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BSTETRICS

uricular acupuncture as a treatment for pregnant womenho have low back and posterior pelvic pain: a pilot study

hu-Ming Wang, MD; Peggy DeZinno, RN, BSN; Eric C. Lin, BS; Haiqun Lin, MD, PhD;ames J. Yue, MD; Michael R. Berman, MD; Ferne Braveman, MD; Zeev N. Kain, MD, MBA

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BJECTIVE: The primary aim of this study was to examine whether 1eek of continuous auricular acupuncture could reduce low back andosterior pelvic pain associated with pregnancy.

TUDY DESIGN: A randomized controlled trial was conducted on preg-ant women who have lower back and posterior pelvic pain. Theseomen were randomly assigned into an acupuncture group, a shamcupuncture group, or a waiting list control group. All participantsere monitored for 2 weeks.

ESULTS: Baseline and day 7 showed significant group differences

ilot study. Am J Obstet Gynecol 2009;201:271.e1-9.

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F � 7; P � .0001). The participants in the acupuncture groupeported a significant reduction of pain and improvement of func-ional status as compared with those in the sham acupuncture andontrol groups.

ONCLUSION: One week of continuous auricular acupuncture de-reases the pain and disability experienced by women with pregnancy-elated low back and posterior pelvic pain.

ey words: auricular acupuncture, pain relief, pregnancy,
n pain (F � 15; P � .0001) and in the disability rating index score pregnancy-related low back pain and posterior pelvic pain
ite this article as: Wang S-M, DeZinno P, Lin EC, et al. Auricular acupuncture as a treatment for pregnant women who have low back and posterior pelvic pain: a

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ow back pain is the second mostcommon neurologic ailment in the

nited States,1 and pregnancy is alsoonsidered as 1 of the major contribut-ng factors to the development of thislinical entity.2,3 Pregnancy-related lowack and posterior pelvic pain (PRLP)onsists of generalized lower back painnd distinct pains located in the poste-ior pelvic area distal and lateral to theumbar-sacral junction.4 In the Unitedtates, more than 2 million pregnantomen are affected by PRLP annually,2

rom the Departments of Anesthesiology (Drublic Health (Dr H. Lin), Orthopedics and Rynecology (Drs Berman and Braveman), andedicine, and Women’s Education and Life LiZinno), New Haven, CT; and the Departme

nd Human Behavior (Dr Kain), University o

resented at the Annual Meeting of the AmericaA, Oct. 13-17, 2007.

eceived Nov. 19, 2008; revised March 6, 2009

eprints: Shu-Ming Wang, MD, Department of A08051, 333 Cedar St., New Haven, CT 06520-

his study was supported by National Center forant R21 AT001613-03.

002-9378/free • © 2009 Mosby, Inc. All rights

For Editors’ Commentary, see Table

nd PRLP is reported to be 1 of the mostommon reasons for sick leave duringregnancy.5-7 The current literature sup-orts that the earlier the onset of PRLP,he more severe the pain and disabilityecome as the pregnancy progresses andhe greater the incidence of prolongedostpartum low back pain and chronic

ow back pain.8 Furthermore, 10-20% ofomen who have chronic low back pain

ng and Mr E. C. Lin), Epidemiology andbilitation (Dr Yue), Obstetrics and

nesthesiology (Dr Braveman), Yale School ofning Center, Yale-New Haven Hospital (Msof Anesthesiology, Pediatrics, Psychiatry,lifornia School of Medicine, Irvine, CA.

ociety of Anesthesiologists, San Francisco,

cepted April 16, 2009.

sthesiology, Yale School of Medicine, PO Box1. [email protected].

Complementary and Alternative Medicine

erved. • doi: 10.1016/j.ajog.2009.04.028

ontents
f
SEPTEMBER 2009 Americ

eport that the onset of the pain origi-ated during their pregnancy.9

Chronic/recurrent low back pain is of-en initiated by an acute episode of lowack pain with local irritation and in-ammation, followed by immobiliza-

ion and abnormal posture caused byhis pain.10 The immobilization and ab-ormal posture leads to worsening of lo-al irritation and inflammation, ulti-ately resulting in the development of

hronic low back pain.11 If an effectiventervention that reduces pain is appliedt the onset of acute low back pain, it mayacilitate the early resumption of dailyctivities and lead to a decrease in thencidence of recurrent and chronic lowack pain.10,11 The introduction of drugherapy during pregnancy, however, ishallenging because of the uniqueness ofhe maternal-fetal circulation and theotential for drug transfer to the fetus.12

his means that nonpharmacologicreatment for PRLP is potentially very at-ractive, both as a means to decrease painuring pregnancy and also to decreasehe risk of chronic back pain throughoutife. Although massage, yoga, acupunc-ure, and related interventions have beenecommended as potential treatments

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an Journal of Obstetrics & Gynecology 271.e1

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2

ity of randomized control trials to sup-ort the benefit of using any of these in-erventions in pregnant women. In fact,recent review articles reveal that there

s an urgent need for high-quality clinicalrials in the evaluation of the currentreatment options for PRLP.14,15

Several clinical studies and 2 review ar-icles indicate that traditional body acu-uncture may serve as a treatment forRLP,14-19 but only 1 study has used au-icular acupuncture as an adjunct forody acupuncture. Wedenberg et al16

howed that the combination of auricu-ar and body acupuncture was superior

FIGURE 1The press needle-semipermanent n

ang. Auricular acupuncture treatment for women with PR

o physiotherapy in relieving the severity d

71.e2 American Journal of Obstetrics & Gynecolo

f pain and the disability related toRLP, but the intervention protocol wasery time consuming, often consisting of-hour treatments and 10 treatments peronth of acupuncturist office visits.

ato-Katzenschlager et al20 demon-trated that auricular acupuncture wasffective in providing relief to nonpreg-ant patients with chronic back pain.uricular acupuncture21 is preferable toody acupuncture, because it is easy topply without undressing the patient orsing sophisticated needle manipula-

ions, as in traditional body acupunc-ure. Last, the use of auricular press nee-

dles

m J Obstet Gynecol 2009.

les (Small; Seirin Pyonex, Shizuoka, a

gy SEPTEMBER 2009

apan) (Figure 1) allows the provision ofontinuous acupuncture interventionhile the patient continues with heraily activities. These observations pro-ided the basis for this study of whetheruricular acupuncture alone can be useds a treatment for PRLP.

The primary hypothesis of this study ishat 1 week of continuous acupuncturetimulation at 3 specific auricular pointsill reduce the severity of pain in preg-ant women with late-trimester PRLP.he secondary hypothesis of this study is

hat an effective reduction of pain causedy PRLP would be concomitant with an

mprovement in the functional status ofhese women.

ATERIALS AND METHODSesign and settingshis randomized controlled clinical trialas conducted at the Center for the Ad-ancement of Perioperative Health atale-New Haven Hospital after obtain-

ng approval from the Human Investiga-ion Committee at Yale Universitychool of Medicine. Participants wereandomly assigned to receive 1 of the fol-owing 3 interventions: (1) acupuncturet specific auricular points, (2) acupunc-ure at nonspecific auricular points, or3) no-intervention control. To reduceias affecting the study results, all pro-pective participants were informed thathey had a 33.3% chance of receiving noreatment until after the completion of a-week study period.

ubjectsarticipants were pregnant women withgestational age of 25-38 weeks, who had

ower back and/or posterior pelvic pain.ll participants were healthy womenith a physical status II in the Americanociety of Anesthesiologists (ASA) clas-ification and had no prior experienceith acupuncture. PRLP was classifiedased on the classification defined byorén et al,22 and exclusion criteria in-

luded any associated nerve root syn-rome, neurologic deficit, fever, abdom-

nal pain, other systemic manifestations,

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nd active uterine contractions.

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www.AJOG.org Obstetrics Research

roup assignmentscupuncture grouparticipants in this group received auric-lar press needles at 3 points (kidney, an-lgesia, and shenmen) (Figure 2). Theseoints were selected based not only onhe close location to the auricular soma-otopic map of the hip and the lumbarpine21 but were also pretested on 50regnant women with PRLP during thereparation phase of this randomizedrial by our research group.

ham acupuncture grouparticipants in this group received auric-lar press needles at 3 nonspecific auric-lar acupuncture points (shoulder,rist, and extraauricular point), whichere used in previous studies and

howed a minimum effect (Figure).23,24 The sham acupuncture groupas included as a control to address is-

ues specifically related to the clinicalcupuncture trial, such as placebo ef-ects, blinding, and subjects’ beliefs.

ontrol grouparticipants in this group received nocupuncture treatment. No-treatmentontrol group was included, because sev-ral clinical acupuncture studies haveuggested that any needle intervention

ight result in some physiologic re-ponses and pain relief.25

easuresackground characteristiche questionnaire was designed toather demographic information, as wells State and Trait Anxiety InventorySTAI).26

isual Analog Scale for Pain (VAS-P)27

he VAS rating system consists of a00-mm line that represents 2 extremes,hat is, no pain (a score of 0) and extremeain (a score of 100). There are ampleata regarding the excellent reliabilitynd validity of this instrument.

isability Rating Index (DRI)28

his instrument contains 12 commonaily activities and requires the partici-ants to rate their level of disability inach activity, with 0 denoting no disabil-ty and 100 denoting maximum disabil-
ty (ie, inability). The measure has dem- c
nstrated satisfactory test-retest andnterrater/intrarater reliabilities, as wells internal consistency.

tudy protocolrenatal health care providers referredll participants to the study who hadack pain without any suspected obstet-ic and/or medical reasons. Prospectivearticipants were instructed by their pre-atal care providers to call the PRLP hot-

ine and a research assistant would ex-lain the nature of the study and conductpreliminary interview of participants’

ymptoms and conditions. If inclusionriteria were met, the women were in-ited to participate in the study, and ver-al consent was obtained. Prospectivearticipants followed up with an ap-ointment with 1 of the physician coin-estigators for further evaluation andossible enrollment. A detailed historyas taken, and a general physical exam-

nation, combined with special focus oneurologic testing pertinent to back and

ower extremities, was conducted to en-ure these potential participants met thenrollment criteria. After this evalua-ion, 1 pregnant woman was referred forurther workup because of the more

FIGURE 2The locations of auricular acupunc


omplicated nature of her back pain, and p


pregnant woman decided not to partic-pate in the study, because she was notomfortable signing the HIPPA consent.

Once a participant was enrolled, aritten consent was obtained, and base-

ine assessments of anxiety (STAI), painVAS-P), and functional status (DRI)ere completed. Participants were ran-omly assigned into 1 of the 3 treatmentroups based on a computer-generatedandomization sheet. The acupuncturistS-M.W.), who is a board-certified anes-hesiologist and a certified acupuncturistith 9 years of clinical acupuncture ex-erience, applied 3 auricular press nee-les to the respective auricular points inhe acupuncture and sham acupunctureroups based on the randomizationcheme. Because of the inconsistenciesnd nonspecifics of commercially madekin conductors in the literature,29 theuricular points used were identified onhe basis of the auricular zone system.21

o avoid any bias caused by the acu-uncturist and the assessor (research as-istant), the acupuncturist adhered to acripted speech during interaction withhe participants and inserted the needlesithout the presence of the assessor. If a

e points


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r sham acupuncture treatment, thecupuncturist told her that a total of 3uricular press needles would be insertednto 1 side of her ear, and these needlesould be left in place for a 1-week periodefore being removed. After the place-ent of these auricular press needles, the

cupuncturist instructed the partici-ants to inspect the integrity of the oc-lusive tape over these needles daily butot to apply any pressure or manipula-

ion over the needle insertion site. If anydverse reaction, such as local redness orncreased pain, occurred, the participantas instructed to contact the study

enter immediately and return for rein-pection, adjustment, and/or possibleemoval of the press needles. All partici-ants, including those in the controlroup, were told that they would besked to report their average level of painVAS-P) and functional status (DRI) onay 7 and again report their average levelf pain on day 14 after enrollment in thetudy. The assessor telephoned everyarticipant, including participants in theontrol group, daily over the study pe-iod to ensure the study protocol was fol-owed. The participants in the controlroup, after the 2-week observation,

FIGURE 3Trial flowchart


ere offered to return to the center i


nd receive auricular acupuncturereatment.

All participants were directed to ad-ere to PRLP self-care, that is, continu-

ng to rest as desired, taking acetamino-hen 650 mg every 6 hours if needed,nd/or applying topical warm and coldompresses to relieve low back pain dur-ng the 2-week study period. However,articipants were instructed not to useny other complementary and alterna-ive treatments (CAM), such as massage,hiropractic manipulations, or physicalherapy.

linding and credibilityo test blinding to treatment and to as-

ess the credibility of the respective treat-ent methods,30-32 all participants who

eceived auricular acupuncture treat-ent were asked to complete a credibil-

ty questionnaire (Appendix) on day 7fter the removal of auricular press nee-les. All assessors were blinded to theroup assignment. The statistician whoerformed the final analysis was blindedo the group assignment.

ample size and statistical analysishe primary aim of this study was toompare 1-week changes from baseline


n pain scores measured by a VAS-P. The w

gy SEPTEMBER 2009

econdary aims of this study were to as-ess the functional status of the partici-ants 1 week after intervention, as mea-ured by DRI, and to determine theherapeutic effect of a 1-week auricularntervention. Sample size was calculatedsing Sample Power statistical softwareersion 1.2 (SPSS, Inc, Chicago, IL). A0% reduction in VAS-P (primary out-ome)33 from the baseline was consid-red to be clinically meaningful for theurpose of the study. The estimatedtandard deviation of change from base-ine is about 25 for VAS in a previoustudy.16 As enrollment gestational age inhis study ranged from 25-38 weeks, wetratified participants into 3 groups:5-29 weeks’ gestation, 30-34 weeks’ ges-ation, and 35-38 weeks’ gestation. Withpower of .85 and a significance level of

05, calculations based on previous dataielded a sample size of 135 women forhe trial. Given an estimated dropoutate of 15%, however, we recruited andditional 24 patients, for a total of 159.

Baseline demographic data, prognos-ic variables, and credibility evaluationsere compared using t tests and �2 tests,

s deemed appropriate. A mixed-effectodel, with random intercept analysis,34

LP. A

as performed for the outcomes, and the

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herapeutic effect of 1-week interventionredictors included the indicator vari-bles of all 3 groups, at day 7 and day 14,nd the interaction terms between thendicator variables of time and group.ubject was treated as a random effect toccount for within-subject correlation. Ifny measure for a time point was miss-ng, the mixed model accounted for the

echanism of missing at random. After

TABLE 1Baseline characteristics of the part

Characteristic

Age, mean (SD), y...................................................................................................................

Gestational age, %..........................................................................................................

25-29 wk..........................................................................................................

30-34 wk..........................................................................................................

35-38 wk..........................................................................................................

Mean (SD), wk...................................................................................................................

Location of pain, %..........................................................................................................

LBP..........................................................................................................

PPP..........................................................................................................

LBP-PPP..........................................................................................................

Nonspecific LBP...................................................................................................................

Previous LBP, %..........................................................................................................

Yes..........................................................................................................

No...................................................................................................................

Previous pregnancy LBP, %..........................................................................................................

Yes..........................................................................................................

No..........................................................................................................

Not applicable...................................................................................................................

First pregnancy, %..........................................................................................................

Yes..........................................................................................................

No...................................................................................................................

Beliefs in acupuncture, mean (SD)...................................................................................................................

Baseline anxiety..........................................................................................................

State, mean (SD)..........................................................................................................

Trait, mean (SD)...................................................................................................................

Education level, mean (SD), y...................................................................................................................

Baseline VAS-P, mean (SD)...................................................................................................................

Baseline DRI, mean (SD)...................................................................................................................

No statistical differences between groups. P � .05.DRI, disability rating index; LBP, lumbar back pain; PPP, po

Wang. Auricular acupuncture treatment for women with

n overall test of treatment effect, the a

ischer protected test was used for pairwiseomparisons to determine the group dif-erences. P � .05 was considered signifi-ant and SPSS was used for analysis.

ESULTSetween Feb. 1, 2005-Jan. 31, 2008, a to-

al of 311 pregnant women with lowerack/posterior pelvic pain were referred

pantsAcupuncture group Sham acu(n � 58) (n � 54)

33 (5) 32 (5).........................................................................................................................

.........................................................................................................................

42 40.........................................................................................................................

36 42.........................................................................................................................

22 18.........................................................................................................................

30 (5) 29 (7).........................................................................................................................

.........................................................................................................................

47 38.........................................................................................................................

42 38.........................................................................................................................

6 8.........................................................................................................................

5 0.........................................................................................................................

.........................................................................................................................

47 46.........................................................................................................................

53 54.........................................................................................................................

.........................................................................................................................

26 28.........................................................................................................................

21 29.........................................................................................................................

53 43.........................................................................................................................

.........................................................................................................................

53 43.........................................................................................................................

47 57.........................................................................................................................

7 (2) 7 (2).........................................................................................................................

.........................................................................................................................

35 (9) 35 (9).........................................................................................................................

37 (8) 37 (8).........................................................................................................................

16 (3) 16 (3).........................................................................................................................

70 (20) 62 (22).........................................................................................................................

63 (25) 57 (28).........................................................................................................................

r pelvic pain; SD, standard deviation; VAS-P, visual analog sc

P. Am J Obstet Gynecol 2009.

s potential participants for this study. g


fter an initial telephone screening, 172ubjects who had met the inclusion cri-eria were invited to participate in thetudy. A total of 161 subjects presentedor the preenrollment appointment, 159ubjects enrolled into the study and 152ubjects completed the 2-week study pe-iod (retention rate of 95.6%) (Figure 3).here were no significant differences inaseline variables between the 3 study

ncture group Control group(n � 47)

32 (5)..................................................................................................................

..................................................................................................................

51..................................................................................................................

30..................................................................................................................

19..................................................................................................................

29 (5)..................................................................................................................

..................................................................................................................

57..................................................................................................................

28..................................................................................................................

11..................................................................................................................

4..................................................................................................................

..................................................................................................................

55..................................................................................................................

45..................................................................................................................

..................................................................................................................

20..................................................................................................................

24..................................................................................................................

56..................................................................................................................

..................................................................................................................

56..................................................................................................................

44..................................................................................................................

7 (2)..................................................................................................................

..................................................................................................................

38 (11)..................................................................................................................

37 (9)..................................................................................................................

16 (3)..................................................................................................................

66 (26)..................................................................................................................

63 (28)..................................................................................................................

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rimary outcomeain at day 7s can be seen in Figure 4, participants

n all groups reported a decrease inain in varying degrees (F � 186; P �

0001), and the participants in the acu-uncture group reported a significanteduction in pain compared with thosef the sham acupuncture group (P �

001) and those of the control group (P.0001). In contrast, the reduction of

ain between the sham acupuncture

FIGURE 4The level of pain at baseline and da

AS, visual analog scale.


FIGURE 5The functional status at baseline a



nd control groups (P � .46) was notignificant. A mixed-model analysisemonstrated that there is a significantroup � time interaction (F � 15; P �0001). More participants in the acu-uncture group had a clinically signif-

cant reduction in pain (eg, 30% reduc-ion) than those of the shamcupuncture group and the controlroup (81% vs 59% vs 47%; P � .015).n addition, 37% of participants in thecupuncture group, 22% of partici-

7


day 7


s

gy SEPTEMBER 2009

ants in the sham acupuncture group,nd 9% of participants in the controlroup became pain-free (VAS-P score

0) at day 7 (P � .003).

econdary outcomesunctional status at day 7imilarly, all the participants, regardlessf their group assignment, reported im-rovement in the functional status afterhe first week (F � 126; P � .0001). Asan be seen in Figure 5, participants inhe acupuncture group reported a signif-cant improvement of functional statusompared with those of sham acupunc-ure and control groups: P � .03 and P �001, respectively. In contrast, the differ-nces of functional status between theham acupuncture and control groupsid not reach statistical significance (P �

60). A mixed-model analysis reveals aignificant group � time interactionF � 7; P � .0001).

herapeutic outcome during-week study periodmixed-model analysis indicated a sig-

ificant reduction of pain over time (F �2.7; P � .0001) in all 3 groups and aignificant group � time interaction (F

4.7; P � .013) (Figure 6). At day 14,8% of participants in the acupunctureroup had a clinically significant reduc-ion of pain, whereas only 32% of partic-pants in the sham acupuncture group (P

.02) and 18% of participants in theontrol group had a clinically significanteduction of pain (P � .001). However,he number of participants who re-

ained pain free at day 14 did not showsignificant difference among the

roups (16% vs 9% vs 6%; P � .25).Only 3 participants in the study (acu-

uncture vs sham acupuncture vs con-rol � 1 vs 2 vs 0) used acetaminophen asn adjunct for pain treatment. The totalonsumption of acetaminophen rangedetween 1300-1950 mg, and none of thearticipants reported that acetamino-hen was helpful for their back pain.

dverse effects experienced duringtudy period and postpartumuring the first week of the study period,of 54 participants in the acupuncture

roup and 3 of 50 participants in the

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ransient ear tenderness, which resolvedpontaneously. No participants experi-nced preterm labor. However, 1 of 54articipants in the acupuncture group, 1f 50 participants in the sham acupunc-ure group, and 1 of 47 participants inhe control group were placed on bedest after the study period was com-leted. No adverse pregnancy outcomesere reported.

OMMENTnder the conditions of this study, we

ound that pregnant women who re-eived a 1-week continuous auricularcupuncture treatment reported signifi-antly less pain compared with those ofhe sham acupuncture and controlroups. At the day 7 follow-up, we foundhat about 80% of the participants in thecupuncture group experienced a clini-ally significant reduction in pain com-ared with 56% of participants in theham acupuncture group and 36% ofarticipants in the control group. Thislinically important outcome was associ-ted with an improvement in functionaltatus as the pain decreased. The reduc-ion of pain continued to the day 14 fol-ow-up. However, the reduction of painas not sustained for every participant,

s the number of the participants whoemained pain free was fewer at day 14han day 7. This observation suggestshat after removing press needles, thereas a return of pain in some of the par-

icipants. Thus, it is important to explorehether an extended continuous auric-lar acupuncture is needed to have a sus-

ained effect, as well as the characteristicsf acupuncture responders vs nonre-ponders in future studies.

Because there are no safety data usinguricular press needles in delivering au-icular acupuncture continuously inregnant women, we chose 1 week as thereatment period, which was derivedrom our clinical experience as a conser-ative treatment duration. Based on theesults of this study, we are confidenthat a 1-week auricular acupuncture cane safely administered in pregnantomen with low back and posterior pel-ic pain at the last trimester of preg-
ancy, because we did not observe any
ajor local irritation, infection, or ad-erse outcome in pregnancy. For a ma-ority of participants receiving thera-eutic acupuncture, pain relief wasubstantial and led to improvement ofunctional status. Hence, this study sup-orts that use of acupuncture at specificuricular points is a safe and effectiveonpharmacologic treatment of an im-ortant clinical entity for which there areurrently few, if any, effective treat-ents. Interestingly, participants in the

ontrol group also experienced reduc-ion of pain without additional treat-

ent other than PRLP self-care. This re-uction of pain may be caused by theelf-care package prescribed in this studyr by the daily inquiry performed by thessessor, or the combination of both.he psychologic impact and effect of

FIGURE 6The therapeutic effect of 1-week in


TABLE 2Credibility test

Variable

Acupgrou(n �

Think the treatment received is areasonable strategy

9 (2)

...................................................................................................................

Relieves lower back pain 8 (3)...................................................................................................................

Will use the treatment again 9 (3)...................................................................................................................

Will recommeded to a friend 9 (2)...................................................................................................................

Satisfied with the treatment 8 (3)...................................................................................................................

All rating scales based on 0 � not at all and 10 � definiteSD, standard deviation.

Wang. Auricular acupuncture treatment for women with PRL


aily inquiry should be assessed in a fu-ure study. Although an economic anal-sis was beyond the scope of this study,he cost for the auricular acupunctureress needle is about $17-20 for 100 perack, and this intervention can be ad-inistered in 3 minutes by an experi-

nced operator. Thus, a future, large-cale randomized controlled trial isefinitely indicated to confirm the po-ential benefits of using thisntervention.

Other methodologic issues related tohis study that should be addressed are asollows. (1) Issues related to VAS-P ashe primary measuring tool for pain dis-rders. Although pain disorders are gen-rally considered to have more than 1 di-ension, for example, affective and

ensory aspects, we used the VAS-P as

vention


cture

)

Sham acupuncturegroup(n � 50)

8 (2) 0.2

..................................................................................................................

7 (3) 0.2..................................................................................................................

9 (2) 0.9..................................................................................................................

8 (3) 0.6..................................................................................................................

8 (3) 0.6..................................................................................................................

ata are mean (SD).

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he assessment tool for the primary out-ome of this study, because it is not onlyffective in assessing the improvement ofain in clinical settings33,35-37 but also isell defined in assessing the clinical sig-ificance of pain reduction.33 Thus, theesults of this study can be more mean-ngful for the practitioners who encoun-er PRLP on a daily basis. As pain disor-ers are usually complex, VAS-P mightot be ideal. Future studies should alsoonsider additional multidimensionalain assessment tools, such as the Briefain Inventory38 and McGill Paincale,39 to name a few, to address differ-nt aspects of pain. (2) Issues related toredibility testing. Although the credibil-ty test is critical in assessing the success-ulness of blinding for clinical acupunc-ure studies,25 auricular acupunctureerformed in this study is different fromhe traditional acupuncture, for exam-le, the type and manipulation of nee-les, as well as the duration of the nee-les’ retention. Furthermore, there areo data in the literature to determinehether the intervention technique anduration introduced in this study are ac-eptable treatment strategies for preg-ant women with PRLP. Thus, some of

he questions in the credibility test32

ere modified to answer our inquiry. (3)ssues related to a single acupuncturist.lthough only 1 acupuncturist per-

ormed all the auricular acupuncture in-erventions, the participants not onlyhink the treatment strategy was accept-ble but also believe the interventionhey received improved their lower backnd pelvic pain regardless of the groupssignment (both the acupuncture andham acupuncture groups; Table 2).herefore, we are confident that neither

he acupuncturist nor the interventionelected in this study introduced any biaso the participants who received the au-icular acupuncture intervention or af-ected the validity of the study results.

In summary, we found that the par-icipants who received a 1-week con-inuous acupuncture treatment at thepecific auricular points had a signifi-ant reduction in pain compared withhose of the sham acupuncture andontrol groups, but the treatment ef-
ect was not sustained in some of the m

regnant women. Thus, long-term ef-cacy of auricular acupuncture as a

reatment for PRLP is still inconclusiveut clearly shows promise. A future

arge-scale randomized control studys indicated to explore the characteris-ics of acupuncture responders vs non-esponders, the optimal duration ofreatment to achieve the sustainedherapeutic effect, and the potential

echanisms of auricular acupuncturenalgesia, as well as detailing the preg-ancy outcomes. f

CKNOWLEDGMENTSe thank the referring network of prenatal care

roviders and participants for their support, asell as Dr James Dziura at the Yale Center forlinical Trial for statistical support and Mrs An-ette Forte for her administrative assistance.

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PPENDIX

nswer each question by circling theumber that seems to best fit your opin-

on about the acupuncture treatmentou received:

. Did this seem like a reasonable strat-egy to reduce the level of low backpain during pregnancy?1 2 3 4 5 6 7 8 9 10unreasonable very reasonable

. How much did this treatment helpyou reduce your low back pain?1 2 3 4 5 6 7 8 9 10not at all very much so

. Would you recommend this treat-ment to a friend who might be havinglow back pain during pregnancy?1 2 3 4 5 6 7 8 9 10would notrecommend

definitely wouldrecommend


. Was this treatment what you had ex-pected?1 2 3 4 5 6 7 8 9 10not what Iexpeced

just what Iexpected

. Was the time involved reasonable?1 2 3 4 5 6 7 8 9 10unreasonable very reasonable

. If you had more back pain in the fu-ture, would you try this treatmentagain?1 2 3 4 5 6 7 8 9 10not at all definitely

. How satisfied are you with this way oftreating low back pain?1 2 3 4 5 6 7 8 9 10not at all very satisfied


1) nsaids acu

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