No immediate changes on neural and muscular mechanosensitivity after first rib manipulation in subjects with cervical whiplash: A randomized controlled trial

1 Ti le: No immedia e changes on neu al and muscula mechanosensi i i y a e i s ib manipula ion in subjec s wi h ce ical whiplash: A andomized con olled ial Sho Ti le: Rib manipula ion in ce ical whiplash Au ho s: Ma a Peña-Salinasa, Jesús Oli a-Pascual-Vacaa,b, Albe o Ma cos He edia-Rizoa, Cleo ás Rod iguez-Blancoa, F ançois Rica dc, Ángel Oli a- Pascual-Vacaa,* a Depa men o Physical The apy, Facul y o Nu sing, Physio he apy and Podia y, Uni e si y o Se illa, Se illa, Spain. b Depa men o Physical The apy, Uni e si a y School o Osuna, Se illa, Spain. c Mad id Os eopa hic School, Mad id, Spain. *Co esponding Au ho : Ángel Oli a-Pascual-Vaca. C/ A icena s/n, 41009 Se illa, Spain. E-mail: [email p o ec ed] Tel: +34 954482168 Fax: +34 954486528 2 Abs ac BACKGROUND: Uppe ib manipula i e he apy appea s o be e ec i e on p ima y complain o shoulde pain, bu i s e icacy has no been e alua ed in subjec s wi h whiplash-associa ed diso de s. OBJECTIVE: To assess he immedia e changes on neu al and muscula mechanosensi i i y a e i s - ib manipula ion in pa ien s wi h neck o ce icob achial pain seconda y o ce ical whiplash (CW). METHODS: A single-blind (e alua o s we e blinded o subjec alloca ion) andomized ial was conduc ed. Fi y- h ee (N=53) subjec s, 34.7 (SD 10.8 yea s; 56.6% emales), wi h ce ical o ce icob achial pain ollowing CW, we e dis ibu ed in o wo g oups. The expe imen al g oup (n=27) unde wen a single i s - ib high- eloci y low-ampli ude manipula ion echnique, while he con ol g oup (n=26) ecei ed a sham placebo in e en ion. Ou come measu es we e aken a baseline and immedia ely a e in e en ion, o he p essu e pain h eshold o e he igeminal, median and ulna ne es, and o e he a ea desc ibed o he loca ion o ense bands in he uppe apezius, masse e , biceps b achii and iceps b achii muscles. RESULTS: No signi ican di e ences in mechanosensi i i y alues we e obse ed a e in e en ion in he be ween-g oups compa ison (p>0.05). CONCLUSION: The use o a sole i s - ib h us echnique has no immedia e e ec on neu al o muscula mechanosensi i i y, when compa ed o placebo, in subjec s wi h ce ical o ce icob achial pain a e CW. 3 Keywo ds. B achial plexus, Manual he apy, Pain h eshold, Ribs, Whiplash inju ies 4 1. In oduc ion Ce ical whiplash (CW) is he mos common auma ollowing mo o ehicle collisions, being a se ious p oblem o i s le el o incidence, he long-las ing symp oms, and he economic bu den in ol ed [1]. E en hough mos o whiplash pa ien s eco e wi hin 3 mon hs o he acciden , li le imp o emen is expec ed a e ha [2]. Pe sis en neck pain is he p edominan symp om wi hin ch onic whiplash- associa ed diso de s (WAD), and usually adia es o he head, shoulde gi dle, and uppe limb a eas [3], wi h 60% o pa ien s epo ing ce icob achial pain in he ch onic s age [4]. The p e alence and incidence o empo omandibula diso de s has also been ound o inc ease a e whiplash auma [5]. Headache is p esen in 50% o 70% o indi iduals in he acu e CW phase [6], and ch onic headache a ibu ed o whiplash inju y anges om 8% [7] o 30% o cases [6]. Among he possible unde lying mechanisms o explain ch onic WAD, cen al sensi iza ion (an inc eased sensi i i y o he ne ous sys em) [8], and widesp ead hype sensi i i y [9], a e widely accep ed. Reduced pain h esholds a he head, neck, ho acic spine and uppe and lowe limbs [10], along wi h changes in neu al mechanosensi i i y pa e ns [11], a e measu es o al e ed cen al pain p ocessing in ch onic WAD. Cu en e idence sugges s a po en ial e ec o spinal manipula i e he apy (SMT) on neu omuscula exci abili y [12], and pain cen al mechanisms [13]. The use o spinal manipula ion has been pu po ed o imp o e sel -pe cei ed pain and p essu e pain sensi i i y in ch onic mechanical neck pain [14,15]. The e seems o be, howe e , no clea e idence o suppo any in e en ion o WAD [16], 5 al hough conse a i e app oaches (including manual he apy) seem o dec ease pain and imp o e unc ionali y in he acu e s age [16]. SMT may help o accele a e he eco e y p ocess [17], and i has shown o elie head, neck and uppe ho acic pain in subjec s wi h WAD [18]. The use o uppe ib and spinal h us manipula ion, ei he alone [19], o in combina ion wi h usual medical ca e [20], is e ec i e on pa ien s wi h p ima y complain o shoulde pain. In ch onic WAD, a sus ained scalene muscles spasm may pull he i s ib up [11], which could a ec he b achial plexus. No p e ious s udy has e alua ed he possible impac o uppe ib h us manipula ion in subjec s wi h WAD. The e o e, he main aim o he ial was o obse e he immedia e changes on neu al and muscula mechanosensi i i y a e a high- eloci y low-ampli ude i s - ib h us manipula ion, when compa ed o placebo, in indi iduals su e ing om ce ical o ce icob achial pain seconda y o CW. 2. Me hods 2.1 S udy Design A con olled, single-blinded (subjec alloca ion o he s udy g oups was blinded o he e alua o s) andomized ial was ca ied ou . The s udy has been conduc ed in ag eemen wi h he CONSORT s a emen . 2.2 Pa icipan s and Eligibili y C i e ia Pa icipan s we e ec ui ed om a p i a e medical cen e. Six y- ou consecu i e pa ien s, who we e diagnosed as su e ing om ce ical o ce icob achial pain ollowing CW auma a e a mo o ehicle collision, we e 6 selec ed. Ele en pa icipan s we e excluded o se e al easons. The inal sample comp ised a o al o 53 pa icipan s (30 women and 23 men), mean age 34.7 yea s (s anda d de ia ion [SD] 10.8), who we e andomly dis ibu ed in o an expe imen al g oup (EG) (n=27) o a con ol g oup (CG) (n=26). No loss o ollow- up was eco ded du ing he s udy ( igu e 1). When he subjec ag eed o pa icipa e, physical and clinical baseline da a we e collec ed. All indi iduals also comple ed he Spanish e sion o he No hwick Pa k Neck Pain Ques ionnai e (NPQ) [21]. The NPQ includes 9 i ems sco ed om 0 (no pain o disabili y) o 4 ( he highes pain o disabili y). Responses a e summed and hen di ided by 36 o 32, i he ques ion ela ed o d i ing is no answe ed, o ge a pe cen age sco e. The ou come measu es (p essu e pain h eshold alues) we e collec ed a baseline and immedia ely a e in e en ion. The inclusion c i e ia we e: a) age be ween 18-50 yea s; b) subjec s wi h neck and/o ce icob achial pain ollowing CW in he 3 mon hs be o e da a collec ion (no minimum in ensi y o pain was equi ed); c) a g ade II CW acco ding o he Quebec Task Fo ce Classi ica ion [22]; and d) a posi i e esponse o he ce ical o a ion la e al lexion es [23]. The es ablished exclusion c i e ia we e: a) his o y o heuma ic, umo o degene a i e diseases; b) he p esence o 2 o mo e posi i e neu ologic signs consis en wi h neu al pain associa ed o disc p o usion o he nia ion a he lowe ce ical spine (muscle weakness, al e ed uppe ex emi y deep endon e lex, and diminished sensa ion o pinp ick in he uppe limb); c) p e ious su ge y in he neck o uppe limb egions; d) use o analgesic and/o an iin lamma o y 7 medica ion in he 48 hou s p io o da a collec ion; e) ha ing unde gone manual ea men in he neck o uppe limb in he eigh weeks be o e he s udy; ) neck pain wi hin h ee mon hs be o e CW; g) any con aindica ion o i s ib manipula ion; and h) an e idence o cen al ne ous sys em in ol emen (e.g., p esence o pa hologic e lexes). All pa icipan s ga e e bal and w i en consen o pa icipa e and he p ocedu es we e conduc ed acco ding o he Wo ld Medical Associa ion Decla a ion o Helsinki. E hical clea ance was ob ained om he Ins i u ional Re iew Boa d. 2.3 Randomiza ion A se o andomized numbe s gene a ed by an ex e nal online websi e (www. andomize .o g) was used as he andom sequence, and was sa egua ded by an assis an no in ol ed in he s udy. Numbe ed balls concealing he ea men alloca ion we e p epa ed inside an opaque bag, and pa icipan s we e asked o pick a ball. 2.4 Sample Size The so wa e ENE 2.0 (GlaxoSmi hKline, London, UK and Uni e sidad Au ónoma de Ba celona, Spain) was used o es ima e he sample size. Based on p e ious esea ch [24], he ollowing pa ame e s we e aking in o accoun : a) a wo- ailed es ; b) an α le el o 0.05; c) a s a is ical powe o 80%; d) a mean sco e di e ence a e in e en ion in he ou come measu e (p essu e pain h eshold) o 0.5 kg/cm2; and e) a SD o 0.5 kg/cm2 a pos in e en ion da a. Fo an alloca ion 8 a io o 1:1 be ween g oups, a leas 26 pa icipan s pe g oup we e necessa y o comple e he ial. 2.5 Ou come measu es The p essu e pain h eshold (PPT), de ined as he minimal amoun o p essu e necessa y o e oke pain o discom o [25], was e alua ed in se e al neu al and muscula si es. Pain h esholds ha e been widely used when assessing subjec s wi h WAD in o de o de ec signs o local and cen al hype exci abili y [10]. A digi al algome e (FDX 25, Wa ne Ins umen s, G eenwich, CT, USA), wi h a 1cm2 con ac a ea, was used wi h an inc easing p essu e o 1kg/cm²/s. The mean o h ee no consecu i e measu emen s, wi h a 30-second es ing in e al, was chosen as he e e ence alue. P essu e algome y is a alid and eliable ool o assess pain p ocessing [26], and has shown a high in e -examine eliabili y [27]. The assessmen loca ions we e: a) he h ee eme ging b anches o he igeminal ne e: sup ao bi al, in ao bi al, and men al ne es [28]; b) he median ne e, a he elbow si e, medial o he endon o he biceps b achii, and he ulna ne e, loca ed be ween he medial epicondyle and he olec anon [9]; and d) he a ea desc ibed o loca e ense bands o e he uppe apezius, biceps b achii (o e he midpoin o he muscle leng h), iceps b achii (loca ed deep in he long head o he muscle, in he medial side o he muscle belly), and masse e (close o he mandibula angle) muscles [29]. 2.6 In e en ions 9 The in e en ion echnique was ca ied ou in bo h g oups by he same physio he apis , wi h o e 10 yea s o clinical expe ience. Subjec s in he EG unde wen a i s - ib h us echnique a he side whe e he ce ical o a ion la e al lexion es was posi i e, o a he mos pain ul side in case he es was posi i e in bo h sides. The echnique was pe o med as ollows [30] ( igu e 2). The subjec was in sea ed posi ion while he he apis s ood behind. One o he he apis ’s hands con ac ed he ib’s body wi h he me aca pophalangeal join o he index inge , while he humb lied o e he sup aspina us ossa, and he es o he inge s we e o e he cla icle. The o he he apis ´s hand was holding he pa ien ’s head, and exe ed ipsila e al ce ical side bending owa ds he i s ib, and con ala e al head o a ion. Then, an in e omedial p essu e was applied o he i s ib un il he end- eel, and his was ollowed by he h us manipula ion. In he CG, a sham-placebo echnique was used. Pa icipan s we e placed in he same posi ion and ollowing he same pa ame e s han in he EG, bu no so - issue ension o a icula h us we e pe o med. The placebo in e en ion was also ca ied ou a he side whe e he ce ical o a ion la e al lexion es was posi i e, o a he mos pain ul side. 2.7 S a is ical Analysis The s a is ical package PASW Ad anced S a is ics 18.0 (SPSS Inc., Chicago, IL, USA) was used o p ocessing he da a. The s a is ical analysis conside ed as signi ican a p- alue < 0.05. 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PLoS One 2015; 10: e0132191. 20 21 Table 1 Baseline clinical and physical cha ac e is ics o he s udy sample Values a e he mean (s anda d de ia ion) unless o days since whiplash inju y, whe e da a a e epo ed in pe cen iles 25, 50 and 75. * P alue, s a is ical signi icance o he be ween-g oup di e ences Table 2 Baseline, inal sco es, and wi hin-g oups di e ences o he ou come measu es To al Sample (N=53) Expe imen al G oup (n=27) Con ol G oup (n=26) P Value * Age (yea s) 34.70 (10.8) 32.11 (9.1) 37.38 (11.9) 0.07 Sex (n,%) Female Male 30 (56.6) 23 (43.4) 16 (59.3) 11 (40.7) 14 (53.8) 12 (46.2) 0.33 Weigh (kg) 73.13 (15.9) 69.37 (14.2) 77.04 (17.0) 0.08 Heigh (m) 1.67 (0.08) 1.66 (0.07) 1.67 (0.09) 0.67 Body Mass Index (kg/cm2) 26.54 (5.1) 27.25 (4.9) 25.56 (5.2) 0.19 Days since whiplash inju y (P25, P50, P75) (13.5, 20, 30) (11, 17, 33) (15, 20, 25.75) 0.43 No hwick Pa k Neck Pain Ques ionnai e 17.17 (6.7) 15.63 (7.4) 18.77 (5.5) 0.08 Pain ul side (n,%) Righ Le 27 (50.9) 26 (49.1) 15 (55.6) 12 (44.4) 12 (46.2) 14 (53.8) 0.89 22 Baseline Pos In e en ion Sco e changes (p e – pos in e en ) P alue PPT sup ao bi al Con ol g oup Expe imen al g oup 1.33 (0.3) 1.39 (0.4) 1.30 (0.3) 1.41 (0.4) 0.02 [-0.05 / 0.10] -0.01 [-0.11 / 0.08] 0.50 0.71 PPT in ao bi al Con ol g oup Expe imen al g oup 1.69 (0.4) 1.79 (0.4) 1.66 (0.4) 1.86 (0.5) 0.03 [-0.06 / 0.12] -0.07 [-0.22 / 0.08] 0.50 0.35 PPT men al ne e Con ol g oup Expe imen al g oup 1.53 (0.4) 1.57 (0.4) 1.53 (0.3) 1.74 (0.6) -0.00 [-0.08 / 0.07] -0.16 [-0.33 / 0.01] 0.93 0.05 PPT median ne e Con ol g oup Expe imen al g oup 2.70 (0.7) 2.75 (0.8) 2.51 (0.7) 2.75 (0.8) 0.18 [-0.00 / 0.37] -0.00 [-0.26 / 0.25] 0.05 0.96 PPT ulna ne e Con ol g oup Expe imen al g oup 3.12 (1.0) 3.30 (1.0) 2.97 (0.9) 3.03 (1.0) 0.14 [-0.06 / 0.36] 0.26 [-0.11 / 0.64] 0.17 0.16 PPT uppe apezius Con ol g oup Expe imen al g oup 1.78 (0.5) 1.83 (0.6) 1.74 (0.5) 1.94 (0.6) 0.04 [-0.09 / 0.77] -0.11 [-0.24 / 0.01] 0.54 0.08 23 Da a a e epo ed as mean (s anda d de ia ion), o mean [95% Con idence In e al] Abb e ia ions: PPT, p essu e pain h eshold (kg/cm2); P, s a is ical signi icance o he wi hin-g oups compa ison. PPT masse e Con ol g oup Expe imen al g oup 1.78 (0.4) 1.84 (0.4) 1.84 (0.4) 1.80 (0.5) -0.06 [-0.17 / 0.05] 0.03 [-0.12 / 0.19] 0.29 0.64 PPT biceps b achii Con ol g oup Expe imen al g oup 1.95 (0.5) 1.91 (0.5) 1.93 (0.5) 1.93 (0.5) 0.02 [-0.14 / 0.18] -0.01 [-0.17 / 0.14] 0.79 0.86 PPT iceps b achii Con ol g oup Expe imen al g oup 2.86 (0.8) 3.10 (1.1) 2.85 (0.9) 3.00 (1.0) 0.01 [-0.19 / 0.21] 0.09 [-0.17 / 0.37] 0.93 0.46 24 Table 3 Analysis o he be ween-g oups di e ences in he ou come measu es Da a a e epo ed as mean [95% Con idence In e al] Abb e ia ions: PPT, p essu e pain h eshold (kg/cm2) Ou come Measu e Mean be ween-g oups sco e changes P alue PPT sup ao bi al ne e 0.04 [0.16 / -0.08] 0.49 PPT in ao bi al ne e 0.10 [0.27 / -0.07] 0.25 PPT men al ne e 0.16 [0.35 / -0.02] 0.08 PPT median ne e 0.18 [0.50 / -0.12] 0.22 PPT ulna ne e -0.11 [0.31 / -0.54] 0.59 PPT uppe apezius 0.15 [0.34 / -0.02] 0.09 PPT masse e -0.09 [0.09 / -0.28] 0.32 PPT biceps b achii 0.03 [0.26 / -0.19] 0.75 PPT iceps b achii -0.09 [0.24 / -0.42] 0.58 25 Figu e 1. Flow diag am o he sample