The effects of arthritis gloves on people with Rheumatoid Arthritis or Inflammatory Arthritis with

15 Pages·2017·1.95 MB·English

by  Yeliz Prior

Prioretal.BMCMusculoskeletalDisorders (2017) 18:224
DOI10.1186/s12891-017-1583-4
STUDY PROTOCOL Open Access
The effects of arthritis gloves on people
with Rheumatoid Arthritis or Inflammatory
Arthritis with hand pain: a study protocol
for a multi-centre randomised controlled
trial (the A-GLOVES trial)
Yeliz Prior1,2, Chris Sutton3, Sarah Cotterill4, Jo Adams5, Elizabeth Camacho6, Nazina Arafin1, Jill Firth7,
Terence O’Neill8, Yvonne Hough9, Wendy Jones10 and Alison Hammond1*
Abstract
Background: Arthritis gloves are regularly provided as part ofthe management ofpeople with rheumatoid arthritis
(RA) and undifferentiated (early) inflammatory arthritis (IA). Usually made of nylon and elastane (i.e. Lycra®), these
arthritis gloves apply pressure with theaims of relieving hand pain, stiffness and improving hand function.
However, a systematic review identified little evidence supporting their use. We therefore designed a trial to
compare the effectiveness ofthecommonest type ofarthritis glove provided in theUnited Kingdom (Isotoner
gloves) (intervention) with placebo (control)gloves (i.e. larger arthritis gloves providing similar warmthto the
intervention gloves but minimal pressure only) inpeople with these conditions.
Methods: Participantsaged18yearsandoverwithRAorIAandpersistenthandpainwillberecruitedfromNational
HealthServiceTrustsintheUnitedKingdom.Followingconsent,participantswillcompleteaquestionnairebooklet,then
berandomlyallocatedtoreceiveinterventionorplaceboarthritisgloves.Withinthreeweeks,theywillbefittedwiththe
allocatedglovesbyclinicalspecialistrheumatologyoccupationaltherapists.Twelveweeks(i.e.theprimaryendpoint)after
completingthebaselinequestionnaire,participantswillcompleteasecondquestionnaire,includingthesamemeasures
plusadditionalquestionstoexploreadherence,benefitsandproblemswithglove-wear.Asub-sampleofparticipants
fromeachgroupwillbeinterviewedattheendoftheirparticipationtoexploretheirviewsoftheglovesreceived.The
clinicaleffectivenessandcost-effectivenessoftheintervention,comparedtoplacebogloves,willbeevaluatedover
12weeks.Theprimaryoutcomemeasureishandpainduringactivity.Qualitativeinterviewswillbethematicallyanalysed.
Discussion:Thisstudywillevaluatethecommonesttypeofarthritisglove(Isotoner)providedintheNHS(i.e.the
intervention)comparedtoaplaceboglove.Theresultswillhelpoccupationaltherapists,occupationaltherapyservices
andpeoplewitharthritismakeinformedchoicesastothevalueofarthritisgloves.Ifeffective,arthritisglovesshould
becomemorewidelyavailableintheNHStohelppeoplewithRAandIAmanagehandsymptomsandimprove
performanceofdailyactivities,workandleisure.Ifnot,servicescandeterminewhethertoceasesupplyingtheseto
reduceservicecosts.
Trialregistration:ISRCTNRegistry:ISRCTN25892131Registered05/09/2016
Keywords:Arthritisgloves,Rheumatoidarthritis,Inflammatoryarthritis,Occupationaltherapy,Handpain,Handstiffness,
Handswelling,Compressiongloves,Splints
*Correspondence:[email protected]
1CentreforHealthSciencesResearch(OT),UniversityofSalford,Frederick
Road,L701AllertonBuilding,Salford,GreaterManchesterM66PU,UK
Fulllistofauthorinformationisavailableattheendofthearticle
©TheAuthor(s).2017OpenAccessThisarticleisdistributedunderthetermsoftheCreativeCommonsAttribution4.0
InternationalLicense(http://creativecommons.org/licenses/by/4.0/),whichpermitsunrestricteduse,distribution,and
reproductioninanymedium,providedyougiveappropriatecredittotheoriginalauthor(s)andthesource,providealinkto
theCreativeCommonslicense,andindicateifchangesweremade.TheCreativeCommonsPublicDomainDedicationwaiver
(http://creativecommons.org/publicdomain/zero/1.0/)appliestothedatamadeavailableinthisarticle,unlessotherwisestated.
Prioretal.BMCMusculoskeletalDisorders (2017) 18:224 Page2of15
Background consider this is between 15-32 mmHg. We also
Rheumatoid arthritis (RA)is achronicinflammatorycon- hypothesizethatarthritisglovesprovidetactilefeedbackto
ditioncausing jointpain,swelling(synovitis),stiffnessand theglovewearerremindingthemtotakemorecareoftheir
muscle loss around affected joints [1]. It affects 1% of the handjoints.Potentially,allmodelsofglove(howevermuch
population,andtwiceasmanywomenasmen.Peakonset pressureand/orwarmththeyapply)maybeactingthrough
isinthe40-60agegroup,itisincurableandcausessignifi- this mechanism. This effect was hypothesized in a pilot
cant disability if untreated [2, 3]. RA is managed with clinical effectiveness and efficacy trial of thumb splints
disease modifying anti-rheumatic drugs (DMARDs), re- [12].
habilitation and self-management education. People with Despite their widespread use, evidence for the effect-
persistent synovitis,whereotherpathologiesareruledout iveness of arthritis gloves is inconclusive. In a recent
(i.e. undifferentiated inflammatory arthritis (IA), who do systematic review, we identified only four trials evaluat-
notyetmeetthecriteriaforRA[4]),alsorequirespecialist ing arthritis gloves. Trials were small and results incon-
care and DMARDs, and are thus treated as if they have clusive [13]. We therefore developed this randomized
RA [1]. Most people with IA and RA have symptoms in controlled trial to evaluate the effectiveness and cost-
bothhands,resultinginproblemswitheverydayactivities, effectiveness of the most commonly used arthritis glove
workandleisure.Manyexperiencefrustrationanddistress (i.e.Isotoner)inpeople withRAorIA.
because of hand pain, stiffness and disability. A third are
workdisabledwithin5years[1]. Feasibilitystudy
ArthritisglovesarecommonlyprovidedbyRheumatology We conducted a feasibility study among patients with IA
occupational therapists to people with IA or RA. These orRA(n=39)in10OccupationalTherapydepartmentsin
arewornforpainreliefduringthedayornightandtoim- Northwest England evaluating mid-finger Isotoner gloves
prove hand function during the day. We surveyed (as these are the commonest type provided and apply the
Rheumatology occupational therapists,identifying that highest pressure). During this study we standardised
most provide arthritis gloves [5]. Provision varies consid- arthritis glove eligibility criteria, glove treatment protocols
erably between occupational therapists but averages a (including the arthritis glove patient information sheet)
thirdofthepatientstheysee.Themostcommonmakeof with participating therapists (North-West College of
glove provided is the mid-finger Isotoner glove (i.e. finger Occupational TherapySpecialist Sectionin Rheumatology:
tipsexposedtoaidhandfunction)andthenextcommon- NWCOTSS-R arthritis glove protocol [14]. The results of
est are Jobskin and Norco oedemagloves[5,6].Provision thestudyarereportedelsewhere[15].
of gloves appears to have risen following a randomised
controlled trial (RCT) demonstrating an alternative treat- Objectives
ment (resting splints) was ineffective in early RA [7]. The primaryobjective is to assess whether there is a clin-
(Glove photographs are in Additional file 1: study icallyimportantdifferenceinself-reporteddominanthand
information). painduringdaytimeactivitybetweenparticipantswithRA
Arthritis gloves are usually made of nylon and elastane or IA receiving intervention gloves (Isotoner gloves) in
(i.e. Lycra®). They are thought to impact on hand symp- addition to usual care compared to participants receiving
toms through providing compression (pressure) and/or placebo gloves (Jobskin classic oedema gloves fitted at
warmth. Some models apply both and others warmth leastonesizetoobigtoensuresimilarwarmthisprovided
only. Isotoner gloves, containing 20% elastane, exert the butminimalpressureonlyisapplied),plususualcare.
highestpressureofthosemakesavailable,at23-32mmHg Thesecondaryobjectivesareto:
[8]. Other makes exert less as these contain less elastane
(e.g. the Jobskin classic oedema gloves exert 15-25 mm i. assesstheeffectivenessofinterventiongloves,
Hg and contain 11% elastane [9]). When properly fitted relative toplaceboglovesonself-reported:
(tobea“snugfit”),theglovesapplycontrolledpressureto non-dominant handpainduringactivity;dominant
the hand [10]. The pressure is thought to: (a) remove and non-dominantnocturnal handpain; handpain
extracellular fluid, thus reducing pain, stiffness and im- duringthe dayatrest;handstiffness;handjoint
proving finger motion; and (b) increase blood flow and swelling;and handfunction.
consequently warmth, reducing pain [10, 11]. The glove ii. evaluatethe cost-effectiveness ofarthritisgloves
material also provides warmth, contributing to pain relief. comparedwith placebogloves, taking intoaccount
Makesofarthritisgloves,whichspecificallyapplypressure, thecost oftheglovesand otherhealthcare resources
are termed compression or oedema gloves. It is unclear usedbyparticipants.
whatatherapeuticlevelofpressureis,asthishasnotbeen iii.exploreparticipants’viewsof:theeffectsofarthritis
identifiedthroughphysiologicalstudies.However,basedon (intervention) andplaceboglovesonhand
pressure information from manufacturers, therapists symptoms,function, and theirdailylives;
Prioretal.BMCMusculoskeletalDisorders (2017) 18:224 Page3of15
acceptabilityofglove wear;and howandwhenthey 3. Severeneuropathies(nervedamage) inthehand
prefertousethese. 4. Severehanddeformities
5. Anycontraindicationsto wearingthegloves
Trialdesign (e.g. eczema,infections, broken skin)
The A-GLOVES trial is a pragmatic, patient-blinded, 6. Previouslyworn arthritisgloves.
multi-centre, superiority randomised parallel group trial
of intervention gloves compared to placebo gloves in Interventions
people with RA or IA and persistent hand pain affecting Occupationaltherapisttrainingingloveprovision
their ability to do daily activities. Analysis will be on an Interventions will be delivered by 27 National Health
intention-to-treat basis. Ethical approval for this study Service (NHS) Rheumatology occupational therapists
has been obtained from the North of Scotland Local Re- (≥Band 6 i.e. clinical specialists). Participating therapists
search Ethics Committee [15-NS-0077]. The study proto- must attend a one-day clinical trial training programme
colwasdevelopedusingtheSPIRITguidelines[16]. delivered by expert Rheumatology occupational thera-
pists and the research team. This will include: trial back-
Methods ground; key study procedures; and practice in providing
Studysetting the intervention and placebo gloves in a standardised
Study participants will be recruited from Rheumatology, manner. The A-GLOVES Occupational Therapy Glove
Occupational Therapy and Hand Therapy departments Provision Manual, developed by the research team with
in 23 hospitals across 17 NHS Trusts in England and the NW-COTSS-R, will be followed when fitting these
Scotlandin the United Kingdom (UK), as arthritis gloves gloves [17].
are most commonly provided by rheumatology occupa- In addition to the training day, the Trial manager will
tionaltherapistsinsecondarycare. conduct sitevisitstoensureallPrincipalInvestigators,re-
search facilitator/s (i.e. nurses/other staff employed in the
Eligibilitycriteria NHS to assist with recruitment into trials) and occupa-
Inclusioncriteria tional therapists involved in the study understand how to
Patients eligible for the trial must comply with all of the explain the study and arthritis gloves appropriately, to
followingat randomization: ensureparticipantsarenotunblindedtotheintervention.
1. Aged ≥18years Glovefitting
2. DiagnosedwithRA orIAbyaRheumatology The intervention group will receive correctly fitted mid-
Consultant finger length Isotoner arthritis gloves. The placebo
3. Havepersistentpaininthe proximal interphalangeal group will receive mid-finger length Jobskin classic
(PIPs)and/ormetacarpophalangeal(MCP)joints oedemaglovesfitted atleastonesizetoolarge,toensure
causingeither they do not apply therapeutic levels of compression.
i) difficultyusingtheir handsduringthe day When fitting gloves, the occupational therapist will
(fordaywearofgloves) or measure participants’ MCP circumference to determine
ii) disturbed sleep (fornight wearofgloves)or the glove size required. Therapists will also use their
iii)limited abilitytousetheirhandswhenwaking/in clinical judgement to determine appropriate fit. Usually,
themorning(fornight wearofgloves) patients requiring gloves receive these for both hands as
4. Willing toweararthritisglovesand participatein their hand pain and/or swelling is bilateral. However, if
thetrial patients have unilateral pain and/or swelling, they are
5. Abletoread andunderstandEnglish and, providedwithagloveonlyfortheaffected hand.
6. Canprovideinformedconsent.
AdditionalInterventions
Exclusioncriteria Allparticipants(inbothinterventionandplacebogroups)
People willbeexcludedfromthe studywho have: will receive a booklet about hand self-management:
“Looking After Your Joints when you have arthritis” [18].
1. Beendiagnosedwithother rheumaticconditions, This booklet is widely provided in clinical practice. They
suchasgout,psoriaticarthritis,ankylosing will also receive an information sheet about hand exer-
spondylitis,connectivetissuedisorders(systemic cises, based on the Strengthening And Stretching For
lupus,systemicsclerosis),resultingininflammatory RheumatoidArthritisoftheHand(SARAH)trialhandex-
arthritisinthehand/s ercise programme for RA [19, 20]. During the 12 weeks,
2. SevereRaynaud’sdiseaseor othercirculatory participants will only receive brief training in joint
disturbancesinthe hand protection and hand exercises, and this will not use
Prioretal.BMCMusculoskeletalDisorders (2017) 18:224 Page4of15
cognitive-behavioural approaches. Most departments do hand exercises) to participants whilst they are in the trial
not normally offer behaviourally based joint protection (i.e. during their 12 weeks participation). However, partici-
and/or hand exercise programmes (or where these exist, pantsarepermittedtoattendPhysiotherapyforlowerlimb
such programmes usually have waiting lists), thus partici- interventions if required.Data on participants’ use of con-
pantsarenotbeingdisadvantaged. comitantcareiscollectedviathe12-weekquestionnaire.
Modifications Outcomes
In some instances, a glove may not be fitted if enlarged The primary outcome measure is ‘hand pain during
PIP joints or finger deformity prevent this. For those moderate activity’ which was considered the most im-
participants with an MCP circumference greater than portant outcome by glove-users in our feasibility study.
23.5 cm (or fingers/hands too large in other respects), This is measured as hand pain in the dominant hand
no gloves will be fitted, as an appropriately large size is during the day, on a typical day, when doing moderate
not available from manufacturers. If the participant can- hand activities, e.g. housework, cooking, Do-It-Yourself,
not be fitted with gloves, they still remain in the trial, in gardening. In our feasibility study, 2% of participants re-
linewith “intention-to-treat.” ceived one glove for their non-dominant hand only. It is
therefore possible that the primary outcome cannot be
Adherence collected ina small number ofparticipantsinthistrial.
Recommendations for when to wear gloves will be based Secondary outcome measures are hand pain when
on individual needs; most, but not all, patients will be resting and at night; stiffness; self-reported hand condi-
provided with gloves for both hands. Most people tion; hand function; disability; and resource use and
experience hand pain during the day and are recom- costs to measure cost-effectiveness of glove provision
mended to wear gloves during activity. Those experien- (Table1).
cing hand pain at night, which interferes with sleep, will
also be recommended to wear gloves at night. Gloves are Participanttimeline
notrecommendedtobeworncontinually.Allparticipants Participants will complete a baseline questionnaire fol-
will receive written information about glove wear and lowing consent and prior to the randomisation at week
care, using the sample information sheet in the A-Gloves zero. Within three weeks of randomisation, an occupa-
OccupationalTherapyGloveProvisionManual[17]. tional therapy glove fitting appointment will be arranged
To check for correct glove fit and any problems, occu- to ensure there is sufficient length of time to wear the
pational therapists will either: within two to four weeks gloves prior to the 12-week follow-up. Two to four
of glove provision offer a review appointment (in person weeks after glove fitting (dependent on each depart-
or by telephone); or ask the participant to get in contact ments’ usual practice), participants will attend an occu-
if experiencing problems, if this is their normal depart- pational therapy review appointment, either in person or
mental policy. At the review appointment, participants by telephone, as per departmental policy. Participants
willbereminded about theirglovewear regimen and the will receive the follow-up questionnaire at 12-week fol-
need to continue to wear the gloves until the 12-week lowing the date of baseline questionnaire completion.
follow-upquestionnaireiscompleted.Attheendoftheir (SeeFigs.1and2).
trial participation, they will be contacted with further in-
structionsabout futureglovewear. Datacollection
Adherencetoglovewearwillbeassessedinthe12-week The baseline questionnaire includes: demographic
follow-up questionnaires, by asking participants to de- factors i.e. age, gender, living situation, number of
scribetheirglovewearforrightandlefthandgloves.This dependents living with them, and employment status;
will include, over the last four weeks, the: average time and condition specific factors, i.e. duration of their
worn during the day and/or at night; and the average symptoms, time since diagnosis, current medication
number of days per week gloves were worn. The partici- regimen and whether they have had a steroid injection/
pantwillalsobeaskedtostatewhethertheyhaveobtained startedonoral steroids within thelast sixweeks.
arthritisglovesfromelsewhere(iftheydidso,asitispos- Both the baseline and the 12-week follow-up question-
siblefor patientstopurchase glovesinshopsand on-line) naire include:
andglovewearrelatedtothese(ifapplicable). Theprimaryoutcome:
Concomitantcare [1]Handpain:measuredonanumericrating scale
Occupational therapists are asked not to provide resting, (NRS) ofhandpaininthedominanthandduring
wrist, finger or thumb splints or any other occupational the daywhendoing moderate handactivities.The
therapy interventions (apart from joint protection and anchorpointsarenopain(0)to severepain(10).
Prioretal.BMCMusculoskeletalDisorders (2017) 18:224 Page5of15
Table1ContentoftheBaselineand12-weekfollow-upquestionnaires
Concept Measurementmethod Details 0-wks 12-wks
DemographicandCondition Dateofbirth ✓
Information
Gender ✓
TimesinceRAorIAsymptomonset ✓
TimesinceRAorIAdiagnosis ✓
Employmentstatus ✓
Maritalstatus ✓
Livingstatus(alone;orwithfamily/ ✓
significantothers)
Medicationregimen(i.e.whatdrugs ✓
dotheytakefortheirarthritis);
Whetherreceivedasteroidinjection/ ✓
oralsteroidinthelast6weeks
Handdominance(i.e.whetherthey ✓
considerthistoberight,leftorboth).
Primaryoutcome HandPainduringactivity 0-10(0=nopain/10=severepain)pointnumericrating ✓ ✓
scaleofhandpaininthedominanthandduring
theday[21]
Secondaryoutcomes HandPain 0-10(0=nopain/10=severepain) ✓ ✓
a)duringatypicaldayduringactivitiesinthelastweek
inthenon-dominanthand;
b)whenresting-separatelyforthedominantand
non-dominanthands;and
c)atnight–separatelyforthedominantand
non-dominanthands.
Stiffness Measuredseparatelyforthedominantand ✓ ✓
non-dominanthands:
a)Patientself-reporteddurationofearlymorning
stiffnessaffectingthehands(hours/min)
b)0-10pointnumericratingscaleofhandstiffness
(no(0)andsevere(10)handstiffness)
Self-reportedhandcondition afivepointratingscaleofverysevere/severe/ ✓ ✓
moderate/good/verygood.
HandFunction TheMeasureofActivityPerformance aself-reportedmeasureof18itemsofperforming ✓ ✓
oftheHand(MAPHAND)[22,23] dailyactivitieswiththehands
TheMichiganHandOutcomes assessesrightandlefthandsseparately:physical ✓ ✓
Questionnaire(MHQ)[24,25] statusofthehand(movement,strength,
sensation:5items);dailyactivitiesperformedwith
thehands/arms(5rightandleft;7bilateral);impact
oftheirconditionontheirnormalactivities(5items);
painfrequency,severityandimpact(5items);
perceivedappearanceoftheirhands(4items);
satisfactionwithhandabilities(6items)
Disability TheHealthAssessmentQuestionnaire[26] 24itemsofdailyfunction ✓ ✓
Economicanalysis EQ5D-3L[27,28] 5-itemsScale(Mobility;Self-care;Usualactivities; ✓ ✓
Pain/Discomfort;Anxiety/Depression
YouruseofNHSandsocialservices a)Anyplannedhospitalovernightstaysinthelast ✓ ✓
3months
b)Listofplannedadmissions
Youruseofhospitalout-patient a)Anyplannedhospitaloutpatientappointments ✓ ✓
appointments lasting4horlessinthelast3months
b)Ifyes,department,specialityandnumberof
appointments
Youruseofdayhospitalappointments a)Anydayorhospitaloutpatientlastingmorethan ✓ ✓
4hbutnotovernightduringthelast3months
b)Ifyes,department,specialityandnumberof
appointments
Prioretal.BMCMusculoskeletalDisorders (2017) 18:224 Page6of15
Table1ContentoftheBaselineand12-weekfollow-upquestionnaires(Continued)
Youruseofaccidentandemergency a)AnyA&Eattendanceinthelast3months ✓ ✓
services b)Ifyes,thenumberofvisitsdidnotleadto
hospitaladmission
c)Wereadmittedintoahospitalasanin-patientfrom
theA&E
d)Ifyes,department,reasonforadmission,whereand
whenadmitted
Youruseofprimaryandcommunity a)UseofservicessuchasGP,Practicenurse,Nurse, ✓ ✓
basedhealthservices Counsellorinthelast3months
b)Ifyes,numberofvisitstoeach
Youruseofprimaryandcommunity a)Useofservicessuchas,occupationaltherapy,Physio, ✓ ✓
basedhealthservices Careworker,Homehelp,Socialworker,Otherinthe
last3months
b)Ifyes,numberofvisitstoeach
Medication CurrentmedicationforRA/IA ✓
Anysteroidinjection/oralsteroids Yes/No ✓
startedinthelast12weeks
Ifyes,thedateoftheinjection/started DD/MM/YY ✓
takingoralsteroids
HealthStatus Yourownhealthstatetoday Measuredbya0-100verticalscale(0=worstimaginable ✓
state&100=bestimaginablehealthstate)
Additionaloutcomes Anyotherupperlimboccupationaltherapyor Typeoftreatmentreceived ✓
physiotherapytreatmentreceivedin
thelast12weeks
Whetherpurchasedorobtainedfrom Yes/No ✓
elsewhere,anyother“arthritis”gloves.
Ifyes,whattypethesewere ✓
Howtheirhandsareincomparisonto (muchbetter/better/nochange/worse/muchworse) ✓
12weeksago,i.e.beforereceivinggloves
Concurrentuseofanyresting,wrist, ✓
fingerorthumbsplints
Adherencetoglovewear Duringthedayandatnightforright/lefthandgloves; ✓
averagetimewornatnight/duringtheday;average
numberofdaysperweekgloveshavebeenworn
Whetherparticipantsconsidered Yes/No ✓
glovesprovidedanybenefit
Whethertheywillcontinuetowear Yes/No ✓
theglovesprovided
Iftheyconsideredtheglovesofany ✓
benefit,whatwerethese
Anyproblemsencounteredwhen Freetext ✓
wearinggloves
ThepainNRSisawidely-usedoutcomemeasurein [2]Stiffness:measuredthrough a)Patient self-reported
RA clinicaltrials. Duringdevelopmentand durationofearlymorningstiffness affectingthe
psychometrictestingofapatient-reportedoutcome hands(hours/minutes);b)0-10pointnumericrating
measure,itwasidentifiedthatparticipants hada scaleofhandstiffness (withanchor pointsofno(0)
strong preferenceforcompleting NRSovervisual and severe(10)handstiffness)-separately forthe
analoguescales.This studyalsoidentifiedtest-retest dominantandnon-dominant hands.
reliabilityofpain(onmovementand atrest)were [3]Self-reportedhandcondition:afive-pointratingscale
betweenr =0.70to0.72.ThepainNRSshad ofverysevere/severe/moderate/good/verygood.
s
significant correlations(p<0.001) with SF36v2 [4]Handfunction:measuredbytheMeasureof
Bodily Painscales(r -0.69to-0.77)[21](Table1). ActivityPerformanceinthe Hand(Map-HAND),
s
And secondary outcomes including: whichhas beenshown tobeunidimensional and
Prioretal.BMCMusculoskeletalDisorders (2017) 18:224 Page7of15
Fig.1A-GLOVEStrial:flowofparticipants
have goodreliabilityand validityinaBritishRA Theoutcomemeasureswithinthebaselineand12-week
population[22,23]andthe Michigan Health questionnairearealsolistedinTable1.
Questionnaire(MHQ),whichassessesforthe right
and lefthandsseparately:physicalstatusofthe
hand(movement,strengthsensation: 5items);daily Patientinterviews
activitiesperformedwiththehands/arms(5right At 14 weeks, participants (n=10–15 from each group)
and left;7bilateral); impact oftheirconditionon will be purposively selected to participate in a semi-
their normalactivities(5items); painfrequency, structured,face-to-faceortelephoneinterviewtoinvesti-
severity andimpact (5items); perceivedappearance gate their views on: benefits or negative effects of glove
oftheir hands(4items); satisfaction withhand wear (including when at work for those who are
abilities (6items) andalso hasgoodreliabilityand employed); glove appearance, quality, comfort, ease of
validity [24,25]. applying; and willingness to buy gloves in future. Pur-
[5]Disability:theHealthAssessment Questionnaire posive sampling will be based on: 1:3 male to female ra-
(24 itemsofdailyfunction) [26] tio (as per the distribution of RA in population), and a
[6]Health-related qualityoflife(HRQoL) ismeasured range of ages, baseline hand pain (mild/moderate/or se-
usingthestandardisedfive-itemEuroQoL,3-level vere) and 12-week self-reported levels of adherence with
version(EQ-5D-3L)[27,28],whichisrecommended glove wear. The semi-structured interview schedule is
byNationalInstituteofHealthandClinical outlinedinTable2.
Excellence(NICE)foreconomicevaluationsin All interviews will be audio recorded, transcribed ver-
clinicaltrialsandhasprovenresponsiveness,reliability, batim and thematically analysed by three researchers to
andvalidityintrialsofinterventionsforRA[29,30]. increasethe validity offindings.
Prioretal.BMCMusculoskeletalDisorders (2017) 18:224 Page8of15
Post-Allocation Inter-
Enrolment Allocation Close-out
view
-1 to 3
1-3w 4-7w
weeks; 0w 12w 16w
TIMEPOINT
4-21 28-49
-21 to -1 Day 0 days days 84 days 112
days days
ENROLMENT:
Eligibility screen X
A-Glove Trial Contact Details X
Informed consent X
Registration form X
Baseline assessment
X
given/mailed to patient
Baseline assessment
X
returnedby patient
Allocation X
INTERVENTIONS:(fitting
and review appointments)
Intervention Glove X X
Placebo Glove X X
ASSESSMENTS:
Demographic data X
1: Hand pain during activity X X
2: Hand pain rest/night;hand
stiffness; hand function; X X
disability; economic data
Medication changes; other
treatment; use other gloves;
perceived change hand X
status; adherence; perceived
benefits and continuing use
OT Record FormPart 1 and 2 X X
Interview (selected X
participants)
Fig.2SPIRITflowchart:scheduleofenrolment,interventionsandassessments
Samplesize Recruitment
This was calculated using data from the feasibility study. At each participating site a Principal Investigator (PI)
Minimal clinically important differences for pain scales (senior occupational therapist/consultant rheumatologist)
inRAareestimatedas1.1pointsona0–10scale[31,32]. will be identified, to be responsible for identification, re-
Themeanchangeinhandpainscoreduringactivity(mea- cruitment, consent and provision of baseline question-
sured four weeks post-intervention) was -1.03 (SD 2.22). naires, along with adherence to the study and treatment
AstheSDfromthefeasibilitydatamightbeanunderesti- protocols,followingGoodClinicalPracticeGuidelines.
mate, the 80% upper one-sided confidence limit of the Members of the health care team and occupational
estimated SD, i.e. 2.48 was used. To identify a 1.1 point therapists at participating sites will identify adult pa-
difference, SD=2.48, p=0.05 and 80% power, 80 partici- tients with RA or IA and persistent hand pain during
pants are required per group. Allowing for a 20% at- the patients’ Rheumatology, occupational therapy or
trition (i.e. non-return of 12 week questionnaire and hand therapy appointment. Either a research facilitator
a small number (up to 2%) not receiving a glove for or occupational therapist will then screen patients for
their dominant hand (because they only require a eligibility using the A-Gloves Trial Eligibility Screening
glove for their non-dominant hand, and therefore not Form. (See Fig. 3 for recruitment procedure). All eligible
providing primary outcome data), we intend to recruit patients will be provided with a study explanation and
205 participants. informationpack.(See Additionalfile1).
Prioretal.BMCMusculoskeletalDisorders (2017) 18:224 Page9of15
Table2A-GLOVESsemi-structuredqualitativeinterviewschedule for six weeks from the date of injection/steroid start. It is
A-GLOVESTrial:QualitativeSemi-structuredInterviewSchedule not anticipated that this will be a common event. If the
participant starts steroids following glove provision and
Opening/MainQuestion
their hands are still symptomatic, they will be advised to
“Havingwornthearthritisglovesforupto12weeks,couldyoutellme
continue glove wear as prescribed, as this is a pragmatic
aboutanynegativeorpositiveeffectsthesehavehadonyourhand
painandhandproblems?” trial. If the patient reports that their hands are no longer
Thefollowingpromptsmaybeusedtoexpandontheanswersgiven: causing them pain or discomfort they will be advised not
to wear the gloves. However, they will remain in the trial
1 Whateffectdidtheyhaveonyourhandpain,handstiffnessand
abilitytouseyourhands? and complete the 12-week questionnaire, as we will be
2 Werethereanyparticularactivitiesyoufoundtheyhelpedwith? conductinganintentiontotreatanalysis.
[Forexample:personalcare;householdactivities;leisure/social Following consent, by the research facilitator or occu-
activities;driving;work]. pational therapist, participants will be provided with a
3 Werethereanyparticularactivitiesyoufoundtheydidnothelp baseline (i.e. 0 weeks) questionnaire to complete and
with?[Forexample:personalcare;householdactivities;leisure/social
return in a Freepost envelope to the trial manager. On
activities;driving;work].
receiptofthe completedquestionnaire,thetrialmanager
4 Howdidyoufindwearingthem?
will enter their details into a web-based MACRO
5 Howwasittoputthemonandoffyourhands? database (managed by Lancashire Clinical Trials Unit
6 Wasthereanythingabouttheglovesortheireffectswhichyou [CTU]) and request that the unblinded CTU staff per-
thinkhelped/hinderedyourhandpainandhandproblems?
form theassignmentoftheintervention.
7 Iftheywerehelpful:whendidyoufindthemhelpfultowear:either
inthedayoratnight(orboth)?
Assignmentofintervention
8 Iftheywerenothelpful:whendidyoufindthemunhelpfultowear:
Allocationandsequencegeneration
eitherinthedayoratnight(orboth)?
Participants will be randomly assigned toeither the inter-
9 Forthoseemployed:Haveyouusedthematwork?Ifyes,werethey
vention or placebo glove group with a 1:1 allocation gen-
helpful?Andinwhatways?Ifnothelpful,whywasthis?
erated and delivered by ‘Sealed Envelope,’ an online,
10 Didyouhaveanyproblemswearingthegloves?
central randomisation service (www.sealedenvelope.com).
11 Whatdidyouthinkoftheglovesappearance?
The randomisation schedule will be stratified by whether
12 Whatdidyouthinkofthequalityoftheglovesyouweregiven? ornottheparticipanthashadachangeinorreceivednew
13 Howdidyoufindcleaningthem? medication(specificallyDMARDs or biologics)within the
14 Wouldyouconsiderbuyingtheminthefuture? lastthreemonths,usingpermutedblocksofrandomsizes.
15 Wouldyouchangeanythingaboutthemtomakeitbetterforyour
use?(e.g.colour,texture,amountofpressureapplied,size,length) Concealmentmechanism
The block sizes or schedule will not be disclosed to the
trial manager, occupational therapists or research facili-
If a site is encountering difficulty screening sufficient tators to ensure concealment. Randomisation will occur
numbers in clinics, then potential participants will be only once the trial manager confirms a participant’s
identified from medical or occupational therapy records eligibility, consent and that they have completed the
by members of the health care team. The patient will baselinequestionnaire.
then bemailedaStudyInformationPackbytheresearch
facilitator or occupational therapist. (See Fig. 4 for Implementation
recruitment procedure). Within three working days of notification by the trial
Atthescreeningstage,participantsidentifiedashaving manager, unblinded CTU staff will perform the random-
had a steroid injection or started oral steroids in the last isation and securely e-mail a referral for either interven-
six weeks, but who otherwise meet the inclusion criteria, tion or placebo gloves to the relevant site. Within three
will not be consented but will be re-screened six weeks weeks of referral, the occupational therapist will make
after thedate ofsteroid injection/startingoral steroids to an appointment and provide the participant with the
re-check trial eligibility. Steroids can reduce hand pain appropriate gloves.
and thus would be a confounding factor in evaluating
glove effectiveness. If at six weeks they are still eligible, Blinding
they willbere-approachedforconsent. Due to the nature of the intervention it will not be
Participants may receive a steroid injection or start oral possible for therapists to be blinded to group allocation.
steroids following consent.If thisoccursbetweenconsent As most sites will only have one Rheumatology occupa-
and glove fitting, the occupational therapist will identify tional therapist, both intervention and placebo gloves
thisattheglovefittingappointmentanddeferglovefitting will commonly be provided by the same occupational
Prioretal.BMCMusculoskeletalDisorders (2017) 18:224 Page10of15
Fig.3Recruitmentandconsentflowchart:rheumatologyclinic/occupationaltherapy
Fig.4Recruitmentflowchartviamedical/OTrecords/healthcarestaffandstudyinformationpackmailed/providedtopatient