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Assessment of the Effectiveness of a Functional Splint for Osteoarthritis of the Trapeziometacarpal Joint on the Dominant Hand

J Rehabil Med 2010; 42: 469–474 ORIGINAL REPORT ASSESSMENT OF THE EFFECTIVENESS OF A FUNCTIONAL SPLINT FOR OSTEOARTHRITIS OF THE TRAPEZIOMETACARPAL JOINT OF THE DOMINANT HAND: A RANDOMIZED CONTROLLED STUDY Ana Claudia Gomes Carreira, OT, Anamaria Jones, PT and Jamil Natour, MD From the Rheumatology Rehabilitation Section, Rheumatology Division, Federal University of São Paulo, Brazil Objective: To assess the effectiveness of a functional splint for trapeziometacarpal osteoarthritis. Methods:
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  ORIGINAL REPORT J Rehabil Med 2010; 42: 469–474  J Rehabil Med 42 © 2010 The Authors. doi: 10.2340/16501977-0542Journal Compilation © 2010 Foundation of Rehabilitation Information. ISSN 1650-1977 Objective: To assess the effectiveness of a functional splintfor trapeziometacarpal osteoarthritis.  Methods: Forty patients with a diagnosis of painful trapezio-metacarpal osteoarthritis of the dominant hand were rando-mized into 2 groups. The study group received the splint atbaseline and used it during activities of daily living for 180days and the control group used the splint only during the evaluations for the rst 90 days and during activities of dailyliving for the following 90 days. Pain, strength, hand func -tion and dexterity (with and without splint) were measured by a blinded assessor at baseline, 45, 90 and 180 days.  Results: The groups were homogenous at baseline for all out- comes evaluated. Pain without the splint was signicantly different between groups over time; the study group experi- enced a decrease in pain beginning with the rst evaluation(45 days), whereas the control group achieved a lower painscore only at the end of the study, after having used the splintfor 90 days. No signicant differences between groups were found for the other parameters. Conclusion: Splint use during activities of daily living for pa- tients with trapeziometacarpal osteoarthritis reduces pain,but does not alter function, grip strength, pinch strength or dexterity.  Key words: functional splint; trapeziometacarpal joint; osteoar-thritis; pain; function.J Rehabil Med 2010; 42: 469–474 Correspondence address: Dr. Jamil Natour, Disciplina de Reumatologia, Rua Botucatu 740, São Paulo SP, Brazil, CEP 04023-900. E-mail: jnatour@unifesp.br  Submitted February 18, 2009; accepted January 15, 2010INTRODUCTIONOsteoarthritis (OA) is one of the most common joint diseases.It affects approximately 12% of the population over 65 yearsin the USA (1,2). In Brazil it affects between 6% and 12% of adult population (3). The incidence is lower among individu-als under the age of 40 years and increases progressively. OAis more common between 51 and 60 years of age and is moresymptomatic among post-menopausal females (1, 4).The prevalence of OA of the hand varies widely. A prospec-tive cohort study did in the Netherlands, based on radiographicdata shows that 67% of women and 54.8% of men may haveone joint affected. The most commonly affected sites are thedistal interphalangeal joints (47.3%), trapeziometacarpal(TMC) joint (35.8%), proximal interphalangeal joints (18.2%)and metacarpophalangeal joints (MCP) (8.2%) (5).Patients with OA of the hand normally experience a loss of manual ability and grip strength, especially when the TMC joint is affected (6–9). The TMC joint has 2 main functionalcharacteristics: freedom of movement and stability (10, 11). Itis considered one of the most important hand joints, as 45% of hand function results from the action of the thumb (12).One of the primary factors in OA of the TMC joint is believedto be the inherent laxity of the volar oblique ligament. Whenthis joint is repeatedly stressed, subluxation occurs, resulting in incongruity of opposing surfaces, inammation and eventual degeneration. These joint changes cause stiffness, which is oftenincreased by the formation of osteophytes in the trapezium or metacarpal base. Movement can be further limited if the TMC  joint becomes xed in a dorsally subluxed position, limiting radial adduction. The thumb metacarpophalangeal joint may become hyperextended in an effort to compensate (13).The main symptoms of OA of the TMC joint are pain in thedorsoradial and volar face of the hand on the projection of  the angle formed by the index nger and thumb in abduction, and loss of grip strength. The aims of conservative treatment include the preservation of the rst interdigital space, pain relief, maintenance of thumb function, orientation regarding joint protection, energy conservation and the use of adapta-tions. In the rehabilitation process, splints are a therapeuticresource that provide patients with the opportunity to achievetheir maximum recovery potential (14–17).Conservative treatment of OA of the TMC includes analge-sics, joint protection, strengthening exercises of the intrinsicand extrinsic muscles of the thumb, assistive devices andsplints. Surgical management may be recommended to re-lieve intractable pain. The procedure used varies accordingto disease stage (13).Splints for OA of the TMC provide external support to the joint,thereby stabilizing the adjacent joints capable of compensatory movements and maintaining the rst joint space (18, 19). The literature on splints for OA of the TMC is scarce, but a number of authors report that many rheumatologists recommend their use,although they do not publish studies on the subject (20). A pro-spective study that examined the effectiveness of steroid injectionin combination with splinting found that this kind of treatment provided reliable long-term relief to the thumb (21). ASSESSMENT OF THE EFFECTIVENESS OF A FUNCTIONAL SPLINTFOR OSTEOARTHRITIS OF THE TRAPEZIOMETACARPAL JOINT OF THEDOMINANT HAND: A RANDOMIZED CONTROLLED STUDY Ana Claudia Gomes Carreira, OT, Anamaria Jones, PT and Jamil Natour, MD From the Rheumatology Rehabilitation Section, Rheumatology Division, Federal University of São Paulo, Brazil   470  A. C. Gomes Carreira et al. A randomized controlled trial (RCT) comparing 2 6-week splint and exercise regimens for patients with trapeziometacar- pal OA found that both groups improved; however, no differ-ences were found between groups regarding pain, strength or hand function (22). Another RCT comparing a custom-madeneoprene splint and usual care found that the splint had noeffect on pain at 1 month, but improved pain and disability at12 months; however, the splint was a rigid rest splint recom-mended for use only at night and the assessor was not blinded(23). Another RCT comparing a joint protection programmealone and joint protection programme with the addition of day/night splints and hot pack/home exercise found that when anexercise regimen and a splint are added to a joint protection programme, there is a greater improvement in pain, stiffness,grip strength and performance on activities of daily living incomparison with the joint protection programme alone (24).A review published in 2007 concluded that, although evidenceregarding the effectiveness of splinting for carpometacarpal OAis underdeveloped, the research to date indicates that splintingmay help relieve pain. Further investigation is recommendedusing a controlled methodology, more thorough reporting of outcomes and tracking of analgesic use. Given the conservativenature and relatively low cost of splinting, it is recommendedthat patients be given the opportunity to try a splint (25).The aim of the present study was to assess the effectivenessof a functional splint for the thumb of the dominant hand of  patients with Grade II and III OA of the TMC joint.METHODS Forty patients with a diagnosis of OA of the TMC joint of the dominanthand were randomized into 2 groups of 20 individuals. Eligibilitycriteria were: a clinical and radiological diagnosis of idiopathic GradeII and III OA of the TMC joint of the dominant hand; (26) either gender; over 40 years of age; and pain in the base of the thumb of thedominant hand of between 3 and 7 on the 0–10 cm visual analoguescale (VAS) for pain.Exclusion criteria were patients with severe deformities of the domi- nant hand that did not allow gripping between the rst, second and thirdngers; deformities of the distal interphalangeal joint; the use of a splint on the thumb in the previous 6 months; surgery on the hand under studyin the previous 6 months or scheduled in the upcoming 6 months; allergyto the splint material; incapacity to respond to the questionnaire and perform the tests; geographical inaccessibility; injections in the handunder study in the previous 6 months; other associated diseases suchas carpal tunnel syndrome, fractures in the carpus, tendonitis, chronic inammatory arthropathy and alterations in the use of anti-inammatory medication and analgesics in the previous 3 months.The present study was approved by the ethics committee. All patientssigned terms of informed consent and were randomly allocated to 2groups of 20 patients: splint group (SG) and control group (CG). Acomputer-generated randomization list was used to randomly allocate patients into the groups and concealed allocation was carried out withopaque sealed envelope.This trial was registered at clinicaltrials.gov (ID: NCT00612248).  Intervention An occupational therapist (ACGC) specialized in rheumatology with10 years experience confected a functional thermoplastic splint for the participants of both groups, the aim of which was to stabilize the TMC  joint, maintaining the pulp of the distal phalange of the index nger freefor gripping with the other ngers and leaving the thumb in a functional  position (Fig. 1) (18). Patients in the SG received the splint on the day of the rst evaluation and took it with them for use during activities of  daily living, including paid or unpaid work. They were instructed toremove it during rest (sleeping), bathing and activities in which theyhad contact with heat. They were also instructed as to how to put thesplint on and cleaning procedures. In cases of discomfort regardingthe use of the splint, patients were instructed to communicate with thetherapist in order to perform the necessary adjustments.Patients in the CG initially used the splint only during the evalua-tions. The splints remained in the possession of the researcher and wereonly given to patients for home use after the third evaluation (T90).Patients of the CG used the splint daily between T90 and T180.  Evaluations Evaluations were carried out by a blinded assessor at baseline (T0),after 45 days (T45), after 90 days (T90) and after 180 days (T180). Allevaluations were performed by a physiotherapist trained to administer the tests. At the beginning of each evaluation the occupational thera- pist in charge of the study inspected the splints of the patients in theSG and gave the splints to the patients in the CG so that all patientssaw the assessor wearing their splints. Patients were instructed not tocomment to the evaluator regarding the use of the splint.The primary outcome was: ã Pain in the base of the thumb – a VAS from 0 to 10 cm was used,for which 0 represents no pain and 10 represents unbearable pain.The patient indicated his/her level of pain on the scale using the tipof a pen. Pain was assessed in 2 stages: ã Pain without the splint  – average pain the patient felt in the previ-ous week without the use of the splint; ã Pain with the splint  – average pain the patient felt using the splintduring the evaluation.The secondary outcomes were: ã Functional capacity – the Disabilities of the Arm, Shoulder and Hand(DASH) questionnaire was used. This instrument is composed of 30questions measuring function and symptoms. It includes 2 items on physical function, 6 items on symptoms and 3 items on social aspects(Q3). There are also 2 optional modules with 4 items each –one for athletes and musicians (Q1) and another for workers (Q2). All itemswere answered based on the patient’s experiences in the previousweek. If the patient did not have the opportunity to perform one of the activities in the previous week, he or she was asked to estimatethe most accurate response. The score ranges from 0 to 96 points,for which higher scores represent worse functional capacity (27). ã Grip strength – the Jamar dynamometer was used. The test was car-ried out of the dominant hand with and without the splint. Patients were seated with the elbow at 90 degrees of exion and the wrist in a neutral position between pronation and supination. The dynamo-meter was set at number 2, in accordance with the instruction manual(PC-5030J1 – Preston/Trenton, Ontario Canada; Mathiowetz, 1984).Measurements were taken in Kgf, from which the mean result wasconsidered for analysis. Participants were verbally encouraged tomake an effort during all measurements. ã Pinch strength – a pinch gauge dynamometer was used. The test was performed with the dominant hand both with and without the splint.Patients were in the same position as in the grip strength test. Three  Fig. 1. Model of confected splint.  J Rehabil Med 42  471  Functional splint for OA of trapeziometacarpal joint  measures were taken for each pinch (tip and key pinch), for whichthe mean in Kgf was considered in the analysis, in accordance withthe instruction manual for the equipment (A853-4-Smith & Nephew/Germantown, USA, Mathiowetz, 1984). Participants were verballyencouraged to make an effort during all measurements. ã Upper limb dexterity – the O’Connor test equipment was used(Lafayette Instrument ® , USA). Dexterity in the O’Connor test is dened as the time it takes to place three pins in one hole on ve rows of the board. Patients performed the test while seated and the board was placed on a table in front of them. Patients were allowedto make a practice run in order to become familiar with the test,following the manufacturer’s instructions. The performance time was recorded in seconds using a chronometer from the rst to fth row (1 st time) and then from the sixth to tenth row (2 nd time). Both times were used for the calculation of the nal score. Statistical analysis A minimum of 17 patients per group were needed in order to identifya 2-cm improvement in the VAS for pain with a 0.05 alpha and 0.20 beta. Forty patients were randomized in order to compensate for a  possible loss of 20%. The signicance level was set at  p < 0.05. Alltests were performed using the SPSS version 10 (SPSS, Chicago, IL,USA) and intention-to-treat analysis was carried out when necessary. Pearson’s χ  2 and Fisher’s exact tests were employed to determine thehomogeneity of the sample. Categorical variables were analysed usingthe Mann-Whitney test.The data were analysed in 2 stages: ã   Period A – comparison between groups over time – between T0 andT90. ã   Period B – comparison between groups over time – between T0 andT180.For data with normal distribution in periods A and B, analysis of variance (ANOVA) for repeated measurements was used to determinedifferences in the behaviour of the groups over time considering theexisting relationship between evaluations of a single individual. When a statistically signicant difference over time was found between groups, the Mann-Whitney or  t  -tests were used to analyse differences at eachtime. Analysis of the VAS for pain score with the use of the splint was performed at T45, T90 and T180 using an independent-sample t  -test, as both groups were only assessed for this parameter beginning at T45, atwhich point the difference was already evident. Pain, strength and dexter-ity parameters with and without the use of the splint were compared in both the SG and CG at each assessment time using a paired t  -test. RESULTSThe groups were homogenous at baseline with regard to age,disease duration, gender, degree of OA of the TMC, domi-nance, race and profession. Median age was 65.5 years in thecontrol group and 64.8 years in the study group. There was a predominance of female subjects, which is similar to the preva-lence of the disease (4, 7). All 40 patients who began the studycompleted all the evaluations; no patient was lost throughout the study period. Fig. 2 shows the patient ow-chart for each step of the study. Table I displays the sample characteristicswith regard to age, disease duration, gender, ethnicity, levelof schooling, profession, pain, DASH, grip strength, pinchstrength and dexterity on the initial evaluation.  Period A – analysis between T0 and T90 A reduction in the VAS for pain without the splint was observedin the SG, whereas pain remained constant in the CG. This dif- ference was statistically signicant between groups (  p = 0.003)(Table II) and was observed at T45 and T90 (  p = 0.013 and  p = 0.002, respectively). In the intra-group comparison, pain reduced in the SG signicantly in T0/T45 (  p < 0.001) and T0/ Table I.  Population characteristics at baseline SG( n = 20)CG( n = 20)  p Age, years, mean (SD)62.8 (8.5)65.1 (10.1) 0.665Duration of disease, years,mean (SD)6.3 (3.4)7.7 (6.1)0.503Gender, female/male, n 20/018/20.147Degree disease, II/III, n 19/120/00.311Ethnicity, white/non-white, n 13/714/60.736Hand dominance, right/left, n 19/120/00.311Pain – VAS, cm, mean (SD)without splint5.1 ( 1.4)5.1 (1.1)0.978Grip strength (Kgf – mean (SD))with splint18.1 (8.8)20.2 (7.3)0.185without splint18.7 (6.8)20.5 (7.7)0.409Pinch strength – key, Kgf, mean (SD)with splint4.6 (1.5)4.9 (1.5)0.413without splint5.4 (1.9)5.2 (1.7)0.625Pinch strength – tip, Kgf, mean (SD)with splint3.5 (1.3)3.4 (1.2)0.775without splint3.3 (1.2)3.1 (0.9)0.303Dexterity, s, mean (SD)with splint334.2 (57.4)333.8 (66.5)0.871without splint357.4 (76.0)359.3 (81.6)0.766Hand function – DASH, mean (SD)Question 12.8 (12.6)1.6 (5.7)0.594Question 215.0 (20.4)22.8 (28.0)0.383Question 342.0 (18.4)39.1 (16.9)0.655SG: study group; CG: control group; VAS: visual analogue scale;DASH: Disabilities of the Arm, Shoulder and Hand questionnaire; Kgf:kilogram force.  Fig. 2. Participants in each stage of the trial.   Assessed for eligibility( n = 93)Did not meet inclusion criteria ( n =37)Refused to participate ( n = 16)40 patients were randomizedAllocated to splintgroup ( n =20)Allocated to controlgroup ( n = 20) n = 20 All patients completedthe study and all data   were analysed   n = 20 n = 20 n = 20 n = 20 AllocationEnrollmentFollow-upT0T45T90T180Analysis n = 20 Both groups used the splintbetween T90 and T180  J Rehabil Med 42  472  A. C. Gomes Carreira et al. T90 (  p < 0.001), demonstrating that the reduction in pain oc- curred in the rst 45 days of treatment and was maintained for  another 45 days (T90). There were no signicant differences between groups over  time regarding the Q1 and Q2 scores of the DASH (  p = 0.524and  p = 0.893, respectively). Both groups had a reduction inQ3 scores (  p = 0.382). Regarding dexterity, grip and pinch strength with and without the splint, there were no signicant intra-group differences over time (Table II).  Period B – analysis between T90 and T180 In the comparison between groups from T0 and T180, there was only a statistically signicant difference in pain withoutthe splint. The signicant difference between groups from T0to T90 regarding pain without the splint remained signicant  between T0 and T180 (  p = 0.009). This demonstrates that,despite the improvement in the CG after using the splint for 90 days during activities of daily living, this improvementdid not match that of the SG at the end of the study, which clearly demonstrates the benet of the splint regarding pain.This benet was already clear by T90 and the improvement in this parameter continued, demonstrating an additional gain for the SG regarding pain without the splint through to T180. No statistically signicant differences between groups were found in Period B for the DASH, strength or dexterity (Table II). VAS for pain with the splint  There was a statistically signicant difference between groups regarding pain during the use of the splint (  p < 0.001 at T45;  p = 0.001 at T90; and  p = 0.026 at T180).  Intra-group comparisons with and without the splint regarding  pain, strength and dexterity In the SG, a statistically signicant difference was found for key pinch strength at T90 (  p = 0.022) and T180 (  p = 0.018), in which strengthwith the splint was lower than without the splint. Regarding dexterity,the test was performed slower with the splint than without the splintat T0 (  p = 0.011). Pain scores were lower during the use of the splint(  p = 0.038 at T45 and  p = 0.009 at T90) (Table III). In the CG, a statistically signicant difference was found for key pinch strength for all the evaluations (  p = 0.003 at T0,  p = 0.004 at T45,  p = 0.011 at T90 and  p = 0.026 at T180), withstrength always lower during the performance of the test withthe splint. Regarding dexterity, the test was performed slower without the splint at T0 (  p = 0.014). Pain scores were lower during the use of the splint at T180 (  p = 0.039) (Table III).DISCUSSIONThe aim of the present study was to assess the effectiveness of asplint for OA of the TMC. The main parameter was pain reported by patients with and without the use of the splint, as pain is one of the reasons for dysfunction in manual abilities and the seeking of medical care. Together with deformities, pain can cause disabilityand dependence in activities of daily living. The participants in the study also complained of difculty in performing daily tasks,correlating this difculty to pain in the TMC joint. The use of a splint during activities of daily living reduced pain in patients with OA of the TMC joint. Both groups showedimprovement – the improvement in the SG occurred early inthe study, whereas improvement in the CG occurred after T90,when this group also began using the splint during activities of  Table II.  Inter-group comparison of hand pain (VAS), functional capacity, grip strength, pinch strength and dexterity T0T45T90T180CGSGCGSGCGSGp 1 CGSGp 3 Pain (VAS – cm)without splint5.1 (1.4)5.1 (1.1)4.8 (1.9)3.1 (2.1)5.2 (2.0)2.9 (2.2)0.003*4.4 (2.5)2.5 (2.6)0.009* p 2 0.9500.013*0.002*0.023*with splint––4.8 (2.6)2.1 (1.6)4.3 (2.2)1.9 (1.9)0.6803.4 (2.6)1.7 (2.1)–  p 2 < 0.001*0.001*0.026*Grip strength, Kgf without splint18.7 (6.8)20.5 (7.7)18.3 (6.9)21.6 (5.8)20.1 (6.1)20.9 (6.4)0.31120.1 (5.2)20.8 (5.3)0.207with splint18.08 (8.8)20.18 (7.3)18.3 (6.8)22.4 (5.5)19.5 (7.6)22.1 (7.2)0.15020.2 (7.1)22.3 (5.6)0.217Pinch strength – key, Kgf without splint5.4 (1.9)5.2 (1.7)5.5 (1.8)5.7 (1.4)5.7 (1.8)5.9 (1.6)0.3605.7 (1.7)6.0 (1.7)0.882with splint4.6 (1.5)4.9 (1.5)4.9 (1.3)5.4 (1.2)5.2 (1.6)5.4 (1.7)0.7425.3 (1.5)5.5 (1.6)0.540Pinch strength – tip, Kgf without splint3.3 (1.2)3.1 (0.9)3.3 (1.2)3.7 (0.9)3.7 (1.1)3.8 (1.1)0.3224.4 (1.3)4.1 (0.9)0.118with splint3.5 (1.3)3.4 (1.2)3.5 (1.3)3.9 (0.8)3.9 (1.2)4.1 (1.2)0.1764.3 (1.0)4.3 (0.8)0.373Dexterity, swithout splint357.4 (76.0)359.3 (81.6)356.5 (146.5)330.8 (94.4)341.4 (117.1)309.5 (89.2)0.255321.7 (67.7)295.7 (80.5)0.316with splint334.1 (57.4)333.8 (66.5)376.1 (157.1)318.1 (70.7)335.0 (97.8)295.4 (59.9)0.092324.6 (63.2)297.1 (66.2)0.114Hand Function – DASHQuestion 12.8 (12.6)1.6 (5.7)0.6 (2.8)1.6 (5.7)2.8 (12.6)3.1 (10.4)0.5242.2 (9.8)2.5 (6.8)0.689Question 215.0 (20.4)22.8 (28.0)15.0 (18.9)20.3 (25.1)13.7 (17.5)19.4 (26.3)0.89316.2 (17.5)15.3 (26.0)0.459Question 342.0 (18.4)39.1 (16.9)34.4 (14.5)31.8 (17.6)35.3 (13.2)28.6 (18.0)0.38232.2 (11.1)22.0 (20.0)0.225Data are reported as mean (standard deviation); SG: study group; CG: control group; T0: baseline; T45: 45 days from baseline; T90: 90 days from baseline; T180: 180 days from baseline; VAS: visual analogue scale; DASH: Disabilities of the Arm, Shoulder and Hand questionnaire; Kgf: kilogramforce; p1: p-value between SG and CG groups over time (T0–T90) using ANOVA; p2:  p -value between SG and CG groups at each time using t  -test; p3:  p -value between SG and CG groups over time (T90–T180) using ANOVA. *Signicant  p -value.  J Rehabil Med 42
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