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    THE JOURNAL OF ALTERNATIVE AND COlfPLel'\fENTARY MEDICINEVolume 5" Number I, 1999, pp. 5-26Mary Ann 'Liebert, Inc.

    Carpal Tunnel Syndrome: Clinical Outcome AfterLow-Level Laser Acupuncture, MicroampsTranscutaneous Electrical Nerve Stimulation, andOther Alternative Therapies-An Open Protocol Study

    KENNETH BRANCO, M.A., Lie.Ac.1and MARGARET A. NAESER, Ph.D., Lic.Ac., DipLAc. (NCCAOM)2

    ABSTRACTObjective: Outcome for carpal tunnel syndrome (CTS) patients (whnpreviuusly failed stan-dard medical/surgical treatments) treated primarily with a painless, noninvasive techniqueutilizing red-beam, low-level laser acupuncture and microamps transcutaneous electricalnerve stimulation (TENS) on the affected hand; secondarily, with other alternative therapies.Design: Open treatment protocol, patients diagnosed with. CTS by their physicians.Setting: Treatments performed by Iicensed acupuncturist in a private practice office ..

    Su.bjects: Total of 36 hands (from 22 women, 9 men)" ages 24-:84 years, median pain dura-tion, 24 months. Fourteen hands fafled 1-2 surgical release procedures.Intervention/Treatment: Primary treatment: red-beam, 670 nm, continuous wave, 5 mW,diode laser pointer (1-7 J per point), and micraamps TENS 900 p,A) onaffected hands. Sec-ondary treatment: infrared low-level Iaser (904 nm, pulsed, 10 W) and/or needle acupunctureon deeper acupuncture points; Chinese herbal medicine formulas and supplements, on case-by-case basis ..Three treatments per week, 4-5 weeks.Outcome Measures: Pre- and posttreatment Melzack pain scores; profession and employ-ment status recorded.Results: Posttreatment, pain, significantly reduced (p < .0001), and 33 of 36 hands (91.6%)

    no pain, or pain reduced by more than. 50%. The 14: hands that failed surgical release, suc-cessfully treated. Patients remained employed, if not retired. Follow-up after 1-2 years withcases less than age 6-0, only 2 of 23 hands (8.3%) pain returned, but successfully re-treatedwithin a few weeks.Conclusions: Possible mechanisms for effectiveness include increased adenosine triphos-phate (Al'P) on cellular level, decreased inflammation, temporary increase in serotonin. Thereare potential cost-savings with this treatment (current estimated cost per case, $12 ,OOOi thistreatment, $1,.00.0). Safe when applied by licensed acupuncturist trained. in laser acupuncture,supplemental home treatments may be performed. by patient. under supervision of acupunc-turist.

    lAcupilll.cture Healthcare Services,Westport, Massachusetts.2Department of Neurology, Boston University School of Medicine and Department of Veterans Affairs Medica!Center, Boston, Massachusetts. .

    5

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    6INt'RODucTION

    CarpalTUlU1el Syndrome (CTS) is an e n -trapment neuropathy of the median nerveat the wrist, due to compression of the mediannerve as it passes from the forearm to thepalm beneath the transverse carpal ligament(Stevens, 1997). A consensus On diagnostic cri-teria for CTS is lacking (Dawson, 1993;Stevens, 1997). However, there are specificsigns and symptoms associated with C'I'S, in-cluding paresthesias, numbness and tinglingin the sensory distribution of the median nervefor thumb, index, middle, and radial side ofring finger, Tine! sign, Phalen sign, hypoes-thesia, nocturnal awakening, specific pain di-agrams fer the hand, and. sometimes handweakness (Matte et al., 1989; Katz et al., 1990;Dawson, 1993; Hennessey and Kuhlman,1997). Nerve conduction studies (NeSs) arethe primary definitive test, although test re-sults considered to be compatible with ersvary somewhat across studies {Stevens, 1987;Feldmanet al., 1987;AAEM Quality Assur-ance Committee, [ablecki et al., 1993; Stevens,1997; Vermix etal., 1998} ..The etiology is unknown, however, CTS oc-cuts more commonly inworkers whose tasksinvolve repetitive hand movements, such ascomputer keyboard typing, operating machin-ery, and assembly line work. Overuse syn-drome (cumulative trauma syndrome, repeti-tive strain injury [RSI])has accounted for morethan 50% of all occupational illnesses in . theUnited States (Rempel et al., 1992); it may be aresult of concentration of the workload on afew smaller groups of muscles (Dawson, 1993).ers may be a minority of the cases of overusesyndrome, however, "collection of relevantdata has been hampered by the lack of con-sensus among researchers in the field." (Daw-.son, 1993, Stock, 1991).Current standard treatments for work-re-lated crs include, initially, conservative treat-ments and later, if necessary, surgical releaseof the transversecarpal ligament, Conservativetreatments include adjusting the work envi-ronment, and using wrist splints and non-steroidal anti-inflammatories (NSAIDs) (Feld-man et al., 1987;Mackinnon and Novak, 1994).

    BRANCO AND NABSERDirect injection of steroids into the carpal tun-nel may provide relief for only 2-4 months(Slater and Bynum, 1993); and at 18 monthsonly 22% of patients may be free of symptoms(Gelberman et al., 1980).Surgical release of the transverse carpal lig-ament is performed in approximately 40% ofcrs cases, with estimates of more than 460,000procedures performed each year, and a directmedical cost of over $1.9 billion (Levine et al.,1993; Palmer and Hanrahan, 1995). Good-to-ex-cellent results for pain relief are observed in80% of these cases, however, only 40% regainnormal function; 5%worsen (Cseuz et all 1966;Armstrong and Villalobos, 1997). Office work-ers return to work in a few weeks; those work-ing in heavier labor require 4--6 months of re-habilitation.crs requires, on average, the longest recu-peration period of all injuries or illnesses thatrequire days away from work (Brogmus andMarko, 1990). In 1995, half of all workers af-flicted with crs missed 30 days or more ofwork (BLS Reports, 1995). According to datafrom one state (Washington State Departmentof Labor & Industries) in 1992-1994, occupa-tional crs averaged 2.9 per lOQO'workers peryear (Daniell et al., 1998). "Two-thirds (67%) re-ceivedcompensation for ... median, 119 lostwork days ... and 27% for permanent partialdisability. Cumulative medical and disabilitycompensation costs during 1986-1994 (inWashington state) were $158- and $225 milliondollars." (Daniell et al., 1998).In 1996, the estima ted;incidence in the UnitedStates was 2 million cases (Brody, 1996), TheNational Council of Compensation Insurancefinds the average claim for CTS to. be $29,000,with the full cost being $100,.000 if lost pro-ductivity is taken into account (BLS Reports,1995). In 1993, the cost to treat one case of erswithout surgery inCalifornia was $5,246, andwith smgery, $20,925 (CTDNEWS, 1995) ..Theaverage cost to treat one case of CTS nation-wide is about $12,000 (Clairmont, 1997); the to-tal cost in1year could be as high as $12 to $24billion.There is need for new, less expensive andmore cost-effective, conservative treatments forCrS1RSI. This article presents clinical outcome

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    CARPAL TUNNEL SYNDROME~ LASER ACUPUNCTURE, LOW-LEVEL LASER 7data for CTS cases treated with a new, alter-native treatment program using primarily two,noninvasive, painless, treatment modalities,eg, red-beam laser and microamps transcuta-neous electrical nerve stimulation (TENS), tostimulate acupuncture points on the affectedhands (Naeser and Wei, 1994; Naeser, Hahnand Lieberman, 1996; Naeser et aLI 1997). Inaddition, other secondary; Oriental medicinetreatment modalities were used, includingstimulation of deeper acupuncture points onthe posterior neck, shoulder, and elbow areawith infrared-beam laser and/or needleacupuncture, moxibustion, Chinese herbalmedicine formulas and/ or supplements. As iscommon practice in traditional Chinese med-icine (TCM), each patient was treated with anindividually determined treatment protocol.The single common treatment that every pa-tient received was the stimulation of handacupuncture points with red-beam laser andmicroarnps TENS. The other secondary, Ori-ental medicine therapies varied from case tocase, as determined by TeM diagnosis (utiliz-ing palpation, pulse diagnosis, tongue diag-nosis, and patient history). This article pre-sents information on how low-level laseracupuncture, microarnps TENS, and other al-ternative treatment modalities were used totreat a series of CTS patients who had failedto obtain pain relief after standard med-ical/surgical treatments for CTS.

    REVIEW OF NEEDLE ACUPUNCTURE TOTREAT CTS PAIN

    There are two uncontrolled, anecdotal clini-cal studies with needle acupuncture to treatCTS. Chen (1990) observed a success rate of97.2%where 35 of 36 cases had good-to-excel-lent outcome after 4-29 treatments (2-8weeks).Fourteen cases had failed surgery; the durationof pain prior to acupuncture ranged from 2months to 10years. Follow-up at a mean of 5.1years showed 24of 29cases (82.8%)to be pain-free. Wolfe (1995) observed a success rate of87.5%for 14of 16CTScases who were treatedwith needle and electroacupuncture, moxibus-tion, and Chinese herbs.

    RATIONALE FOR LOW-LEVEL LASERACUPUNCTURE TO TREAT CTS PAINSince the early 1980s, low-level lasers have

    been used anecdotally to stimulate acupunc-ture points (instead of needles) to help treatpain (Kleinkort and Foley, 1984). Low-levellaser acupuncture also has been used to helptreat paralysis and spasticity in adult stroke pa-tients (Naeser et al., 1995),and cerebral palsyin babies and children (Lidicka and Hegyi,1994; Asagai et al., 1994); its wide variety ofuses is reviewed byNaeser and Wei (1994).Theuse of low-level laser to promote wound heal-fig and treat a variety of pain disorders hasproduced variable results (there are no defini-tive guidelines yet determined for ideal wave-length ofthe laser beam, power ofthe laser out-put, number of joules, frequency of treatments,etc.); these topics have been reviewed by Bas-ford (1989;1993).Low-level laser stimulation is noninvasive,

    and it produces no feeling when applied to theskin--no heat, no cold, no pain. The high-level,cutting lasers used in.surgery are around 300W. Low-level lasers in the range of 5-500 mWare classified by the Food and Drug Adminis-tration (FDA) as class IIIb lasers (U.S.Depart-ment HHS, 1985). When used within FDAsafety guidelines (not shown directly into theeyes), and approved by an InstitutionalReviewBoard.Jow-level laser studies are considered tobe "Nonsignificant RiskDevice Studies" (FDA,1986,p. 7-96).

    EFFECT OF LOW-LEVEL LASER ON THECELLULAR LEVEL

    While the mechanisms through which laserstimulation affects cells are not completely un-derstood, research on this has been underwaywith low-level, red-beam, helium neon (HeNe)laser since the 1960s(Mester et al., 1967;Gama-leya, 1977; Mester et al., 1982;Mester et al.,1985; Karu, 1987), and reviewed by Basford(1989; 1993). There is an optical window be-tween 600 and 1300nm wavelength (red-beamto near-infrared), for laser penetration into hu-man skin (Anderson and Parrish, 1981)..Red-

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    8beam laser light appears to have a shallow pen-etration, O.8-mm direct energy (Seitz andKleinkort, 1986t whereas lasers in the infraredrange have a deeper: penetration, up to 1.5inches (Seitz and Kleinkort, 1986; Hudson,1997),.As. the laser beam passes through tissue,however, it is rapidly reduced in its incidentintensity. For example, with red-beam laser, theincident intensity may be only 37%, within onlya few millimeters. However/with infrared laser,the penetration may be several millimetersmore (Basford, 1993; Kolari, 1985; Andersonand Parrish, 1981).Hudson (1997) has observeda 904-nm infrared laser beam to be detectableat greater than 50% output power, at l-inchdepth penetration inbovine muscle tissue (10W, pulsed at 3500 pulses per second (pps); Re-spond Systems model 2400, Branford" C'l'), Thelow-level laser effects are not based on thermalmechanisms; there is perhaps no more than aO.l"C to O. .7S"C increase (Basford, 1989; 1993;Walsh et 1 3 . 1 . , 1995).Basic research with red-beam, low-level laser

    has observed the following effects on the cel-lular level in rat liver mitochondria {Passarella,1989): (1) The optical properties of mitochon-dria are influenced by BeNe laser irradiation(Passarella et al., 1983). (2)Adenosine triphos-phate (ATP) extrasynthesis occurs in mito-chondria after HeNe laser irradiation (Pas-sarella et al., 1984; Passarella et al., 1987). (3)Laser irradiation generates new mitochondrialconformations as revealed by electron ID kcroscopy studies (Passarella et al., 1988). (4)Oxygenconsumptionhas been observed to sig-nificantly increase with a 660-run laser, 10rnW 10m 2 output (at 0.6 J/cm:2 and 1.2 Jlcm2)(Yu et al., 1997). Other significant cellularChanges were also observed including in-creased phosphate potential and energy charge(at 1.8 J/c012 and 2.4 J / c 0 1 2 ) in the Yu et a1.(1997) study.

    OTHER. POSSIBLE EFFECTS OFLOW-LEVEL LASER..Low-level laser biostimulation WilY have ananti-inflammatory effect. Goldman et al, (1980)observed an anti-inflammatory effect inrheumatoid arthritis; a decreased level of cir-

    BRANCO AND NAESERculating immune complexes as measured byplatelet aggregation was observed during theuse of real (not sham) laser. Palmgren et al,(1989), also working with rheumatoid arthritiscases, observed real laser treatments with an820-nm infrared diode laser on the finger joints,as well as sham laser treatments, to signifi-cantly decrease pain; however, only those pa-tients.recei vingthe real treatments also showeda significant trend toward decrease in. sedi-mentation rate and number of leukocytes.Walke.r (1983) has suggested that HeNelaser affects serotonin metabolism, because alarge increase in urinary excretion of 5-hy-droxyindoleacetic acid was noted after 10 red-beam, BeNe laser treatments, in patients whowere successfully treated for chronic pain af-ter 30 treatments, in a placebo-controlled,double-blind study. Sham stimulation had noeffect.Walker and Akhanjee (1985) have suggestedthat because' low-level laser produces no de-tectable thermal change, itmay be photochem-ical reactions that alter neuronal activity. Pho-tons may interact withchromophores (opticallyactive molecules) on nerve membrane (Ander-son and Parrish, 1982;Regan and Parrish, 1982;Smith, 1980). Walker and Akhanjee (1985) alsomention that alternatively, light may interactwith rhodopsin kinase or a rhodopsin kinase-like protein that occurs indifferent areas of thenervous system (Somers and Klein, 1984).

    EFFECT OF LOW-LEVEL LASER ONNERVE CONDUCTION

    The effect of low-level laserirradiation on theconduction velocity of the median or superfi-cial radial nerve in asymptomatic human vol-unteers has been examined with conflicting re-S"Ll1tS. Snyder-Mackler and Bork (1988) reporteda .significant increase in latency in the superfi-cial radial nervecomparedto placebo (p < .01)using red-beam, ReNe laser at19 m JI d1U2. Bas-ford et al. (1993),however, using 830-nm (near-infrared) at 1.2 J per point, observed a signifi-cant decrease ip < .016, p < .046) in motor andsensory distal latencies (DL) respectively, rela-tive to placebo control. Other studies with 830-nm laser, especially at 1.5 J Iem2, have shown. .

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    CARPAL TUNNEL SYNDROME, LASER ACUPUNCTURE, LOW-LEVEL LASER 9significant increases in antidromic conduction ceived a total of 16 treatments (Meyer and Ne-latencies (Baxter et al., 1994; Lowe et al., 1994). brensky, 1983).

    LOW-LEVEL LASER TO TREAT CTS PAINIn an uncontrolled study with open protocol,23 cases with CTS (30 hands) were treated with830 nm, 30 mW laser (9 J per point), at 5 pointsalong the median nerve at the wrist/hand(Weintraub, 1997). A normalization of DL com-pound muscle action potential (CMAP) in 11hands and tendency to improve in23.4% wasobserved, reversing CTS in 77% of cases. Alsoin a separate uncontrolled study, with 35CTS/RSI cases, using 830 run, 100 mW laser(12-30 J per point), Wong et al. (1995) success-fully treated 91.4% of cases by treating only at

    the posterior neck region (C5-TI, not thewrist/hand) over an 8-month period (10 treat-ments). No NCS data were included in theWong et al. (1995) study.Rat ionale fo r m ic ro am ps TENS to trea t CTS painMost standard TENS devices use milliamps,and the patient feels a tingling sensation underthe TENS pads. Milliamps TENS is believed toreduce pain, in part, through the Gate ControlTheory (Melzack and Wall, 1965). Microamps

    TENS is different and the patient feels nothing.E ffects of Microamps on the C ellu la r L ev el. Mi-croamps stimulation has been observed to havean effect on adenosine triphosphate (A T P) con-centrations and protein synthesis on the cellu-lar level in rat skin (Cheng et al., 1982). In theCheng study, ATP concentrations were in-creased by as much as 300% to 500

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    10

    10.3). The duration of hand pain ranged from3 to 30 months, mean, 14.6 months, SD, 10.6;median, 15 months). The pretreatment nerveconduction study data showed the cases tohave only mild/moderate CTS, ie, the motordistal Iatencieswere 6.5 IIl$or less, and the sen-sory latencies were 4.4 InSor less (n =7), or ab-sent (n = 3). No severe CTS cases with abnor-mal electromyogram were included.The low-level laser acupuncture and mi-croamps TENS treatment protocol (number ofjoules andtreatrnent times) used in the con-trolled research is similar to the treatment pro-tocol in the present clinical outcome report (ex-plained below, under T re atm en t M eth od ).Briefly, the red-beam laser and microampsTENS were used on the affected hand; and theinfrared laser was used on deeper acupuncturepoints on the posterior neck, shoulder and el-bow areas. Patients felt no stimulation duringany of the treatments (real or sham).The shallow acupuncture points on the handwere treated with the 15 InW red -beam laserwhile the patient was seated at a table and thehand was placed behind a hanging black cur-tain, Most of thes, shallow points were treatedwith 1 J per point (66.6 seconds; or 33.2 Jjcm2).The deeper acupuncture points on thepeste-.rior neck, shoulder and elbow were treatedwith invisible infrared laser that, of course, thepatient could not see, even during the real in~frared laser beam emission. USIng the lOWpulsed infrared laser, the deeper acupuncturepoints were treated first with a higher fre-quency pulse rate (3500 pps for 1 minute, 1.8JI cm/), then at lower frequency pulse rates fora few minutes (584 pps for 1minute, 0.3 J /cm2;and 73 pps for 1minute, O.04J/tm2). Treatmenttimes varied from case-to-case depending onthe type and location of pain. Patients weretreated threetimes a week (every other day);they received about 1 month of real or shamtreatments, with a cross-oyer design for 1moremonth of treatments. All cases received a series

    BRANCO AND NAESERof real and sham treatments. The persons ob-taining the Melzack pain scores and the NerveConduction Study data were blind as to whichtreatmentcondition the patient had just com-pleted. No additional Oriental medicine treat-ment modalities were used with these researchsubjects.There was a significant reduction in theMe1zack pain scores after the real treatments(p = .0048),.but not after the sham. The meanMelzack pain score, pre-real treatment was 17.5(SD, 11.5); the mean Melzack pain score, post-real treatment was 4.1 (SD, 6.0). The meanMelzack pain score, pre-sham treatment was14.6 (SD, 11.2); the post-sham mean was, 11.4(SD, 13..7). .There was a significant decrease in the me-dian nerve, sensory latencyafter the real treat-ments (p = .006), but not after the sham treat-ments. The mean sensory latency, pre-tealtreatment was 3.98 (SD,0.72); the mean sensorylatency, postreal treatment was 3.73 (SD, 0.68).The mean sensory latency, pre-shamtreatmentwas 4.09 (SD, 0.58); the postsham mean was4.07 (SD, 0.66). There WaS no significant de-crease in the median nerve, motor latency af-ter either the real treatments or the sham treat-ments .All 10 patients were able to resume prior

    work with less or no painincluding computerkeyboard, handyman (cement laying, electricalwiring), house painter, plumber ..All cases haveremained stable in their pam reduction at 1-3years follow-up, except for one case.! This con-trolled research project is continuing.METHODS

    SubjectsA total of 36 hands were treated in this clin-

    ical outcome report. There were 31 CTS cases(22 females, 9 males) (Table I) ..The age at en-try ranged from 24-84 years (mean, 55.2, SD,

    lThis complex:case was a 59~year-oldwoman who had hadinsulin-dependent diabetes since age21; she had sus-tained a brain stem and left frontallobe stroke affecting the CTS hand 2 yeats prior to the laser acupuncture treat-ments. Her CTS painreturned Within 1 year after completion of laser acupuncturetreatments, and although somefollow-uptreatments initially relieved the pain for 3 more months, these treatments became ineffective. Subsequentsteroid injection into the carpal canal also failed to provide pain relief beyond a 3~monthpe)'_iod,

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    CARPAL TUNNEL SYNDROME,. LASER ACUPUNCTURE, LOW-LEVEL LASER18..9; median, 50 years), All cases had previ-ously received standard medical treatmentwithout successful pain relief. This includedNSAIDs and wrist splints ..Also, 17 of 36 hands(47.2%) had been treated with 1-3 cortisone in-jections; and 14 of 36 hands (38.8%) had re-ceived 1-2 surgeries for release of the trans-verse carpal ligament The duration of painprior to thi!::jnew alternative treatment programranged from 2 months to 18 years; median, 24months. The diagnosis of CTS had been madeby the patients' physicians. Data from nerveconduction study (NeS) and eleotromyogra-phy (EMG) were available for 6 cases (all intheolder age group, >60 years of age) (Table 1). .Stevens (1997) has stated that there is no uni-versally agreed on standard for the diagnosisof C'IS, or method of grading the severity ofCTS; rather a combination of clinical and elec-trodiagnostic information.should be used ..Withthis caveat in mind; electrodiagnostic stan-dards from a variety of sources (Feldman et al.,1987; Stevens, 1997i Vennix et at, 1998) wereused to define severity of CTS, as follows: bor-derline/mildCTS: 4.3 ms median nerve, motorDL across the carpal tunnel, and .3.4 InS, me-dian nerve, sensory latency; moderate CTS:greater than 4.3 ms to 7.0 IUS., motor DL, and3..4 ms or more, median nerve, sensory la-tency; and severe C'I'S: greater than 7.0 ms,motor DL, or evidence of denervation on elec-tromyogram.T re a tmen t Me th o dAll treatments were performed by KB ..withopen protocol in the acupuncture office. Priorto the first treatment and immediately after thelast treatment-each patient was administeredthe McGill-Melzack Pain Questionnaire(Melzack, 1975).Signed, informed consent was

    obtained.F Patients were treated every other

    2Low-l!3vellaserbiostim.u1ation for treatmentof pain isconsidered Investigational by the FDA. The licensedacupuncturist is registered with an Independent Institu-tional Revlew Board for Laser Acupuncture Research. NQmedical claims are-made. The laser beam is never showndirectly into the eyes " Themicroamps TENS device is notused with pregnant women, or with patients whq havea pacemaker.

    11day on a Monday, Wednesday, Friday sched-ule; or on a Tuesday, Thursday, Saturdayschedule, for 4~5 weeks (12-15treatmetlts).Each treatment lasted 45 minutes.The two treatment modalities (red-beamlaser and microamps TENS) that were appliedon the affected hands in the research programat the Boston D.V.A Medical Center, were alsoapplied on the affected hands in this clinicalstudy, with the same treatment protocol. Thesetwo modalities were considered to be the pri-mary treatment modalities in this open-proto-col clinical study, because these two deviceswere used in an identical manner on all cases.The other secondary modalities (explained later)were added and adjusted on a case-by-casebasis.A less expensive red-beam laser was used inthis open-protocol, clinical study. Instead of us-ing the IS-mW, 632.8-nro, gas tube HeNe laser,an inexpensive, continuous-wave, 5-mW, 670-nm, red-bearn, diode laser lecture pointer (LPSF1, ITO brand) was used (Naeser and Wei,1994; Naeser et al., 1997). The 5-mW laserpointer had an aperture of5-mm diameter. Thelaser pointer was placed directly over eachacupuncture point on the skin. The-5-rrtw laser:required .a total of 200.seconds to produce 1 J(39.2 seconds equals 1 JIcm2 energy density).As a practical matter for use inthe clinic, a timeof 3 minutes was used (180.seconds) as an ap-proximate time for 1 J (0..9J). Most acupunc-ture points on the hand were treated with 1 J(4.6 J/cm2). There were three steps to this pri-mary portion of this alternative treatment pm-gram:

    Step 1. laser applied to the wrist. The tip ofthe laser pen was physically placed onto the skinat the median nerve are-aat the center of the dis-tal wrist crease (acupuncture point/Pericardium7) for approximately 21 minutes (6-7 J) ; a totalof 21 minutes (1260.seconds) equals 6.3 J (32.1J / cm2).Step 2. microamps TENS applied to thewrist. The MicroStim 100 TENS device has twoelectrodes-a primary electrode and a ground-ing pad. The primary electrode is a metallic, cir-cular-shaped electrods with four small (2-mm

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    16

    FIG. 1. Demcnstrationef the two pr ima 'ry treatmentmodalities (red-beam laser acupuncture and microarnpstranscutaneous electrical nerve stimulation [TENS]) usedwith carpal tunnel syndrome patients in this clinical out-come study. The 5-mW, red-beam, laser pointer is usedto stimulate acupuncture points on the hand, Here, thelaser Is shown in place at an acupuncture point on theright thumb, near the (:OI11erat the base of the fingernailbed (acupuncture point, Lung 11). Th e laser is used onthis acupuncture point for 3 minutes (approximately 1 J ior 4.6 J !.crj.l2 energy density). Additional acupuncturepoints on the fiilgers/handl wristare treated in this m a n -ner (see txt) , The electrodes, for the MiCIoStim 100 TENSdevice are placed at the wrist. The primary electrode isplaced 0n the palmar surface, at the center of the distalwrist crease, near the median nerve (acupuncture point,,Pericardium 7), and the grounding pad Ii:>placed on theback of the wrist (Triple Warmer 4), The 45-m:l:nutetreat-ment is painless an:d noninvasive, Itma,y be performedinthe office of a licensed acupuncturist, or supplementaltreatments maybe performedathrrme, under supervisionof the acupuncturist.

    diameter} light-emitting diodes (monochro-matic but not coherent, red light). The primaryelectrode is about the size of a fifty-cent coin.This primary electrode was placed onto thesame area treated inStep 1 . (Pericardium 7) (Fig.1 ) . . The grounding pad electrode was placedonto. the back of the wrist (acupuncture point,Triple Warmer 4).The power was gradually increased until atingling sensation was felt at eitherelectrodesite, then itwas immedia. te ly turned down untilthere was no sensation at all. The ideal pettingis usually around 200 to 500 M A . Itis importantthat the patient feels nothing during the treat-ment.The MicroStim 100TENS device uses a 15,000-Hz carrier wave with a biphasic current, A mod-ulated frequency of 292Hz was used for the first

    BRANCO AND NAESER2 minutes, followed by a lower frequency of 9.25Hz 0 . 1 ' 0.3 Hz for the next 18 minutes.

    Step 3. lllserapplied to the fingers and hand.While the TENS device was in place at thewrist, the .red-beam laser was applied to otheracupuncture points on the affected hand, for 3minutes. per point (approximately 1 J i or 4 ..6J ICIh2 per point) (Fig_1), These points includedthe following acupuncture points: Lung ItLarge Intestine 1, Pericardium 9, TripleWarmer I, Heart 9, Small Intestine 1, distalBaXiepoints in the web spaces between the fin-gers, Triple Warmer 5, Large Intestine 4, Peri-cardium 8, Heart 7 and 8, and Lung 9 and 10.All points were treated at each treatment ses-sian. The acupuncturist often used 2--4 laserpointers at once, to treat 2-4 acupuncturepoints at once, inorder to save time.Additional secondary, alternative treatmentmodalities. Additional secondary, Oriental med-icine therapies were used on an individualcases-by-case basis, including Chinese herbalmedicineformulas, supplements, moxibustion,and stimulation of deeper acupuncture pointson the posterior neck, shoulder, and elbow areawith infrared-beam laser and/or needleacupuncture, as necessary. As is common prac-tice inTeM! each patient was treated with anindividually determined treatment protocolbased on palpation, Pulse diagnosis, Tonguediagnosis, and patient history (Maciocia, 1994).Pulsed infrared laser treatments. In mostcases, additional deeper acupuncture paints(especially points sensitive to palpation), weretreated on the posterior neck area, shoulder(acupuncture point, Large Intestine 15) and el-bow (acupuncture points Large Intestine. 11and 10), according to the acupuncture meridi-ans that were involved, and distribution of pos-sible radiating pain, using a pulsed, 10-W, 904-rim, infrared diode laser (Respond Laser model2400, Respond Systems, Branford, CT), as ex-p lamed above, within the real versus shamlaser acupuncture treatment section ..This laseremits six different pulse frequencies that rangefrom 73 pps to 3500 pps. Usually, the high-fre-quency pulse rate was used first (3500 Fps for1minute, 1.8 J/cm2), followed by lower pulsefrequency rates for a few minutes (584 pps for

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    CARPAL TUNNEL SYNDROME, LASER ACUPUNCTURE, LOW-LEVEL LASER 17TABLE 2. SUMMARY DATA f~ORTHREE SEPARATE A .E GROUPS, AND ALL C."'RPAL 'TVNNEL SYNDROME eASElS (11 = 31CASE'S; 36 HANDS), BEFORE AND AFrER L A S E R ACUPUNCTURE, MICROAMPS TENS AND OD:lER ALTERNATIVE THERAPIES

    D ura tio n o f Melzack 'puin Melzack pa in Change l N um b e )" o jA.ge p ain p rio r to s c o r e score in laserenter laser b e fo r e l as e r a ft er l as er M elzack pa in acupuncturestudy acupuncture acup~ncture acupuncture score treatments

    Age 60 yearsr z =12 handsMean 75.8 years 65.5 months 34.3 8 -26.3 14:2S.D. 6.8 57.7 12.9 1l.4. 16.7 1:5Median 77 48 35.5 1 -28.5 ]5.0R a n g e 65 to 84 1 year to 18 years 8 to 51 o to30 o to -51 11 to 15All CTS cases

    11 = 36 handsMean 55.2 years 37.3 months 32.1 3 .6 -285 13.4S.D. 18.9 41.8 1l.6 8.1 13.5 2.1Median 50 24 32.5 0 -29 15.0Range 24 to 84 2 months to 18 years 2 to'Sl o to 30 o to -51 5 to 15

    TENS, transcutaneous electrical nerve stimulation; CTS, carpal tunnel syndrome.

    1 minute, 0.3 J Icrn2;and 73 Fps for 1 minute,0.04 J Iern"), Treatment times varied from caseto case depending on the type and location ofpain. If the patient had a TCMdiagnosis of De-ficient Qi and Deficient Blood, the 3500pps ratewas not always used, and more time was usedwith the lower frequencies, especially the 584pps rate. The patient felt nothing from the in-frared laser.Needle and moxibustion acupuncture treat-

    ments. In some patients, the deeper acupunc-ture points on the posterior neck, shoulder, andelbow areas (especially points sensitive to pal-pation), were also treated with standardacupuncture needles; orwith small intradermalneedles (3--6 mm in length) that were some-times taped in place for a few days. Additionalbody acupuncture points were stimulated withstandard needle acupuncture, as necessary, ona case-by-case basis, according to TCM diag-nosis. Wolie (1995)has summarized common

    TCM diagnoses and treatments for CTS, in-cluding standard acupuncture needle, moxi-bustion and Chinese herbal therapies. Thesecommon TCM diagnoses were also observedamong the cases treated in the present study.For example, in case 19,where cold hands werea major problem for the patient (an ice creamserver, with 6-month duration of pain), theTCMdiagnosis ofCold Obstruction was made,and additional treatment with moxibustionwas performed on the hand (superficial heat-ing of acupuncture points with the herb,A i em is ia v ulg a .r is ).Chinese Herbal Medicine Formulas. In addi-tion, some patients used Chinese herbal medi-cine formulas in pill form, on an individualcase-by-case basis, according to TCM diagno-sis/ as directed by the acupuncturist. The mostcommon TCM diagnosis requiring Chineseherbal therapy, was the diagnosis of DeficientQi and Deficient Blood (oftenDeficient Kidney

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    1840

    35

    G) 30~8e n 25-cto e, 20.lI:0ra 1 5~G):Ec: 1 0raG):E 5

    0-5

    BRANCO AND NAESER

    Pre- LaserAcupuncture Treatment

    Age Groups-- -a--- Grea te r Ihan 6 .0 Years. . . . . _ . 4 . 0- 6 . 0 Y e a rs--0-- Less' than 4. 0 Years

    Post- LaserAcupun cture Treatment

    FIG. 2. Mean Melzack pain scores for three separate age groups, before and after this alternative therapy programincluding p r i n : t a r i ! y red-beam, laser acupuncture and microamps transcutaneous electrical nerve stimulation (TENS)on the affected hand. A two-way, mixed design analysis of variance (ANOVA) showed a significant change in theMelzack pain SCoresposttreatment (p < .0001), but no effect of age group and no. interaction between age group andtreatment (see text).

    Essence). These patients were given the for-mula, Astra Essence, inpill form (Health Con-cerns, Oakland, CA)_Supplements. In most cases, the dietary sup-

    plement, omega-3 fish oil capsules+ was alsoused, according to the protocol of Omura(Omura et al., 1992;Omura, 1994).Omura etal. (1992)has observed with bi-digital O-ring,resonance testing that many chronic pain pa-tients present with a subclinical, viral infec-tion in the area of pain; it is often herpes sim-plex type I virus on one side of the body, andtype II, on the opposite side. None of the pa-

    tients who participated in , this clinical out-come study were examined by Dr. Omura,therefore it is not known if any of them had asubclinical, viral condition. in the mediannerve area, at the wrist. Patients were offeredthe option of trying the Omura treatment pro-tocol with omega-3 fish oil capsules. Most pa-tients used this for the duration of the treat-ments (4-5 weeks), in addition to the othertreatments administered.There were no negative side effects or unto-

    ward events observed with any aspects of thisalternative treatment program.

    3The omega-S fish oil capsules (SDV, Boca Raton, FLor M.Le International, Jersey City, N J ) were used. Three timesa day, the patient took one capsule with water, on an empty stomach, followed by 3 0 seconds of massage at the "wristrepresentation area" on the firtgers (distal interphalangeal joint on the index and ring fingers), in order to promotevasodilation to the "wrist target-organ." These "wrist-representation areas" on the distal finger joints are anadapta-lion of the Korean. Hand Acupuncture System (Yeo, 1988, P: 239, P: 245) ..The pwpose of massage at the target "rep-resentation" areas (distal finger joints) was to increase vasodilation at the target sites (wrist areas), thus promotingincreased blood flow with the supplements or herbs, to that target area. It would be too painful to massagethe wristarea, directly. No endorsements. of omega-S fish oil, or medical claims are suggested for this experimental protocol,

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    RESULTSCARPAL TUNNEL SYNDROME, LASER ACUPUNCTURE,LOW-LEVEL LASER 19

    Data :for the 31 patients were examined ac-cording to age at entry (Table 2 and Fig. 2).There were three age groups: (1) less than 40years (7 cases, 8 hands); (2) 40-60 years (12cases, 16 hands); (3) older than 60 years (12cases, 12 hands). A two-way, mixed-designanalysis of variance (ANOVA) was performedwith age as the between-subjects factor, and theMelzack pain scores (pretreatment and post-treatment) as the repeated measure. There wasa significant main effect for change in theMelzack pam scores F(1,33) = 154.27, P 60 years) had a signif-icantly longer duration of pain that group 1(p = .047) and group 2 (p = .026) Crable 2).Number of treatmentsThe three age groups differed in the numberof treatments F(2,33)= 3.31, P -= .049. Post h ocanalysis with Scheffe test showed there was aborderline significant difference between thenumber of treatments between g1'OUp3 andgroup 1 (p = .052). This difference is mainlydue to an outlier in group 1,who only requiredfive treatments (case 1) (Table 1).Overall, for the 36hands, analysis of variancewith one repeated measure (pretreatment andposttreatment Melzack pain scores) showedthat posttreatment, the pain scores were sig-

    nificantly reduced F(1,35) = 161.25, P < , 0 001 ) ,with a mean pain s-core reduction of -28.5points (SO, 13.5). Pretreatment, the mean painscore was 32.1 (SD, 11.6); Posttreatment, 3.6(SO, 8.1) (Table 2). In summary, 28 of 31 pa-tients (90.3) reported reduced pain after thesetreatments, at a level of either no pain, or pain.reduced by more than 50% (33/36 hands,91.6%). All 12 cases (14 hands) who had previ-

    ously failed with surgical release, obtainedpain relief after this alternative treatment pro-gram (cases 3, 6, 8, 9, 10, 12, 14, 18, 22, 23, 25,31), This included two patients who had failedtwo surgical release procedures on the samehand (cases 9, 31) (Table 1)..A ge group less than 4 0 y e a r sPosttreatment, 7 of7 cases (8/8 hands,100%) attained pain scores of 0, and all caseseither continued to work during treatment orreturned to work There was one workmen'scompensation case (case 1), a secretary Whowas able to return to work after treatment, Shehad a short duration of pain (3 months) andrequired only five treatments ..Two of eighthands had failed with ccrtisone injections

    (cases 3,4); two of eight hands had failed withsurgical release (cases 3, 6);a:ll were success-fully treated,In follow-up at 1-2 years, only 1 of 7 cases(1/8 hands, 12.5%) required additional treat-ments (case 3, female maintenance worker; af-ter 4-5 months, nine treatments) Crable 1).Thus, pain control had remained stable in 7of 8 hands (875%)ater 1-2 yea_rsin the lessthan :40 age group, without follow-up treat-

    ment.

    A ge group 40-60 yearsPosttreatment, 11 of 12 cases (15/16 hands,

    93.7%) attained pain scores of 0 (14 hands), orreduced pain by more than 50% (1hand), Therewere three workmen's compensation cases: 1returned to work full-time (case 17, factoryworker in packaging/wrapping) and 2 casesreturned to work part-time (cases 8 and lOJcomputer operators in the same office; bothwith posttreatment pain scores of 0, but whorequested only part-time work status). Eightother cases who were already working at timeof entry into treatment continued to work. Onlycase 16 (housewife) was not employed outsidethe home.The single case in this 40-60 age group whofailed to obtain pain relief (case 11,.age 47, com-puter operator and weight lifter) continued toabuse his hands throughout treatment, per-forming heavy weight lifting daily. After this

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    20

    alternative therapy program, this patient un-derwent cortisone injection. He continued tolift weights and obtained no long-term, benefitfrom this latter treatment.Eight of 16 hands in this group had failedwith cortisone injections (cases 8, 9R&L, 10,14R&L_, 17, 18), and 8 of 16 hands had failedwith surgery (cases 8, 9R&L, 10, 12R&L, 14, 18);all of these cases achieved satisfactory pain re-lief after this alternative therapy program.Their posttreatment pain scores were all 0, ex-cept case 18~ who had a posttreatment painscore of 12 (pretreatment, 41).Sum mary: first two age groupsAcross 1:hefirst two age groups 40 years,and 40-60 years) where most cases were em-

    ployed (ages 24-56 years), 18 of 19 cases (23/24hands, 95.8%) were successfully treated withthis alternative therapy program. Among these18 cases. successfully treated, only 2 cases re-quired follow-up treatments within the firstyear (2/13 hands, 8.7%). Ten of the 24 hands inthese first two age groups had failed with cor-tisone injections, and 10 had failed withsurgery; all of these hands obtained satisfactorypain relief. Pain control remained stable after1-2 years without any follow-up treatments in21 of 23 hands (91.3%).. An employed cases (n =18) remained employed in professions includ-ing secretary, repair service. maintenanceworker, autobody mechanic, teacher, computeroperator, nurse's aid, artist/painter, nail tech-nician, photographer, factory worker, and icecream server.A ge group older than 6 0 yearsPosttreatment, 10 of 12 cases (10/12 hands,

    83.3%) attained pain scores of 0 (n =6) or painreduction. of more than 50% ( 1 1 . = 4). All caseswere retired. Seven of 12 hands (58.3%,) hadfailed with cortisone injection (cases 20, 21, 22,23,25,30,31); and 6 of 7 of these cases obtainedpain relief after this alternative therapy pro-gram (all except case 30). Four of the 12 hands(33.3%) had failed surgery (cases 22,23,25,31);and 4 of 4 of these cases obtained pain relieffollowing this alternative therapy program(Table 1).In follow-up at 1-2 years, among the 10hands successfully treated, 3 hands had return

    BRANCO ANP NAESERof pain for no known reason, at 1-3 monthsposttreatment, requiring 6-8 additional treat-ments (cases 21, 26, 31), again with good res-olution of pain. Two other cases also had re-turn of pain for no known reason, however,each case had a new major medical problem.Case 2,5, age 76 , required additional treatment6 months later, at 2 months postcoronary by-pass surgery; his pain score again returned too . Case 29, age 81, required additional treat-ment 2 months later, after a mild stroke; how-ever, after 8 treatments there was no reduc-tion in hand pain, Thus, the long-termoutcome in this CTS case with stroke was sim-ilar to that for the stroke case in Footnote 1.Both cases had central nervous system in-volvement plus peripheral nervous system in-volvement, and both cases had no long-termCTS pain relief.In summary, in this oldest age group, paincontrol was less stable within the first year,where 5 of 10 cases (50%) required follow-uptreatments. In 4 of 5 of these cases (80%), sat-isfactory pain relief was again achieved.N erve co nd uctio n stud iesAs mentioned above, under Subjects, datafrom NCS and EMG were available for only 6

    cases in this clinical outcome report, an in theoldest age group (,Table 1). There were twomild CIS cases (case 22, with 3.75 ms, motorDL; sensory latency, 3.65 ms: and case 23, with4.3 ms, motor DL; sensory latency, absent), andone moderate CTS case (case 20, with 5.3 ms,motor DL; sensory latency not reported); allhad good pain relief after this alternative ther-apy program. There were, however, 3 severeCTS cases (case 28, with abnormal EMG; case29, with 8.6 ms, motor DL; and case 30, with7.08 ms, motor DL). Two of these three severeCTS cases did not have satisfactory pain re-duction after 15 treatments. The third severeCTS case (case 29, age 81, with 8.-6 IDS, motorDL) had initially good pain relief after 15 treat-ments, however, after a mild stroke at 2 monthsafter the last treatment, her pain returned andit was not alleviated after 8 follow-up treat-ments.In summary, 3 of 3 severe CTS cases didnot have satisfactory pain relief.Insummary, NCS data may be predictive ofgood versus poor response to this alternative

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    CARPAL TUNNEL SYNDROME, LASER ACUPUNCTURE, LOW-LEVEL LASER 21therapy program. Results from the presentstudy, as well as those from the' ongoing con-trolled research (Naeseret al., 1996, Naeser,1997a) suggest that good pain reduction islikely with low-level laser and microampsTENS if the motor latency is less than 7.0 ms(sensory latency may be absent). No pain re-duction is likely to occur, however, if the mo-tor latency is more than 7.0 ms or denervationis present on EMG. More cases should be stud-ied with. electrodiagnostic testing.

    DISCUSSIONOverall, 28 of 31 cases (90 . 3%) and 33 of 36hands (91.6%) treated with this alternative ther-apy program obtained successful pain relief in4--5weeks. This significant pain reduction (p


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