Assessment of phonophoresis and iontophoresis in the treatment of carpal tunnel syndrome: a randomized controlled trial

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Assessment of phonophoresis and iontophoresis in the treatment of carpal tunnel syndrome: a randomized controlled trial
  Rheumatol Int (2012) 32:717–722DOI 10.1007/s00296-010-1706-9  1 3 ORIGINAL ARTICLE Assessment ofphonophoresis andiontophoresis inthetreatment ofcarpal tunnel syndrome: arandomized controlled trial Eda Gurcay · Ece Unlu · Ahmet Gurhan Gurcay · Reyhan Tuncay · Aytul Cakci Received: 14 May 2010 / Accepted: 28 November 2010 / Published online: 14 December 2010 ©  Springer-Verlag 2010 Abstract To de W ne the role of phonophoresis and ionto-phoresis of corticosteroids in conjunction with wrist splintuse in the treatment of carpal tunnel syndrome (CTS)compared to wrist splint use alone, 52 CTS subjects wereanalyzed based on clinical and electrophysiological criteria.A prospective, randomized controlled trial was carried outto assess symptom severity, motor skills, and hand functionaccording to the Boston Symptom Severity Scale (BSSS),grip strength, and nine-hole peg test (NHPT), respectively,on the initial visit and in the 3rd month after treatment. Thepatients underwent conservative interventions randomly asfollows: (1) 3weeks of phonophoresis with betamethasonein conjunction with wrist splint use (group I, n: 18) or(2) 3weeks of iontophoresis with betamethasone in con- junction with wrist splint use (group II, n: 16) or (3) wristsplint use alone (control, group III, n: 18). The mean age of the patients was 43.7 § 8.4 (range 24–57) years. Groups I, II,and III showed a signi W cant and further improvement inBSSS at the 3rd month evaluations compared with baseline( P <0.001, P =0.001, P <0.001, respectively), but no sig-ni W cant change was observed in grip strength or NHPT( P >0.05). There was a statistically signi W cant di V  erencebetween the phonophoresis and control groups after treat-ment only regarding BSSS, in favor of phonophoresis( P =0.012). We recommend the use of wrist splints espe-cially with phonophoresis for relief of symptoms in patientswith CTS. Our results demonstrated no superiority amongthe treatment groups. Further, transdermal steroid treat-ments are not key determinants of e Y cacy with respect tomotor skills and hand dexterity. Keywords Carpal tunnel syndrome · Phonophoresis · Iontophoresis · Symptom severity scale · Hand function · Wrist splint Introduction Carpal tunnel syndrome (CTS) is the most frequentlyencountered peripheral nerve lesion caused by the compres-sion of the median nerve at the wrist. It frequently a V  ectswomen. The estimated prevalence of CTS is 2.7% in thegeneral population [1, 2]. The majority of cases are idio- pathic, but hand/  W nger tendonitis and repetitive wrist move-ments are known related etiologies [3].Clinical symptoms of CTS include pain in the hand,forearm, elbow, or even shoulder, paresthesia or hypoesthe-sia in the median nerve territory in the hand, and weaknessor atrophy in the abductor pollicis brevis or opponens polli-cis. These impairments cause aching discomfort and maycause a loss of hand dexterity and disability in daily livingactivities [1, 2]. Criteria for diagnosis of CTS include posi- tive Tinel’s sign at the wrist and Phalen’s or reverse Pha-len’s test (within 1min), and abnormal nerve conductionstudies with clinical symptoms [4].Conservative interventions in CTS include rest, splintingof the wrist, local and systemic steroids, physical therapymodalities, and use of non-steroidal anti-in X ammatorydrugs (NSAIDs) when symptoms occur [5–8]. E. Gurcay ( & ) · E. Unlu · R. Tuncay · A. CakciDepartment of Physical Therapy and Rehabilitation, Ministry of Health Ankara Diskapi Yildirim Beyazit Education and Research Hospital, P.O. Box 06010, Ankara, Turkeye-mail: dredagurcay@gmail.comA. G. GurcayDepartment of Neurosurgery, Ministry of Health Ankara Numune Education and Research Hospital, Ankara, Turkey  718Rheumatol Int (2012) 32:717–722  1 3 The transdermal drug delivery system presents severaladvantages compared to injections, although skin is themajor barrier for the application of transcutaneous drugs.Phonophoresis is an available technique for the enhance-ment of transdermal absorption of NSAIDs into in X amedtissues by the application of ultrasound. There are severalstudies of phonophoresis with various parameters, includ-ing intensity, frequency, duration, and continuous or pulsat-ing mode [7, 9]. Iontophoresis uses electrical current as a physical force to introduce various ions into the skin bya controlled drug delivery system [10]. Although cortico-steroids are commonly used with iontophoresis and phono-phoresis to reduce in X ammation associated withmusculoskeletal in X ammatory disorders, there are fewreports in the literature supporting the concept that suchtreatments with corticosteroid may facilitate recovery fromthe nerve compression in CTS [10–14]. The aim of this study was to assess the role of phono-phoresis and iontophoresis of corticosteroids in conjunctionwith wrist splint use in the treatment of carpal tunnel syn-drome with regard to relief of symptoms and e V  ects onmotor skills and hand dexterity and to compare results tothose obtained with wrist splint use alone. Materials andmethods A prospective, randomized clinical trial was conductedin a hospital that serves individuals with social securityinsurance provided for blue- and white-collar workersand their relatives. The patients with a clinically sus-pected diagnosis of primary CTS were referred to theelectromyography (EMG) laboratory of a Physical Ther-apy and Rehabilitation clinic. Fifty-four patients werediagnosed as CTS using clinical and electrophysiologi-cal evidence [median nerve peak sensory conductionvelocity below 41.26m/s, median mixed nerve conduc-tion velocity (at 8cm) below 34.05m/s, and/or record-ing a distal motor latency (DML) above 3.6ms from theabductor pollicis brevis] [15, 16]. All electrodiagnostic tests were performed by the same physician with aMedelec Synergy (Oxford, UK) electromyograph.Only mildly or moderately a V  ected patients wereincluded in the study. We selected female patients, andall subjects were housewives. The exclusion criteriawere systemic diseases with increased risk of CTS,axonal degeneration of the median nerve, previous ste-roid therapy or surgical treatment for CTS, or contrain-dication for steroid use. Of the 54 patients enrolled, 2(3.7%) dropped out during the follow-up [1 was lost tofollow-up, one had di Y culty in attending the clinic regu-larly], and 52 patients were included in the study. Theevaluation was made bilaterally but only the W ndings of the dominant hand were analyzed.Patients were assessed by Boston Symptom SeverityScale (BSSS), grip strength, and nine-hole peg test(NHPT). All groups were asked to complete the BSSS forthe assessment of symptom intensity. The scale consists of 11 questions with multiple-choice responses, scored from 1point (mildest) to 5 points (most severe) [17].Grip strength is commonly used in clinical practice toassess hand function and motor skills [18]. Jamar Dyna-mometer (Baseline Hydraulic Hand Dynamometer, Irving-ton, NY, USA) was used at the second handle position asthe best measure of grip strength [19].To evaluate the hand dexterity and function, patientswere assessed using the NHPT [20]. The NHPT consists of a square board with nine holes; a container for the pegs isattached to the board. The patient is instructed to pick uppegs one at a time and place them into the holes in anyorder until all holes are W lled; the pegs are then removedfrom the holes one at a time and returned to the container.A chronometer was started by the examiner as soon as thesubject touched the W rst peg and stopped when the last pegtouched the container. The container was then placed onthe opposite side of the pegboard, and the test repeated on theopposite hand.The patients were randomized into three groups. Threetreatment protocols were distributed evenly in an equalnumber of envelopes; patients chose treatment protocols bychance.In group I ( n =18), phonophoresis with 0.1% betameth-asone was applied over the area of the carpal tunnel at a fre-quency of 1MHz and an intensity of 1W/cm 2 , atcontinuous mode (Bosch, Electro-Therapy System,Germany). This therapy was applied for 10min/session,3days/week, for 3weeks. The patients in group II ( n =16)were treated using 0.1% betamethasone iontophoresis fromthe positive electrode at a dosage of 2mA for 10min/day,3days/week, for 3weeks. Positive electrode, of the samepolarity as the ion, was placed on the line of the wrist; neg-ative electrode was placed on the dorsal aspect of the fore-arm. Galvanic current (Petas Petgal 250, Turkey) was usedfor ion transfer. Group III ( n =18) patients were instructedto use wrist splint alone. Patients were advised to applycustom-made volar thermoplastic wrist splints in the neu-tral position for night-only wear, for 3weeks .  The BSSS,grip strength test, and NHPT were applied before and in the3rd month after treatment. Flow diagram of the patients isshown in Fig.1.All patients were informed about the nature of the study,and all procedures were in accordance with the HelsinkiDeclarations of 1975. Approval was obtained from the localethics committee prior to the commencement of the study.  Rheumatol Int (2012) 32:717–722719  1 3 Statistical analysisSPSS 15.0 program (SPSS Inc., Chicago, IL, USA) wasused for statistical analysis. Descriptive statistics weregiven as mean, standard deviation, and numbers. Parametervalues before treatment (T0) and at the 3rd month aftertreatment (T1) were compared with paired samples t  -test orWilcoxon signed-ranks test. Analysis of variance (one wayANOVA test) or Kruskal–Wallis test with Bonferroni cor-rection was used to compare the di V  erences among thegroups. The signi W cance level was set at P <0.05. Results Study participants ranged in age between 24 and 57years,with a mean of 43.7 § 8.4years. Clinical symptoms varied induration from 8 to 45months. CTS was on the right hand in45 patients and on the left hand in 7 cases. Groups were simi-lar regarding demographic variables (Table1). No side e V  ectswere reported in any of the groups at the end of the treatment.At T1 (3rd month after treatment), BSSS scores wereimproved in group I ( P <0.001), group II ( P =0.001), andgroup III ( P <0.001) compared to T0 scores (baseline)(Fig.2). To compare the di V  erences between groups, posthoc tests were completed using Bonferroni correction tocontrol for the conduct of multiple tests. There was a sig-ni W cant di V  erence between treatment groups with respect toBSSS ( F  =4.599; P =0.015). The only statistically signi W -cant di V  erence was between the phonophoresis and controlgroups in favor of phonophoresis ( P =0.012).Hand function and motor skills (grip strength) of groupsI, II and III did not improve at T1 with respect to T0( P >0.05) (Fig.3). There was also no di V  erence betweengroups regarding grip strength at T0 and T1 (  X  2 =2.546; P =0.280).NHPT was applied to determine hand function and dex-terity. The scores obtained at T1 did not di V  er from the T0performances ( P >0.05) (Fig.4). Intergroup performancecomparison regarding NHPT did not reveal any improve-ment at T1 with respect to T0 (  X  2 =0.418; P =0.811). Fig.1 Flow diagram for randomized subject assignment in this study Gro u p II (n=18) Iontophoresis, in conj u nction with wrist splint u se O u tcome data at 3 rd  month Gro u p II patients (n=16) Total n u mber of patients that co u ld have been re g istered (n = 54) Excl u sion: Systemic diseases with increased risk of CTS, Axonal de g eneration of the median nerve, P revio u s steroid therapy or s u r g ical treatment for CTS, Contraindication forsteroid u se. Gro u p I (n=18) P honophoresis, in conj u nction with wrist splint u se Gro u p III (n=18) Control g ro u p, wrist splint u se alone O u tcome data at 3 rd  month Gro u p III patients (n=18) 1 was lost to follow- u p, 1 had diffic u lty inattendin g  theclinic re gu larly O u tcome data at 3 rd  month Gro u p I patients (n=18) Table1 Demographic data of the patientsGroup I (phonophoresis)( n =18)Group II (iontophoresis) ( n =16)Group III (control) ( n =18)Age (year)44.0 § 8.744.1 § 9.543.0 § 6.9Symptom duration (month)21.0 § 8.320.6 § 7.918.5 § 9.0Education (year)7.2 § 1.57.5 § 2.37.2 § 2.2  720Rheumatol Int (2012) 32:717–722  1 3 Discussion In this study, phonophoresis and iontophoresis in conjunc-tion with wrist splint use were compared with resultsobtained with wrist splint use alone in the treatment of CTS. Symptom severity improved in all groups after treat-ment, but no superiority was determined among the treat-ment groups with respect to motor skills and handdexterity.Ultrasound has been widely used in hand therapy to pro-mote recovery after nerve and tendon injuries. Phonophore-sis, which is considered a fast, painless, and non-invasivetreatment option, is often applied with transdermal anti-in X ammatory medications percutaneously into in X amedtissues [11]. Corticosteroid gel, methyl salicylate cream andbetamethasone in ultrasound gel are some commonly useddrugs that have demonstrated delivery rates at above 80%[21]. Phonophoresis using betamethasone showed signi W -cantly good results in the short-term follow-up in chronichemophilic synovitis of the knee. Betamethasone furtherenhances the anti-in X ammatory action and facilitates earlyrestoration of functions [22].Iontophoresis is a method of transdermal introduction of ionized drugs, especially for corticosteroids, into the skinby means of electricity [9]. The procedure is safe, simple,and inexpensive and has an extremely low risk of sidee V  ects and complications if properly performed. It wasexperimentally proven that the drug penetration into tissuefollowing iontophoresis in primates was considerable(more than 1.5cm) and included the joint capsules [23].The depth of penetration for 1MHz US is 2–5cm whilethat of 3MHz US is only 1–2cm [24], so consideration of the depth of the target tissue is important. Transcutaneousapplication of corticosteroids over the carpal tunnel wouldbe a preferable route of medication administration. Thedepth of penetration of medications through the skin greatlydepends on the lipophilicity of the solution [25, 26]. The e Y cacy of topical application of corticosteroids is limited,since they are hydrophilic. The concentration of drugdetected at the skin was 50–200 times greater than at themaximum depth of penetration. Other studies have demon-strated that iontophoresis formed a depot of the medicationat the epidermal and dermal planes [26, 27]. Splinting of the wrist in neutral position for nocturnalwear is the most e V  ective non-aggressive treatment in CTS.It is advised for resolution of clinical symptoms, especiallyfor pain relief [6].Usefulness of iontophoresis with hydrocortisone acetatecombined with ultrasound in patients with CTS was evalu-ated by Dakowicz and Latosiewicz [11]. They reported thatthe use of combined procedures of iontophoresis withhydrocortisone and ultrasound diminished subjective com-plaints (pain, paresthesia) of patients with CTS.Comparison of the e Y cacy of local corticosteroidinjection with iontophoresis of dexamethasone sodiumphosphate in the treatment of CTS with follow-up at2and 8weeks was done by Gokoglu etal. [13]. A sig-ni W cant improvement was found in the clinical examination Fig.2 BSSS before treatment ( T0 ) and 3months after treatment ( T1 ).*  BSSS   Boston Symptom Severity Scale 01020304050T0T1T0T1T0T1Group I (p<0.001)Group II (p=0.001)Group III (p<0.001) Fig.3 Grip strength before treatment ( T0 ) and 3months after treat-ment ( T1 ) 01020304050607080T0T1T0T1T0T1Group I (p>0.05)Group II (p>0.05)Group III (p>0.05) Fig.4 NHPT before treatment ( T0 ) and 3months after treatment ( T1 ).*  NHPT   Nine-Hole Peg Test 01020304050 T0T1T0T1T0T1 Group I (p>0.05)Group II (p>0.05)Group III (p>0.05)  Rheumatol Int (2012) 32:717–722721  1 3 variables, visual analog scale, symptom severity scale,and functional status scale scores of the patients in bothtreatment groups at 2 and 8weeks compared to baseline,but symptom relief was greater with injection of cortico-steroids. In another study, the e Y cacy of local cortico-steroid injection, phonophoresis and iontophoresis inthe treatment of CTS was compared with 2- and 4-monthfollow-up visits. The W ndings showed that steroidinjection was superior to iontophoresis and phonophore-sis in the treatment of CTS and that the most sensitiveneurophysiologic parameters in follow-up were medianand ulnar distal latency to the fourth digit, sensorymedian distal latency to the second digit, and ulnar distallatency to the W fth digit [13]. For short-term treatment of CTS, steroid phonophoresis was applied as a usablemethod to relieve symptoms [28]. Baysal etal. [29] investigated the therapeutic e V  ect of di V  erent combina-tions in the conservative treatment of CTS and sug-gested the combination of splinting, exercise, andultrasound therapy as a preferable and e Y cacious con-servative means of treatment in CTS. In another study,the e Y cacy of splinting and oral steroids in the manage-ment of CTS was compared, and the results demon-strated greater improvement in functional status score inthe steroid group [30].The limitations of this study were the short follow-upand small number of subjects in the groups. However,our study has some methodological superiority with itsprospective, randomized design and the use of well-established validated clinical scores for clinical assess-ment. The other strength was the low dropout rate duringthe follow-up.Based on the results of our study, we observed no addedbene W t or increased motor skills or hand dexterity in thegroups after treatments. Symptomatically, an improvementwas demonstrated from the patient’s perspective. It can eas-ily be said that none of the groups was superior and that thetransdermal steroid treatments are not key determinants of bene W t regarding hand function. Considering these W nd-ings, we recommend the application of wrist splints espe-cially with phonophoresis to provide a better life quality asconcerns the patient’s symptoms and better patient satisfac-tion. Further studies with larger sample size and longerfollow-up may permit more de W nitive conclusions aboutthe relative e V  ectiveness of these treatment modalities,particularly with regard to motor skills and hand function. References 1.Atroshi I, Gummesson C, Johnsson R, Ornstein E, Ranstam J,Rosen I (1999) Prevalence of carpal tunnel syndrome in a generalpopulation. JAMA 282:153–1582.Dawson DM, Hallet M, Millender LH (1990) Carpal tunnel syn-drome. Entrapment neuropathies. In: Dawson DM, Hallet M, Mil-lender LH (eds) Little Brown, Boston. pp25–923.Werner RA, Andary M (2002) Carpal tunnel syndrome: patho-physiology and clinical neurophysiology. Clin Neurophysiol113:1373–13814.Kanaan N, Sawaya RA (2001) Carpal tunnel syndrome: moderndiagnostic and management techniques. Br J Gen Pract 51:311–3145.Scholten RJ, de Krom MC, Bertelsmann FW, Bouter LM (1997)Variation in the treatment of carpal tunnel syndrome. MuscleNerve 20:1334–13356.Hayward AC, Bradley MJ, Burke FD (2002) Primary care referralprotocol for carpal tunnel syndrome. Postgrad Med J 78:149–1527.Mitragotri S, Farrell J, Tang H, Terahara T, Kost J, Langer R(2000) Determination of threshold energy dose for ultrasound-induced transdermal drug transport. JControl Release 63:41–528.Marshall S, Tardif G, Ashworth N (2007) Local corticosteroidinjection for carpal tunnel syndrome. Cochrane Database Syst Rev18:CD0015549.Mitragotri S, Blankschtein D, Langer R (1997) An explanation forthe variation of the sonophoretic transdermal transport enhance-ment from drug to drug. JPharm Sci 86:1190–119210.Costello CT, Jeske AH (1995) Iontophoresis: applications in trans-dermal medication delivery. 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Clinicalelectromyography, nerve conduction studies. In: Oh SJ (ed) Wil-liams and Wilkins, Baltimore, pp496–57517.Sezgin M, Incel NA, Serhan S, Camdeviren H, As I, Erdogan C(2006) Assessment of symptom severity and functional status inpatients with carpal tunnel syndrome: reliability and functionalityof the Turkish version of the Boston questionnaire. Disabil Reha-bil 28:1281–128518.Tredgett MW, Davis TR (2000) Rapid repeat testing of gripstrength for detection of faked hand weakness. JHand Surg25:372–37519.Bechtol CO (1954) Grip test: the use of a dynamometer withadjustable handle spacings. JBone Joint Surg Am 36:820–82420.Mathiowetz V, Weber K, Kashman N, Volland G (1985) Adultnorms for the nine hole peg test of W nger dexterity. Occup Ther JRes 5:24–3821.Cameron MH, Monroe LG (1992) Relative transmission of ultrasoundby media customarily used for phonophoresis. Phys Ther 72:142–14822.Saraf SK, Singh OP (2005) Management of chronic hemophilicsynovitis in children by phonophoresis. 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