have persistent pain. At the 12 month follow-up, pain had reoccurred in 13 of the 20 patients. Acupuncture was then offered again to these patients. Eleven of the patients had treatments repeated and their results were similar to the original study. Macdonald et al. (1983) conducted a single-blind, randomized, placebocontrolled trial of acupuncture for treating chronic low back pain. In this study eight patients were treated with acupuncture and nine were treated with a placebo, which consisted of a mock transcutaneous nerve stimulation. The needles were insert ry superficially at a depth of no more than four millimeters. All of the participants had chronic low back pain that failed to respond to conventional methods for a year and had been referred for pain relief by orthopedic surgeons or ■fieumato.ogis.s. A 0 to 10 visual analog scale was utilized prior to treatments and again the treatments. Pam was based on several activities such as waling on .eve, grorntd, sitting on a hard 24 chair, and climbing stairs. Patients received up to ten treatments, which „ere performed weekly. If a treatment failed to produce beneficial effects, then the needles were left in place twice as long the next time. If this failed, then electroacup •uncture was performed. The pain relief for the acupuncture group was 77.35% versus 30.14% for the placebo group. Acupuncture significantly increased the experimental group’s functional status when compared to the placebo group. Summary There are several types of acupuncture, all of which revolve around the concept that disrupting the energy flow of the body leads to illness. Traditional Chinese medicine acupuncture is the most widely utilized. Several western theories attempt to explain how acupuncture works. Though imperfect, the theory of endorphins is the most common belief today. There are several complications that can result from acupuncture treatments, but these occur very infrequently. Although there are many studies of the potential usefulness of acupuncture, there are few that meet western standards of high quality, randomized, and controlled studies (“Acupuncture”, 1998). Between 1976 and 1989, only 14 controlled studies of acupuncture for low back pain were published, and within these studies, ac back pain was not addressed (Helms, 1995). This chapter reviewed two acute low back pain studies and four chronic back pain studies. Also included in this p were the licensing and educational requirements for acupuncturists as wdl as th. role of the nurse practitioner. 25 Chapter III Methodology This chapter describes the methodology used to assess the effectiveness of acupuncture for patients with acute low back pain. Included in this chapter are the hypothesis, operational definitions, research design, sample, data collection, and instrumentation for this study. Hypothesis Adult subjects between the ages of 20 and 50, who have acute low back pain, will record a decrease perception pain after a single acupuncture treatment. Operational Definitions The following are the operational definitions for this study: 1. An acupuncture treatment is the placement of 8 to 20 fine, disposable, stainless steel needles, into the proper acupoints of meridians to enhance, restore, and balance the flow of Qi. 2. Acute low back pain is that which is located over the lumbar sacral region and has been present for less than 3 months. 3. Pain is a numerical representation on the 0 to 10 pain scale, where 0 is equivalent to no pain and 10 is equivalent to the most severe pain. 4. Subjects are between the ages of 20 and 50, have no serious underlying pathology as defined by their physician, and have acute low back pain. 26 Research Design This was a retrospective study. Data was collected from the medical and acupuncture records of two physicians who are certified in acupuncture. A 0 to 10 pain scale was utilized prior to and 24 hours after a single acupuncture treatment. The goal of this research was to examine the effectiveness of acupuncture for acute low back pain. Setting and Procedures The setting for this research was a primary care practice, and a hospital based pain clinic, both located in northwestern Pennsylvania. The subjects with low back pain were evaluated by a practitioner for any serious underlying pathology. If a serious condition was suspected, those patients were excluded from this study. If a serious condition was ruled out, subjects were offered an acupuncture treatment. Most patients were offered treatments after rest, ice, nonsteroidal anti-inflammatory drugs and other means failed. Traditional Chinese acupuncture was utilized in this research. The patients were contacted the following day of their acupuncture treatment and their pain was reassessed utilizing the pain scale. Sample The researcher reviewed the medical and acupuncture records of 12 subjects between the ages of 20 and 50, who had low back pain for less than 3 months. Practitioners had ruled out serious underlying pathology prior to the acupuncture treatment. Any subject with a possible serious underlying pathology was not included in this research sample. 27 Informed consent All patients included in this study were contacted by telephone by either the acupuncturist or the office personnel for consent. All of the data collected remained confidential and no names or other identifying information was reported. The clinical acupuncturist gave the researcher permission to use patient information that was previously collected and confidentiality was maintained. Instrumentation The tool used for this research was a simple 0 to 10 pain scale (Appendix A). Instructions were given to each subject explaining how to fill out the pain scale. The scale itself was set up in a horizontal fashion with a 0 to the left and a 10 to the right. A 0 represented no pain whereas a 10 represented the most severe pain the patient has ever had. The scale was filled out in the office prior to the acupuncture treatment. The patient’s pain was reassessed, and documented using the same pain scale, the next day. Data Analysis The data collected consisted of the patient’s age, sex, duration of pain, pre­ treatment pain score, and post-treatment pain score. A one-tailed dependant t-test was then calculated to discern any significant change in perception of of pain (Appendix B). Summary This retrospective study was conducted at a primary care practice as well as a 28 hospital-based pain clinic in northwestern Pennsylvania. Criteria for admission to the study were defined. A pain rating tool was completed by each subject prior to their acupuncture treatment, and again the next day. The results of the pain scales were used to determine if a significant decrease in pain perception was noted by the subjects. 29 Chapter IV Analysis of Data This chapter presents the results of this retrospective study concerning patients perceptions of low back pain prior to and after a single acupuncture treatment. Data on duration of pain, ages, sex and differences in pre-treatment and post-treatment scores among subjects are included. Sample Group The researcher conducted this study at two physician offices in northwestern Pennsylvania in July 1999. Medical and acupuncture files were utilized. A 0 to 10 pain scale was completed by each subject prior to the acupuncture treatment. The subjects were then contacted by the acupuncturist the next day to re-evaluate and document their pain status. The sample size was 12, of which 5 were female and 7 were male (Table 1). The average age was 37.7 years and the average duration of pain was 7.3 weeks. Results Data were analyzed using a one-tailed t-test for correlated groups. The null hypothesis for this study stated that there is no significant change in the subject’s perception of acute low back pain 24 hours after a single acupuncture treatment. The alternative hypothesis stated that there is a significant decrease in the perception of pain after 24 hours. Pre-treatment scores averaged 7.6 and post-treatment scores averaged 5.6 (Table 1). The difference in scores was squared and added; the total 70 (Table 1). 30 Table 1 Subject Information Duration of Pain Score Pre-treatment Post-treatment Difference D IF Age Sex 33 F 6 Wks. 7 5 2 4 48 F 12 Wks. 6 2 4 16 38 M 10 Wks. 5 5 0 0 45 F 8 Wks. 7 6 1 1 32 M 7 Wks. 8 5 3 9 28 M 10 Wks. 7 5 2 4 49 F 8 Wks. 8 6 2 4 46 M 1 Wk. 7 6 1 1 27 M 12 Wks. 10 9 1 1 34 F 10 Wks. 8 6 2 4 37 M 2 Wks. 8 3 5 25 36 M 2 Wks. 10 9 1 1 7.3 Wks. 7.6 5.6 24 70 Avg. 37.5 Note. Values were rounded to the nearest tenth. Sum 31 The t-test score of 4.88 was compared to a list of significant values to test the hypothesis (Appendix B). Since 4.88 was greater than the table value of 1.796 (alpha < 0.05), the hypothesis is supported. Thus, this study found that there was a significant decrease in the perception of low back pain in patients 20 to 50 years old, who were evaluated 24 hours after a single acupuncture treatment. Based on the results of this study, one acupuncture treatment significantly reduced the subjects’ perception of acute low back pain. Eleven of the twelve research subjects perceived some pain reduction 24 hours after being treated with acupuncture. The one subject who did not respond to the treatment did not worsen. A minimal difference was noted when comparing gender and pain relief (Table 2). Table 2 Mean Gender Differences Average Males Females 38.4 41.8 Duration of Pain in Weeks 6.3 8.8 Pre-Acupuncture Score 7.9 7.2 Post-Acupuncture Score 6.0 5.0 Points of Reduced Pain 1.9 2.2 Age of Subject 32 The female subjects averaged 3.4 years older than the male subjects. The females had been experiencing acute back pain for an average of 2.5 weeks longer than the males. The female population in this study averaged a pre-acupuncture pain score of 7.2 and a post-acupuncture pain score of 5.0. Their average reduction in pain totaled 2.2. The women responded slightly better to the acupuncture treatment with an average decrease in pain points of 2.2 compared to 1.9 points reported by the men. Summary This chapter presented results of this retrospective study to assess changed perception of low back pain 24 hours following one acupuncture treatment. Twelve subjects were included. A 0 to 10 pain rating scale was utilized. Data were analyzed using a one-tailed dependant t-test. The research found that a single acupuncture treatment significantly reduced the perception of low back pain after 24 hours in 12 adult subjects, between 20 and 50 years of age. 33 Chapter V Discussion This chapter summarizes the results of this research. The purpose of this study was to assess the effectiveness of acupuncture for subjects aged 20 to 50 with acute low back pain. A one-tailed dependant t-test was used to determine significance. Discussion, conclusions, and recommendations for future research are included in this chapter. Summary This research was a retrospective study that included 12 subjects from two practitioners’ offices in northwestern Pennsylvania. The subjects were experiencing low back pain and asked to rate their pain on a 0 to 10 scale. Twenty-four hours following an acupuncture treatment, their pain status was reassessed using the same pain scale. This research found, on the average, a significant decrease in pain perception. A significant correlation was found between a single acupuncture treatment and pain relief. Like the studies by Shugai (1992) and Runshu (1993), this study also showed that subjects with acute low back pain benefited from acupuncture. A major difficulty with acupuncture studies is the individualistic nature of treatment plans. Two subjects with the same ailment are often treated differently (Nurses Handbook of Alternative & Complementary Therapies, 1998). Low back pain may be treated 20 different ways depending on the different schools of practice and clinical findings (Petersen, 1996). There may also be variability between acupuncture practitioners. This raises the 34 question of comparability between studies. Western medicine has attempted to follow standardized protocols that may not demonstrate the full effectiveness of acupuncture treatments (NIH, 1998). Another problem with acupuncture research is the poor assessment of long term effects. Most studies do not follow-up with subjects past a few months (Richardson & Vincent, 1985). The works of Shugai (1992) and Runshu (1993) are examples of significant pain reduction, but contain no record of the longevity of pain relief. Double-blind randomized acupuncture studies are difficult to perform (Nurses Handbook of Alternative & Complementary Therapies, 1998). These types of studies are also very expensive. An article appearing in The Economist (Getting the Needle, 1997) indicated that a proper acupuncture trial cost many thousands of dollars. Forming a control group is also a problem when attempting to organize an acupuncture study. Mock TENS is one way of creating a control group. The disadvantage is the absence of the skin pricking sensation that is normally produced by TENS. Many researchers find this an unacceptable control. The more widely accepted control is sham acupuncture, the placement of needles in nonacupuncture sites (Acupuncture, 1998). Even though sham acupuncture is the most acceptable control for double blind studies, problems do exist. The first is eliciting the Hawthorne effect: when a treatment of no therapeutic value evokes an improvement in a patients condition, brought on by the mere act of treating (Getting the needle, 1997). Longworth and 35 McCarthy (1997) wrote that where true acupuncture may give 70% pain relief, sham acupuncture may produce 50% relief. Since they believed that the variability of these figures is +/- 15%, both treatments could actually be equally effective. Other problems with sham acupuncture are inserting the needles too deeply and too close to the meridians (Longworth & McCarthy, 1997). Conclusions Much of the research on acupuncture has focused on its use for painful conditions. According to the NTH Consensus Statement (Acupuncture, 1998), efficacy of acupuncture has been shown when treating adults with postoperative and chemotherapy-induced nausea and vomiting, as well as with postoperative dental pain. The consensus statement further reports that acupuncture may be useful as an adjunct treatment, or an acceptable alternative treatment, for other conditions including low back pain. With the increasing incidence of low back pain in recent years, further research will be required to show that acupuncture may play a role in decreasing disability, absenteeism, and medical costs. The theory of Qi is supported by this research. When specific pomts along meridians are stimulated by needles, the balance and enhancement of the flow of Qi occurs. Once the flow was corrected, the subjects perceived a decrease in their pain. 36 Recommendations Further research is needed to investigate acupuncture in treating acute low back pain. Based on the results of this study, as well as limitations of this study, the following recommendations are made: 1. Double-blind studies are the gold standard of western medicine. One group of research subjects should receive acupuncture and the other group should receive sham acupuncture. The sham needling should involve very superficial needle placement and the meridians should be avoided. Distant anatomical sites should be used, with a small number of needles. 2. Larger sample size should be used to increase generalizability. 3. Include subjects from different demographic and racial groups. 4. 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Rockville, MD: Bigos, Bowyer, & Braen. 41 Weiss, R. (1995, January-February). Medicine’s latest miracle. Health, 1-7. 42 Appendix A Pain Scale I I I I I 0 1 2 3 4 I 5 6 I 7 I 8 I 9 I 10 43 Appendix B Mathematics for t-Test Calculations Step 1: Calculating the Mean of Sample Difference Scores D / Number of Subjects 24/12 = 2 Step 2: The Sum of Squares of Sample Difference Scores D2 - [(D)(0)] /12] 70 - [(24)(24) / 12] = 22 Step 3: t-Test for Correlated Groups Mean of Sample Difference Score Sum of Squares of Sample Difference Score / (Subjects)(Subjects - 1) 2/22 132 = 4.88 Step 4: Comparing t-Test Value with Significant Value = 4.88 > 1.761, Therefore the hypothesis is accepted (Pagano, 1998).