Intramuscular and Periosteal Acupuncture in Patients Suffering From Chronic Musculoskeletal Pain - A Controlled Trial

7/29/2019 Intramuscular and Periosteal Acupuncture in Patients Suffering From Chronic Musculoskeletal Pain - A Controlled Trial

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Papers

Intramuscular and periosteal acupuncture inpatients suffering from chronic musculoskeletalp a m - a controlled trialYlva Hansson, Christer Carlsson, Elisabeth Olsson

YI va Hat issunphysiotherapistampimctuHxtThe Research inciDevelopment UniiJmthind CountyCouncilOstersund, SwedenChrister Carlssonmedical acupuncturistDept of NeurosurgeryLund UniversityHospitalSwedenElisabeth OlssonprofessorDept of NeurobiologyCare Sciences andSocietyKarolinska InstiiutetStockholm, SwedenCorrespondence:Elisabeth Oissonel isabeth.oisson @ ki .se

AbstractBackground Periosteal acupuncture has shown promising results in clinical practice. The aim w as to comparthree patient groups: one with intramuscular acupuncture, one with periosteal acupuncture, and a thirinformation control group, with respect to clinically relevant pain relief, physical functioning and intake oanalgesics in patients with chronic musculoskeletal pain in the neck or low back or both. We reported thpsychological changes in these patients in a previous issue of this journal.Methods 144 consecutive patients with nociceptive pain for >3 months, aged 18-70 years were alternatelallocated to: intramuscular acupuncture (n=59); periosteal acupuncture (n=55); or control group witinformation only (n=30). All patients were encouraged to stay active. Acupuncture was administered with eigtreatments during five weeks, and two optional additional treatments after one month. Pain was estimated wita daily VAS in a pain diary and with an average weekly pain score. Clinically relevant pain relief was defineas at least a 30% decrease -om the initial value. Physical functioning was evaluated with Disability RatinIndex. All estimations were performed prior to treatment, one week after, and one, three and six monthafter treatment.Results There w ere no differences between the effects of the two acupuncture m ethods. There were differencbetween each of the two acupuncture groups compared with the control group on all test cas ions up to onmonth after treatment with respect to the pain diary and one week after treatment with respect to pain last wee(P


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PaperPerios tea l acupuncture has shown promis ingresults in the clinic.'' In an experimental study inhealthy volunteers,'" electrical stimulation of theperiosteum was superior to st imulat ion ofmusculature and skin in alleviating pain originatingfrom periosteum and musculature. The efficacy ofperiosteal stimulation in a clinical sen ing w as testedby Weinet et al who showed a superiori ty ofperiosteal electrical stimulation to placebo stimulationwith respect to pain relief but not to other physicalfunctioning in patients with osteoarthritis of theknee." As we could not find any reports ofcomparisons between intramuscular and periostealacupuncture in patients with chronic pain in the neckand low back, we undertook a study with thehypothesis that periosteal stimulation is superior tointramuscular stimulation for pain relief, physicalfunctioning and psychological variables, themechanisms for this being the same as for otherfonns of acupuncture stimulation, An acceptance ofthis hypothesis would increase treatment efficiency.Our first, recently published report of other outcomesfrom the same study showed no differences betweenthe two techniques with respect to psychologicalvariables.'"

The present aim was to compare three patientgroups, one with intramuscular acupuncture, onewith periosteal acupuncture and a third informationcontrol group, with respect to clinically relevantpain relief, physical functioning and consumption ofanalg esics in pat ien ts suffering from ch ronicmusculoskeletal pain in the neck or low back orboth.Material and MethodsPatientsAll patients seeking primary care for musculoskeletalneck or low back pain or both referred forphysiotherapy between 1996 and 2000 in Krokom , asparsely p opulated municipality in northern Sweden,formed the study population. The criteria for inclusionwere: age 18-70 years, and pain originating fromthe neck or low back for over three months, thatcould be provoked by active or passive movem ent ierotation, and/or extension. Criteria for exclusionwere: other serious medical conditions; a coagulationdisorder; t reatment with anticoagulants orantidepressants;fibromyalgia;" pregnancy; symptoms

sensation and signs of neurological deficits withinthe area of pain;'* diagnosis of substance addiction;treatment with acupuncture within three months priorto enrolment; and/or inability to speak and readSwedish.

The patients were divided into three groupsaccording to neck pain, low-back pain or both. Thepatients in each group were allocated alternately tointramuscular acupuncture (IMA) and periostealacupuncture (PA). We originally calculated that 50patients in each grou p w ould be sufficient to detecta clinically meaningful difference in pain scoresbetween groups, using parametric statistics. Afterthe first 41 patients had been allocated in this way acontrol group (CG) was added as the research teamwas revised and the new team considered this a wayof strengthening the quality of the study. No resultswere available at that stage; no new power calculationwas conducted. For the subsequent three years, everythird presenting patient regardless of location of painwas assigned to the control group. When thetreatment grou ps had reached a sufficient n um ber,an additional 14 consecutive patients were includedas controls to mak e this group sufficiently large aswell . The pat ients were nei ther charged foracupuncture nor did they receive compensation forparticipating in die trial.

TreatmentAt each measurement time point, all patients wereencouraged by the treating physiotherapist to beact ive and to maintain and increase mobil i ty,particularly in the painful parts of the body. Thisencouragement was given as routine to all patientswho were treated for these problems during thatperiod in that primary care unit.Intramuscular acupuncture (IMA )Standard W estern style intramuscular acup uncturewas used in traditional acupuncture points withinthe painful area (Table 1 )."'"'Wh en the practitionerfelt the characteristic resistance at a depth of insertionof usually ]-3cm, the needle was twirled until thepatient felt the characteristic needle sensation ienum bness, soreness or slight pain. De qi was elicitedtwo additional times during each session. The numberof needles inserted was successively increased from4 to 12 in accordance with the patient's response to


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PapersTable I Description of acupuncture according to STRICTA guidelines

1 Acupuncture rationaleIn both groups Western style acupuncture w ith individualised point localisation according to pain distribution.

2 Needling detailsPoints used

Number of needles

Depths of insertion

Responses elicited

Needle stimulationNeedle reiention timeNeedle type

3 TVeatment regimenTreatment sessionsFrequency of treatment

4 Co-interventions5 Practitioner6 Control intervention

IMA - acupuncture points within painful areaPA-acupuncture points in lender areas within pain distribution (Fig I); bilateralI M A - 4 - 1 2P A - 2 - 8IMA - to characteristic resistance fett by practitionerPA - to periosteumIMA - Ji- (fiPA - radiating sensationIMA - manual rotationPA - periosteal tapping30 minutesChinese stainless steel disposable needles O.3x3O-5Omm (neck). 0.4x50-7 5mm (back)

2 per week for 3 w eeks, then 1 per week for 2 weeks. Afler 1 month, 2 optional ueatmcnts nsame kindAdviceExpert in orthopaedic manual therapies; University courses in acupuncture; >200() treatmenis oeach type performed betre start of studyIndividual advice to control groupBlinding of participants with respect to acupun cture.

IMA - intramuscular acupuncture; PA - periosteal acupuncture

Periosteal acupuncture (PA)The needles were inserted in tender areas, not alwaysstandard acupuncture points, at sites on the underlyingperiosteum, and then used to prick a small periostealarea (5-10mm in diameter). 2-A times per second, forapproximately 10 seconds (Table 1 ). All patients felta radiating sensation, and tbe needles remainedinserted just away from the periosteum for another 30minutes, without further stimulation. Tbe number ofneedles employed was increased successively fromtwo to eight (Fig IB).'-

The combination of acupuncture points waschosen individually on the basis of pain location.Thus, points on the neck and lower back were usedas local points and certain acupuncture p oints on theupper and lower limbs, respectively, were employedas distal points.'^

All treatments were carried out by the samephysiotherapist (YH). who specialises in acupunctureand had performed more than 2000 treatments ofeach type prior to the study (Table 1 ).'^

Both types of acupuncture were administered

during each of the following two weeks for 3minutes per session. One month after the series treatments w as completed and evaluated, tbe patienwere offered a maximum of two follow up treatmenofthe same kind one week apart.

Tbe study was single blind with respect to type acupuncture stimulation.Control group (CG)Apart from tbe routine encouragement to be activand m obile at all measurement points, these patienalso received information from the evaluat inphysiotherapist. They were promised acupunctufollowing the three month control period.Outcome methods

Current pain by pain diary (PD )This was estimated by the patient in a pain dia

employing a standard visual analogue scale (VAwith the anchor points 'no pain' and 'worst imaginabpain"." It was completed three times a day for sevedays. From tbe maximal values for each day, th


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Paperk, : ; i r

Figure lA

GB20,GB12Cervical articularpillar area C5-C6


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PapersThe paiti diary, often used in pain clinics and inscientific studies, was chosen because pain ratingsconsisting of n umerous ratings have shown goodreliability and the sample was relatively small.'*

Average pain during the last week (PLW)This was also estimated with a VAS, A single

rating of pain has sufficient psychometric strengthto be useful in comparing relatively large grou ps ofindividuals with chronic pain.'* PLW is often usedin primary care.

Intake of analgesicsAnalgesics were categorised as simple analgesics

(eg anti-inflammatory drugs, paracetamol) weakopioids (eg dextropropoxifen, codeine) and others(eg muscle relaxant and combinations of simpleanalgesics and weak opioids). Consumption {yes orno) was registered weekly during every seven dayevaluation period. Use of two tablets or less duringthe evaluation period w as ignored.

Physical fiinctioningThis was assessed using the Disability Rating

Index (DRI). Patients scored their capacity to performeach of the 12 activities in this self administeredquestionnaire on a VAS with endpoints markedO='without difficulty" and IOO='not at all*. Thevariables were organised into three subscales: comm onactivities; more demanding activities; and work nslatedactivities," Reliability and validity of the DRI weregood when tested in relevant patient grou ps.''' "'

Pain, intake of analgesics and physicalfunctioning were assessed one week prior totreatment and one week after treatment plus one,three and six months after the end of treatment. Anadditional assessment of pain level and intake ofanalgesics was recorded in the pain diary (PD) inthe middle of the treatment period, ie between thefourth and fifth treatments. In the control group thesame assessments were made at corresponding times,but only for one month after the end of treatment.

The first three assessments were carried out in theclinic, whereas the three and six month assessmentswere based on questionnaires delivered by mail.Statistical m ethodsRecent research show s that the frequendy used VAS

analysis as ordered categorical data, not continuoudata."""'' On the initial evaluation the patients wercategorised according to severity of pain for each othe two pain variables, with low pain indicated bless than 30mm, medium pain between 30 an60mm and high pain m ore than 60m m on the VASrespectively. We defined clinically relevant pairelief as follows: for those with low pain, a reductioof 10mm or more on the VAS; for those witmedium pain, a reduction of 20mm or more; anfor those with high pain, a reduction of more tha30mm. Farrar et al showed in large samples opatients with chronic pain that a 30% reduction opain measured in a l inear scale, or a two stedecrease when evaluated on an 11 step numericarat ing scale, could be regarded as cl inical lrelevant.'^'" Thus, w e used non-parametric statisticthe ch i square and sign tests for analyses of paiand intake of analgesics, and the Mann-Whitnetest, the K ruskal-Wallis test and Friedman 's ANOVAby ranks for analyses of physical functioning.'^ Foanalyses the SPSS 12,0 (Statistical package foSocial Science) and the SAS system were used. Thlevel of significance was set to P


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Table 2 Demographics

Paper

Intramuscularacupuncture

(n-59)Periosteal

acupuncture(n=55)

Control group(11=30)

Wi>mcn/menAge mean, years (SD)On sick leave >50%UnemployedRetired >65yearsRetired i year

Accepted the two extra treatments

40/1950 (9.8)244I

10

191426

752

37/1849 (t 1.8)16187

20U24104514

18/1245(13)16204124146

24

respectively. Reasons for dropout were other medicalcondition or injury, not related to acupuncture.Demographic data are presented in Table 2.''Between group comparisonsThere were no differences between the effects onthe two treatment groups in any of the outcomevariables at any assessment period {Tables 3,4).

When each treatment group was compared withthe control group (CG) before treatment, nodifferences were found reg arding pain (Table 3) orintake of analgesics (Table 5), whereas bi)th treatmentgroups registered higher scores than the CG incapacity for demanding ac tivities (data not shown).

Tahli' 3 Numbers of patients with different categories ofinitial pain rating (numerical rating scale 0-100)

IM A PA CGPain DiaryLow 60Pain Last WeekLow 60

586

203259152024

557

2127558

2819

295159

28iO126

IMA - intramuscular acupuncture:PA - periosleal acupuncture;

When each treatment group was compared with theCG after treatment, a higher proportion of patients inboth treatment groups had obtained clinically relevantpain relief with respeet to the median current painby diary (PD) and to pain last week (PLW). for PD onall test occasions up till one month after treatmentand for PLW one week after treatment (P


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PapersTable 4 Total num bers of patiens scoring pain diary and pain last week, and responders at v arious time points

M i d d l e of t r e a t me nt 1 w e e kl n t r a mu. sc u ) a r a i upunc t ur e g r o upPain dia ryR e s p o n d e r s% r e sponde r sPain las t weekR e s p o n d e r s% r e s p o n d e r s

5727

47%*

P e r i o s t e a l a c u p u n c t u r e g r o u pPain dia ryR e s p o n d e r s% r e s p o n d e r sPain las t weekR e s p o n d e r s% r e sponde r sC o nt r o l g r o upPain dia ryR e s p o n d e r s% r e sponde r sPain las t w e e kR e s p o n d e r s% reRponders

5520

36%

*

284

14%**

5729

51 %5922

37%

5528

51 %5328

53%

295

17%283

]i%

I mo nt h

5729

51%5925

42%

5425

46%5524

44%

295

17%286

2\%

3 m o n t h s

5427

50%5521

.18%

5223

44%521835 %

6 m o n t h s

5224

46%5215

29%

5324

45%511529%

va l ue s are n u m b e r s or %; see text for def ini t ion of r e s p o n d e r s* noi a s se s se d

Table 5 N u m b e r s of pa t i e n t s us i ng no a na l g e s i c s , a nd numbe r s e ng a g e d in w o r k r e l a t e d a c t i v i t i e s , a nd m e d i a n D i sa b i l i tyR a t i ng Inde x ( D R I) sc o r e

Beforetreatment

I n t r a m u s c u l a r a c u p u n c t u r e g r o u p

N o a nd l ge s i c sW o r k i n g (n=)

M e d i a n DR I

1 9 / 5359

64P e r i o s t e a l a c upunc t ur e g r o up

No n^tlgesicsWorking {n=)Median DRIControl groupNo analgesicsWorking (n=)Median DRI

2 1 / 5 5

5357 .5

13 /29

2846

M i d d l e oft r e a t me nt

23 / 55OS

3 0 / 5 2*P


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Papertreatment. The PA patients increased their capacity indemanding activities up to three months and in workrelated activities up to one month after treatment.There were no diiferences in physical functioningin the CG patients (Table 5). No correlations wereobserved between the level of ini t ial pain andresponse to acupuncture (da ta not shown).Comparisons betweeti analyses performed withparametric statistics and different forms of non-parametric statistics showed no differences (data notshown).DiscussionThis is the first time that the effect of periostealacupuncture on pain, intake of analgesics andphysical functioning have been tested in patientswith chronic musculoskeletal pain in the neck andlow back. Our hypothesis that deeper or periostealstimulation is superior to the more frequently usedintramuscular stimulation was not confirmed in thisstudy. An explanation may be the similarity inacupuncture dosage. The patients in the IMA grouphad more needles in traditional acupuncture pointsand were stimulated three times; the PA group hadfewer needles and were stimulated only once in theperiosteum. Con sidering the clinical hyp othesis thatperiosteal stimulation is much stronger, the differencein stimulation was rather small. Another reason maybe the clinical fact that patients react differently toacupuncture stimulation, and that the optimal dosagethus varies t)etween individual p atients. This cau sesa problem in al l studies where pat ients areconsecutively recruited and randomised to treatmentgroups with different stimulation techniques andwith the same amount of stimulation to all patients.

Our finding that there were differences betweeneach acupuncture group and the control group inratings of pain, but not in physical functioning or inintake of analgesics, is also consistent with those ofother studies of acup uncture as a single interventionfor patients with chronic low back pain or chronicos teoar thr i t i s of the knee .* '" Accordingly,acupuncture, regardless of method, combined withencouragemen t to stay active and mob ile, is superiorto the same encouragem ent plus information, togetherwith a promise of later t reatment, in yieldingclinically relevant pain relief. To increase physicalfunctioning, a more extensive exercise programme is

Forty five percent of the pat ients receivingacupuncture had cl inical ly relevant pain rel iefrecorded in pain diaries up to six months after theend of treatment regardless of acupuncture m ethod.These findings are consistent with findings inrandomised studies on relevant patient groups wherepain relief remained up to three and even six mo nthsafter end of treatm ent.''"'

The d ecrease in pain last week (PLW) in the PAgroup one month after treatment corresponded wellwith the changes in anxiety in our study of the samepatients previously reported. ' ' An estimation ofaverage pain during the preceding week is probablymore influenced by emotional factors than areestimations of current pain three times a day in adiary. These find ings may indicate that each m ethodof estimating pain evaluates difterent aspects of pain,with both yielding valuable information.

We regard ed adv ice and information as arelevant con trol interve ntion ," as it is the usual firstcare for a majority of patients with neck or back painin Swedish primary care. Alone, however, it is notregarded as an evidence based treatment of chronicpain.

Since we had limited access to acupuncture naivepatients, we chose to accept the disadvantages of notcontrolling for n onspecific effects, ie we did not usea placebo control. Randomising patients instead ofalternately allocating the patients to the interventiongroups would have strengthened the results. Weconsider this study as otie of acupuncture dosage, iea phase II study.

The absence of a scale of global improvementwas counteracted by categorisation of the pain levelsand by increased demands on pain relief in relationto the initial pain level.The lack of validation of our way of definingpain relief as clinically relevant is partly compensatedfor by the fact that calculations with parametricstatistics and different forms of non-parametricstatistics gave similar results.ConclusionsNo differences were found between periosteal andintramuscular acupuncture in patients with chronicmusculoskeletal pain in the neck or low back. Onemonth after end of treatment, a higher prop ortion ofpatients in both acupuncture groups had clinically


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Papersinformation control group. Six months aftertreatment, 45% of the patients in the acupuncturegroups had ob tained clinically relevant pain reliefAcknowledgementsThis study was supported by grants from JmtiandCounty Council and Crown Princess Margareta'sWorking Group for the Visihly Disabled.Conflict of interestNo conflict of interest has been declared by theauthors.Summary points

Periostea! acupuncture is used as an alternative tointramuscular needling, but there is little evidence onwhich is more effectiveThis controlled Irial found no difference between theseforms of acupuncture for pain relief in patients with neckor low back painBoth treatmenLs were superior to information only

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Intramuscular and Periosteal Acupuncture in Patients Suffering From Chronic Musculoskeletal Pain - A Controlled Trial