체외충격파치료[근골격계질환] 근막동통증후군

Abstract

평가 배경 체외충격파치료 [근골격계질환]은 상완골 내상과염 및 외상과염, 족저근막염, 견관절 석회화 건염, 골절 지연유합 등에 체외에서 충격파를 병변에 가해 혈관 재형성을 돕고, 건 및 그 주위조직과 뼈의 치유 과정을 자극하거나 재활성화시켜, 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 그 외 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, 발ㆍ발목 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 근막동통증후군에 대해 안전성 및 효과성에 대한 과학적 근거를 평가하고, 이를 제시하였다.

평가 방법 체외충격파치료 [근골격계질환] 근막동통증후군에 대한 안전성 및 효과성 평가를 위해 체계적 문헌고찰을 수행하였다. 모든 평가방법은 평가목적을 고려하여 “체외충격파치료 [근골격계질환] 근막동통증후군 소위원회(이하 ‘소위원회’라 한다)”의 심의를 거쳐 확정하였다. 소위원회 구성은 정형외과 2인, 재활의학과 2인, 마취통증의학과 1인, 영상의학과 1인, 근거기반의학 1인의 위원으로 소위원회 전문가 7인으로 구성하였다. 평가의 핵심질문은 근막동통증후군 환자에서 체외충격파치료는 안전하고 효과적인가이었고, 안전성은 시술 관련 부작용 및 합병증을 지표로, 효과성은 통증, 기능, 삶의 질을 기준으로 평가하였다. 체계적 문헌고찰은 핵심질문을 토대로 국외 3개, 국내 5개 데이터베이스에서 검색하여 문헌선정 및 배제기준에 따라 두 명의 검토자가 독립적으로 선별하고 선택하였다. 문헌의 비뚤림위험 평가는 Risk of Bias (RoB)와 Risk of Bias Assessment 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 정량적 분석(quantitative analysis)과 정성적(qualitative review) 분석을 적용하였다. 체계적 문헌고찰 결과의 근거 수준은 Grading of Recommendations Assessment, Development and Evaluation (GRADE) 접근 방법으로 평가하였다.

평가 결과 체외충격파치료 [근골격계질환] 근막동통증후군의 안전성과 효과성은 총 19편(국내 2편, 국외 17편)을 기준으로 평가하였다. 대상 환자수는 총 915명(중재:433명, 비교: 482명)으로 모두 근막동통증후군으로 진단받은 환자이었다. 19편(RCT 18편, NRS 1편)의 비뚤림위험 수준은 불확실하거나 낮은 수준이었으나, 특히나 배정순서 은폐, 연구 참여자 및 연구자에 대한 눈가림과 결과 평가에 대한 눈가림 항목에 대한 비뚤림위험은 불확실하거나 높은 수준이었다.

안전성 안전성은 시술관련 합병증 또는 부작용을 지표로 평가하였다. 근막동통증후군 환자를 대상으로 체외충격파치료를 시행한 총 19편의 문헌 중 시술관련 부작용 및 이상반응을 보고한 연구는 RCT 8편이었다. 8편 중 1편에서 중재군의 1% (2/202명)에서 일시적 민감 반응이 보고되었으며 모두 추가적인 치료 없이 해결되었다고 보고하였다.

효과성 효과성은 통증, 기능, 삶의 질을 기준으로 평가하였다. 통증은 visual analogue scale (VAS), numeric pain rating scale (NPS), patient global assessment (PGA), pain pressure threshold (PPT)로, 기능은 neck disability index (NDI), Oswestry disability index (ODI), Constant Murley score (CMS), Range of Motion (ROM)으로, 삶의 질은 SF-36 신체기능으로 분석하였다. 체외충격파치료와 통증유발점 주사를 비교한 RCT 연구들을 양적합성한 결과, 통증(VAS, NPS; 6편, Weighted Mean Difference (WMD) –0.27, 95% CI –0.92~0.05, I2=45%, PPT; 6편, Standardized Mean Difference (SMD) 0.20, 95% CI -0.26~0.66, I2=71%), 기능(NDI, ODI; 4편, SMD –1.01, 95% CI –2.58~0.57, I2=96%)은 체외충격파치료와 통증유발점 주사 치료군간 효과차이가 없었다. 체외충격파치료군에서의 삶의 질(SF-36; 1편, WMD 8.50, 95% CI 7.80~9.20)이 통증유발점 주사군에 비해 통계적으로 유의하게 개선되었다. 1편의 NRS에서는 통증(VAS; WMD –1.60, 95% CI –2.05~-1.15, PPT; WMD 1.42, 95% CI 0.89~1.95), 기능(ODI; WMD –0.51, 95% CI –0.99~-0.03)측면에서 체외충격파치료가 통증유발점 주사군에 비해 효과적이라고 보고하였다. 체외충격파치료와 보존적 요법을 비교한 RCT 연구들을 양적합성한 결과, 통증(VAS, PGA; 9편, WMD –0.90, 95% CI –1.86~0.07, I2=90%, PPT; 6편, SMD 0.34, 95% CI –0.47~1.15, I2=84%), 기능(NDI; 6편, WMD –1.47, 95% CI –6.11~3.18, I2=90%. CMS; 3편, WMD 0.07, 95% CI –4.18~4.31, I2=0%)측면에서는 군간 차이가 없었으나 관절가동범위(ROM external rotation; 1편, WMD 11.0, 95% CI 6.77~15.23, ROM internal rotation; 1편, WMD 9.0, 95% CI 5.27~12.73)와 SF-36 신체기능영역(SF-36 신체기능; 3편, WMD 13.71, 95% CI 9.60~17.82, I2=4%)측면에서는 체외충격파치료가 보존적 요법에 비해 효과적이었다. 체외충격파치료와 보존적 요법(비교군과 동일)을 병행치료하는 군과 보존적 요법군을 비교한 RCT 연구들을 양적합성한 결과, 체외충격파치료와의 병행치료군에서의 VAS로 측정된 통증 정도(VAS; 4편, WMD –0.92, 95% CI –1.52~-0.32, I2=60%)와 NDI로 측정된 기능 정도(NDI; 3편, WMD –1.57, 95% CI –2.28~-0.86, I2=0%)는 보존적 요법에 비해 통계적으로 유의하게 개선되었다. PPT로 측정된 통증(PPT; 4편, SMD 0.29, 95% CI –0.26~0.84, I2=64%)과 CMS, 관절간동범위로 측정된 기능정도(CMS; 2편, WMD 0.74, 95% CI –1.79~3.27, I2=0%, ROM external rotation; 2편, WMD 6.76, 95% CI –4.70~18.23, I2=99%, ROM internal rotation; 2편, WMD 6.61, 95% CI –4.95~18.18, I2=99%)기준에서는 군간 효과차이가 없었다. 체외충격파치료와 Sham 체외충격파치료를 비교한 RCT 연구들을 양적합성한 결과, 통증(VAS; 2편, WMD –1.54, 95% CI –2.35~-0.72, I2=0%, PPT; 2편, SMD 1.77, 95% CI 1.16~2.38, I2=0%), SF-36 신체기능영역(SF-36 신체기능영역;1편, WMD 22.5, 95% CI 12.1~32.9)은 체외충격파치료가 Sham 체외충격파치료에 비해 통계적으로 유의한 개선효과가 있었다.

결론 및 제언 소위원회에서는 현재 문헌적 근거를 바탕으로 다음과 같이 결과를 제시하였다. 소위원회에서는 근막동통증후군 환자를 대상으로 시행한 체외충격파치료는 심각한 부작용이 발생하지 않으며, 기존 기술과 유사한 수준의 안전성을 가진 것으로 평가하였다. 효과성은 Sham 체외충격파치료와 비교하였을 때 우위에 있으며, 통증유발점 주사 또는 보존적 요법과는 통증 완화 및 기능 개선 측면에서 유사한 효과를 나타냈다. 따라서 소위원회에서는 근막동통중후군 환자에서 체외충격파치료는 안전한 기술이며, 통증유발점 치료 또는 보존적 요법과 효과가 유사한 기술로 평가하였다. 2022년 제2차 의료기술재평가위원회(2022.02.18.)에서는 소위원회 검토 결과에 근거하여 의료기술재평가사업 관리지침 제4조제10항에 의거 “체외충격파치료 [근골격계질환] 근막동통증후군”에 대해 다음과 같이 심의하였다. 근막동통증후군 환자에서 체외충격파치료는 안전한 기술이며, 통증완화, 기능개선, 삶의 질 측면에서 기존의 통증유발점 주사 또는 보존적 요법과 효과 차이가 없다는 현재까지의 문헌적 근거를 고려하여 ‘조건부 권고함’으로 심의하였다(권고등급: 조건부 권고함).

주요어 근막동통증후군, 체외충격파치료, 통증완화, 기능개선

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 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 additional 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 myofascial pain syndrome among the disorders for which ESWT [musculoskeletal disorders] is applied.

Methods A systematic review was performed to assess the safety and effectiveness of ESWT [musculoskeletal disorders] for myofascial pain syndrome. All assessment methods were finalized after the review by the “ESWT [musculoskeletal disorders] for myofascial pain syndrome reassessment subcommittee” (hereinafter referred to as “subcommittee”) with consideration for the purpose of the assessment. The subcommittee was composed of seven experts – two each from orthopedic surgery and rehabilitation medicine and one each from anesthesia and pain medicine, radiology, and evidence-based medicine. The key question in the assessment was “Is ESWT safe and effective for treating patients with myofascial pain syndrome?” Safety was assessed based on procedure-related adverse events (AEs) and complications as the indicators, while effectiveness was assessed based on pain, function, and quality of life (QoL) as the indicators. For the systematic review, articles were searched in three international and five domestic databases based on the key question. 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 for randomized controlled trials (RCTs) and the Risk of Bias Assessment for Non-randomized Studies (RoBANS) for non-randomized studies (NRSs). 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 qualitative review since quantitative analysis was not possible. 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 myofascial pain syndrome were assessed based on a total of 19 articles (two domestic and 17 overseas articles). The patient population consisted of a total of 915 patients (intervention groups: 433 patients and control groups: 482 patients) who were all diagnosed with myofascial pain syndrome. The level of RoB in 19 studies (18 RCTs and 1 NRS) was uncertain or low, and in particular, the level of RoB for allocation concealment, participant and investigator blinding, and outcome blinding was uncertain or high.

Safety Safety was assessed based on procedure-related AEs and complications as the indicators. Among a total of 19 studies on ESWT applied to patients with myofascial pain syndrome, eight RCTs reported on procedure-related AEs and adverse reactions. Of these eight RCTs, one RCT reported transient sensitive reaction in 1% of patients (2 out of 202 patients) in the intervention group, which was resolved without additional treatment in all cases.

Effectiveness Effectiveness was assessed based on pain, function, and QoL as the indicators. Pain was assessed using Visual Analogue Scale (VAS), Numeric Pain Rating Scale (NPRS), Patient Global Assessment (PGA), and pain pressure threshold (PPT); function was assessed using Neck Disability Index (NDI), Oswestry Disability Index (ODI), Constant Murley Score (CMS), and range of motion (ROM); and QoL was assessed using SF-36 physical functioning scale. Quantitative synthesis of RCTs that compared ESWT and trigger point injection (TPI) showed no difference in effectiveness between ESWT and TPI groups with respect to pain (VAS, NPS: 6 articles, weighted mean difference (WMD): –0.27, 95% CI: –0.92~0.05, I2=45%; PPT: 6 articles, standardized mean difference (SMD): 0.20, 95% CI -0.26~0.66, I2=71%) and (NDI, ODI: 4 articles, SMD: – 1.01, 95% CI: –2.58~0.57, I2=96%). On the other hand, ESWT group showed statistically significant improvement in QoL, as compared to TPI group (SF-36: 1 article, WMD: 8.50, 95% CI: 7.80~9.20). One NRS reported that ESWT was more effective than TPI with respect to pain (VAS; WMD: –1.60, 95% CI: –2.05~-1.15; PPT; WMD: 1.42, 95% CI: 0.89~1.95) and function (ODI; WMD: –0.51, 95% CI: -0.99~-0.03). Quantitative synthesis of RCTs that compared ESWT and conservative therapy showed no difference between the groups with respect to pain (VAS, PGA: 9 articles, WMD: –0.90, 95% CI: –1.86~0.07, I2=90%; PPT: 6 articles, SMD: 0.34, 95% CI: -0.47~1.15, I2=84%) and function (NDI: 6 articles, WMD: -1.47, 95% CI: -6.11~3.18, I2=90%; CMS: 3 articles, WMD: 0.07, 95% CI: -4.18~4.31, I2=0%). On the other hand, ESWT was more effective than conservative therapy with respect to ROM (external rotation: 1 article, WMD: 11.0, 95% CI: 6.77~15.23; internal rotation: 1 article, WMD: 9.0, 95% CI: 5.27~12.73) and physical function (SF-36 physical functioning score: 3 articles, WMD: 13.71, 95% CI: 9.60~17.82, I2=4%). Quantitative synthesis of RCTs that compared ESWT combined with conservative therapy (same as the control) and conservative therapy alone showed statistically significant improvement in pain measured by VAS (VAS: 4 articles, WMD: -0.92, 95% CI: -1.52~-0.32, I2=60%) and function measured by NDI (NDI: 3 articles, WMD: –1.57, 95% CI: –2.28~-0.86, I2=0%) in ESWT + conservative therapy group, as compared to conservative therapy alone group. Meanwhile, there were no differences between the two groups in pain measured by PPT (PPT: 4 articles, SMD: 0.29, 95% CI: –0.26~0.84, I2=64%) and function measured by CMS and ROM (CMS: 2 articles, WMD: 0.74, 95% CI: –1.79~3.27, I2=0%; external rotation: 2 articles, WMD: 6.76, 95% CI: –4.70~18.23, I2=99%; internal rotation: 2 articles, WMD: 6.61, 95% CI: -4.95~18.18, I2=99%). Quantitative synthesis of RCTs that compared ESWT and sham ESWT showed statistically significant improvement in pain (VAS: 2 articles, WMD: –1.54, 95% CI: –2.35~-0.72, I2=0%; PPT: 2 articles, SMD: 1.77, 95% CI: 1.16~2.38, I2=0%) and physical function (SF-36 physical functioning score: 1 articles, WMD: 22.5, 95% CI: 12.1~32.9) in ESWT group, as compared to sham ESWT group.

Conclusions and recommendations Based on the evidence currently available through existing literature, the subcommittee presented the following findings: ESWT applied to patients with myofascial pain syndrome caused no serious AEs and has safety at a level similar to that of existing technologies. While ESWT showed superior effectiveness than sham ESWT, ESWT showed similar effectiveness as TPI or conservative therapy with respect to pain relief and functional improvement. Accordingly, the subcommittee concluded that ESWT for patients with myofascial pain syndrome is a safe technology with similar effectiveness as TPI therapy or conservative therapy. 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 myofascial pain syndrome” based on the subcommittee findings in accordance with Article 4-10 of the Guidelines for Management of Health Technology Reassessment Project. ESWT for patients with myofascial pain syndrome is “conditionally recommended” based on evidence in literature published to date indicating that it is a safe technology with no differences in effectiveness for pain relief, functional improvement, and QoL, as compared to existing TPI or conservative therapy (Grade of recommendation: Conditionally recommended).

Keywords: Myofascial pain syndrome, Extracorporeal shock wave treatment, Pain relief, Functional improvement