만성요통및하지방사통환자에서감압치료 (KNX 7000 ) 와견인치료의단기치료효과 박소현, 김철승, 이동규, 안상호 The Journal of Korean Society of Physical Therapy 박소현, 김철승, 이동규 1, 안상호 1,2 영남대학교병원의료기기임상시험센터, 1 영남대학교의과대학재활의학교실, 2 영남대학교의료공학연구소 The Short Term Effects of the Decompression (KNX 7000 ) and Traction Device on Pain in Patients with Chronic Low Back Pain with or without Radicular Pain So Hyun Park, PT. PhD; Chul Seoung Kim, PhD; Dong Gyu Lee, MD 1 ; Sang Ho Ahn, MD, PhD 1 Medical Devices Clinical Trial Center of Yeungnam University Hospital; 1 Department of Physical Medicine and Rehabilitation, College of Medicine, Yeungnam University; 1 Department of Physical Medicine and Rehabilitation, College of Medicine, Yeungnam University; 2 Institute of Biomedical Engineering Yeungnam University Purpose: The purpose of this study is to evaluate the short term effects of the traction and decompression device, which is a newly developed domestic medical device, on pain and functional activity in patients with chronic low back pain with or without radicular pain. Methods: Forty patients with chronic low back pain were included and allocated to decompression (n=20) and traction groups (n=20). They received decompression or traction therapy for 20 minutes a day, 3 days per week for two weeks. For evaluating pain and functional activity, a visual analogue scale (VAS) for low back pain and the Oswestry back pain disability index (ODI) were obtained on pre treatment, and at 6, 12 and 15 days after treatment. Patients satisfaction levels were measured 15 days after treatment. Results: VAS was significantly decreased at 12 days and 15 days post treatment compared to pre treatment in both groups (p<0.05). ODI was significantly decreased at 12 days and 15 days post treatment compared to pre treatment in the decompression group (p<0.05). However, there was no significant difference between the two groups in the VAS and ODI scales (p>0.05). Patients satisfaction levels were significantly higher in the decompression group than in the traction group (p<0.05) Conclusion: These findings suggest that decompression therapy might be effective for increasing functional activity in patients with low back pain and could provide patients with higher satisfaction than traction therapy. This study provided validity data for the therapeutic effects of the decompression device in patients with low back pain and it will be useful for medical cost development and patient education of this device. Keywords: Low back pain, Decompression, Traction, Clinical trial 논문접수일 : 2011년 5월 24일수정접수일 : 2011년 7월 23일게재승인일 : 2011년 8월 2일교신저자 : 안상호, spineahn@ynu.ac.kr I. 서론 요통은현대사회의좌식생활과더불어가장흔히발병하는만성질환으로전인구의 20~30% 가추간판인한요통을경험하 였으며, 연령이증가할수록발병도가높으며빈번한재발로인해지속적관리가필요하다. 1 이에대한의료비용지출, 노동력상실이증가하면서요통에대한관심이증가되고있다. 2 요통을발생시키는원인으로추간판장애가가장흔하다. 만성요통및하지방사통환자에서감압치료 (KNX 7000 ) 와견인치료의단기치료효과 29
J Kor Soc Phys Ther 2011;23(5):29-34 추간판장애로인한통증은크게두가지양상으로나타나며척추와주위조직에분포하는동통신경을자극하여발생하는요통과신경근을압박하여나타나는하지방사통으로분류된다. 3 추간판장애로기인하는통증에대한일반적인치료법으로수술적치료와보존적치료가있다. 수술적치료는침습적이며수술로인한역학적변화를야기시킬수있어비수술적치료의효과가없는경우에실시하도록권장되고있으며대부분은비수술적치료인휴식, 약물및주사치료, 전기치료, 운동치료, 견인치료등을실시하게된다. 3-6 이중견인치료는추간공의공간을확보하고, 추간판탈출을완화시키며, 내압을감소시켜신경자극을경감시킬수있어통증완화에효과가있으며임상에서널리시행되고있는치료방법이다. 7,8 현재까지대부분의기계를이용한견인치료는흉곽과골반을당김으로써요추분절전체적인견인을유도하고있어견인이필요한분절에서만의치료가불가능하다. 9,10 이와관련된문제점으로원인이되는부위에대한견인을유도하기위하여강도높은견인을실시함으로써통증의원인이되는분절이외의약화된연부조직의손상, 인접한불안정성분절의견인, 이차적반사성근경축등이발생하며이는추간판내감압유도에효과적이지못하며통증을악화시킬수있다. 9-11 반면수기에의한견인은원인이되는요추분절만을치료할수있는반면장시간지속적인견인을수행하기어려운단점이있다. 10,12 최근이에대한단점을보완하기위해견인하는분절을선택하여요추분절신전을유도함으로써특정부위에서견인을유도하는감압치료가시행되고있다. 7,13-16 감압치료는기계를이용하여지속적으로추간판의압력을감소시키고, 추간판내공간을넓혀줌으로써추간판의높이를복구할수있으며, 16 작은견인력으로선택부위를지정하여효과적인감압유도가가능하여이차적근긴장을발생시키지않는다. 8,14 외래환자의비수술적감압치료의통증완화효과에대해제시한연구는있지만후향적인연구였고, 15 추간판높이증가에대해몇몇문헌에서제시하고있지만이러한연구들은단일군집단에서시행된연구였으며, 7,16 견인치료와감압치료의비교연구에서는요통환자의기능평가가제시되지않았으므로, 14 감압치료가기존의견인치료와비교해서추간판으로인한요통환자의통증및기능에미치는영향에대한전향적이고체계적인연구는부족하다. 따라서본연구에서는하지방사통을포함하는만성요통환자를대상으로단기간의감압치료와기존의견인치료가요통과요통으로인한신체적기능지수에미치는영향에대해체계적이고, 통제된임상시험을통해알아보고자한다. II. 연구방법 1. 연구설계및대상 본연구는 2009년 9월 24일에서 2010년 6월 24일까지 대학병원에요통을주소로내원한환자약 200명중병력, 이학적검사, 자기공명영상검사를통해선별된 40명의대상자에게전향적, 무작위배정, 단일맹검임상시험을실시하였다. 대상자는무작위배정을통해감압치료를받는감압치료군과견인치료를받는견인치료군으로구분하여각집단에 20명씩배정되었다. 피험자수를산출하기위해 NCSS 2007프로그램 (NCSS, 미국 ) 을사용하였다. 일차유효성평가지수를요통에대한시각상사척도 (Visual Analogue Scale, VAS) 로선정하였고, 치료전과치료후의시각상사척도의차이가 2, 표준편차를보수적으로 3으로가정하고, 유의수준 0.05, 검정력 80%, 탈락률 10% 를고려하여군당피험자수를 20명으로산출하였다. 대상자의선별기준은 1) 18세에서 70세사이의요통또는하지방사통을주소로한성인남녀, 2) 진찰과자기공명영상을통해요천추추간판탈출증으로진단된자, 3) 오스웨스트리장애설문지 (Oswestry back pain disability index, ODI) 의점수가 20% 이상인자, 4) 6개월동안통증이지속된자로하였다. 대상자의제외기준은 1) 최근 6개월동안척추, 고관절, 골반에수술을받은자, 2) 척추분절성불안정으로진단된자, 3) 척추분리증, 척추전방전위증으로진단된자, 4) 염증성척추질환, Figure 1. Study design. The diagram shows the flow of patients treated with decompression or traction. The patients were selected according to medical history, physical examination and MRI. Total 33 patients were analyzed. 30 The Short Term Effects of the Decompression (KNX 7000 ) and Traction Device on Pain in Patients with Chronic Low Back Pain with or without Radicular Pain
박소현, 김철승, 이동규, 안상호 5) 척추측만증, 6) 퇴행성척추후만증, 7) 최근 2주내척추중재시술을받은자, 8) 척수나척수의종양이있는자, 9) 임산부로하였다. 참여대상자의무작위배정을위해 Excel 2007 (Microsoftware, 미국 ) 을사용한무작위코드를 40개생성하였고, 연구와관련이없는간호사가연구대상자의등록순으로무작위번호를부여하는방식을사용하여감압치료군과견인치료군으로배정하였다. 무작위배정후총 40명의대상자중감압치료군 3명, 견인치료군 4명이중도탈락하였다. 감압치료군 2명, 견인치료군 4명의참여철회의원인은치료효과에대한불만이었으며, 감압치료군 1명이정신과적질환으로중도탈락하였다 (Figure 1). 본임상시험은영남대학교병원임상연구윤리위원회 (IRB) 의승인받았으며모든대상자는연구의목적과방법에대하여충분한설명을듣고이에자발적동의를한후에연구에참여하였다. 2. 치료중재모든대상자에게처음방문일을기점으로하루 20분, 이틀에한번, 2주간에걸쳐총 6회의치료중재를실시하였다. 치료중재를위해감압치료군에게는감압치료기 (KNX-7000, Hanmed, 한국 ) 를적용하였다. 앙와위자세에서발목을고정시키고, 다리길이를편안한상태로맞춘후담당의및물리치료사의검진후치료가필요한부위와매트의롤러위치를맞추었다. 프로그램을시행하게되면매트가체중의 30% 의신연력으로견인할수있도록매트의경사도를선택하였고, 롤러가작동하게되면요추의신전을유도하여선택부위의감압치료가시행된다. 감압치료기의스트레칭을위한고관절신전과외측굴곡기능은사용하지않았다. 견인치료군에는일반적으로물리치료실에서사용하는견인치료기 (OZ Orthotrac OL140, Ozi-Giken Co. Ltd, 일본 ) 를적용하였고앙와위에서무릎을 70 굴곡한상태로수행하였다. 견인치료는유지시간 (hold time) 과휴지시간 (rest time) 의비율은 60:30초로설정하였고휴지시간에사용되는견인력은유지시간에사용되는견인력의 1/2로설정하였다. 두군에적용되는신연력은체중의 30% 로동일하게제공되었다. 3. 측정도구치료효과를판별하기위해치료전, 치료시작 6일후, 12일후, 15일후시각상사척도및오스웨스트리장애설문지를조사하였다. 또한치료시작 15일후만족도조사를실시하였다. 시각상사척도는한쪽끝을 아프지않다, 다른한쪽끝은 상상할수있는가장아픈통증 으로표시되어있는 100 mm 자를이용하여환자가직접표시하도록하였다. 오스웨스트리장애설문지는요통으로인한신체적기능의 장애를측정하는평가도구로, 총 9개항목으로구성되고, 각항목당 0~5 점을부여하여항목별점수를합하여총점으로나눈후백분율로표시하였다. 17 치료에대한만족도를조사하기위해만족 (4점), 대체로만족 (3점), 대체로불만족 (2점), 불만족 (1점) 인 4가지로척도로나눈설문지를사용하였고, 두군간의차이를비교하였다. 18 만족 (excellent) 은본인이기대한정도로치료결과에만족한다는수준, 대체로만족 (good) 은본인이기대하는정도까지는아니지만다시통증이있다면이치료를받겠다는수준, 대체로불만족 (fair) 은효과가없었던것은아니지만다시통증이있다면이치료를택하지않겠다는수준, 불만족 (poor) 은이전의치료의효과와같거나더나쁘다는수준으로조사하였다. 4. 자료분석각집단의치료전의평가변수에대해독립 t-검정과카이제곱검정을통해집단간차이가있는지확인을하였다. 분석은중도탈락한피험자의결과는분석에서제외하는 per-protocol 따라시행하였다. 시각상사척도, 오스웨스트리장애설문의집단내, 집단간차이를분석하기위해이원반복측정분산분석을사용하였다. 각집단내에서측정일간의차이를검정하기위해일원반복측정분산분석을사용하였다. 이원반복측정분산분석의집단간차이를분석을위해사후검정으로 LSD 검증법을실시하였으며, 일원반복측정분산분석의집단내차이검정을위해다중비교를실시하였다. 만족도조사는정규성검정을만족하지못하여비모수검정인 Wilcoxon rank sum test를사용하였다. 모든분석은유의확률 0.05미만에서수행되며, 프로그램은 SPSS 12.0. for windows를사용하였다. III. 결과 1. 연구대상자의동질성검정본연구에참여한대상자의일반적인특징은 Table 1과같다. 총 33명의피험자의평균연령은감압치료군이 45세, 견인치료군이 51세였으며두집단간유의한차이는나타나지않았다 (p>0.05)(table 1). 2. 집단간, 집단내통증변화감압치료군과견인치료군에서모두시각상사척도의시점에따른유의한차이가나타났지만 (p<0.05), 집단간차이및교호작용은유의하게나타나지않았다 (p>0.05)(table 2). 만성요통및하지방사통환자에서감압치료 (KNX 7000 ) 와견인치료의단기치료효과 31
J Kor Soc Phys Ther 2011;23(5):29-34 Table 1. Homogeneity test between decompression and traction groups Decompression group Traction group Mean (SD) Mean (SD) t or χ2-value Age 45.4 (11.1) 51.9 (7.5) -1.94* 0.06 Weight 61.7 (11.4) 61.4 (12.7) 0.07* 0.94 Height 164.2 (8.2) 160.5 (8.0) 1.31* 0.20 Male/Female 5/12 5/11 0.06 0.81 All data reported as mean(standard deviation) The asterisk(*) indicates the results of independent t-test The cross( ) indicates the results of chi-square test p-value Table 2. Comparison of visual analogue pain scale (VAS) between decompression and traction groups VAS Decompression group Traction group Mean (SE) Mean (SE) f-value p-value (1) pre 4.39 (0.29) 4.50 (0.35) factor 6.01 0.00 (2) 6 day 4.02 (0.19) 4.13 (0.38) group 0.04 0.84 (3) 12 day 3.61 (0.28) 3.80 (0.41) factor Xgroup 0.21 0.88 (4) 15 day 3.78 (0.31) 3.67 (0.37) f-value 2.89 3.40 p-value 0.04* 0.04* Multivariate Test (1)-(3) (1)-(3)/ (1)-(4) Post hoc (1)-(3) All data reported as mean (standard error) The asterisk(*) indicates the results of repeated measure of one factor analysis and significance at the p<0.05 level The cross( ) indicates the results of repeated measure of two factor analysis and significance at the p<0.05 level pre: pre-treatment 6, 12, 15 day: 6, 12, 15 day after treatment 3. 집단간, 집단내요통으로인한신체기능의장애지수의변화 감압치료군에서오스웨스트리장애설문점수의시점에따른유의 한차이가나타났지만 (p<0.05), 견인치료군에서는유의하게나타나지않았고 (p>0.05), 감압치료군과견인치료군의집단간차이및교호작용은유의하게나타나지않았다 (p>0.05)(table 3). Table 3. Comparison of Oswestry back pain disability index (ODI) between decompression and traction groups ODI Decompression group Traction group Mean (SE) Mean (SE) (1) pre 34.77 (2.73) 33.767 (2.82) factor 12.17 0.00* (2) 6 day 32.73 (2.57) 30.407 (3.22) group 0.00 1.00 (3) 12 day 25.71 (2.20) 29.013 (3.35) factor Xgroup 1.72 0.19 (4) 15 day 28.10 (2.64) 28.173 (3.44) f-value 13.04 2.85 p-value 0.00* 0.07 Multivariate Test (1)-(3)/(1)-(4)/(2)-(3)/(3)-(4) Post hoc (1)-(2)/(1)-(3)/(1)-(4) All data reported as mean (standard error) The asterisk (*) indicates the results of repeated measure of one factor analysis and significance at the p<0.05 level The cross ( ) indicates the results of repeated measure of two factor analysis and significance at the p<0.05 level pre: pre-treatment 6, 12, 15 day: 6, 12, 15 day after treatment f-value p-value 32 The Short Term Effects of the Decompression (KNX 7000 ) and Traction Device on Pain in Patients with Chronic Low Back Pain with or without Radicular Pain
박소현, 김철승, 이동규, 안상호 4. 집단간만족도비교 집단간만족도를비교한결과감압치료군에서평균 2.94, 견인치료군에서평균 2.29으로감압치료군의치료에대한만족도가유의하게높은결과를나타내었다 (p<0.05)(table 4). Table 4. Comparison of patients satisfaction between decompression and traction groups Patient Satisfaction Mean SD Decompression group 2.94 0.77 Traction group 2.29 0.61 W-value(P-value) 167.50 (0.03*) All data reported as mean (standard deviation). The asterisk(*) indicates the results of wilcoxon rank sum test and significance at the p<0.05 level. IV. 고찰 본연구는만성요통환자에게감압치료와일반적인견인치료를무작위배정, 단일맹검의통제된연구방법을통해실시하였고, 그결과두치료가모두통증에효과적이지만단기간기능향상을위해서는감압치료가효과적이고, 환자만족도역시감압치료가우수함을알수있었다. 본연구에서통증은두집단에서모두치료전과비교해서치료시작 12일후에감소되었고, 신체기능은감압치료시작 12일후에유의하게향상되어단기간기능향상을위해서감압치료가효과적임을알수있었다. 본연구에서사용된감압치료기는침대기울기에따른견인과롤러를이용한선택부위요추신전을이용한감압을포함한다. Fritz 등 19 은치료초기에견인치료와신전을동시에유도하는것이견인치료만실시하는것보다효과적이라제시하였고, Park과 Kim 14 은추간판탈출환자에게감압치료와견인치료를실시하여통증과추간판탈출, 하지직거상검사를실시한결과감압치료시통증이감소함에따른추간판탈출과하지직거상이개선되고, 견인치료시에는통증이감소되었지만유의한차이가나타나지않음을보고하여견인치료보다감압치료가효과적임을제시하였다. 또다른연구에서도추간판성 94명의요추아급성기, 만성기환자의감압치료에대한후향적연구에서통증척도가유의하게감소됨을보고하여요통환자에게감압치료가통증과기능에효과적임을제시하였다. 15 감압치료기로 100 파운드까지견인력을주었을때추간판내압이점차적으로감소되고, 8 감압치료에의해통증이감소할수록추간판높이가증가된다는연구로유추해볼때, 16 감압치료는선택부위에효과적인감압작용을통해추간판의스트레스감소, 추간판공간확보 로신경자극을완화시키고, 영양공급을통해통증을감소시킬것이라생각한다. 11,16 본연구에서주목할점은시각상사척도결과는두군에서비슷한경향을나타내었지만오스웨스트리척도에서는감압치료군에서만유의한차이를나타낸점이다. Devine et al 20 은일반적으로요통평가를위해시각상사척도와오스웨스트리척도를많이활용하고있지만두가지척도는강한상관성을가지지않으므로통증과기능평가를위해두가지척도를분리해서사용하기를권장하였다. 또한오스웨스트리척도는비수술적치료시점수의변화폭이작고, 21 수술에대한오스웨스트리척도의최소임상적의미변화 (Minimal Clinically Important Change, MCIC) 가질환이나시술에따라 10~20점이라제시하였다. 22-232 이를감안한다면보존적인치료방법인감압치료시치료전과치료 12주후에오스웨스트리점수차이가약 9점이라는것은기능향상을위해감압치료가우수하며오스웨스트리척도가시각상사척도보다민감한척도임을제시한다. 본연구에서치료를종료한 3일후에조사한환자의만족도측면에서는감압치료가견인치료보다유의하게높았고, 자발적중도탈락역시감압치료시 2명, 견인치료시 4명으로감압치료의만족도가상대적으로높음을알수있었다. 견인치료의만족도가 2.29으로대체로불만족에가까운반면, 감압치료의만족도가 2.94로대체로만족한다는수준즉, 본인이기대하는정도까지는아니지만다시통증이있다면이치료를받겠다는수준의만족도를표시하였다. 본연구에서추간판탈출로인하여 6개월이상의만성요통을겪고있는환자를대상으로한임상시험인것을감안하면감압치료의만족도는비교적높다고볼수있다. 본연구에서는요통에영향을미치는근긴장도의변화, 추간판높이, 요추내압과같은정량적분석을실시하지못하여감압치료에대한명확한기전을밝히지못하였고, 만족도조사의항목이다양하지않아객관성이부족하였다. 최근다양한형태의감압치료와견인치료가임상에서널리적용되고있으나치료여건상약물이나운동효과를배제한단일화된보존적치료효과에대한과학적근거를제시하기어렵다. 본연구는선택부위의신전을유도하는새로운형태의국산감압치료기에대한체계적이고통제된임상시험을통해추간판탈출증으로인한만성요통환자에서감압치료가견인치료보다통증으로인한기능을개선시키는데효과적이며, 치료에대한만족도도높음을알수있었다. 이러한연구는임상에서요통환자치료시널리활용되고있는물리치료방법에대한과학적근거제공과새로개발된국산감압치료기기의임상적효과를제시함으로써치료수가산정, 환자교육을위한타당성있는근거자료로써활용될수있을것이다. 만성요통및하지방사통환자에서감압치료 (KNX 7000 ) 와견인치료의단기치료효과 33
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