평가 배경

체외충격파치료 [근골격계질환]은 상완골 내상과염 및 외상과염, 족저 근막염, 견괄절 석회화 건염, 골절 지연 유합 등에 체외에서 충격파를 병변에 가해 혈관 재형성을 돕고, 건 및 그 주위조직과 뼈의 치유 과정을 자극하거나 재활성화 시켜, 통증의 감소와 기능의 개선을 위한 치료법이다.

체외충격파치료 [근골격계질환]은 현재 비급여 행위(조-84)로 사용되고 있으며, 의학적 비급여의 급여화 추진과 관련하여 건강보험심사평가원과의 협의를 통해 재평가 항목으로 발굴되었다. 이에 2020년 제5차 의료기술재평가위원회(2020.05.11-13.)에서는 체계적 문헌고찰을 통해 해당 기술의 안전성 및 효과성을 평가하며 이때 적용 부위를 크게 ‘어깨 및 상지’, ‘고관절 및 요추부’, ‘하지 및 족부’로 나누어 평가하도록 심의하였다. 이후 소위원회와 의료기술재평가위원회에서의 추가적인 논의를 통해 체외충격파치료의 대표적 적응 질환으로, 상지 부위에서는 어깨 건병증, 내외측 상과염을, 하지 부위에서는 대전자동통증후군, 족저근막염, 아킬레스건병증, 무릎건병증, 불유합/지연유합, 근막동통증후군을 선정하고 이에 대해 평가하기로 하였다.

체외충격파치료 [근골격계질환]에 대한 재평가 수행 중, 2021년 3월 건강보험심사평가원으로부터 그외 질환에 대해 재평가를 추가 의뢰받았다(예비급여부-265, ‘21.03.23.). 2021년 제5차 의료기술재평가 위원회(‘21.05.14.)에서는 심평원에서 추가 의뢰된 16개 질환(골관절염, 피로골절, 무혈성괴사, 박리성 골연골염, 내전근 건병증, 거위발 건병증, 비골근 건병증, 발․발목 건병증, 골수 부종, 오스굿-슐라터 병, 경골 스트레스 증후군, 근육 염좌, 뒤퓌트랑, 발바닥 섬유종증, 드퀘르벵 병, 방아쇠 수지)에 대해 평가계획서 및 소위원회 구성에 대해 심의하였다.

이에 체외충격파치료 [근골격계질환]에 대해 안전성 및 효과성에 대한 과학적 근거를 제공하고, 의료기술의 적정 사용 등 정책적 의사결정을 지원하고자 체외충격파치료(extracorporeal shock wave therapy, ESWT)의 재평가를 수행하였다. 본 보고서에서는 체외충격파치료 [근골격계질환]의 적용 질환 중 ‘골관절염’에 대해 안전성 및 효과성에 대한 과학적 근거를 평가하고, 이를 제시하였다.

평가 방법

동 기술에 대한 안전성 및 효과성 평가를 위해 체계적 문헌고찰을 수행하였다. 모든 평가방법은 평가 목적을 고려하여 “체외충격파치료 [근골격계 질환] 골관절염에 대한 안전성 및 효과성 평가 소위원회(이하 ‘소위원회’라 한다)”의 심의를 거쳐 확정하였다. 평가의 핵심질문은 “ESWT는 골관절염 환자에서 통증을 완화하고 기능을 개선하는 데 있어 임상적으로 안전하고 효과적인가?”이며, 안전성은 시술

관련 부작용 및 이상반응 지표로, 효과성은 통증경감, 기능개선, 삶의 질 지표로 평가하였다.

체계적 문헌고찰은 핵심질문을 토대로 국외 3개, 국내 5개 데이터베이스에서 검색하여 문헌선정 및 배제기준에 따라 두 명의 검토자가 독립적으로 선별하고 선택하였다. 문헌의 비뚤림위험 평가는 연구유형 별로 Cochrane의 Risk of Bias (RoB)와 Risk of Bias Assessment tool for Nonrandomized Studies (RoBANS)를 사용하여 두 명의 검토자가 독립적으로 수행하여 의견합의를 이루었다. 자료추출은 미리 정해놓은 자료추출 양식을 활용하여 두 명의 검토자가 독립적으로 수행하였으며, 의견 불일치가 있을 경우 제3자와 함께 논의하여 합의하였다. 자료분석은 양적 분석(quantitative analysis)이 가능한 효과성 영역에 대해서는 메타분석을 수행하였고, 양적 분석이 불가능한 안전성에 대해서는 질적 검토(qualitative review) 방법을 적용하였다. 체계적 문헌고찰 결과의 근거 수준은 Grading of Recommendations Assessment, Development and Evaluation(GRADE) 접근 방법으로 평가하였다.

평가 결과

체외충격파치료 [근골격계질환] 골관절염의 안전성과 효과성은 총 17편(무작위배정비교임상시험 15편, 후향적코호트연구 2편)에 근거하여 평가하였다. 총 17편의 문헌에서 분석대상으로 삼은 대상자 수는 총 1,095명(중재 592명, 503명)이었다. 비교시술은 거짓 치료(sham/placebo ESWT)를 비롯하여 운동 및 물리치료 등, 관절 내 주사요법, 초음파, 레이저 등을 다루었다.

안전성

전체 17편의 문헌 중 안전성 지표인 ESWT 관련 부작용 및 이상반응 발생여부를 보고한 연구는 9편 이었으며, 나머지 연구들은 관련 내용을 다루지 않았다.

ESWT 치료군을 거짓 치료군(sham/placebo ESWT)과 비교한 7편 중 4편에서는 증상 발생 사례가 없었으며, 3편에서 일시적이고 경미한 합병증이 보고되었다. 이 중 1편(Hamman et al., 2020)은 군 간 구분 없이 전체 대상자 중 2명에서만 일시적인 피부발적이 발생하였고, 다른 1편(Ediz et al.,2018)에서도 중재군에서만 경미한 타박상 또는 일시적인 연조직 부종이 발생한 것으로 보고하였다. 나머지 1편(Zhong et al., 2019)에서는 중재군에서 통증, 피부발적, 작열감, 종창, 진전, 자각과민, 점상출혈 등의 사례가 보고되었고, 비교군에서도 동일 증상이 중재군보다 적은 수로 발생하였으나, 군 간 통계적으로 유의한 차이는 아닌 것으로 보고하였다. ESWT를 각각 물리치료와 레이저치료와 비교한 각 1편씩의 문헌에서는 중재군과 비교군 모두에서 부작용 및 이상반응이 발생하지 않은 것으로 나타났다.

효과성

동 기술의 효과성은 17편의 문헌(무작위배정비교임상시험 15편, 후향적코호트연구 2편)에서 보고한 통증경감 정도, 기능개선 여부, 삶의 질을 기준으로 평가하였다. 통증은 Visual Analogue Scale(VAS) 또는 Numeric Rating Scale (NRS)로, 기능개선 여부는 Western Ontario and McMaster Universities Arthritis Index (WOMAC), Lequesne index, Knee injury and Osteoarthritis Outcome Score (KOOS), Range of Motion (ROM) 등의 지표로 평가되었으며, 삶의 질을 보고한 문헌은 없었다.

통증경감 정도는 총 16편의 문헌에서 VAS 또는 NRS 지표로 보고하였다. ESWT를 거짓 치료군과 비교한 9편의 연구 중 6편에서 중재군과 비교군 모두에서 시술 전후 통증이 경감됨을 확인하였고, 나머지 3편에서는 중재군에서만 통계적으로 유의한 수준의 경감을 보고하였다. 9편 중 8편에서 전 추적 관찰기간에 걸쳐 중재군이 비교군에 비하여 통계적으로 더 유의한 통증경감 효과를 보고하였고, 나머지 1편(Imamura et al., 2017)에서는 군 간 유의한 차이가 없이 중재군과 비교군이 동등한 수준인 것으로 확인되었다. 운동 또는 물리치료와 비교한 5편의 연구 중 4편에서 양 군 모두에서 시술 전후 유의한 통증경감을 보고하였고, 중재군이 비교군에 비하여 통계적으로 더 큰 효과를 보이는 것으로 나타났다. 나머지 1편의 연구(Gunaydin et al., 2021)는 양 군 모두에서 통증이 경감되었으나, 활동상태 별로 구분하였을 때 수면 및 스쿼트 동안에는 비교군의 경감정도가 더 컸고, 휴식 시에는 군 간 유의한 차이가 없는 것으로 나타났다. ESWT를 각각 관절 내 주사치료와 레이저치료와 비교한 각 편의 연구에서는 양 군에서 모두 통증이 경감되었으며, 관절 내 주사의 경우 군 간 동등한 수준인 것으로, 레이저치료의 경우 중재군에서 더 유의한 경감효과를 보고하였다.

무작위배정비교임상시험 13편의 연구결과를 통합한 결과, ESWT와 모든 보존적 치료에 대한 WMD는 -1.80 (95% CI: -2.47, -1.14)으로 ESWT가 비교군에 비해 통증경감 효과가 더 큰 것으로 나타났으나, 연구 간 이질성은 매우 높았다(I2=91%). 비교자 별 구분에서는 양 군 간 유의한 차이가 없는 것으로 보고한 1편의 관절 내 주사치료 관련 내용을 제외한 모든 비교치료군과 비교 시 중재군에 더 유의한 효과를 보이는 것으로 확인되었다.

기능개선 여부는 WOMAC, Lequesne Index, KOOS, ROM의 지표로 평가하였다.

WOMAC 지표를 다룬 문헌은 총 13편으로 거짓 치료군과 비교한 7편 중 6편에서 양 군 모두에서 기능개선을 확인하였고, 나머지 1편은 중재군에서만 통계적으로 유의한 수준의 개선을 보인 것으로 나타났다. 군 간 비교 시 7편 중 6편에서 전 추적관찰기간에 걸쳐 중재군의 효과가 비교군보다 우수한 것으로 보고하였고, 나머지 1편(Imamura et al., 2017)은 WOMAC 세부영역 중 통증에서만 그 차이가 통계적으로 유의하였고, 경직과 기능제한 영역에서는 군 간 차이가 없는 것으로 보고하였다. 운동 또는 물리치료를 수행한 군과 비교한 4편의 연구에서는 3편이 양 군 모두에서 시술 전후 유의한 기능개선을 보고하였고, 중재군의 개선효과가 더 큰 것으로 나타났다. 나머지 1편(Eftekharsadat et al., 2020)에서는 양 군 모두에서 시술 전후 유의한 기능개선 효과를 보였으나 군 간 비교 시 3주차시점에는 중재군에서의 기능개선효과가 유의하게 큰 것으로, 7주 시점에는 군 간 유의한 차이가 없는 것으로 보고하였다. ESWT를 각각 관절 내 주사치료와 레이저치료와 비교한 각 1편의 연구에서는 양 군 모두에서 개선효과가 확인되었으며, 군 간 비교 시에는 관절 내 주사는 군 간 동등한 수준이었고, 레이저치료의 경우 중재군에서 더 유의한 기능개선 효과를 보고하였다.

WOMAC 하부지표 중 통증에 대한 점수만을 제시한 1편의 연구(Imamura et al., 2017)를 제외한 무작위배정비교임상시험 10편에 대한 메타분석 결과, WMD는-11.79 (95% CI: -21.09, -2.48)으로 ESWT가 비교군에 비해 더 효과적인 기능개선을 보이는 것으로 나타났으나, I2는 99%로 매우 높은 이질성을 보였다. 비교자 별 구분 시 거짓 치료군(6편) 대비 중재군에서 더 유의한 기능개선 효과를 확인하였고, 운동 또는 물리치료(3편), 관절 내 주사치료(1편)와 ESWT간에는 유의한 차이가 없는 것으로 나타났다.

Lequesne Index 지표를 다룬 문헌은 총 6편으로 모든 연구에서 ESWT는 시술 전후 유의한 기능개선을 가져온 것으로 나타났다. 중재군과 비교군의 군 간 비교에 있어서도 관절 내 주사요법과 비교한 1편(Lee et al., 2017a)에서만 유의한 차이가 없는 것으로 나타났다. 6편의 무작위배정비교임상시험에 대한 메타분석 수행 결과, WMD는 -2.28 (95% CI: –4.18~-0.38)으로 ESWT가 비교군에 비해 더 효과적인 기능개선을 보이는 것으로 나타났으며, I2는 95%이었다. 비교자 별 구분 시 거짓 치료군(4편)과 초음파치료(1편)에서만 중재군에 더 유의한 효과를 확인하였고, 관절 내 주사치료(1편)에서는 군 간 유의한 차이가 없는 것으로 확인되었다.

KOOS 지표로 평가된 문헌은 2편으로 거짓 치료군과 비교한 1편(Hamman et al., 2020)은 중재군에서만 유의한 기능개선을 보고하였고, 운동과 비교한 연구(Gunaydin et al., 2021)은 양 군 모두에서 시술 전후 유의한 향상을 보고하였고, 군 간 비교시에도 동등한 수준의 개선효과를 보였다. 2편의 무작위배정비교임상시험에 대한 메타분석 결과, WMD는 –4.10 (95% CI: –6.01~-2.18)으로 중재군이 비교군에 비하여 유의하게 효과적인 기능개선을 보이는 것을 확인하였다(I2=0%).

ROM을 평가한 연구는 5편이었다. 물리치료와 비교한 Lizis 등(2017)의 연구에서 보고한 5주 시점의 신전 결과를 제외하고, 나머지 연구들에서 보고된 결과는 모두 중재군에서 시술 전후 유의한 기능개선을 보였으며, 중재군과 비교군 군 간 비교에 있어서도 5편 전 편에서 중재군이 통계적으로 유의한 수준으로 비교군보다 관절 가동범위가 더 크게 개선된 것으로 나타났다. 총 5편의 연구에 대한 메타분석 결과, 굴곡 및 신전의 구분 없이 결과를 제시한 3편의 연구에서 WMD는 10.5 (95% CI 2.03~18.97, I2=91%)였으며, 나머지 2편의 연구에서 굴곡과 신전 WMD는 각각 9.21 (95% CI 1.77~16.66, I2=93%)과 0.78 (95% CI -2.94~4.50, I2=90%)이었다.

결론 및 제언

소위원회에서는 현재 문헌적 근거를 바탕으로 다음과 같이 결론을 제시하였다.

골관절염 환자를 대상으로 한 체외충격파치료는 중재시술에서 보고된 시술 관련 부작용 및 이상반응이 일시적이고 경미한 수준이고, 비교중재와 비교 시에도 통계적으로 유의한 차이가 없었으므로 소위원회는 타 보존적 치료와 비교하여 유사한 수준의 안전성을 가진 의료기술로 평가하였다.

체외충격파치료 후 통증경감, 기능개선 효과가 보고되었고, 메타분석 결과에 있어서 비교군보다 중재군에서 더 유의한 효과를 확인된 점들을 감안할 때 소위원회는 동 시술이 골관절염 환자의 통증경감 및 기능개선에 도움을 줄 수 있을 것으로 판단하였다. 그러나 평가에 반영된 대부분의 정보들이 중등도 수준의 비뚤림 위험이 있는 의 연구들로부터 도출된 점, 환자군 특성 및 ESWT 시행방법이 연구 별로 상이하여 시술방법의 표준화에 대한 향후 추가 연구가 필요하다는 소위원회의 의견을 제시하였다.

2022년 제2차 의료기술재평가위원회(2022.02.18.)에서는 소위원회 및 통합 소위원회 검토 결과에 근거하여 의료기술재평가사업 관리지침 제4조제10항에 의거 “체외충격파치료 [근골격계질환] 골관절염”에 대해 다음과 같이 심의하였다.

골관절염 환자에서 체외충격파치료는 안전하나, 효과성에 대한 결론을 내리기에 근거가 명확하지 않아 체외충격파치료 [근골격계질환] 골관절염을 ‘근거 불충분’으로 결정하였다(권고등급: 불충분).

주요어

골관절염, 체외충격파

Osteoarthritis, Extracorporeal Shockwave Therapy, ESWT

Background

Extracorporeal shock wave therapy (ESWT) [musculoskeletal disorders] is a treatment method that involves applying extracorporeal shock wave to the lesion to promote vascular regeneration and reactivate or stimulate healing in tendons and surrounding tissues and bones to achieve pain reduction and functional improvement in cases with humeral medial epicondylitis, humeral lateral epicondylitis, plantar fasciitis, calcific tendinitis of the shoulder, or delayed union of fracture.

ESWT [musculoskeletal disorders] is currently used as a non-coverage service (SZ083) and it was identified as an item for reassessment through discussion with the Health Insurance Review and Assessment Service (HIRA) in relation to implementation of coverage for uninsured medical benefits . Accordingly, during the fifth session of the Committee of Health Technology Reassessment in 2020 (May 11–14, 2020), the decision was made to assess the safety and effectiveness of this technology by a systematic review with the applied areas divided largely into “shoulders and upper extremities,” “pelvic and lumbar regions,” and “lower extremities and feet.” Subsequently, based on additional discussions by the subcommittee and the Committee of Health Technology Reassessment, shoulder tendinopathy and medial and lateral epicondylitis in the upper extremities and greater trochanteric pain syndrome, plantar fasciitis, Achilles tendinopathy, knee tendinopathy, nonunion/delayed union, and myofascial pain syndrome in the lower extremities were selected as typical indications for ESWT for inclusion in the assessment.

While the reassessment of ESWT [musculoskeletal disorders] was being conducted, additional request for reassessment of other disorders from HIRA was received in March 2021 (Preliminary Coverage Division-265; March 23, 2021). At the fifth session of the Committee of Health Technology Reassessment in 2021 (May 14, 2021), the committee deliberated on the assessment plan and subcommittee composition for the 16 disorders additionally requested by HIRA (osteoarthritis, fatigue fracture, avascular necrosis, osteochondritis dissecans, adductor tendinopathy, pes anserine tendinopathy, peroneal tendinopathy, foot/ankle tendinopathy, bone marrow edema, Osgood-Schlatter disease, medial tibial stress syndrome, muscle sprain and strain, Dupuytren's contracture, plantar fibromatosis, de Quervain's disease, and trigger finger).

Accordingly, reassessment of ESWT was conducted to provide scientific evidence for the safety and effectiveness of ESWT [musculoskeletal disorders] and support policy decision-making, including appropriate use of health technology. This report presents the findings on the assessment of scientific evidence for the safety and effectiveness of ESWT [musculoskeletal disorders] for “osteoarthritis” among the disorders for which ESWT [musculoskeletal disorders] is applied.

Methods

A systematic review was performed to assess the safety and effectiveness of this technology. All assessment methods were finalized after the review by the “ESWT [musculoskeletal disorders] for osteoarthritis safety and effectiveness reassessment subcommittee” (hereinafter referred to as “subcommittee”) with consideration for the purpose of the assessment. The key question in the assessment was “Is ESWT clinically safe and effective in relieving pain and improving function in patients with osteoarthritis?” Safety was assessed based on procedure-related adverse events (AEs) and adverse reactions as the indicators, while effectiveness was assessed based on pain relief, functional improvement, and quality of life (QoL) as the indicators.

The articles for the systematic review were searched in three international and five domestic databases. Two reviewers independently screened and selected the articles in accordance with the inclusion and exclusion criteria. Two reviewers independently performed risk of bias (RoB) assessment and reached a consensus on the findings – using Cochrane’s Risk of Bias Tool and the Risk of Bias Assessment for Non-randomized Studies (RoBANS) depending on the type of study. Data extraction was performed independently by two reviewers, using a predetermined format. Any disagreements were resolved by discussing the matter with a third person to reach a consensus. Data were analyzed by meta-analysis for effectiveness domains that could be quantitatively analyzed, whereas qualitative review was used for safety domains that could not be quantitatively analyzed. The systematic review results were assessed for level of evidence using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) method.

Results

The safety and effectiveness of ESWT [musculoskeletal disorders] for osteoarthritis were assessed based on a total of 17 articles (15 randomized controlled trials [RCTs] and 2 retrospective cohort studies). The total sample size analyzed in 17 articles was 1,095 (intervention: 592 and control: 503). Comparators used included exercise and physical therapy, including sham treatment (sham/placebo ESWT), as well as intraarticular injection therapy, ultrasound, and laser therapy. 

Safety

Among 17 articles, nine articles reported on ESWT-related AEs and adverse reactions. The remaining articles did not discuss relevant content. 

Among seven articles that reported on comparison between ESWT and sham therapy (sham/placebo ESWT) groups, four articles reported no incidence of symptoms, while three articles reported transient and mild AEs. Of these, one article (Hamman et al., 2020) reported transient skin redness in two patients with no differentiation by group, while another article (Ediz et al., 2018) reported mild bruising or transient soft tissue edema only in the intervention group. The remaining one article (Zhong et al., 2019) reported pain, skin redness, burning sensation, swelling, tremor, hypersensitivity, and petechia in the intervention group. The same symptoms also appeared in the control group, but in fewer number of cases, and the difference between the two groups was not statistically significant. In one article that compared ESWT and physical therapy and another article that compared ESWT and laser therapy, there were no AEs and adverse reactions in both the intervention and control groups. 

Effectiveness

The effectiveness of this technology was assessed based on pain reduction, functional improvement, and QoL reported in 17 articles (15 RCTs and 2 retrospective cohort studies). Pain was assessed using the Visual Analogue Scale (VAS) or Numeric Rating Scale (NRS), while functional improvement was assessed using the Western Ontario and McMaster Universities Arthritis Index (WOMAC), Lequesne index, Knee injury and Osteoarthritis Outcome Score (KOOS), and range of motion (ROM). Meanwhile, there were no articles that reported on QoL. 

Level of pain reduction, measured by VAS or NRS, was reported in 16 articles. Among nine articles on comparison between ESWT and sham therapy, six articles reported pain reduction after the intervention in both the intervention and control groups, while the remaining three articles reported statistically significant pain reduction only in the intervention group. Moreover, eight of nine articles reported more statistically significant pain reduction in the intervention group throughout the observational period, while the remaining one article (Imamura et al., 2017) reported similar pain reduction with no significant difference between the two groups. Among five articles on comparison to exercise or physical therapy, four articles reported significant pain reduction after the intervention in both groups, with the intervention group showing more statistically significant effect, as compared to the control group. In the remaining one article (Gunaydin et al., 2021), both groups showed pain reduction. However, when differentiated by activities, the control group showed greater pain reduction during sleep and squatting, while there was no significant difference between the two groups during rest. In one article with comparison between ESWT and intraarticular injection therapy and another article with comparison between ESWT and laser therapy, both groups showed pain reduction. With intraarticular injection therapy, the level of pain reduction was similar in both groups, whereas with laser therapy, the intervention group showed more significant pain reduction. 

Synthesis of results in 13 RCTs showed that the weighted mean difference (WMD) for ESWT and all conservative therapies was -1.80 (95% CI: -2.47, -1.14), with ESWT groups showing greater pain reduction than the control groups, but heterogeneity between studies was very high (I2=91%). When differentiated by comparators, the intervention group showed greater significant effect than the non-intervention groups, except for intraarticular injection therapy reported in one article. 

Functional improvement was assessed using WOMAC, Lequesne Index, KOOS, and ROM as the indicators. 

WOMAC was used in 13 articles. Among seven articles on comparison with sham therapy group, six articles reported functional improvement in both groups, while the remaining one article reported statistically significant improvement only in the intervention group. With respect to comparisons between groups, six of seven articles reported that the intervention group showed superior effect than the control group throughout the follow-up period. Meanwhile, the remaining one article (Imamura et al., 2017) reported that the difference was statistically significant only in pain domain of WOMAC, with no difference between the groups with respect to stiffness and functional limitation domains. Among four articles on comparison with exercise or physical therapy, three articles reported significant functional improvement after the intervention in both groups, with the intervention group showing greater improvement effect. The remaining one article (Eftekharsadat et al., 2020) reported significant functional improvement after the intervention in both groups, but the improvement effect was significantly larger in the intervention group after 3 weeks and no significant difference between the groups after 7 weeks. In one article with comparison between ESWT and intraarticular injection therapy and another article with comparison between ESWT and laser therapy, both groups showed improvement effect. With intraarticular injection therapy, the level of functional improvement was similar in both groups, whereas with laser therapy, the intervention group showed more significant functional improvement. 

In the meta-analysis of 10 RCTs, excluding one study that presented only pain score among the domains of WOMAC (Imamura et al., 2017), the results showed WMD of -11.79 (95% CI: -21.09, -2.48), with ESWT groups showing greater functional improvement than the control groups, but heterogeneity between studies was very high (I2=99%). When differentiated by comparators, the intervention group showed more significant improvement effect than the sham therapy groups (6 articles), while there were no significant differences between ESWT and exercise or physical therapy (3 articles) and intraarticular injection (1 article). 

In six articles that used Lequesne Index, ESWT showed significant functional improvement after the intervention. In the comparisons between the intervention and control groups, only one article with comparison to intraarticular injection (Lee et al., 2017a) reported no significant different. In the meta-analysis of six RCTs, the results showed WMD of -2.28 (95% CI: –4.18~-0.38), with ESWT groups showing greater functional improvement than the control groups (I2=95%). When differentiated by comparators, the intervention group showed more significant effect only when compared to sham therapy groups (4 articles) and ultrasound therapy group (1 article), while there were no significant differences between ESWT and intraarticular injection (1 article). 

There were two articles with assessment using KOOS. In one article with comparison to sham therapy group (Hamman et al., 2020), only the intervention group showed significant improvement effect. In the article with comparison to exercise (Gunaydin et al., 2021), both groups showed significant improvement after the intervention and comparison between the two groups showed similar level of improvement effect. In the meta-analysis of two RCTs, the results showed WMD of –4.10 (95% CI: –6.01~-2.18), with ESWT groups showing greater functional improvement than the control groups (I2=0%).

There were five articles with assessment based on ROM. All articles reported significant functional improvement in the intervention group after the intervention, except the study by Lizis et al. (2017) that compared ESWT to physical therapy and reported extension outcomes after 5 weeks. Comparisons between the intervention and control groups also showed more statistically significant improvement in ROM in the intervention groups than in the control groups in all five articles. In the meta-analysis of five studies, the results showed WMD of 10.5 (95% CI: 2.03~18.97, I2=91%) in three articles that presented the results without differentiating flexion and extension. In the remaining two articles, WMD in flexion and extension was 9.21 (95% CIL 1.77~16.66, I2=93%) and 0.78 (95% CI: -2.94~4.50, I2=90%), respectively. 

Conclusions and recommendations

Based on the evidence currently available through existing literature, the subcommittee presented the following findings:

The subcommittee concluded that ESWT applied to patients with osteoarthritis caused only transient mild procedure-related AEs and adverse reactions and there was no statistically significant difference in safety as compared to comparator interventions. Accordingly, the subcommittee concluded that ESWT for patients with osteoarthritis is a safe health technology similar to that of other conservative therapies. 

Considering that pain reduction and functional improvement were found after ESWT and that the intervention groups showed more significant effect than the control groups, the subcommittee concluded that this technology could help reduce pain and improve function in patients with osteoarthritis. However, the subcommittee also concluded that additional studies are needed in the future to standardize this procedure since most of the data were derived from studies with moderate level of RoB and patient characteristics and ESWT methods varied between studies. 

During the second session of the Committee of Health Technology Reassessment in 2022 (February 18, 2022), the following conclusions were made on “ESWT [musculoskeletal disorders] for osteoarthritis” based on the subcommittee findings and integration subcommittee review in accordance with Article 4-10 of the Guidelines for Management of Health Technology Reassessment Project.

ESWT for patients with osteoarthritis may be safe, but evidence for its effectiveness is inconclusive. Accordingly, the level of evidence for the effectiveness of ESWT [musculoskeletal disorders] for osteoarthritis was determined to be “insufficient” (Grade of recommendation: Insufficient).

Keywords

Osteoarthritis, Extracorporeal shock wave therapy (ESWT)

요약문 ······································································································· i

알기 쉬운 의료기술재평가 ···································································· I

Ⅰ. 서론 ····································································································· 1

  1. 평가배경 ···························································································· 1

    1.1 평가대상 의료기술 개요 ···························································· 2

    1.2 국내외 보험 및 행위등재 현황 ················································· 4

    1.3 질병 특성 및 현존하는 의료기술 ············································· 6

    1.4 관련 교과서 ·················································································· 8

    1.5 국내외 임상진료지침 ·································································· 8

    1.6 체계적 문헌고찰 현황 ································································· 10

  2. 평가목적 ····························································································· 10

Ⅱ. 평가 방법 ····························································································· 11

  1. 체계적 문헌고찰 ················································································ 11

    1.1 개요 ································································································ 11

    1.2 핵심질문 ························································································ 11

    1.3 문헌검색 ························································································ 12

    1.4 문헌선정 ························································································ 12

    1.5 비뚤림 위험 평가 ········································································· 13

    1.6 자료추출 ························································································ 13

    1.7 자료합성 ························································································ 13

    1.8 근거수준 평가 ··············································································· 14

  2. 권고등급 결정 ···················································································· 14

Ⅲ. 평가결과 ······························································································· 15

  1. 문헌선정 결과 ···················································································· 15

    1.1 문헌선정 개요 ··············································································· 15

    1.2 선택문헌 특성 ··············································································· 16

    1.3 비뚤림 위험 평가결과 ·································································· 27

  2. 분석 결과 ····························································································· 29

    2.1 안전성 ····························································································· 29

    2.2 효과성 ····························································································· 32

    2.3 GRADE 근거평가 ··········································································· 47

Ⅳ. 결과요약 및 결론 ················································································· 51

  1. 평가결과 요약 ····················································································· 51

    1.1 안전성 ····························································································· 51

    1.2 효과성 ····························································································· 51

  2. 결론 ······································································································ 53

Ⅴ. 참고문헌 ································································································ 55

Ⅵ. 부록 ········································································································ 56

  1. 의료기술재평가위원회 ······································································· 56

  2. 소위원회 ······························································································· 60

  3. 문헌검색현황 ······················································································· 61

  4. 비뚤림위험 평가 및 자료추출 양식 ················································· 64

  5. 최종선택문헌 ······················································································· 68