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CHAPTER 14/ MANUAL THERAPY IN PATIENTS WITH LOW BACK PAIN / 153
A
B
FIG. 14-2. Mobilization without impulse of the lumbar spine (A) and mobilization without impulse using the postisometric relaxation of the antagonistic muscle groups (B) also described as neuromuscular therapy (NMT). C: Arrow indicates the direction of isometr ic muscle contraction. D: Arrow indicates the direction of mobilization. (From Dvor ak J, Dvorak V, Schneider W , et al.Musculoskeletal medicine (man­ual therapy), 3rd English ed. Stuttgart/New York: G. Thieme Verlag, 2004, with permission.)
C
D
FIG. 14-3. Schematic drawing of the function of intersegmental rotatory muscles. (From Dvorak J, Dvo­rak V, Schneider W, et al. Musculoskeletal medicine (manual therapy), 3rd English ed. Stuttgar t/New York:G. Thieme Verlag, 2004, with permission.)
154 /SECTION II/ALTERNATIVES TO TRADITIONAL NONOPERATIVE TREATMENT
right. These techniques then attempt to increase spinal motion by stretching the incriminated shortened muscles and restoring mobility (Tables 14-1, 14-2).
CLINICAL MODEL FOR USE OF MANUAL THERAPY
Rehabilitative efforts for low back pain, especially when chronic, often present both a diagnostic and therapeutic challenge. Many practitioners of manual therapy have found it useful to approach to this complex clinical presen­tation by addressing specific clinical parameters first. They then attempt to integrate the findings (or lack thereof) within the greater clinical context. Three major domains of decision making have been identified as important when considering manual therapy for patients with lo w back pain or sciatica. These domains of diagnosis, in turn, are often further subdivided into specific subcategories.
According to this diagnostic approach there are three separate but interrelated thought processes involved when formulating a diagnosis for a patient where man­ual therapy is being considered. The f irst domain, the “structural diagnosis,” refers to specific organic pathol­ogy and relies on the ability to define an objective veri-
fiable pathologic lesion (e.g., disc herniation), osteo­porosis, spondylosis, spinal stenosis, spondylolisthesis, and others. The second domain refers to a “functional diagnosis” that is based on both manual and functional performance tests including such findings as muscle spasm or muscular contraction, gross range of motion, focal intersegmental restrictions in motion, spinal bio­mechanics, posture, and gait. The third level of infor­mation in the diagnostic process is the domain of the patient’s “pain perception” including those that exacer­bate or decrease the pain and the psychosocial issues that affect pain.
This model infers that the resolution or diminution of a patient’s pain can only occur when there is improvement on all three domains. The practitioner of manual therapy, using this model, will often include specific and individ­ually tailored rehabilitation ex ercises along with carefull y chosen passive physical therapeutic modalities all the while being cognizant of the patient’s psychosocial situa­tion. The unique clinical setting of the manual medicine practitioner, where there is physical contact with the patient and often multiple office visits, allows for a closer doctor-patient interaction than is commonly noted in con­ventional medical practices.
TABLE 14-1. Overview of some of the most commonly used manual therapy techniques
Manual therapies
Manual medicine techniques Therapeutic massage
Mobilization with impulse without impulse Soft tissue techniques techniques
Thrust techniques Counterstrain technique Ar ticulator y technique Swedish-type massage
1. Chiropractic adjustment Craniosacral technique Deep pressure technique Effleurage (stroking)
2. Osteopathic Thrust Functional technique Diaphragmatic release Pétrissage (kneading) Terminology Muscle energy technique Lymphatic pump technique Friction (rubbing) Thrust is also known as: Myofascial release technique Mesenteric release Tapotement (percussion)
1. High-velocity/low Ligamentous release Pectoral release Acupressure impulse technique or technique Stretch techniques: Lateral, Bindegewebsmassage
2. Manipulation (nonspecific, Myofascial trigger point linear, diagonal, etc. Deep tissue massage general term) technique Traction Lymphatic massage
a
As with any classification, this table should be used as a general guide rather than a definitive one, since there is a considerable amount of overlap among the v arious manual medicine techniques, as well as with some of the massage techniques.
Visual techniques Reflexology
Remarks: Remarks: Remarks: The nonthrusting techniques Soft tissue techniques are There are numerous types
Mobilization Common massage
Shiatsu Sports massage (variation
Combined techniques
Neuromuscular treatment I Integrating/movement Neuromuscular treatment II approaches Neuromuscular treatment III 1. Alexander technique
2. Feldenkrais method
3. Rolfing
4. Many others
typically take into account used for preparation or of massage approaches articular and/or soft tissue can be used independently. with even more variations motion restrictions.
a
of Swedish massage)
CHAPTER 14/ MANUAL THERAPY IN PATIENTS WITH LOW BACK PAIN / 155
TABLE 14-2. Comparison of the ter ms “manipulation” and “mobilization” showing continental differences
Europe USA Comments
Manipulation Refers usually to the thrusting A rather general term, which may When possible, and in order to
Mobilization Refers essentially to any type Usually refers to the various It is best to qualify the type of
From Dvorak J, Dvorak V, Schneider W. (eds). Manual medicine 1984. Heidelberg: Springer Verlag, 1984, and Dvorak J., et al.Manual medicine: diagnostics and therapy, 3rd English ed. Stuttgart:Thieme Publisher, 2004, with permission.
techniques, which are also refer to any therapeutic avoid confusion, the newer known as high-velocity/low- procedure in which the hands terminology of “mobilization-with­amplitude techniques or the are used to treat the patient, impulse” (= thrust = high­“mobilization-with-impulse” including thrust techniques. velocity/low-amplitude [HVLA] techniques. technique)
or
Chiropractic adjustment is a “mobilization-without-impulse”
generic term with over 100 (= nonthrust techniques) should sub-techniques, including the be used. high-velocity/low-amplitude (HVLA) thrust and the low-force techniques.
Osteopathic manipulative
treatment (OMT) encompasses
the entire spectrum of manual therapies from thrust to nonthrust, including the soft tissue techniques.
of induced tissue or joint nonthrusting and soft tissue mobilization used. movement which is then techniques. qualified by describing the presence or absence of impulse forces (thrust vs. nonthrust techniques, respectively).
INDICATIONS AND CONTRAINDICATIONS FOR SPINAL MANIPULATION
The appropriate application of manual medicine proce­dures, as with any other treatment approach, requires not only theoretical knowledge and training about the indica­tions and contraindications of a particular technique, but also a high level of technical skill and experience by the practitioner (1–3). Unfortunately the identification of the patient likely to respond to manual therap y is not yet clear. This lack of information has, as in the case of many med­ical procedures, led to reliance on consensus conferences to determine the indications for manual medicine.
In 1990, the RAND Corporation, which has produced appropriateness guidelines for several health care provider groups, convened two expert panels to help establish indications for spinal manipulation for back pain conditions (4). These indications, when appropri­ately applied, would include by far the majority of patients with low back problems (4). These panels stated that, in the absence of contraindications, a short trial of therapy using spinal manipulation for patients with lower back pain with or without sciatica was appropriate.
The absolute or relative contraindications to manual ther­apy identified by these panels included progressive neuro-
logic deficits from any cause, the most common of which are disc herniation, space-occupying lesions, and progres­sive spinal stenosis. Other contraindications include seg­mental hypermobility due to pathologic and traumatic frac­tures, acute rheumatoid inflammatory joint disease, destructive bone lesions secondary to tumor or infection, and bleeding disorders due to metabolic, congenital, or medication causes. Some of these conditions may show some symptomatic relief because of manual therapy as long as the mobilizations and the therapeutic massage tech­niques are carefully chosen and cautiously applied.
Major complications from manual therapy applied to the lumbar spine appear to be extremely rare. There have been a few case reports of cauda equina syndrome following lumbar manipulation (5) but it is not yet evi­dent whether the cases would have progressed in the natural course of the disc herniation or were directly affected by a manipulation. Thus far there are no good data indicating spinal manipulation can adversely affect lumbar discs. The risk of irreversible cauda equina syn­drome was estimated by Shekelle et al. (6) to be as low as 1 in 100 million lumbar spine manipulations, but this estimate was based only on reported cases and presum­ably there are a number of additional cases w here a tem­poral relationship exists.
156 /SECTION II/ALTERNATIVES TO TRADITIONAL NONOPERATIVE TREATMENT
One point that is evident from both clinical practice and the scientific literature is that manual therapy is not a panacea and not all patients with low back pain respond with reduction of symptoms. Explanations for this varia­tion in patient responses include three possibilities (7): (a) an inadequate workup of the patient’s symptoms lead­ing to a wrong diagnosis; (b) the unnecessary or inappro­priate application of manual therapy (the diagnosis may have been correct but treatment was “wrong”); and (c) the probability that, for many patients with lo w back pain, there may be no current adequate treatment.
EFFECTIVENESS OF MANUAL THERAPY IN THE TREATMENT OF BACK PAIN SYNDROMES
One of the difficulties in performing randomized clin­ical trials to determine the effectiveness of manual ther­apy is the ability to perform a double-blind study and the inability to establish a placebo treatment. This is not unique to the manual therapies, but is true of all active treatment approaches including the physical therapies and exercise. The comparison of manual medicine treat­ment approaches with other treatment interventions and the development of placebos based on touching the patient or performing massage, however, have allowed certain conclusions to be drawn regarding effectiveness of the manual therapies relative to no treatment and to many of the common approaches to patients with low back pain. Currently there are more than 45 randomized clinical trials, more than almost any other treatment approach to low back pain, that have attempted to evalu­ate the effectiv eness of the manual and manipulati ve ther­apies. There are also over 50 reviews of the studies that have been published in peer-reviewed journals. It is only possible to list a few of these in a short chapter on the topic and to discuss some of the key findings and con­clusions from these papers.
An example of the type of study that has been attempted to look at the effectiveness of manual therapy is a prospective randomized clinical study by Koes et al., published in 1992 (8), where 256 patients with chronic low back pain were referred for one of four categories of treatment (manipulation, physical therapy, placebo, or treatment by a general practitioner). The patients in the manipulation group and those in the active physical ther­apy group show ed a more fa v orab le outcome at the 3- and 6-week follow-up than those who had been assigned to either the placebo group or treatment by the general prac­titioner. Howev er , by 12 weeks the differences had almost entirely disappeared. Yet, patients in the manual medicine group had received less treatment (5.4 treatment sessions versus 14.7 treatments) than those in the physical therapy group, and the authors thought that this might be regarded as a considerable advantage. The acceptance of the treatment was greater by the patients in the manual medicine group than in the other treatment groups. In a
follow-up paper, the authors noted that improvement in the main complaint was larger with manipulative therapy (4.5 times) than with physiotherapy (3.8 times) after 12 months’follow-up (difference 0.9; 95% confidence inter­val 0.1 to 1.7). Manipulative therapy also resulted in larger improvements in physical functioning (difference
0.6; 0.1 to 1.3). The authors concluded that manual ther­apy and physiotherapy are better than general practitioner and placebo treatments, and that manipulative therapy is slightly better than physiotherapy after 12 months. These observations are similar to those presented in the retro­spective study by Patijn (9).
Triano et al. (10) elected to use a sham manipulation as a control group in an attempt to create a placebo. These authors reported on a prospective clinical trial of 145 patients who had experienced chronic back pain who were randomized into three groups according to specific manipulation, sham manipulation, and a group who re­ceived instruction materials. Two-week follow-up revealed that the group that had received specific manip­ulation showed a signif icantly lower visual analog pain scale value and a greater willingness to participate in rehabilitation, that is there was a greater trust in actively participating in their program. The recent study by Aure et al. (11), on the other hand, looked at the issue as to whether manual therapy was, as effective as well- estab­lished treatment approaches such as exercise. They eval­uated patients with chronic low back pain randomized to either exercise or manipulation with 1-year follow-up to compare the effect of manual therapy to exercise therapy in work-disabled patients. Although improvement was observed in both groups, the manual therapy group showed signif icantly greater improvement than the exer­cise therapy group in all outcome variables. Immediately after the 2-month treatment period, 67% in the manual therapy group and 27% in the exercise therapy group had returned to work.
Reviews of the literature on the manual therapies have included meta-analyses, reviews grading the method­ologic quality of the clinical trials, and the use of evi­dence tables and best evidence synthesis such as that done through the Cochrane Collaboration. Koes et al. have published a series of reviews of the scientific litera­ture over the past 12 years using a described method of ranking the quality of the clinical trials. This group per­formed one of the earliest meta-analyses of the manipu­lation literature in 1991. Unfortunately 36 of the random­ized clinical studies that they reviewed were thought to have low methodologic quality scores. They noted that approximately half of the studies indicated a positive result for manual medicine approaches on patients suffer­ing from various disorders although the most favorable results were often in the studies with low methodologic scores. Similar observations were made when evaluating studies that looked at the evidence in favor of other treat­ments such as physical therapy and training therapy (12),
CHAPTER 14/ MANUAL THERAPY IN PATIENTS WITH LOW BACK PAIN / 157
and the evidence for these common treatment approaches was often less than that for the manual therapies. In 1991, Shekelle et al. (4), in a very detailed and critical evalua­tion of the randomized clinical trials, came to a similar conclusion with a slightly different emphasis. These authors thought that spinal manipulation had been demonstrated to be of short-term benefit in certain patients, particularly those with uncomplicated acute lower back pain. They based this conclusion on a meta­analysis of a subset of seven clinical trials in which re­covery at 3 weeks could be compared with that of other therapies. The pooled estimate showed a 17% higher like­lihood of recovery in fa vor of spinal manipulation. Again, a substantial number of trials were excluded from the meta-analysis by these investigators because most of the published randomized clinical trials at the time had used outcomes measured on a quantitative scale, such as pain and disability, rather than dichotomous outcomes.
The most comprehensive systematic reviews involving an array of different treatments for low back pain have been performed by van Tulder et al. (13,14) on a regular basis over the past few years with regular re-analysis of the newer trials. These authors have assessed the methodolo gic quality of the trials and used specific evidence-based rules to determine the presence and strength of evidence of effi­cacy. They concluded that for acute low back pain there was evidence to suggest that spinal manipulation is better than placebo, physical therapy, exercise, and short-wave diathermy. For chronic lower back pain, they found strong evidence that spinal manipulation was better than placebo, and moderate evidence that it was better than the treatment offered by a general practitioner, massage, bed rest, and analgesics. Bronfort et al. (15) published a systematic review of the efficacy of spinal manipulation emphasizing the magnitude of treatment effects compared to other treat­ments in determining the strength of evidence. These authors elected to set aside the conclusions by the investi­gators of the individual randomized clinical trials and to focus on the data only. Their analysis reached a conclusion similar to that of van Tulder et al. in that there is evidence of short-term eff icacy for spinal manipulation in patients with both acute and chronic lower back pain.
SUMMARY
Although manual therapy is one of the oldest and most widely practiced treatments for low back pain, there has been a rapid growth over the past 20 years in its accep­tance and use on an international basis. This is primarily due to the publication of a large number of clinical trials,
most of which suggest that this therapeutic approach is at least as efficacious as other established treatment approaches and is more efficacious than placebo and usual medical care.
There remain, however, numerous unanswered ques­tions concerning manual therapy. The exact physiologic effects and mechanisms of manual therapy are not known. The relative effectiveness of the choice of man­ual therapy approach depends primarily on the training and experience of the clinician. Current experimental and clinical research is beginning to look at these issues and hopefully, within the near future, it will be possible to identify the patient who would most likely benefit from manual therapy and to explain the mechanism through which the treatment effect is achieved.
REFERENCES
1. Dvorak J, Dvorak V, Schneider W, et al. Musculoskeletal medicine (manual therapy), 3rd English ed. Stuttgart/New York: G. Thieme Ver­lag, 2004.
2. Lewit K. Nebenwirkungen und kontraindikationen der manuellen ther­apie im bereich der halswirbelsaeule. Manuelle Medizin, 1987;25 (2092):42–43.
3. Schneider W. Muskulaere dysbalance. Der informierte Arzt, Gazette Medicale, 1988;2(1077):66–70.
4. Shekelle PG, Adams AH, Chassin M. The appropriateness of spinal manipulation for low-back pain: indications and ratings by a multidis­ciplinary expert panel. Santa Monica, CA: RAND Corporation, 1991.
5. Haldeman S, Rubinstein SM. Cauda equina syndrome in patients undergoing manipulation of the lumbar spine. Spine 1992;17(12): 1469–1473.
6. Shekelle PG, Adams AH, Chassin MR, et al. Spinal manipulation for low-back pain. Ann Intern Med 1992;117(7):590–598.
7. Kraft GH. The physiatric approach to upper limb pain syndromes. In: Physical medicine and rehabilitation clinics of North America. Philadelphia: WB Saunders, 1996.
8. Koes BW, Bouter LM, van Mameren H, et al. The effecti v eness of man­ual therapy, physiotherapy, and treatment by the general practitioner for nonspecific back and neck complaints: a randomized clinical trial. Spine 1992;17:1:28–35.
9. Patijn J, Durinck JR. Effects of manual medicine on absenteeism. J Manual Med 1991;6(2):49–53.
10. Triano JJ, McGregor M, Hondras MA, et al. Manipulative therapy versus education programs in chronic low back pain. Spine 1995;20:948–955.
11. Aure OF, Nilsen JH, Vasseljen O. Manual therapy and exercise therapy in patients with chronic low back pain: a randomized, controlled trial with 1-year follow-up. Spine 2003;28(6):525–531; discussion 531–532.
12. Koes BW, Assendelft WJ, Van der Heijden GJ, et al. Spinal manipula­tion and mobilisation for back and neck pain: a blinded review. Br Med J 1991;303:1298–1303.
13. van Tulder MW, K oes BW, Bouter LM. Conservative treatment of acute and chronic nonspecific low back pain. A systematic review of ran­domized controlled trials of the most common interventions. Spine 1997;22(18):2128–2156.
14. van Tulder MW, Koes BW, Metsemakers JF, et al. Chronic low back pain in primary care: a prospective study on the management and course. Fam Pract 1998;15(2):126–132.
15. Bronfort G, Haldeaman S. Spinal manipulation in patients with lumbar disc disease. Spine Surg 1999;11(2):97–103.
CHAPTER 15

Acupuncture and Reflexology

Marianne L. Magnusson and Malcolm H. Pope
COMPLEMENT AR Y AND AL TERN A TIVE MEDICINE IN TREATMENT OF LOW BACK PAIN
Despite the increased use and acceptance of complemen­tary and alternative medicine (CAM), there is relatively little information available concerning efficacy. A survey of 542 patients attending 16 family practice clinics was conducted to determine patients’ reasons for using CAM and the impact of CAM on health and well-being (1). Approximately 21% of the patients used one or more forms of CAM, of which the most common were chiro­practic (34.5%), herbal remedies (26.7%), and massage therapy (17.2%). In spite of poor evidence for eff icacy, CAM is used for low back pain (LBP) more frequently than for any other indication. Expert opinions on the use of CAM for LBP could therefore be helpful until more randomized controlled trials (RCTs) are available. Ernst and Pitller (2) sent a questionnaire to 50 clinical experts on LBP to assess the perceived clinical effectiveness of CAM for four categories of LBP. The conclusions were that expert opinion is in favor of the effectiveness of acupuncture for acute uncomplicated LBP, whereas homeopathy was perceived ineffective for LBP.
REFLEXOLOGY
Furlan et al. (3) conducted a Cochrane Review on mas­sage therapy. Four randomized controlled trials met the inclusion criteria. Two trials were of high and two were of low methodolo gic quality. None evaluated massage as the main intervention. Rather, it was the control intervention in studies evaluating manipulation, electric stimulation, and a lumbar corset. There was limited evidence showing that massage is less effective than manipulation immedi­ately after the first session and moderate evidence show­ing it is less effective than transcutaneous electric nerve stimulation (TENS) during the course of sessions in relieving pain and improving activity. At the completion of treatment and at 3 weeks after discharge there was no
difference among massage and manipulation, electric stimulation, or corsets, but this evidence is limited. The reviewers concluded that there is insufficient evidence to recommend massage as a stand-alone treatment for non­specific LBP.
Reflexology has been in existence for many thousands of years and can be considered a type of massage. It was first practiced in India, China, and Egypt and then intro­duced to the West at the beginning of the 20th centur y as zone therapy (4). It was suggested that pressure on spe­cific par ts of the body could have an anesthetizing effect on a related area. The body is divided into 10 equal verti­cal zones, and pressure on one part of a zone is said to affect all structures within that zone. It was taught that “bioelectric energy” flowed through these zones to “reflex points” in the hands and feet. In the 1930s, the zone therapy was refined into what was termed “foot reflexology,” which suggests that “congestion” or tension in any part of the foot mirrors “congestion” or tension in a corresponding part of the body (5).
Charts with organs superimposed on the foot, hand, or ear are used to map these points. The reflexologist looking for constrictions or painful areas probes the theoretical reflex points by using the charts to determine what body part corresponds to that area of the foot (or hand or ear, etc.). There are areas that are said to correspond with the lumbar spine. Several products (e.g., sandals, shoe inserts, foot massage devices) are sold based on this theory.
Jarvis (6) concluded, because of a carefully conducted trial, that reflexology could not reliably f ind conditions known to be present and thus was not predictive or ther­apeutic. Jarvis concludes that reflexology has little poten­tial for direct harm, but can mislead people into believing that it can be used for screening or having real therapeu­tic value. No scientific trials were found that showed any value of reflexology for lumbar spine problems. Jarvis advises us to be skeptical of therapeutic claims beyond the ability of foot massage for relaxation.
158
CHAPTER 15/ACUPUNCTURE AND REFLEXOLOGY / 159
ACUPUNCTURE
Acupuncture, a form of Eastern medicine that has been practiced for many centuries, is the stimulation of special “points” on the body, usually by the insertion of fine nee­dles. Originally there were 365 such points, correspond­ing to the days of the year, but the number identif ied by proponents during the past 2,000 years has increased gradually to over 2,000 (7). Acupuncture uses the merid­ian systems of the body (Chinese system of energy flow in the body) to promote healing and treat injury and dis­ease. Through the insertion of needles into well-def ined acupuncture sites, the nervous system is stimulated to release chemicals in the muscles, spinal cord, and brain. These chemicals will either change the experience of pain, or they will trigger the release of other chemicals and hormones that influence the body’s own internal reg­ulating system. The improved energy and biochemical balance produced by acupuncture results in stimulating the body’s natural healing abilities, and in promoting physical and emotional well-being. The use of heat and electric stimulation at the acupuncture sites is thought to augment the therapeutic effect of needling and is used particularly in treating chronic pain (8).
The following mechanisms have been proposed to explain acupuncture’s presumed action on pain: The effects of acupuncture, particularly on pain, are partially explica­ble within a conventional physiologic model, which sug­gests that acupuncture stimulates A
fibers entering the
δ
dorsal horn of the spinal cord. This mediates segmental inhibition of pain impulses carried in the slower, unmyeli­nated C fibers and, through connections in the midbrain enhances descending inhibition of C fiber pain impulses at other levels of the spinal cord. This helps explain why acupuncture needles in one part of the body can affect pain sensation in another region. Acupuncture is also said to stimulate release of endorphins and other neurotransmit­ters such as serotonin. This is likely to be another mecha­nism for the effects of acupuncture, such as in acute pain (8). Another explanation is the “gate theory”, which sug­gests that if pain fibers car ry impulses from an acupunc­ture site, impulses from a painful body organ will be unable to reach the brain. Attention can be diverted from a symptom by stimulating or irritating another part of the body. Psychological mechanisms—including suggestion, operant conditioning, and other psychological mecha­nisms—may be involved in the placebo effect.
Theory and Practice
Acupuncture is based on ancient Chinese medical phi­losophy, which views illness quite differently than con­temporary science (9). In ancient China, diseases were not systematically described or classified (10). Internal organs, which were felt to be intermediaries between the body and nature, were assigned qualities representing
emotional states, colors, and seasons. Some organs, such as the “triple warmer,” were imaginary. There were no concepts of modern physiology, biochemistry, nutrition, or mechanisms of healing. There was no knowledge of the existence of cells, the circulation of the blood, the function of nerves, or the existence of hormones. Knowl­edge of anatomy was incomplete.
Diagnosis
Traditional Chinese diagnosis does not correlate with modern scientific concepts. An ill person was considered out of balance with nature and its two opposing forces, yin and yang. Yin represented the feminine, passive, or accepting qualities and yang the masculine, aggressive, or forceful ones. Diseases were not described or named. Diagnoses were made from examining the pulse (of which there were supposedly six variations) and the tongue, which was said to v ary in appearance with certain disease states.
Treatment
Although the details of practice differ between schools, all traditional acupuncture theory is based on the concept of yin and yang. Illness is seen as excess or deficiency in various exogenous and endogenous pathogenic factors, and treatment is aimed at restoring balance. This reestab­lishing of “balance” and “harmony” supposedly occurs as symptoms improve. Since there was no formal study of diseases or description of their natural history , the ancient Chinese could rarely determine how an illness actually improved. Treatments were chosen by trial and error, and perpetuated by personal experience. Since there were no scientific criteria for success or failure, the judgment that “healing” had taken place was based on the word of the therapist or the patient.
Acupuncture points were assigned to “meridians” on the surface of the body . These supposedly represent chan­nels through which flows the life force, “Ch’i” (or “Qi”). Insertion of needles at the designated points was said to increase or decrease the flow of Ch’i to achieve a more normal and harmonious state (7).
The life force, Ch’i, has no basis in human physiology. The meridians are imaginary; their locations do not relate to internal organs, and therefore do not relate to human anatomy. Acupuncture points are also imaginary. (Various acupuncture charts give different locations for the points.) These concepts continue to form the basis of modern acupuncture therapy even though extremely sophisticated methods are used to measure its reputed biochemical effects. Although scientific methods may be applied to biochemical studies, many published reports are based solely and uncritically on clinical anecdotes and tradition (11). In conclusion, the existence of “merid-
160 /SECTION II/ALTERNATIVES TO TRADITIONAL NONOPERATIVE TREATMENT
ians,” “acupuncture points,” or Ch’i has never been sci­entifically validated.
VARIATIONS AND OFFSHOOTS OF ACUPUNCTURE
Acupressure
Acupressure uses firm digital pressure on trigger or acupuncture points. Shiatsu, a modified form of acupres­sure, is a form of Japanese traditional medicine (12).
Auriculotherapy
Auriculotherapy is based on the notion that the body and organs are represented on the ear (13). Needles are placed in the imaginary points representing the diseased organs. There is no scientific evidence that these points exist or that auriculotherapy has any therapeutic value (14).
Staplepuncture
In staplepuncture, staples are placed at acupuncture points on the ear, typically to aid smoking cessation or drug withdrawal.
PROS AND CONS OF ACUPUNCTURE
The World Health Organization recognizes the use of acupuncture in the treatment of a wide range of medical problems including neurologic and muscular disorders:
1. Digestive disorders: gastritis and hyperacidity, spas­tic colon, constipation, diarrhea.
2. Respiratory disorders: sinusitis, sore throat, bronchi­tis, asthma, and recurrent chest infections.
3. Neurologic and muscular disorders: headaches, facial tics, neck pain, rib neuritis, frozen shoulder, tennis elbow, and various forms of tendonitis, LBP, sciatica, and osteoarthritis.
4. Urinary, menstrual, and reproductive problems.
5. Smoking cessation.
The National Council Against Health Fraud (NCAHF)
believes:
1. Acupuncture is an unproved modality of treatment.
2. Its theory and practice are based on primitive and fanciful concepts of health and disease that bear no relationship to present scientific knowledge.
3. Research during the past 20 years has failed to demon­strate that acupuncture is effectiv e against an y disease.
4. Perceived effects of acupuncture are probably due to a combination of expectation, suggestion, counterir­ritation, operant conditioning, and other psychologi­cal mechanisms.
5. The use of acupuncture should be restricted to appro­priate research settings.
6. Insurance companies should not be required by law to cover acupuncture treatment.
7. Licensure of lay acupuncturists should be phased out (15).
EVIDENCE OF ACUPUNCTURE EFFICACY
Symptom relief with acupuncture is difficult to assess because there is no objective standard of measurement. Double-blind studies comparing the insertion of needles at acupuncture points and at other points (“sham acupunc­ture”) are difficult to design. If an experienced acupunc­turist locates the points, the practitioner’s expectations may be transmitted to the patient. If an inexperienced person inserts the points, misplaced needles may undermine the results. Moreover, practitioners may differ about the loca­tion of the points, so it may be difficult to find a patch of skin that has not been labeled an “acupuncture point.” Chronic pain is often cyclic, with periods of relief. Since people often request help when their pain is most severe, spontaneous improvement may occur, independent of the treatment (16). The natural history of most acute pain is that it improves with time and no intervention. Thus, there may be reports of improvement of symptoms from any intervention. There is general agreement that 30% to 35% of subjects’ pain improves from suggestion or placebo effect alone. Thus, measuring a small difference between placebo and acupuncture requires a large number of sub­jects to show as little difference as 25%. People who vol­unteer for acupuncture may have a conscious or uncon­scious bias toward the procedure and thus may be more prone to suggestion.
RESEARCH EVIDENCE
Richardson and Vincent analyzed 28 studies on the effect of acupuncture on pain. All were published between 1973 and 1986 in English language peer­reviewed journals. Fifteen showed no difference in effec­tiveness between acupuncture and control groups. Thir­teen showed some effectiveness for acupuncture over control groups, but not all controls were the same. (Some were compared to sham acupuncture, some to medical therapy, etc.) Overall, the differences were small (17,18).
The NCAHF Task Force on Acupuncture evaluated the above studies, as well as more recent ones, and found that reported benefits varied inversely with quality of the experimental design. The greater the benefit claimed the worse the experimental design. Most studies that showed positive effects used too few subjects to be statistically significant. The best designed experiments—those with the highest number of controls on variables—found no difference between acupuncture and control groups (15). In 1989 Dutch epidemiologists reported similar conclu­sions in 91 separate clinical trials of acupuncture for var­ious disorders. They also found that the stricter the con-
CHAPTER 15/ACUPUNCTURE AND REFLEXOLOGY / 161
trols, the smaller the difference between acupuncture and control groups (19).
Research evidence also shows that acupuncture has greater effects than placebo. Randomized trials have found that true acupuncture is more effective in relieving pain than a “sham” technique, such as inserting needles away from true points (however, the aforementioned dis­agreement about the localization of points should be con­sidered). Of the numerous studies on nausea, a condition that readily lends itself to placebo controlled trials, almost all show that stimulating true acupuncture points is more effective than stimulating false points. Studies showing that acupuncture can af fect anesthetized animals provide further evidence that its effects probably cannot be explained purely in psychological terms (7).
It is less clear whether acupuncture has clinically important benef its in the conditions for which it is typi­cally used. Much of the research evidence comes from hospital-based studies of acute conditions such as post­operative pain rather than studies of chronic conditions in primary care. Moreover, most trials have had small num­bers of patients and only short-term follow-up. Overall, evidence from several randomized controlled trials sup­ports the use of acupuncture in pain conditions, particu­larly migraine, headache, and postoperative pain. Such trials also provide e vidence of an effect of acupuncture in substance misuse, nausea, and stroke. Trials of acupunc­ture in asthma and hay fever have produced conflicting results. Systematic reviews and randomized controlled trials suggest that acupuncture is probably not of benefit for stopping smoking, tinnitus, or obesity.
ACUPUNCTURE AND LBP
The use of acupuncture to treat LBP has increased dra­matically in the past few decades. In spite of this, there is very sparse scientific documentation of outcomes from these treatments. In one study, 12 patients suffering chronic LBP were treated with both acupuncture and TENS. The order of treatments was balanced, and changes in the intensity and quality of pain were measured with the McGill Pain Questionnaire. Pain relief was produced in both groups and lasted between 23 hours for TENS and 40 hours for acupuncture. The difference between the treat­ments was not statistically significant. According to the authors, both methods could be equally effecti ve, and prob­ably have the same underlying mechanism of action (20). However, as there was no pure control treatment group the pain relief could be a Hawthorne effect or the two treat­ments were equally effective or ineffective.
Carlsson and Sjölund (21) randomly assigned 50 patients who had been suffering chronic LBP for a min­imum of 6 months and had tried a variety of other thera­pies to a manual acupuncture group, an electroacupunc­ture group, or a placebo group. Treatment was delivered once per week for 8 weeks and follow-up treatments
after 6 months or longer. The placebo group was given mock stimulation. An independent and blinded-to-treat­ment assessment (clinical interview, physical examina­tion) at baseline and at follow-ups at 1, 3, and 6 months classified the patient’s pain as improved, unchanged, or worse. Subjectively, patients reported pain intensity at the follow-ups. At the 1-month independent assessment, 16 of 34 patients in the acupuncture group and 2 of 16 in the placebo group improved (p < .05). There was also a significant decrease of pain intensity at 1 and 3 months in the acupuncture group. Sleep pattern was less dis­turbed and total intake of analgesics dropped dramati­cally after the treatment period in the acupuncture group, but not in the placebo patients. After 6 months, 14 acupuncture patients and two placebo patients were still improved (p < .05). There was no difference between types of acupuncture.
Kalauokalani et al. (22) analyzed 135 patients with chronic LBP who received acupuncture or massage in a randomized trial. Before randomization, study participants were asked to describe their expectations regarding the helpfulness of each treatment on a scale of 0 to 10. The primary outcome was level of function at 10 w eeks as mea­sured by the modified Roland Disability Scale. Improved function was observed for 86% of the participants with higher expectations for the treatment they receiv ed as com­pared with 68% of those with low er e xpectations ( p < .01). Furthermore, patients who expected greater benef it from massage than from acupuncture were more likely to expe­rience better outcomes with massage than with acupunc­ture, and vice versa (p < .03). The study suggests that patient expectations may influence clinical outcome inde­pendently of the treatment itself. In contrast, general opti­mism about treatment, divorced from a specific treatment, is not strongly associated with outcome.
Cherkin et al. (23) randomized 262 patients with per­sistent LBP to receive traditional Chinese medical acupuncture (n < 94), therapeutic massage (n < 78), or self-care educational materials (n < 90). Telephone inter­viewers masked to treatment group assessed symptoms and dysfunction. Follow-up was available for 95% of patients after 4, 10, and 52 weeks, and none withdrew for adverse effects. Treatment groups were compared after adjustment for pre-randomization covariates using an intent-to-treat analysis. At 10 weeks, massage was signif­icantly superior to self-care on the symptom (p < .01) and the disability scale (p < .001). Massage was significantly superior to acupuncture on the disability scale (p < .01). After 1 year, massage was not better than self-care but was better than acupuncture on the symptom and dys­function scales (p < .002 and p < .05, respectively). The massage group used the least medications and had the lowest costs of subsequent care (p < .05). Therapeutic massage was effecti v e for persistent LBP, pro viding long­lasting benefits. Traditional Chinese medical acupuncture was relatively ineffective.
162 /SECTION II/ALTERNATIVES TO TRADITIONAL NONOPERATIVE TREATMENT
A systematic review to assess the effects of acupunc­ture as treatment of nonspecific LBP was conducted by van Tulder et al. (24). Eleven studies were included, of which only two were of high quality. In the review, van Tulder et al. disagree with the original authors’ conclu­sions in 7 of the 11 studies. According to v an T ulder et al., there was no difference between acupuncture and control in seven trials. Acupuncture was superior in only two studies, whereas the results were unclear in the remaining two trials. Thus, 9 of the 11 studies could not show that acupuncture was more effective than placebo or sham acupuncture, nor with trigger-point injection or TENS. The reviewers’ conclusions were that this systematic review did not indicate that acupuncture is effective for the treatment of back pain.
A meta-analysis by Ernst et al. (25), of randomized controlled trials on acupuncture for back pain involving data from nine studies, showed improvement with acu­puncture compared with control intervention with an odds ratio of 2.30 (95% confidence interval 1.28 to 4.13). It was concluded that collectively, the data implied that acupuncture is superior to various control interventions, although there was insufficient evidence to prov e whether it is superior to placebo.
Although both studies, which virtually used the same RCTs, conclude that there is not enough evidence to prove acupuncture more effective than any other treat­ment, they present contradicting results. This is due to the different methods of assessing methodologic quality and of summarizing the results that were chosen. Because of the low quality, methodologic problems, and in some tri­als, the use of an invalid acupuncture treatment, van Tul­der et al. used a qualitative analysis, which took into account the levels of evidence rather than a statistical pooling across trials. Ernst et al. used a meta-analysis and quantitatively pooled the results from the trials.
SAFETY OF ACUPUNCTURE
As with all CAM, the absence of a formal system for reporting adverse effects means that acupuncture’s safety is difficult to assess. The definition of adverse effect varies and both under- and over-reporting occur. Most adverse effects are relatively minor events such as bruis­ing and dizziness but more serious events have been reported such as hepatitis and pneumothorax (26,27). A prospective study of over 55,000 acupuncture treatments given in a college for medically trained acupuncturists confir ms that acupuncture is probably safe in qualif ied hands (28). Only 63, mostly minor, adverse events were identified, and no cases of serious adverse events such as pneumothorax, infection, or spinal lesions were reported, although these have been described in the literature (27).
The adverse effects of acupuncture are probably related to the nature of the practitioner’s training. A sur-
vey of 1,135 Norwegian physicians revealed 66 cases of infection, 25 cases of punctured lung, 31 cases of increased pain, and 80 other cases with complications (29). A parallel survey of 197 acupuncturists, who are more apt to see immediate complications, yielded 132 cases of fainting, 26 cases of increased pain, 8 cases of pneumothorax, and 45 other adverse results (29).
In summary , because the quality of the RCTs that e val­uated acupuncture was generally poor, the effectiveness of acupuncture for treating acute or chronic back pain is unclear. However, acupuncture seems to be relatively safe (30).
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