Effectiveness of a cognitive-behavioral group intervention for knee osteoarthritis pain: protocol of a randomized controlled trial.

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by  Helminen, Eeva-Eerika

Helminenetal.BMCMusculoskeletalDisorders2013,14:46
http://www.biomedcentral.com/1471-2474/14/46
STUDY PROTOCOL Open Access
Effectiveness of a cognitive-behavioral group
intervention for knee osteoarthritis pain: protocol
of a randomized controlled trial
Eeva-Eerika Helminen1,2*, Sanna H Sinikallio3, Anna L Valjakka4, Rauni H Väisänen-Rouvali1 and Jari P Arokoski1,5
Abstract
Background: Knee osteoarthritisis the most common type of arthritis, with pain being itsmost common
symptom. Little is known about thepsychological aspectsof knee osteoarthritispain. There is an emerging
consensus among osteoarthritis specialists about theimportance ofaddressing notonly biological but also
psychosocial factors intheassessment and treatment ofosteoarthritis. As few studies have evaluatedthe effect of
psychological interventions on knee osteoarthritispain, good quality randomized controlled trials are needed to
determine their effectiveness.
Methods/Design:We intend to conduct a 6-week single-blinded randomized controlled trial with a 12-month
follow-up. Altogether, 108 patients aged from 35 to 75 years with clinical symptoms and radiographicgrading
(KL 2–4)of knee osteoarthritis will be included.The clinical inclusion criteria are pain within the last year inor
around the knee occurring onmost days for atleast one month, and knee pain of≥40 mm on a 100-mm visual
analogue scale in theWOMAC pain subscalefor one week prior to study entry.Patientswith any severe psychiatric
disorder, other back or lower limb pain symptoms more aggravating than knee pain, or previous or planned lower
extremity joint surgery will be excluded. The patients will be randomly assigned to a combinedGP care and
cognitive-behavioralinterventiongroup (n= 54) or to a GPcare control group (n = 54).The cognitive-behavioral
intervention will consist of6 weekly group sessions supervised bya psychologist and a physiotherapist experienced
inthe treatment ofpain. The main goals of theinterventionare to reduce maladaptive pain coping and to increase
theself-management of pain and disability. The follow-up-pointswill be arranged at3 and 12 months. The primary
outcome measure will be theWOMAC pain subscale. Secondary outcome measureswill include self-reports ofpain
and physical function, a health related quality of life questionnaire, and various psychological questionnaires.
Personnel responsibleof thedata analysis will be blinded.
Discussion: Thisstudy addresses the current topic of non-pharmacological conservative treatmentof knee
OA-related pain. We anticipate thatthese results will provide important new insights to the current care
recommendations.
Trial registration: CurrentControlled Trials ISRCTN64794760
Keywords: Osteoarthritis, Pain management,Cognitive-behavioral, Psychological, Intervention study
*Correspondence:[email protected]
1DepartmentofPhysicalandRehabilitationMedicine,KuopioUniversity
Hospital,P.O.B.1777,FI-70211Kuopio,Finland
2KuopioHealthCentre,P.O.B.227,FI-70101Kuopio,Finland
Fulllistofauthorinformationisavailableattheendofthearticle
©2013Helminenetal.;licenseeBioMedCentralLtd.ThisisanOpenAccessarticledistributedunderthetermsoftheCreative
CommonsAttributionLicense(http://creativecommons.org/licenses/by/2.0),whichpermitsunrestricteduse,distribution,and
reproductioninanymedium,providedtheoriginalworkisproperlycited.
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Background controlled trial (RCT) testing a 10-week group-based CB
Osteoarthritis (OA) is the most common form of arth- programon 40OA patients[17]. They concluded thatin
ritis and a major contributor to functional disability [1]. the long term, physical and psychological functioning
It represents a major social and health problem in the did not differ between the CB and the education control
elderly,imposinganincreasinglyheavyeconomicburden group. In 2011, Riddle et al. published the results of a
on social welfare and health care systems. This is due to quasi-experimental study testing an 8-session individual
the need for surgical and medical interventions and fre- pain coping skills training (PCST) program in patients
quent absenteeism from work [2]. Although not all OA with elevated pain catastrophizing who were scheduled
is symptomatic, the World Health Organization has esti- for knee arthroplasty [18]. They found that the PCST
mated that OA is the cause of disability in at least 10% program resulted in significantly greater reductions in
ofthepopulation overtheageof60years[3]. pain severity and catastrophizing, and greater improve-
Knee OA is the most common type of arthritis. The ments in function when compared with the usual care
main symptom of knee OA is pain, which is generally cohort. Somers et al. recently reported the results of an
related to joint use and relieved by rest. However, the RCT studying the effects of a PCST program and a
association between radiological changes in knee OA behavioral weight management intervention [19]. They
and the severity of pain or the level of disability is not concluded that the combination of these two treatments
straightforward. As OA progresses, the pain may be- yielded significantly better outcomes in terms of pain,
come more persistent and also manifest itself at rest. In physicaldisability,stiffness,activity,arthritisself-efficacy,
addition to pain, loss of function and joint stiffness are and weight self-efficacy than either of the intervention
typical symptoms of OA, which often lead to difficulties modalitiesaloneorthatevidentinthe control group.
inperformingdaily activities. Thereareseveraltrialsthathaveusedbehavioralinter-
The assessment and treatment of pain is vital to the ventions with similarities to CB principles as well as
management of OA [4]. It is known that chronic pain is studies that have integrated CB principles with other
associated with increased considerable psychological dis- forms of rehabilitation in OA patients. For example,
tress, such as anxiety and depression. One population Hurley et al. conducted an RCTassessing the effects of a
study from 17 different countries found that depression combined exercise, self-management, and active coping
and anxiety disorders occurred significantly more often strategies rehabilitation program [20]. They found over
in individuals with self-reported arthritis, with depres- the long-term, that the rehabilitated participants enjoyed
sion present in 5−10% of those with arthritis [5]. In better physical function, lower community-based health
another study conducted by Smith and Zautra, measures care costs, medication costs, and total health and social
of anxiety and depression emerged as independent and care costs as well as concluding that there was a high
significant predictors ofcurrent andfuturepain [6]. probability (80–100%) that the program was cost effect-
The cognitive-behavioral (CB) perspective presented ive. On the other hand, Keefe et al., adopted an RCT
by Turk et al. [7] is the most widely accepted model in setting to investigate the separate and combined effects
the field of pain psychology. It has led to the identi- of spouse-assisted pain coping skills training and exer-
fication of cognitive and other psychological factors that cise training in patients having persistent osteoarthritic
are associated with pain severity and disability. If one knee pain [21]. They concluded that the kind of in-
considers the constructs that have the strongest em- tervention combining spouse-assisted coping skills train-
pirical support, factors like pain catastrophizing [8], ing and exercise training could improve physical fitness,
fear-avoidance [9], self-efficacy and lack of perceived strength, pain coping, and self-efficacy in patients suffer-
control [10,11], and passive pain coping [12] have been ing from painduetoOA.
claimed to be of importance. Factors, such as pain cata- One CB-based approach in treating pain-related dis-
strophizing and pain-related fear, have been found to be ability and chronicity is the 6-session group intervention
strongly and consistently associated with pain severity model presented by Linton [22]. The model was ori-
and disability in patients with musculoskeletal pain [13] ginally developed for early identification and interven-
and kneeOA [4]. Low self-efficacy and helplessnesshave tion in the prevention of musculoskeletal pain [23,24].
also been identified as predictors of disability in OA The standardized 6-session program focused on coping,
patients[14,15]. function and cognitions and the application of learning
According to several reviews, psychological factors in- principlestoallowtheindividualtoutilizemoreadaptive
fluence not only pain and disability, but also in particu- methods of pain management and active coping [22].
lar the transition from the presence of acute to chronic The model has previously been tested in RCTsetting in
pain [13,16]. However, there have been relatively few patients with back and neck pain [23-25]. In these stud-
attempts to prevent chronic disability in OA by adopting ies, the CB intervention led to less short- and long-term
a CB approach. Calfas et al. conducted a randomized work absenteeism, fewer health care visits, decreased
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perceived risk and fear-avoidance beliefs, and a larger Table1Inclusionandexclusioncriteria
number ofpain-freedays. Inclusioncriteria:
The present study aims to explore the effectiveness 1. Age35–75years
and cost-effectiveness of the CB group intervention
2. Painwithinthelastyearinoraroundthekneeoccurringon
describedbyLinton[22],modifiedforpatientswithknee mostdaysforatleastamonth[27]
OA. As far as we are aware, there have been no previous 3. Kneepaingreaterthanorequalto40mmona100-mmvisual
studies using this approach in patients with knee OA. analoguescale(VAS)intheWOMAC*[28-31]painsubscalefor
oneweekpriortostudyentry
The working hypothesis is that patients with symptom-
atic knee OA will benefit from this kind of CB rehabili- 4. KL**2–4[32]radiographickneeosteoarthritis
tation program. More specifically, we intend to examine 5. Abletoattend6interventionsessions
the effect of the intervention in terms of self-reported Exclusioncriteria:
physical function and pain, pain-related work abstinence, 1. Severepsychiatricorpsychologicaldisorder***
the number of pain-related health care visits, and health- 2. Otherbackorlowerlimbpainsymptomsmoreaggravatingthan
relatedqualityoflife(HRQoL).Wealsoaimtodetermine kneepain
theeffectoftheinterventiononseveralpsychologicalvari- 3. Previousorplannedlowerextremityjointsurgery
ablessuchasdepression,anxiety,senseofcoherence,pain 4. Inabilitytocompletethestudy****
catastrophizing, kinesiophobia, self-efficacy, and life satis- *WesternOntarioandMcMasterUniversitiesOsteoarthritisIndex.
faction.Finally,weplantorunacost-utilityanalysisofthe **Kellgren–Lawrenceradiologicscoreforkneeosteoarthritis.
***Psychoticillnessesorpsychologicaldisordersthathadledtohospitalization
interventionbasedonquality-adjustedlifeyears(QALY). ordisabilitytowork.
****Inabilitytofillinthequestionnairesoruncertaintyinabilitytocomplete
thestudyduetopossiblechangesinthenearfuturerelatedtohealth,family,
Methods/Design
orlivingconditions.
Design
The proposed research is a 6-week open study with letterwillbesenttothosesubjectswithKLgrade≥2,which
follow-up-points at 3 and 12 months from the beginning has been used as a cut-off to classify knee OA [33]. In
of the study. The participants will take part in 6 group conjunction with this recruitment strategy, advertisements
meetings each lasting 2 hours. The meetings will be requesting potential study candidates to contact the study
supervised by a trained psychologist and a physiotherap- doctors will be placed in the facilities of local primary care
ist according to a CB intervention model presented by providersaswellasintheoutpatient clinicsoftheDepart-
Linton [22]. At the beginning of the study, prior to the ment of Orthopedics and the Department of Physical
randomization, all the patients will participate in groups andRehabilitationMedicineatKuopioUniversityHospital.
ofabout20peopletohearalectureregardingthe current Physiciansandsurgeonsworkingattheselocationswillalso
treatment guidelines for knee OA provided by the study be informed about the study and asked to distribute the
doctors.They will alsoreceivethe patient-version booklet advertisementstopatientswithkneeOA.
of the Finnish Current Care (CC) guideline on knee and All study candidates will receive a recruitment letter
hip OA [26]. The study protocol does not interfere with containing information about the study as well as a pre-
theusualcarethattheparticipantsmayreceivefromtheir liminary questionnaire and an informed consent form.
general practitioner (GP) in primary health care during The preliminary questionnaire will contain a compre-
thestudyperiod.Questionnaireswillbesenttoallpartici- hensive list of other comorbidities, including psychiatric
pants at the beginning of the study and at two follow-up illnesses. In the preliminary questionnaire the patients
points (3 and 12 months). The inclusion and exclusion will be asked if they have other back or lower limb pain
criteria for the study patients are listed in Table 1. The symptoms that are more aggravating than their knee
studydesignisillustratedinFigure1. pain (yes/no). After receiving the signed informed con-
sent and the questionnaire, the study doctors will check
Participantsandrecruitment the knee radiographs based on KL classification and
Our aim is to recruit 108 patients mainly from primary determine the patient’s eligibility according to the inclu-
care providers in the Kuopio area of eastern Finland. sion and exclusion criteria of the study (Table 1). Poten-
Our primary recruitment strategy is to dispatch recruit- tial study patients will be able to contact the study
ment letters to patients aged from 35 to 75 years who doctors by phone or email throughout the recruitment
have had knee radiographs with knee OA changes taken process withany questionsconcerningthetrial.
in public primary care locations (Kuopio Health Centre The patients will be randomly assigned to either the
or Kallaveden Työterveys). The study doctors will check GP care and intervention group (n = 54) or the GP care
the knee radiographs of each patient from an X-ray data- control group (n = 54). Randomization will be con-
base and knee radiographs will be graded according to the ducted in blocks of six, separately for men and women.
Kellgren-Lawrence(KL)classification[32].Therecruitment A computer-generated code for randomization will be
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Figure1Thestudydesign.GP=generalpractitioner;CB=cognitive-behavioral;WOMAC=WesternOntarioandMcMasterOsteoarthritisIndex;
RAND-36=theRAND36-itemhealthsurvey;15D=generic15Dinstrument;BDI-21=21-itemBeckDepressionInventory;BAI=BeckAnxiety
Index;TSK=TampaScaleforKinesiophobia;PCS=PainCatastrophizingScale;PSEQ=PainSelf-EfficacyQuestionnaire;LS=lifesatisfaction;
SOC=senseofcoherence;GAC=globalassessmentofchange.
constructed by a statistician who will not meet the study problem solving (in pairs/teams, 15–20 min), skills train-
patients, and it will be administered via sealed opaque ing (15–20 min), homework assignments (15 min) and a
envelopes. The personnel responsible for data collection résumé (feedback) of the session (15 min). A patient
will be blinded to group assignment and will not be example of a knee OA pain patient will be used through-
involved in providing the interventions. The code for out the intervention as a basis for discussion and practice
randomization will be opened only after the statistical inproblemsolving.Anoutlineofeachsessionispresented
analyses have been performed after the 12-month fol- in Table 2. The psychologist is the principal leader of the
low-up point. CB intervention. The physiotherapist’s tasks are to lead
the relaxation exercises, provide the information of OA
Intervention pain mechanisms in the first session, offer advice about
A CB group intervention with 6 weekly sessions will be suitable exercises in the second session, and facilitate the
supervised by an experienced psychologist and a physio- group in general when needed. Both the intervention and
therapist. The sessions will take place in a group of 8–10 thecontrolgroupwillcontinuesidebysidewiththeusual
persons according to the model presented by Linton [22]. GP care that patients may receive in the primary care
Each session will last for 2 hours with a 15–20-minute throughoutthestudy.
break to enhance peer support and social bonding. The The same psychologist and physiotherapist who are
outline of the sessions will include an introduction both experienced in group-based rehabilitation interven-
(15 min), lecture (knowledge and insight, max 15 min), tions as well as in pain management will arrange the CB
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Table2Anoverviewofthecontentofthecognitive-behavioralinterventionbasedonLinton(2005)[22]
Session Focus Skills Objectives
1 Causesofpainandthe Problemsolving (cid:129)Toprovideinformationaboutthecausesofpain.
preventionofchronicproblems
Appliedrelaxation (cid:129)Toprovideinformationabouttheriskofchronicpainproblems.
Learningandpain (cid:129)Tohelpparticipantsinidentifyingrelevantfactorsinone’sownpain
problem.
(cid:129)Totrainproblem-solvingandrelaxationskills.
(cid:129)Toteachpaincontroltechniques.
2 Managingyourpain Activities,maintaindaily (cid:129)Toprovideinformationabouttherelationshipbetweenactivityand
routines musculoskeletalpain.
Schedulingactivities
Relaxationtraining (cid:129)Tohelpparticipantsinunderstandingfearavoidancebehavior.
(cid:129)Toteachparticipantstoidentifygoalsforasatisfyingactivitylevel.
(cid:129)Toteachmanagementskills:scheduling,pacing,gradedincrease.
(cid:129)Toteachcognitiveskillstominimizeproblemswithactivities.
(cid:129)Tointroducestressandstressmanagement.
3 Promotinggoodhealth,controlling Warningsignals (cid:129)Toprovideinformationhowpainproblemsmaybeprevented.
stressathomeandatwork
Cognitiveappraisal (cid:129)Toprovideinformationhowtoutilizethoughtsandbehaviorsin
preventiveefforts.
Beliefs (cid:129)Toteachhowtoapplyvariousskills(relaxation,activity
management,beliefs,pausesetc.)ascoping.
(cid:129)Tohelptheparticipantstoidentifytargetsfordevelopingcoping
strategies.
(cid:129)Toteachappliedrelaxationascopingstrategies.
4 Adaptingforleisureandwork Communicationskills (cid:129)Toprovideopportunitiestoreceivereinforcementforcorrect
”coping”approximationsfromthegroup.
Assertiveness
Risksituations (cid:129)Toprovideinformationabouthowworkplaceandfamilymaybe
influencedbytheparticipant’spainproblem.
Applyingrelaxation
(cid:129)Toprovideinformationandcopingstrategiesconcerningsituations
wheretheworkplaceandfamilymayinfluencetheparticipant’spain
perceptions.
(cid:129)Toteachassertivenessinusingthecopingskillslearnt.
(cid:129)Tohelpparticipantstoidentifysupportivebehaviorsfromothers.
(cid:129)Toteachparticipantstopromptthesebehaviorstopromote
positiverelationshipswithfamilyandfriends.
(cid:129)Toteachhowtoapplyrapidrelaxationtorisksituations.
(cid:129)Toteachparticipantshowtoemployseveralcopingtechniquesin
socialsituations.
(cid:129)Tobegintoplanapersonalcopingprogram.
5 Controllingflare-ups Planforcopingandflare-ups (cid:129)Toprovideinformationaboutflare-upsandmaintenance.
Copingskillsreview (cid:129)Toteachhowtouseappliedrelaxationascoping.
Appliedrelaxation (cid:129)Toteachhowtoapplytheirskillstocopewithflare-ups.
Ownprogram (cid:129)Todevelopapersonalizedcopingprogram.
(cid:129)Todevelopaself-carestrategythatmayreducetheneedfor
healthcarevisits.
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Table2Anoverviewofthecontentofthecognitive-behavioralinterventionbasedonLinton(2005)[22](Continued)
6 Maintainingandimprovingresults Riskanalysis (cid:129)Toreinforceappropriatecopingbehaviors.
Planforadherence (cid:129)Toprovideinformationaboutmaintenanceandadherence.
Ownprogramfinalized (cid:129)Toteachparticipantstodoriskanalysisandenhanceadherence.
(cid:129)Toteachparticipantsaboutenhancingandfine-tuningtheir
program.
(cid:129)Toevaluatethecourseandparticipants’progress.
program for all the intervention groups. They have been Responses for the 24 items are registered on a 0–100 mm
trained for this particular CB intervention by going visualanaloguescale(VAS).
through in detail the session manual for therapists [22] SecondaryoutcomesofthestudywillincludeWOMAC
anditsFinnishtranslatedversiontogetherwiththeother stiffnessandphysicalfunctionsubscales[28-31],aswellas
membersoftheresearchgroup. numeric pain rating scales of the worst and mean pain
during the previous week and past three months. The
health-related quality of life will be evaluated with 15D
Outcomeassessment [58] and RAND-36 [56,57]. The use of pain medication,
The assessment points of this study are the baseline and the number of knee OA-related health care visits, sick
3 and 12 months, at which time points the question- leave days, rehabilitation and pensions will be recorded.
naires will be sent by post to the patients with a pre- The patients will also be asked to complete several psy-
paid return envelope. At the baseline, information will chological questionnaires at the assessment points: de-
be gathered on the demographics, comorbidities, work pression will be evaluated with Beck's Depression
history, and previous rehabilitation measures. The pri- Inventory (BDI-21) [34-37], anxiety with Beck's Anxiety
mary and secondary outcomes and other measures are Index (BAI) [38,39], sense of coherence with a 13-item
listedinTable3. sense of coherence scale (SOC) [40-46], catastrophizing
The primary outcome measure of the study is the withthePainCatastrophizingScale(PCS)[47,48],kinesio-
WesternOntarioandMcMasterUniversitiesOsteoarthritis phobia withTampa Scale of Kinesiophobia (TSK) [49,50],
Index (WOMAC) self-reported pain subscale [28,29], pain self-efficacy with Pain Self-Efficacy Questionnaire
which is to be measured with the pain subscale of the (PSEQ) [51,52],and lifesatisfaction(LS) witha 4-item LS
Finnish version of the WOMAC [30,31]. The Finnish scale [53-55]. Finally, some questions concerning major
WOMAC consists of three dimensions: pain (5 items), life events and the global assessment of change will be
stiffness (2 items), and physical functioning (17 items). included.
Table3Outcomesandothermeasures
Primaryoutcomemeasure*
Self-reportedpain WOMAC(VAS)[28-31]painsubscale
Secondaryoutcomemeasure* Measurement
Self-reportedphysicalfunction,painandstiffness WOMAC(VAS)physicalfunctionandstiffnesssubscales[28-31],NPRS,mean
andworstpain(pastweek,3months)
Depression,anxiety,senseofcoherence,paincatastrophizing, BDI-21[34-37],BAI[38,39],13-itemSOCscale[40-46],PCS[47,48],TSK[49,50],
kinesiophobia,self-efficacy,andlifesatisfaction PSEQ[51,52],4-itemLSscale[53-55]
Health-relatedqualityoflifeandcosteffectiveness RAND-36(SF-36)[56,57],15D[58],QALY[58],OA-relatedsickleave,useofpain
medication,kneeOA-relatedhealthcarevisits,rehabilitationandpensions
GAC GAC
Othermeasures Measurement
Identifyingriskforpersistentpain ÖrebroMPQ[59]
Majorlifeevents Openquestion
Adherence Attendanceatmeetings
*Theprimaryendpointfordataanalysisis12months.Alloutcomemeasureswillbeundertakenatbaselineandafter3and12months.WOMAC=Western
OntarioandMcMasterOsteoarthritisIndex;NPRS=numericpainratingscale;BDI-21=21-itemBeckDepressionInventory;BAI=BeckAnxietyIndex;SOC=sense
ofcoherence;PCS=PainCatastrophizingScale;TSK=TampaScaleforKinesiophobia;PSEQ=PainSelf-EfficacyQuestionnaire;LS=lifesatisfaction;RAND-36=
theRAND36-itemhealthsurvey;15D=generic15Dinstrument;QALY=quality-adjustedlifeyears;OA=osteoarthritis;GAC=globalassessmentofchange;
MPQ=MusculoskeletalPainQuestionnaire.
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Statisticalanalysis OA, and the results may have a significant impact on
The mean (±SD) knee joint pain score (WOMAC,VAS) current care recommendations. Since knee OA is the
was estimated by using the results of the knee joint pain most common form of arthritis, representing a major
scores in previous studies [60,61]. Since the knee pain economicburdenonsocialwelfareandhealthcaresystems
has to be ≥40 mm on a 100-mm VAS (WOMAC) in this forbothsocietyandindividualpatients,itisworthwhileto
present study, we postulated that there will be a mean of find novel cost-effective interventions promoting conser-
at least 48±16.2 mm in the WOMAC pain subscale at vative treatment. Third, it is important to evaluate this
baseline. In our study the 20% reduction in primary out- kind of CB intervention since cognitive and psychological
come (WOMAC pain) due to the intervention was con- factorsareknowntoplaymajorrolesinchronicpain,pain
sidered as being clinically relevant in accordance with severity and disability. Moreover, evidence-based guide-
the OMERACT-OARSI set of responder criteria [62]. In lines indicate that one should adopt a the combination
the comparison of the mean pain scores between the of pharmacologic and nonpharmacologic modalities to
groups, 54 patients per group are needed according to a achieve adequate management of knee OA [64-66]. With
power calculation with the two-tailed Student t-test with respect to nonpharmacologic treatment modalities, it has
a 5% significance level and 80% power, assuming a 20% beenoccasionally recommended thatpatients should par-
dropout rate [63]. ticipate in self-management programs with psychosocial
Demographic characteristics and baseline data will be interventions [64]. We hope that the results of the cost-
summarized by descriptive statistics. Randomly missing effectivenessandcost-utilityanalysisoftheproposedstudy
data in the longitudinal set-up will be imputed using willfavourtheirinclusionintothecurrentcarerecommen-
expectation–maximization algorithm before the analysis dationsinthefuture.
in order to follow the intention to treat principle. Data The study protocol has some limitations. First, due to
on various psychological variables predicting reported volunteer bias, the results of psychological intervention
knee pain will be assessed by multiple regression analysis. studies may have limited generalizability [67]. Second, as
Foroutcomesmeasuredonacontinuousscale,differences the majority of the study patients will probably originate
between groups in the mean change from the baseline to from primary care, the results of this study will mainly
12monthswillbeevaluatedusingthelinearmixedmodel- apply to that environment. Third, the CB protocol pre-
ing. The model assumptions will be checked by standard sented by Linton [22] indicates that patients participat-
diagnostic plots. The participant rating of the global as- ing in a CB-type intervention should be evaluated to
sessment of change will be compared between the two ensure that they are at risk of developing a persistent
groupsusingthetwo-tailedStudentt-test. pain problem. Linton himself has developed a question-
Cost-effectiveness of the intervention will be evaluated naire, the Örebro Musculoskeletal Pain Questionnaire
bycost-utilityanalysiswhichisatechniquesthatincorpo- (MPQ) [59], to be used for this purpose. In our study,
rates the expenses of the intervention as well as the costs however, we have decided not use this questionnaire or
oftheuseofhealthcareservicesandpainmedication,sick any other cognitive or psychological evaluation as part
leaves,rehabilitationandpensions.Utilityanalysisisbased of the inclusion criteria. One reason for this decision is
onmeasurementofQALYfrom15D[58].Lifeexpectancy that the Örebro MPQ has only been validated in back
with 0%, 3% and 5% discounting will be incorporated in pain patients, and there is a lack of data concerning the
theanalysis.Thecost-effectivenessoftheinterventioncan similarity of pain experiences in back and knee OA pain
beevaluatedbydividingtheoverallcostswiththeQALY. in general. Furthermore, our inclusion criteria already
include several pain measures, assessing both intensity
and duration of pain. We consider that by applying to
Discussion these criteria, in all probability, the patients would be at
There are several reasons why this study will advance risk of developing a persistent pain problem if they were
our understanding of effective interventions to improve not already suffering from it. However, the Örebro MPQ
conservative knee OA treatment. First, there have only will be included in the baseline patient questionnaire for
been a few studies evaluating the effect of psychologi- analysis purposes. With the availability of the final data
cal interventions on knee OA pain. Thus, good quality of the study, it will be interesting to see whether those
RCTs are needed to determine their effectiveness. As patientsdeterminedtobeatriskofdevelopingapersistent
present, very few studies have evaluated a CB inter- pain problem according to the Örebro MPQ have bene-
vention for knee pain treatment, as far as we are aware fitedmorefromthisintervention.
this will be the first study to tackle this particular CB Another limitation of the study might be the different
intervention model in treating OA patients. Second, the amountofattentionpaidtothetwogroups.As thegroup
proposed research will address the very current topic of patients in the intervention will receive 12 hours more
of non-pharmacological conservative treatment of knee attention, a Hawthorne effect [68-70] is probable.
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However, all patients will receive the same basic instruc- theparticipants.E-EH,JAandSSdraftedthemanuscript.AVtranslatedthe
tions about knee OA treatment according to Finnish CC Sessionmanualfortherapists.E-EHtranslatedthepatientexampleofthe
Sessionmanualfortherapists.JAandE-EHappliedfortheprojectfunding.
guideline [26] when they are listening to a lecture deliv-
Allauthorshavereadandapprovedthefinalmanuscript.
ered by a general practitioner prior to the randomization.
Thislecturewillbeheldingroupsofabout20peopleand Acknowledgements
the whole research group will be present to answer ques- ThestudypsychologistandphysiotherapistarefundedbytheDepartment
ofPhysicalMedicineandRehabilitation,KuopioUniversityHospital.In
tions. During the lecture the patient-version booklet of
addition,E-EHandSSaresupportedbyanEVOresearchgrantfromKuopio
Finnish CC guideline on knee and hip OA [26] will be UniversityHospital.
handed out to all participants. The participants in both
Authordetails
groupsalsowillcontinuetoreceivestandardcare(i.e.nor-
1DepartmentofPhysicalandRehabilitationMedicine,KuopioUniversity
malroutinecareofferedbytheirowngeneralpractitioners Hospital,P.O.B.1777,FI-70211Kuopio,Finland.2KuopioHealthCentre,P.O.B.
includinganalgesicsandphysiotherapy). 227,FI-70101Kuopio,Finland.3InstitutionofPublicHealthandClinical
Nutrition,UniversityofEasternFinland,KuopioCampus,P.O.B.1627,FI-70211
BDI-21, BAI, 13-item SOC scale, TSK, PSEQ and LS
Kuopio,Finland.4SubstanceAbuseandMentalHealthUnitofRaisio,
questionnaires have been used in several clinical studies Nallinkatu3,FI-21200Raisio,Finland.5InstituteofClinicalMedicine,University
in Finland [35-37,39,44-46,50,52-55]. However, at pre- ofEasternFinland,KuopioCampus,P.O.B.1627,FI-70211Kuopio,Finland.
sent BDI-21and13-item SOC scales havebeenvalidated
Received:7August2012Accepted:24January2013
in Finland [37,46] and the validation process of TSK is Published:29January2013
almost complete. We have available translated versions
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