평가 배경 

신장분사치료(Stretch and Spray Therapy)는 스트레칭(stretching)의 선행으로 통증이 있는 부위에 냉각 스프레이를 적용하는 기술로, 근막동통증후군, 염좌, 타박상 등에서 근막통증유발점, 운동점, 압통점 등을 비활성화시켜 통증 완화 및 경직 감소로 기능을 회복시키는 치료법이며, 동 기술은 2005년 8월부터 행위비급여 항목의 기술이다. 

건강보험심사평가원은 신장분사치료에 대한 급여화 타당성 검토 등 관련 정책결정에 필요한 근거자료를 도출하기 위해 임상적 안전성 및 효과성에 대한 재평가를 본원에 의뢰하였다(건강보험심사평가원 예비급여부-265, 2021.03.23.). 이에 2021년 제6차 의료기술재평가위원회(2021.6.11.)에서 동 건의 평가계획을 심의받아 재평가를 수행하였다.  

평가 방법

체계적 문헌고찰을 통해 신장분사치료의 임상적 안전성 및 효과성을 평가하였다. 본 평가를 위해 총 8인(재활의학과 2인, 정형외과 2인, 마취통증의학과 2인, 근거기반의학 2인)의 소위원회를 구성하였으며 2021년 8월 3일부터 2021년 11월 8일까지 3회의 소위원회 개최를 통해 동 기술의 안전성 및 효과성을 평가하였다. 

체계적 문헌고찰의 평가대상은 근막동통증후군, 염좌, 타박상 환자를 대상으로 하였으며, 안전성은 신장분사치료 중재로 인한 부작용 및 이상반응을 기준으로 평가하였고, 효과성은 통증개선정도 등의 지표로 평가하였다. 문헌의 비뚤림위험 평가는 연구설계에 따른 평가도구(RoB, RoBANS)를 사용하여 두 명의 검토자가 독립적으로 수행 후 의견 합의를 이루었다. 자료추출은 미리 정해 놓은 양식을 활용하여 수행하였으며, 의견 불일치가 있을 경우 제3자와 함께 논의하여 합의하였다. 자료분석은 연구별 최종 선정된 문헌의 양적 분석이 불가능하여 모두 질적으로 기술하여 검토하였다. 본 평가에서 수행한 체계적 문헌고찰 결과는 Grading of Recommendations Assessment, Development and Evaluation (GRADE)을 이용하여 근거수준을 평가하였다. 

평가 결과

신장분사치료 평가에 선택된 문헌은 총 2편으로, 모두 근막동통증후군을 대상으로 시행하였으며 염좌, 타박상을 대상으로 수행한 연구는 확인되지 않았다. 연구유형별로 무작위배정 비교임상시험 연구 1편, 비무작위 비교연구 1편이 해당되었다. 

안전성

신장분사치료와 관련하여 부작용 및 이상반응을 보고한 내용은 확인할 수 없었다. 

효과성 

신장분사치료의 효과성은 총 2편으로 무작위배정 비교임상시험 1편, 비무작위 비교연구 1편이 해당되었으며, 통증개선정도에 대해 보고하였다. 

경부 근막동통증후군을 대상으로 시행한 무작위배정 비교임상시험 1편에서는 결합조직마사지를 시행한 대조군에 비해 신장분사치료군의 통증유발점 개수에서 유의한 감소가 있었으며(우측 p˂0.05; 좌측 p˂0.001), 그 외 통증 점수, 관절가동범위, 허혈성 통증역치 및 통증내성은 그룹 간 유의한 차이가 확인되지 않았다. 또한 관절가동범위 측정 결과, 결합조직마사지를 적용한 대조군에서 좌측 회전 범위의 값이 유의하게 증가한 것으로 확인되었다(p˂0.05).

상부승모근 근막동통증후군을 대상으로 시행한 비무작위 비교연구 1편에서는 신장분사치료, 온습포요법, 초음파 열요법, 심부압박 연조직마사지 중재 후 통증역치 및 역치변화지수(index of threshold change, ITC)를 보고하였다. 치료 전후 통증역치의 비율을 의미하는 ITC 값은 심부압박 연조직마사지 요법에서 신장분사치료, 온습포요법, 초음파 열요법에 비해 유의하게 높은 값으로 확인되었으며(p˂0.05), 신장분사치료, 온습포요법, 초음파 열요법 간의 ITC 값은 유의한 차이가 없는 것으로 보고되었다. 

결론 및 제언

신장분사치료 재평가 소위원회는 본 평가를 통해 다음과 같이 제언하였다.

염좌, 타박상에 대한 신장분사치료의 안전성 및 효과성 결과를 보고한 문헌은 확인되지 않았다. 근막동통증후군을 대상으로 한 2편의 문헌 검토 결과, 중재의 안전성과 관련하여 보고한 내용은 확인되지 않았으며, 1편의 문헌에서 결합조직마사지와 비교 시 통증유발점 개수의 유의미한 감소를 보고하였으나, 이 결과만으로 신장분사치료의 임상적 효과성을 평가하기에 적절하지 않다고 판단하였다. 이에 소위원회는 근막동통증후군, 염좌, 타박상 환자를 대상으로 신장분사치료의 안전성과 효과성을 판단하기에 문헌적 근거가 충분하지 않다고 평가하였다. 

2022년 제1차 의료기술재평가위원회(2022.1.14.)는 의료기술재평가사업 관리지침 제4조제10항에 의거 ‘신장분사치료’에 대해 소위원회 검토 결과에 근거하여 다음과 같이 심의하였다. 

근막동통증후군, 염좌, 타박상 환자를 대상으로 통증 완화 및 경직 감소를 목적으로 시행되는 신장분사치료의 효과성에 대한 결론을 내리기에 근거가 제한적이므로 불충분으로 심의하였다(권고등급: 불충분)

주요어

신장분사치료, 근막동통증후군, 통증유발점, 염좌, 타박상 

Stretch and spray, Myofascial Pain Syndromes, Trigger Points, Sprains and strains, Contusions

Background

The Stretch and Spray Therapy is a health technology that applies a cooling spray to an area with pain prior to stretching. The method alleviates pain and reduces stiffness by deactivating myofascial trigger points, motor points, tender points, etc. for patients with myofascial pain syndrome, sprains and strains, contusions, etc. This technology has been an item of non-reimbursable treatment act since August 2005.

Health Insurance Review and Assessment Service (HIRA) commissioned National Evidence-based healthcare Collaborating Agency (NECA) for reassessment on clinical safety and effectiveness for stretch and spray therapy in order to derive evidence data necessary for policy decision-making, such as reviewing the validity of reimbursement in national health insurance coverage (HIRA Preliminary Benefit Division- 265, March 23, 2021). Therefore, the assessment protocol of the same case was reviewed at the 6th Health Technology Reassessment Committee (June 11, 2021) in 2021 and reassessment of the technology was performed.

Methods

The clinical safety and effectiveness of stretch and spray therapy were evaluated through conducting systematic literature review. For this reassessment, a Sub-committee consisting of a total of eight experts (two in rehabilitation medicine, two in orthopedics, two in anesthesiology, two in evidence-based medicine) was formed, and three sessions of Sub-committee meetings were held from August 3, 2021 to November 8, 2021 to evaluate the safety and effectiveness of this technology.

The patients in the systematic review were those with myofascial pain syndrome, sprains and strains, and contusions. Safety was evaluated based on side effects and adverse events caused by the stretch and spray therapy intervention, and effectiveness was evaluated with outcome measures such as the level of pain improvement. The risk of bias in the literature was assessed independently by two reviewers using the assessment tools (Risk of Bias (RoB), Risk of Bias Assessment for Nonrandomized Studies (RoBANS)), and the two reviewers performed an independent assessment, respectively, and draw consensus on the final conclusions. Data extraction was performed according to the predetermined format, and in case of any disagreement, discussions were held with a third party to draw consensus. As for the methods of data analysis, quantitative analysis was not possible for articles finally selected through the process, and the review was performed by qualitative description of the studies. For results of the systematic review conducted in this assessment, Grading of Recommendations Assessment, Development and Evaluation (GRADE) was used to evaluate the level of evidence.

Results

There are a total of two articles selected for the evaluation of stretch and spray therapy, all of which were conducted for myofascial pain syndrome, and no studies on sprains, strains, or contusions were confirmed. By types of study, there were one randomized controlled trial and one non-randomized controlled study.

Safety

There were no studies that reported side effects or adverse events related to stretch and spray therapy.

Effectiveness

The effectiveness of stretch and spray therapy was reported in two articles, with one randomized controlled trial and one non-randomized controlled study, and these articles reported on the level of improvement in pain. 

In one randomized controlled trial conducted on patients with cervical myofascial pain syndrome, there was a significant decrease in the number of trigger points in the stretch and spray therapy group compared to the control group that was treated with connective tissue massage (right p˂0.05; left p˂0.001). Other outcome measures such as scores of pain scale, range of motion (ROM), ischemic pain threshold and pain tolerance did not show a significant difference between the groups. Also, as a result of ROM measurements, there was a significant increase in the value of rotational range of motion on the left side in the control group treated with connective tissue massage (p˂0.05).

In one non-randomized controlled study conducted for patients with myofascial pain syndrome in the upper trapezius, pain threshold and index of threshold change (ITC) were assessed after intervention of stretch and spray therapy, hot pack therapy, ultrasound therapy, and deep friction soft tissue massage. The ITC value, which represents the ratio of pain threshold before and after the treatment, was found to be significantly higher in deep friction soft tissue massage therapy than that in stretch and spray therapy, hot pack therapy, and ultrasound therapy (p˂0.05). There was no significant difference in ITC values between stretch and spray therapy, hot pack therapy and ultrasound therapy.

Conclusion and Suggestions

Based on the assessment in this report, the Stretch and Spray Therapy Reassessment Sub-committee suggested the following.

There were no published literature on the outcomes of safety and effectiveness of stretch and spray therapy for patients with sprains, strains, and contusions. As a result of literature review on two articles that reported on myofascial pain syndrome, there was no report on the safety of the intervention. In one of the articles, there was a significant decrease in the number of trigger points compared to that of connective tissue massage; however, it was considered not appropriate to assess the clinical effectiveness of stretch and spray therapy based on this reported outcome alone. Therefore, the Sub-committee determined that the evidence from literature was not sufficient to determine the safety and effectiveness of stretch and spray therapy for patients with myofascial pain syndrome, sprains/strains, and contusions. 

At the 1st Health Technology Reassessment Committee (January 14, 2022) in 2022, the following conclusion was made based on the result of the review by the Sub-committee for stretch and spray therapy in accordance with Article 4, Paragraph 10 of the Management Guidelines for Health Technology Reassessment Project.

Since there is limited evidence to conclude on the effectiveness of stretch and spray therapy for pain alleviation and stiffness reduction in patients with myofascial pain syndrome, sprains & strains, and contusions, the Grade of Recommendation for the technology was determined as “Insufficient” (Grade of Recommendation: Insufficient).

Keywords: Stretch and spray, Myofascial Pain Syndromes, Trigger Points, Sprains and strains, Contusions

요약문 (국문) ⅰ

알기 쉬운 의료기술재평가 ⅳ

Ⅰ. 서론 1

  1. 평가배경 1

    1.1 평가대상 의료기술 개요 1

    1.2 국내외 보험 및 행위등재 현황 2

    1.3 질병 및 현존하는 의료기술 4

    1.4 국내외 임상진료지침 5

    1.5 관련 체계적 문헌고찰 및 일차문헌 현황 5

    1.6 기존 의료기술평가 6

  2. 평가목적 6

Ⅱ. 평가방법 7

  1. 체계적 문헌고찰 7

    1.1 개요 7

    1.2 PICOTS-SD 7

    1.3 문헌검색 8

    1.4 문헌선정 9

    1.5 비뚤림위험 평가 9

    1.6 자료추출 10

    1.7 자료분석 10

    1.8 근거수준 평가 10

  2. 권고등급 결정 10

Ⅲ. 평가결과 11

  1. 문헌선정 결과 11

    1.1 문헌선정 개요 11

    1.2 선택문헌 특성 12

    1.3 비뚤림위험 평가 결과 13

  2. 체계적 문헌고찰 분석결과 15

    2.1 안전성 15

    2.2 효과성 15

    2.3 GRADE 근거수준 평가 18

Ⅳ. 결과요약 및 결론 20

  1. 평가결과 요약 20

    1.1 안전성 20

    1.2 효과성 20

  2. 결론 21

Ⅴ. 참고문헌 22

Ⅵ. 부록 23

  1. 의료기술재평가위원회 23

  2. 소위원회 24

  3. 문헌검색현황 25

  4. 비뚤림위험 평가 및 자료추출 양식 29

  5. 최종선택문헌 32