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Journal of Bodywork and Movement Therapies (2007) 11, 129140 Bodywork and Journal of Movement Therapies CAM RESEARCH Designing a polarity therapy protocol: Bridging holistic, cultural, and biomedical models of research $ Leslie E. Korn, Ph.D., MPH, RPP, LMHC , Rudolph C. Ry ¨ser, Ph.D Center for Traditional Medicine, 1001 Cooper Pt Rd SW, PMB 140-214 Olympia, WA 98502, USA Received 16 June 2006; received in revised form 12 August 2006; accepted 14 August 2006 KEYWORDS Polarity therapy; American Indian; Caregiver research methods; Stress Summary One of the methodological challenges of conducting CAM therapies research and in particular, biofield/touch therapies research is the development and use of methods that are compatible with the holistic nature of the therapy. Biomedical scientists claim that the ‘‘gold standard’’ of research must be the randomized clinical trial (RCT), which includes a standardized protocol. Conducting an RCT on a biofield/touch therapy often results in structural and conceptual conflicts with the clinical standards necessary to holistic therapies. This paper discusses a polarity therapy protocol designed as an intervention for the reduction of stress in American Indian family caregivers of patients with dementia. The protocol is designed to maximize efficacy and cultural congruency, adhering to the integrity of the holism, while addressing challenges arising from randomized controlled trial methods. The protocol developed for this study is presented and discussed. & 2006 Elsevier Ltd. All rights reserved. Introduction One of the methodological challenges of conduct- ing research into complementary and alternative medicines (CAM) therapies and in particular, bio- field/touch therapies is to use methodologically rigorous approaches that are also congruent with the holistic qualities of the therapy. In this paper we discuss the factors considered in the develop- ment of a 2-year Caregiver Study: a study of the feasibility and efficacy of polarity therapy (PT) as a therapeutic intervention to reduce stress among American Indian caregivers of family members suffering from dementia. Compatibility of research methods with a holistic therapy enhances the likelihood that researchers will capture the range of responses, both gross and subtle, that are commonly observed in clinical practice. Biomedical scientists contend that the ‘‘gold standard’’ of research must be the ARTICLE IN PRESS www.intl.elsevierhealth.com/journals/jbmt 1360-8592/$ - see front matter & 2006 Elsevier Ltd. All rights reserved. doi:10.1016/j.jbmt.2006.08.007 $ Doi of other paper in this series: 10.1016/j.jbmt.2006. 08.010. Corresponding author. E-mail address: [email protected] (L.E. Korn).

Designing a Polarity Therapy Protocol

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Page 1: Designing a Polarity Therapy Protocol

Journal of Bodywork and Movement Therapies (2007) 11, 129–140

Bodywork and

Journal of

Movement Therapies

CAM RESEARCH

Designing a polarity therapy protocol:Bridging holistic, cultural, and biomedical modelsof research$

Leslie E. Korn, Ph.D., MPH, RPP, LMHC!, Rudolph C. Ryser, Ph.D

Center for Traditional Medicine, 1001 Cooper Pt Rd SW, PMB 140-214 Olympia, WA 98502, USA

Received 16 June 2006; received in revised form 12 August 2006; accepted 14 August 2006

KEYWORDSPolarity therapy;American Indian;Caregiver researchmethods;Stress

Summary One of the methodological challenges of conducting CAM therapiesresearch and in particular, biofield/touch therapies research is the development anduse of methods that are compatible with the holistic nature of the therapy.Biomedical scientists claim that the ‘‘gold standard’’ of research must be therandomized clinical trial (RCT), which includes a standardized protocol. Conductingan RCT on a biofield/touch therapy often results in structural and conceptualconflicts with the clinical standards necessary to holistic therapies. This paperdiscusses a polarity therapy protocol designed as an intervention for the reduction ofstress in American Indian family caregivers of patients with dementia. The protocolis designed to maximize efficacy and cultural congruency, adhering to the integrityof the holism, while addressing challenges arising from randomized controlled trialmethods. The protocol developed for this study is presented and discussed.& 2006 Elsevier Ltd. All rights reserved.

Introduction

One of the methodological challenges of conduct-ing research into complementary and alternativemedicines (CAM) therapies and in particular, bio-field/touch therapies is to use methodologicallyrigorous approaches that are also congruent withthe holistic qualities of the therapy. In this paper

we discuss the factors considered in the develop-ment of a 2-year Caregiver Study: a study of thefeasibility and efficacy of polarity therapy (PT) as atherapeutic intervention to reduce stress amongAmerican Indian caregivers of family memberssuffering from dementia.

Compatibility of research methods with a holistictherapy enhances the likelihood that researcherswill capture the range of responses, both gross andsubtle, that are commonly observed in clinicalpractice. Biomedical scientists contend thatthe ‘‘gold standard’’ of research must be the

ARTICLE IN PRESS

www.intl.elsevierhealth.com/journals/jbmt

1360-8592/$ - see front matter & 2006 Elsevier Ltd. All rights reserved.doi:10.1016/j.jbmt.2006.08.007

$Doi of other paper in this series: 10.1016/j.jbmt.2006.08.010.!Corresponding author.E-mail address: [email protected] (L.E. Korn).

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randomized clinical trial (RCT), which includes astandardized protocol (Walker and Anderson, 1999;Berman and Straus, 2004; Miller et al., 2004). Yetcarrying out an RCT with a biofield/touch therapyoften conflicts with the clinical practices asso-ciated with holistic therapies. These practices areoften tailored to the specific patient and adjustedfrom session to session, influenced by therapisttechnique and intuition. Clinicians consider all ofthese factors as contributing to synergistic effectsthat lead to efficacy. Holistic researchers andtherapeutic practitioners contend that to acceptthe methods of RCT’s without regard to holisticfactors results in reducing the essence of holism bymeans of separating the constituent parts from thewhole. This outcome ruptures effective implemen-tation of the therapeutic philosophy that forms thebasis for the therapeutic practice that stresses therestoration of the whole from the parts. Thisconflict is further amplified when one begins toapply analytic methods to the acquired data.Walach (2004) describes the ‘‘efficacy paradox’’suggesting that many CAM interventions produceboth strong, non-specific effects and weak, specificeffects. Faced with this paradox, research scien-tists may be led to disregard the ‘‘absoluteeffectiveness’’ of a strong effect, which may bemore apparent than in studies with large specific,but weaker overall effects. Like many CAM inter-ventions, Polarity proposes to bring about systemicbalance and deep relaxation, thus allowing theinnate capacity for self-healing to be restored andre-vitalized. In contrast to prioritizing specificoutcomes, balance for each individual is a uniqueand dynamic process. Hence the adage amongpolarity practitioners that whatever response re-sults during or following a polarity session, whetherit is deep sleep, hunger, memories, tears or joy, allare reflections of the return to equilibrium thatbalancing the energy fields facilitates. Teasing outspecific contributions to efficacy, singular or syner-gistic while measuring the ‘‘whole picture’’ is thusthe developing challenge to clinical research onCAM therapies (Verhoef et al., 1999; Ai et al.,2001). How then can treatment protocols bestandardized without jeopardizing the potentialfor efficacy derived from an individualized ap-proach to therapy? How can we use measures thatcapture the range of human experience during PT?Finally, how do the cultural attributes and norms ofthe subject population influence protocol design?These questions led to the design of a uniform PTprotocol for a randomized, controlled trial. Achiev-ing a consistent protocol served effectively for theCaregiver Study target sample population whileretaining the integrity of the therapy process itself.

In this paper a standardized 21-point PT protocolis presented and the rationale for its designexplored for use in the study of the efficacy of PTin the reduction of stress in American Indian familydementia caregivers. The study using the protocolwas designed as a single blind, randomized con-trolled trial designed to respond to racial andethnic health disparities by addressing the dearthof CAM research with American Indian populationsand the paucity of research on PT in particular. TheCaregiver Study was designed to assess feasibilityand safety and to quantitatively assess outcomesthat included a hypothesized decrease in stress,depression, anxiety, and improvement in sleep,health functioning, quality of life and personalgrowth. Qualitative data collection was designed toprovide an opportunity to explore participantnarratives across a variety of domains includingspirituality.

Note: The 21 point protocol will be describedfully in the next issue of JBMT.

Background on PT

PT is a syncretic energy medicine, biofield/touchtherapy, developed by Randolph Stone, DO, DCduring the early 20th century. Polarity evolved froman integration of traditional Ayurvedic medicineand energy meridian therapies with the manipula-tive therapy traditions of early 20th century‘‘drugless’’ cranial-osteopathic medical practi-tioners. There are four integrative aspects to thepractice of PT: polarity bodywork, energetic nutri-tion, stretching postures, and communication/facilitation. The Caregiver Study concentrated onthe use of the Polarity Bodywork protocol.

A major principle of PT is that health and healingare attributes of energy that flow in a natural andunobstructed state. Artful touch, focused atten-tion, intention—empathy and love—are the inter-personal foundations of the practice (Association,1996). Stone described concepts of energetic, myo-fascial, and structural manipulation based on whathe referred to as ‘‘wireless energy currents’’(Stone, 1986) a concept that is linked to fieldtheory (Korn, 1987) and to hypotheses of energytransduction between cosmic energy, chakras,neural plexi, and the endocrine glands (Tiller,1997). Thus structural and functional relationshipsoccur within the context of an overarching conceptof the five sensory/motor elements (ether, air, fire,water, earth) and the deep energy currents ofneural plexi, represented by the image of thecaduceus, the ancient icon of the autonomicnervous system.

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The goal of PT is to trace (by palpation) andrelease (by skilled touch) those energy blockagesthat manifest as pain or dysfunction. To do this, thepractitioner applies three depths of touch depend-ing on whether the energy blockage reflects ahyperactive, hypoactive, or neutral state of activ-ity. The hands (and the consciousness behind them)facilitate polarization of currents by placement onopposing poles (e.g. right hand in negative poleposition or left hand in positive pole position) onthe body. Elaborate placement charts derived fromfunctional, structural and energetic traditions in-form these hand placements. Touch techniquesrange from very light palpation (5–10 g of pressuresimilar to methods utilized in cranial–sacral ther-apy, healing touch, reiki and therapeutic touch), amedium touch where pressure meets tissue resis-tance, and deep pressure manipulation through themyofascia, similar to the techniques of Rolfing(Neo)-Reichian practitioners and myofascial deeptissue massage applied to break up stagnation,crystalline deposits, and scar tissue. Pressure onenergy points, rocking, gentle traction, stretching,and rotation of joints are some of the methods usedto help the patient achieve deep relaxation,improve respiratory and digestive function and setthe stage for the innate capacity for healing.Polarity posits that the patient will also gaingreater self-awareness of behavioral and cognitiveinfluences on their health, and undertake anincreasingly responsible role in creating a healthierlifestyle (Table 1).

Evolution of PT

Dr. Randolph Stone was born Rudolph Bautsch inAustria in 1890 and immigrated to the United Statesof America in 1898. He settled with his family inWisconsin and then in Minnesota. In the 1920s Dr.Stone completed his primary medical certificationas a Doctor of Osteopathic Medicine (DO) and thenreceived his Doctor of Chiropractic (DC) and a

Doctor of Naturopathic Medicine (ND). He main-tained his practice in Chicago and in India workingwith patients considered incurable using techni-ques learned from many other healing systems.Stone studied yogic meditation in Beas, Punjab,India for personal development and yoga andAyurvedic medicine deeply influenced his thinking.His theories and techniques suggest that theprinciples of polarization are universal phenomenaand his ideas were influenced by Dr. AlbertEinstein’s atomic theories of the early 20th century.Thus Polarity is not only a set of techniques but aprinciple, he proposed, that should guide alltherapeutic application including both diagnosisand energy balancing at the physical, emotional,mental, and spiritual levels of existence. While hewrote about the reciprocal effects of emotion onautonomic dysregulation, he did not emphasize theintegrative psychosomatic processing that hasevolved with Polarity into the fulsome process-oriented bodywork therapies of the early 21stcentury. Indeed, by all accounts, this deeplyspiritual, gifted healer’s no-nonsense approach toverbal processing consisted of no more than togive a ‘‘Dutch Uncle talk’’ to his patients andto leave it at that (Stone, 1986). NeverthelessStone encouraged the extension of his work, byleaving out critical details in his charts, he said, inorder to stimulate new thinking and avoid clinicaldogma. Among the many contributions that havefollowed since his death in 1981 at the age of 91include those made by a small cadre of practi-tioners who are dually trained in both Polarity andwestern psychological counseling, who emphasizethe use of PT for somato-emotional health (Korn,1987, 1996, 2000; Kiewe, 1989; Gilchrist, 1993;Axt, 1996).

Research on PT

! Polarity has been evaluated in one randomizedstudy to explore its effects on cancer fatigue and

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Table 1 Principles and practice of polarity therapy.

Integrates bodywork, exercise, nutrition and self-awarenessEnergy and biofield balancing uses three depths of touch: Satvic, (light); Rajasic, (moderate); Tamasic, (deep)Hands are placed at two poles, energy flows between these contactsRight hand is positive, left hand negativePractitioner enters into focused, relaxed state of awareness; facilitates deep relaxation, energy flow, self-awarenessBalance of the elements: ether, air, fire, water, earthTwo dimensions of efficacy: release of energy blockages and flow of electromagnetic and wireless currents; andincreased self awareness and appropriate healing relationship with practitionerPrinciple of engagement: practitioner heal thyself

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health quality of life. This study found astatistically significant reduction in cancer-re-lated fatigue in the Polarity treatment groupcompared to the controls (Roscoe et al., 2005).

! Axt (1996) conducted research on PT andcranial–sacral therapy for the treatment ofautism and children with special developmentalneeds, with results suggesting functional im-provement in behavior.

! In an unpublished hospital-based study under-taken with patients in the critical care unit,Clifford (1997) reports administering PT to 70patients with a range of acute and chronicillnesses, 20 staff members and one physicianto assess the degree of relaxation as a result oftreatments. A feeling of peace, rest, or deeprelaxation was noted in 194 sessions.

! Benford et al. (1999) undertook an experimentalstudy of PT that showed statistically significantfluctuation in Gamma radiation during treat-ment, leading Benford to hypothesize thatradiation hormesis might underlie one mechan-ism of action in PT.

Fields of action

Biofield/touch therapies like Polarity appear tofacilitate response associated with a reduction insympathetic activity (Rowlands, 1984; Cox andHayes, 1999; Gehlhaart, 2000) by stimulatingvagal response and improved circulatory, lympha-tic, and immune response while regulating circa-dian rhythm and the primary respiratorymechanism (Sills, 2002). Biofield therapies resultin a reduction in pain (Sansone and Schmitt, 2000),anxiety (Gagne and Toye, 1994) cancer-relatedfatigue (Roscoe et al., 2005), quality of life (Metz,1992) depression (Rowlands, 1984; Field, 2000;Wardell and Engebretson, 2001) and improvedenergy (Lee et al., 2001) mood, and sleep (Smithet al., 1999).

PT has also been referred to as ‘‘meditativetouch’’ (Korn, 1987) as it induces somatic empathy(Korn, 1987, 1996)—a state of consciousness thatfacilitates therapist–patient psychophysiologicalentrainment (Korn, 1996; Oschman, 2000) and astate of reverie associated with a predominance oftheta brain waves (Korn, 1987, 1996; Green, 1990).Somatic empathy is also the substrate fordyadic state-specific research. (Tart, 1998) Thisheuristic method of inquiry engages dual conscious-ness or the observing self so that both therapist andclient may observe and study phenomena fromwithin the altered state engendered by thetherapy.

Background on dementia familycaregivers

There are 45 million family caregivers in the UnitedStates, 23% of whom report caring for a familymember with dementia or Alzheimer’s. Caring for apatient with moderate to severe dementia createsconditions of chronic stress for the caregiver (Teeland Press, 1999; Czaja et al., 2000; Freeman,2001). Caregivers experience a greater risk ofdepression, more illness days, more physicianvisits, increased fatigue and increased risk ofmortality than non-caregivers (Schulz and Beach,1999).

Caregivers have a diminished immune response(Vedhara et al., 1999) that may contribute to theirincreased incidence of acute illness or exacerbationof preexisting illness, resulting in higher rates ofprimary care physician utilization (Schulz andBeach, 1999). The dynamic of caregiver stress andburden results in a reciprocal decrement in thequality of life for the patient and often leads to theinstitutionalization of the patient (George andGwyther, 1986). Institutionalization results in amore substantial economic burden on the patient’sfamily and to society. Elder care providers in thestudy region reflect agreement with other long-term care professionals when they suggest thatquality of life for patients is based on their abilityto remain in the home. Yet even upon institutiona-lization, the caregiver most often remains essentialto the care of the patient, and even as certainstressors are obviated by departure from the home,the caregiver continues to experience an objectiveburden (Aneshensel, 1995; Whitlach and Feinberg,1995; Naleppa, 1996; Levesque et al., 1999) thatsurvives as long as the loved one. The physical andemotional demands on the caregiver are paralleledby the on-going experience of loss of affiliative,shared activities between the caregiver and patient(Lynch-Sauer, 1990; Bradley and Cafferty, 2001). Asdementia progresses, the patient loses the cogni-tive capacities to communicate their needs andfeelings, which limits interpersonal communicationbetween the caregiver and patient. The caregiverof a family member with dementia patient experi-ences ‘‘living loss’’, during which a primary orimportant object of attachment disappears, evenas s/he remains alive (Doernberg, 1986). Attach-ment has been defined as: ‘a relationship thatdevelops between two or more organisms as theirbehavioral and physiological systems become at-tuned to each other’ (Field, 1985, p. 415). Thecapacity to provide psychological and physicalsafety is called psychobiological attunement (Field,1985) or affect synchrony (Reite and Capitanio,

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1985). The ongoing loss and threat of separationhold profound psychophysiological and spiritualimplications for the caregiver (Acton and Miller,1996; Acton, 1997). In addition to the emotional,physical, and financial burdens of dementia care,the loss of interpersonal, tactile reciprocity be-tween the patient and the caregiver is seldomaddressed by conventional interventions. Touch isthe original, pre-verbal language that mediates thepsychobiological template of attachment through-out the life cycle (Korn, 1996) and may provide amethod of communicating that is especially at-tuned to the needs of the dementia patient andcaregiver.

Public health and biofield/touch therapies

There are over 80,000 certified massage therapistand body workers in the USA and over 30,000 nursespracticing some form of touch therapy. There areover 1200 members of the American PolarityTherapy Association (APTA), and numerous PTtraining programs within technical schools, com-munity colleges and medical schools and tens ofthousands of others who practice PT and otherbiofield/touch therapies under other licensures andcertifications. With the growth of CAM education,there is a substantial growth of biofield/touchtherapy practitioners, yet with the exception of afew states funding mechanisms have as yet failedto provide payment avenues to ensure wide-spread delivery of services across the socio-economic spectrum. In short, there is a largecorps of people poised to enter into public healthservice to address the most pressing needs ofelders and their caregivers. One of the goals ofthis research is to provide evidence that changespublic policy in support of the delivery of biofield/touch therapies as a component of public healthstrategies.

American Indian family dementia caregivers

American Indian tribes number more than 690(recognized and unrecognized) heterogeneous na-tions and peoples. American Indian caregivers andelders often attain elder status by their fourth orfifth decade in contrast to non-Indians (Jervis andManson, 2002) and increasingly many caregivers ofelders are in their second and third decade. Whileconstituting a small proportion of the caregiverelderly, between 1980 and 1990 the aging AmericanIndian population grew by 52% (Services, 1997), anincrease of 35% over the total older population. Theexpectation is that the number of Indian elderly

will reach 700,000 (twice as many women as men)by the year 2050 (Jervis and Manson, 2002).Epidemiological data on dementia and caregiversin Indian communities are sparse and amongNorthwest Indian communities research data anddelivery of long-term care support services is eithernon-existent or at a nascent stage. While researchamong non-Indians focuses generally on individualor family caregiver burden, caregiving amongAmerican Indians may pose a greater strain on thecommunity as a whole, rather than just theindividual caregiver. American Indian caregiversexperience similar challenges as non-Indians: thecompeting demands of family and work, distanceand relocation, and lack of resources required forproviding care (Services, 1997). Barriers such aslower priority service, little appreciation forlocal needs, and excessive regulations exacerbatethese problems. Prejudice and discrimination arethe most frequently cited service barriers forprimary health care (Services, 1997). During thepreliminary focus groups to design the study, oneelder, a former tribal chairwoman, spoke of herfrustration in trying to obtain services for herown family in need saying: ‘‘I would spend all dayfilling out paperwork, for what? It never came toanything?’’

Caregiver intervention research

Caregiver interventions have focused on helpingthe caregiver cope with the multi-faceted chal-lenges of caring for someone who may be incon-tinent, aggressive and unable to eat unassistedduring the day and awake, confused and ambula-tory in the middle of the night as a result of thedisease. A variety of caregiver interventions toreduce stress and enhance coping including psycho-educational, pharmacological therapies, behavioraltherapies, and technology-based communicationshave been studied in non-Indian populations produ-cing conflicting results. Some interventions reducecaregiver psychological morbidity and depression,in particular when they are individualized, inten-sive and delivered at home (Schulz, 2000; Gitlinet al., 2001). Results from studies of respite care(the delivery of ‘‘relief’’ in the form of anotherprovider or a group day care experience) suggestthat respite can be useful to relieve caregiverstress and improve mood (Conlin et al., 1992). Lackof respite care has been identified as one factorcontributing to institutionalization (Gaugler et al.,2005). Some studies suggested only modest effectsfrom respite care with the effects linked to receiptof adequate amounts of support. (Zarit et al., 1999;

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Strang and Haughey, 1999) or find that efficacydepends upon multidimensional factors such asexpectation, meaning, and number of hours pro-vided (Strang and Haughey, 1999). Other researchhas focused on teaching caregiver skills to managebehavioral problems.

Formal respite opportunities are rare or rarelyused in Indian communities and the availability offormal respite is nascent. There is also significantresistance to respite among many people (regard-less of cultural heritage) who state they prefertheir privacy and thus decline the offer to have ahelper or stranger or even another family memberin the home to provide assistance to their family.This reticence may be more pronounced in Indiancommunities where privacy in response to socialservice agencies remains strong, and where thecultural imperative is toward the acceptance ofresponsibility for elder care.

In this study respite care was chosen as thecontrol for two reasons: (a) it is a well-studiedstandard of care intervention to which we couldcompare PT and (b) new federally funded caregiverprograms were introduced to local tribes andemphasized the delivery of respite care. Howeveras it turned out ‘‘respite’’ or taking time off was achallenging concept to embrace as many partici-pants would say during screening: ‘‘I don’t need thehelp, my mother does!’’ This initial conceptualobstacle collided with the practical challenge forcaregivers to undertake a rest activity when theprimary stressor is indeed the lack of time resultingfrom multiple responsibilities.

Cultural isomorphism of PT

The feasibility of the study was dependent upon theacceptance of PT as a modality congruent with thetarget population’s health-seeking constructs. Thehistorical focus of American Indian traditionalmedicine practitioners is on the restoration ofbalance and alignment with harmonious forces.American Indian elders and their apprentices on,near and distant from Indian reservations continueto practice traditional systems of medicine includ-ing healing with touch. In a Tribal Elders Surveyconducted in 1992 with elders from eight tribesthroughout the United States 35 percent reportedusing traditional medicine, either by itself (9percent) or in combination with traditional andconventional medicine (26 percent) (Services,1997). There is a significant practice of traditionalmedicine among elders in the Pacific Northwest; itvaries in use and application, and a substantialproportion of it remains secret or is derived from

syncretic spiritual practices integrating indigenoustraditions with post-colonial religions (Jilek, 1981).Several of the syncretic religions prominent in theNorthwest, such as the Shakers, Native AmericanChurch and the more traditional Smokehouse,Longhouse, Dreamer and Winter Spirit Dance waysof living include methods of biofield/touch therapyhealing. Biofield/touch therapies are a culturallycongruent approach for tribal peoples of the PacificNorthwest, having a history of using touch andmassage therapies as a traditional form of healing.There is also a small but growing use of CAMservices such as Polarity, massage, and Reiki, onand off reservations, with some reservation-basedclinics incorporating the use of various forms ofbodywork. Yet there is also a powerful reticence,especially among elders (even among themselves orbetween tribal members) to speak freely of theirpractices due in large part to their personalexperience in boarding schools or in society-at-large where cultural practices were systematicallysuppressed until recently and during a long periodfrom the late 19th century when the US govern-ment imposed legal prohibitions against manycultural and healing rituals (White, 1998; Jonaitis,1991). Such practices were frequently punishedby imprisonment and often with hanging. Forthese many reasons; the use of touch for healingamong some tribal members, the intergenerationalmemory of touch associated with traditionalmethods of healing, and a growing acceptance ofmassage and complementary bodywork therapiesprovided by tribal clinics or HMOs, that PTappearedto be an acceptable modality to explore with aSalish and Non-Salish urban and rural population(Table 2).

Study hypotheses

This study was designed to address whether PT canreduce stress, depression, and anxiety, and im-prove the quality of life for caregivers of dementiapatients. As an exploratory study, data were alsocollected on the feasibility of recruitment, theutility and acceptability of the measures and thesafety of the protocol.

We proceeded from three hypotheses: thatcaregivers receiving PT would experience reducedlevels of stress, as compared to the controlsubjects. Stress levels were measured by indicesof adrenal stress response (24 h salivary cortisol,DHEA, Circadian rhythm), 24 h heart rate variability(HRV) and the perceived stress scale (PSS). Thesecond hypothesis was that caregivers receiving PTwould experience a greater reduction of depression

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and anxiety, as compared to the control group.These measures included the Penn State WorryQuestionnaire, the Center for EpidemiologicalStudies-Depression scale, the Nijmegen scale whichmeasures hyperventilation-anxiety syndrome andthe Pittsburgh Sleep Quality Index. Hypothesisthree was that caregivers receiving PT wouldexperience an improvement in quality of life,which was measured by Health Status (SF-36) andthe caregivers Quality of Life-Alzheimer’s Dementiascale (Logsdon et al., 1998). The Stress-RelatedGrowth Scale (Park, 2004) a thematic qualitativeanalysis of clinical narratives and a clinical exam bya registered nurse blind to group assignment atweek 1 and week 9. The stress-related growth scalewas used to complement the ‘‘negative stress’’measures by collecting information on the positiveeffects of stress on personal growth.

Protocol design

The research team undertook focus group discus-sions with key informants on and off reservationsand among dementia caregiver professionals tocollect preparatory information about the per-ceived problems of caregivers and the potentialinterest in this study. A tribal consultative groupconstituted for the study advised about theproposed polarity protocol, measures, the languageused to convey the nature and purpose of theintervention and to assist in the process ofrecruitment.

The use of the term ‘‘subject’’ is pejorative insome research circles and is amplified as a concernamong minority populations, especially AmericanIndians, many of whom have experienced orobserved ‘‘helicopter research’’ Oberley and Ma-cedo (2004, p. 260) state: ‘Helicopter researchoccurs when researchers swoop in, gather data, and

leave. Helicopter researchers build no capacityrecommend no change and invest no funding. Theyleave behind a community’s distrust and regret.’There has been significant research trauma inIndian country and attention to language andmeaning (substituting the word participant forsubject) and active inclusion in decision makingregarding all elements of the project facilitatedeffective partnerships. A tribal liaison was identi-fied to provide support via bi-directional commu-nication between the research team and the tribalcommunities and to provide periodic reports totribal councils and community groups.

The inclusion/exclusion criteria were adaptedfrom the study, Resources for Enhancing Alzhei-mer’s Caregiver Health (REACH) criteria, a multi-site study of caregivers and modified to addresssome of the measures. For example, heart ratevariability measures autonomic nervous systemfunction; however, it does not change as aphysiological value after the age of 65 or 70;likewise, individuals with diabetic neuropathy wereexcluded as their HRV is negatively affected. Thesetwo exclusions reduced the potential pool forrecruitment. The inclusion/exclusion criteria in-cluded: The caregiver is between the age of 27 and70, has been in the caregiver role for at least sixmonths, provides at least four hours of supervisionor direct assistance daily, there would be no changein psychoactive medication during the study peri-od, does not have condition associated with severedisability or death and is not participating in anyother caregiver intervention study. Exclusion cri-teria included, no acute inflammation or infection,deep vein thrombosis, cellulitis of the feet or legs,no surgical emergency or psychoses, no conditionsthat prohibit subject from lying in a supineposition, no substance use disorder, arrhythmias,heart failure, Pacemaker devices, or diabeticneuropathy.

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Table 2 Polarity therapy 21-point protocol for dementia caregivers.

Inclusion criteria: ages 27–70, giving care at least 4 h daily to dementia family member, American Indian/AlaskaNativeExclusion criteria: no diabetic neuropathy, no substance abuse, no arrhythmiasStandardized 21-point and body contacts designed to reduce stressParticipants randomized to treatment or control group based on high/low stress levelsAssessments integrate psychological self-reports, biological and physiological measures at baseline, weeks 2, 5,and 9Biological stress is measured by 24 h circadian cortisol and DHEA rhythmPhysiological stress is measured by 24 h heart rate variability5minutes pre and post treatment interview contributes to qualitative dataBodywork treatment is 50min duration each week for 8 weeks

Note: A detailed description of the points used in this protocol will be given in the next issue of JBMT.

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The design of the standardized PT (and the studymethods in general) had to include three majorqualities:

Cultural congruence

The protocol had to be culturally acceptable to aspiritually, socially, economically, and triballyheterogeneous population of Northwest AmericanIndian caregivers. This includes addressing theneeds of people who may never have experiencedbiofield/touch therapies, or for whom religion,belief system or personal or social traumatic historymight preclude acceptance and study adherence.Because many principles of polarity therapy arederived from Ayurveda and Hindu imagery, theteam eliminated any religious or imaginal refer-ences that might cause offense. The decision aboutprotocol development included additional compo-nents that were respectful of the diversity of localtribal traditions. For example, treatment wouldinvolve wearing light cotton clothes rather than bewithout clothes, would not involve touching poten-tially sensitive anatomical areas, such as contact onthe coccyx or pubic bone or near the breasts, astouching these areas would not be acceptable formodest individuals. The content and process ofpolarity therapy is not well known, even amongmany bodywork professionals, and words such asenergy, bodywork, massage, and healing all havedifferent meanings in the explanatory models ofdiverse tribal (and non-tribal) populations. Toexplain polarity, we used a variety of words andconcepts to explain the principles and methodsinvolved, and tailored language and demonstra-tions to address the specific needs and referencepoints of our participants.

Broad spectrum efficacy

The primary aims of the specific protocol are toreduce stress and improve health (sleep, depres-sion, anxiety) and the quality of life amongcaregivers of people with dementia. Thus, theprotocol had to, theoretically, reduce stress inalmost anyone, and maximize the physical, mental,emotional, and spiritual aspects of the therapy.This required that the design at baseline shouldfacilitate the induction of parasympathetic dom-inance and optimally, allow for the potential for adeep reverie, which might result in creative(hypnagogic) imagery, and spiritual phenomena.The PT developed was designed to maximizeefficacy in almost anyone and was informed bythe primary author’s 30 years of clinical experience

with Polarity. This involved identifying points,holds, and manipulations that could be considereda core set of techniques. It was designed tomaximize parasympathetic induction and energyflow, and include a variety of hand placementsthroughout the whole body, employ a range oftechniques, ranging from light to moderate depthof touch for pressure points, rocking, and manip-ulation of soft tissue and would be consideredminimally invasive by a population known formodesty. The design of the protocol includedidentifying the attribution of qualities associatedwith the points and manipulations from a perspec-tive of both esoteric and allopathic anatomy andphysiology alike (see 21 point tables provided innext issue of JBMT). By identifying the names ofenergetic anatomical and structural point locationsfrom several culturally determined disciplines wecould also understand better the ‘‘language’’ andmeaning of the taxonomies of those disciplines.This approach may in the future inform our under-standing of mechanisms of action.

Control group acceptability

Randomized controlled trials require a controlgroup that allows for comparison between inter-ventions. During the initial stages of the study wedesigned a simple respite provision in whichalternative care coverage would be provided forthe care recipient while the caregiver chose toleave the home for three hours and undertake anystress reduction activity she or he wished. Howeverwithout a choice of an explicit activity thisapproach to respite proved to be unacceptable tothose randomized into the control group and this inturn challenged adherence to the study. As a result,early on respite was ‘‘enhanced’’ by providing a‘‘choice’’ of relaxation activities that were nottouch related. This fulfilled the option to ‘‘choose’’how time was spent away from caring for theirfamily member and also responded to the need tobe provided ‘‘something’’ that felt equivalent tothe polarity treatment. The combination of respitecare that provided time away from the familymember and included a relaxation opportunity oftheir choosing (yoga, retreat, music therapy)provided an ‘‘equivalent’’ enhanced respite inter-vention that emphasized time spent away,‘‘choice’’ and the relaxation itself. Hence, wewould not be comparing to the specific type ofrespite, but to an individualized, self-chosenapproach to stress reduction. The controls receivedthe same ‘‘time away’’ as did the interventiongroup and the same testing procedures including

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a pre- and post-activity qualitative interviewstructured like the qualitative interviews of theintervention group.

Therapist training

A polarity practitioner is trained in theories andprinciples as well as numerous protocols and thetherapist is encouraged to integrate the needs ofthe client and the presenting complaints or requestswith a sharpened intuitive process that is fueled byobservation and understanding the processes ofchange. However, in this study, the protocol andprocess was pre-defined, providing eight 50-minsessions of 21 specific points and manipulations,conducted over a period of 8 weeks. A detailedtherapist manual was designed to teach the PT andto ensure that all verbal interactions were standar-dized from the start to finish of each session. Theprotocol required training the practitioners so theirpalpation and energy-balancing skills were suffi-cient and that their interpersonal skills emphasizedreceptivity rather than directivity. The practitionerswere trained to adhere to a set protocol ofmanipulations, a behavior that as a general rule isintrinsically opposite to a polarity practitioner’snormal mode of practice. The PI trained allpractitioners and their clinical work was validatedfor point location, sensitivity of depth of touch, andenergy flow. Following group training in the protocol(most of the points and manipulations were gen-erally known to the practitioners) individual practi-tioners were required to log 10 sessions (includingwith the other trainees) of the protocol and requesta ‘‘graduation’’ session with the PI who conducted afinal training session that included ‘‘role play’’ foradherence to language and communication as wellas the treatment itself. The therapist ‘‘quality’validation process included a ‘supervisory compo-nent’’ and because senior bodywork practitionerswere chosen, training proved to be rapid. Eachpoint has an ideal depth of pressure that along withindividual idiosyncrasies, forms a matrix of pressurethat is further informed by individual tolerance topain and sensitivity to pleasure; pressure that toolight or too deep can miss the mark that optimizesenergy flow and self-awareness. Indeed the qualityof the touch itself is the conduit for somaticempathy. PT was conceived for this protocol as a‘‘quiet’’ type of bodywork where, like the experi-ence of meditation, the phenomenology associatedwith intensified introspective self-awareness be-comes louder as the reciprocity of sensation (forexample through movement or pressure) betweenthe dyad becomes quieter.

The natural process of PT encourages discussionbetween therapist and client before and after asession. This 10-min interview contributed to thecontent of the qualitative data for both treatmentand control and was collected in a manner similarto the process used within the natural clinicalsetting. The 10-min limit was challenging from acultural perspective (it is rude to cut off or setlimits on discussion among many cultural groupsincluding Northwest Indians) yet was important inorder to reduce the potential confounding role ofverbal exchange as a major element of efficacy.These methodological choices highlight the para-dox inherent in studying a ‘‘healing process’’ whereindividual needs and variations in the healingdynamic of the clinical setting are artificiallylimited by the research design seeking standardiza-tion.

Measures and evaluation process

This study was designed to provide an integrativeapproach to measuring clinical changes in responseto PT and to capture effects associated withphysical, mental, emotional, and spiritual health.The criteria for measures included that they mustbe (a) as non-invasive as possible, (b) culturallyacceptable and sensitive to the study population,(c) provide meaningful information to the partici-pant at the end of their participation in the study,and (d) represent a spectrum of quantitative andqualitative measures that included psychological,physiological, and biological indices. Very fewstandardized measures have been used with Amer-ican Indian populations and even fewer, amongtribes in the Pacific Northwest. We chose measuresthat either had been found valid and reliable(Manson et al., 1990) or reviewed proposedmeasures with the tribal advisory committee.

Cultural validity of measures

Studies using measures tested on predominantlyEuro-American subjects require the evaluation ofthe cultural validity for use with the AmericanIndian population. The participant population waspredominantly Salish, and also included a signifi-cantly diverse sample of Indians from many tribeswho have settled in the Pacific Northwest. TheSalish peoples have substantial exposure to westernmedicine and have been subject to varying degreesto European acculturation dating back to intensivecolonization in the 19th century (Jilek, 1974; Shoreand Manson, 1981).

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The psychological self-reports included the PSS,the Penn State Worry Questionnaire, the Center forEpidemiological Studies Depression Scale (CES-D),the Pittsburgh Sleep Quality Index, The HealthStatus Questionnaire (HSQ), the caregivers qualityof life—Alzheimers caregivers (Logsdon et al.,1998) and Stress-Related Growth Scale (Park andFenster, 2004). Physiological measure included 24 hHRV to measure autonomic stress and 24 h cortisol-DHEA circadian rhythm analysis to measure thebiological stress response. To our knowledge therehave been no studies using either 24 h HRV or 24 hcortisol as measures of stress in American Indianpopulations. A medical exam conducted by aphysician or nurse blinded to group assignmentcollected basic functional parameters of bloodpressure, heart rate, co-morbid conditions, andpharmaceutical and herbal medicine use. We alsoincluded questions about trauma history because ofthe effects of historical and intergenerationaltrauma on communities and individuals and thechronic effects of stress on the mind/body. We alsoincluded the Nijmegen scale, an indicator ofhyperventilation syndrome (Chaitow et al., 2002).Because hyperventilation is closely related toanxiety we wanted to assess this affective statevia the somatic lens hypothesizing that the inclu-sion of diaphragmatic points in the protocol mightbe especially effective at addressing this form ofdistress.

Phenomenological responses such as spiritualexperiences and imagery often occur in responseto PT however direct questions about theseexperiences could be considered intrusive in thispopulation. Hence, open-ended questions aboutone’s experience provided an opportunity toexplore these self-reflective moments unobtru-sively. These qualitative data were collectedimmediately before and after the treatment ses-sions using five questions similar to those used in aregular clinical setting, such as: ‘‘Please tell mehow you feel’’ and ‘‘Is there anything about yourexperience you wish to share with me’’. Thisprovided an opportunity for participants to givevoice to their experience and to provide informa-tion about the process of making meaning thatcomplements self-reports and bio/physiologicaldata thus allowing for data validation acrossanalytic methods.

Concluding discussion

There are numerous considerations in the design ofa biofield/touch therapy clinical research study.The PT protocol was standardized for research with

American Indians of the Pacific northwest in orderto: bridge some of the methodological challengesinherent in using the methods of an RCT, to addressculture-specific requirements for protocol accept-ability and to maximize efficacy while addressingthe conceptual conflicts between standardizationand the intuition process inherent in biofield/touchtherapies. While Dr. Stone never explicitly referredto the influence of American Indian practices on hiswork, he was an Osteopath and Chiropractortrained in the eclectic tradition of the early 20thcentury United States when settlers’ materiamedica continued to be profoundly influenced byAmerican Indian healing traditions. Whatever cul-tural influences may have been in effect, Polaritytherapy is a modern CAM modality with links touniversal indigenous cultural memories and provedto be acceptable to those recruited. Out of 89people screened for participation, 44 were eligiblebased on inclusion/exclusion criteria. Two peopledeclined to participate for ‘religious’’ reasons. Of42 subjects enrolled, four in the control groupdropped out before the 9 weeks concluded, oneparticipant dropped out of the treatment group dueto a personal crisis. Paradoxically, the protocolitself was perhaps more acceptable to the partici-pants than to the therapists, for whom sticking to aprotocol proved counter-intuitive and challengingat the start. In future papers we will address bothclinical outcomes and findings on recruitment andretention.

Note: The next issue of JBMT will carry anillustrated description of the main aspects of theprotocol developed for treatment of dementiapatient caregivers.

Acknowledgments

Special thanks to Dr. Rebecca Logsdon who played acentral role in the design of the study, and toCandace Chaney, Connie McCloud, Natalie Metz,Tiffany Waters, to the project therapists AnastasiaBrencick, Tracey Dickerson,Trish Hinman, AmyRobertson, and Annie Wall. The ‘‘polarity therapydementia caregivers project was supported byGrant Number R21-AT001627-01A1 awarded to theCenter for Traditional Medicine an agency of TheCenter for World Indigenous Studies by the NationalInstitutes of Health, National Center for Comple-mentary and Alternative Medicine. The views,analysis and conclusions of this paper are solelythe responsibility of the authors and do notnecessarily represent the official views of theNational Center for Complementary and Alter-native Medicine, National Institutes of Health.

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Additional financial support was provided by theAssured Home Health and Hospice, Centralia,Washington and the Lewis-Mason-Thurston AreaAgencies on Aging, Olympia, Washington.

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