Clinical and Economic Evaluation of Point-of-care Ultrasound-guided Infiltration for Subacromial and Carpal Tunnel Syndromes in Primary Care: a Cluster-randomized Study Protocol. (Q-EPICAP)
2026년 7월 2일 업데이트: Marta Ortega Bravo, Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
The aim of this clinical trial is to determine whether point-of-care ultrasound-guided corticosteroid injection is more effective than conventional injection guided by anatomical landmarks or standard oral medication for patients with upper-extremity conditions (subacromial impingement syndrome [SAS] or carpal tunnel syndrome [CTS]) in primary care.
The main questions this study seeks to answer are:
Does ultrasound-guided injection provide superior long-term pain relief compared to blind anatomical injection and oral medication?
Does ultrasound-guided injection lead to better functional recovery and improved health-related quality of life in patients?
Is ultrasound-guided injection a cost-effective strategy from both the healthcare system and societal perspectives (including reducing sick leave)?
This study represents the quantitative phase of the mixed-methods Q-EPICAP study. Researchers will compare three parallel groups across 23 primary care centers to determine the most effective and efficient treatment strategy.
Participants will:
Receive one of three assigned treatments: blind anatomical infiltration (Group I), ultrasound-guided infiltration (Group UI), or standard oral drug therapy (Group P).
Attend follow-up assessments at baseline and at 15, 30, 90, and 180 days after the initial intervention.
Complete questionnaires to assess pain intensity (Visual Analog Scale), upper limb function (ASES or Boston Disability Assessment Questionnaire), and quality of life (EQ-5D-5L).
Provide data on medical resource utilization and sick leave to assess socioeconomic costs.
연구 개요
상태
상태
모집하지 않고 적극적으로
정황
정황
개입 / 치료
개입 / 치료
상세 설명
Upper extremity pathologies, particularly subacromial impingement syndrome (SAS) and carpal tunnel syndrome (CTS), represent a significant clinical and socioeconomic burden for primary care systems, primarily due to functional disability and prolonged sick leave.
Although corticosteroid injections are frequently used, traditional blind injections guided by anatomical landmarks often lack anatomical precision. Point-of-care ultrasound-guided injections offer greater accuracy and better short-term clinical outcomes; however, their cost-effectiveness in routine clinical practice has not yet been adequately assessed.
This pragmatic, prospective, multicenter, cluster-randomized clinical trial includes 23 participating primary care centers (clusters) in Lleida, Spain, with a 6-month longitudinal follow-up. This study constitutes the quantitative phase of the mixed-methods Q-EPICAP project.
A total of 225 adult patients diagnosed with SAS or CTS and presenting with baseline pain (VAS ≥ 3) were divided into three parallel groups:
- Group I: Anatomical landmark-guided infiltration.
- Group UI: Ultrasound-guided infiltration performed by family physicians.
- Group P: Standard oral pharmacological treatment.
Data collection was performed at baseline and at 15, 30, 90, and 180 days post-intervention. The primary outcome measure was pain intensity (VAS). Secondary outcomes included upper limb function (ASES and Boston questionnaires), health-related quality of life (EQ-5D-5L), and a comprehensive economic evaluation (cost-effectiveness and cost-utility indices) that integrates the perspectives of healthcare systems and society.
연구 유형
연구 유형
중재적
등록 (추정된)
등록
225
단계
단계
- 4단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Lleida
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Lleida, Lleida, 스페인, 25100
- Instituto Universitario de Investigación en Atención Primaria (IDIAP Jordi Gol)
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- Patients aged 18 years or older presenting in primary care. Clinical diagnosis of subacromial impingement syndrome (shoulder pain from tendon compression) or carpal tunnel syndrome (wrist nerve compression). Moderate to severe pain intensity, defined as a score of greater than or equal to 3 on the Visual Analog Scale (VAS >= 3) at baseline. Patient must understand the study procedures and provide written informed consent.
Exclusion Criteria:
- Previous corticosteroid infiltration in the target joint/structure within the last 6 months. History of major trauma, active infection, or previous surgery in the affected shoulder or wrist. Underlying systemic inflammatory diseases (for example, rheumatoid arthritis, polymyalgia rheumatica). Known hypersensitivity or contraindications to corticosteroids (Betamethasone) or local anesthetics (Mepivacaine). Pregnancy or breastfeeding. Red flags suggesting tumor, fracture, or severe neurological deficit.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
팔의 수
3
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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활성 비교기: Standard Oral Treatment
Patients in this cohort are treated exclusively with standard systemic oral drug treatment of routine clinical practice and physiotherapy recommendations according to established clinical guidelines, without receiving local procedures.
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Prescription of systemic oral pharmacological treatment according to standard clinical practice and guidelines, which may include individual or combined use of the following therapies, or no pharmacological prescription if deemed appropriate by the clinician:
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활성 비교기: Conventional Infiltration
Patients in this cohort receive a corticosteroid infiltration, blinded to anatomical landmarks, for subacromial impingement syndrome or carpal tunnel syndrome, administered by primary care physicians following standard clinical practice.
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Local infiltration consisting of a combination of a corticosteroid and a local anesthetic, administered in a 1:1 volume ratio (1 ml + 1 ml, total volume 2 ml):
In the Conventional Infiltration group, the solution is injected using the standard anatomical landmark technique (blind technique). |
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활성 비교기: Ultrasound-Guided Infiltration
Patients in this cohort receive an ultrasound-guided corticosteroid infiltration, performed by advanced-trained primary care physicians, ensuring anatomical accuracy during the procedure, and following standard clinical practice.
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Local infiltration consisting of a combination of a corticosteroid and a local anesthetic, administered in a 1:1 volume ratio (1 ml + 1 ml, total volume 2 ml):
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change from Baseline in Pain Intensity using the Visual Analog Scale (VAS)
기간: Baseline (Day 0), 3 months, 6 months, and 9 months post-intervention.
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Pain intensity will be assessed using the Visual Analog Scale (VAS), where patients rate their pain on a line from 0 (no pain) to 10 (worst possible pain).
The primary endpoint is the change in the score from baseline to 3, 6, and 9 months.
Higher scores indicate greater pain intensity.
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Baseline (Day 0), 3 months, 6 months, and 9 months post-intervention.
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change from Baseline in Shoulder Function using the American Shoulder and Elbow Surgeons (ASES) Score
기간: Baseline (Day 0), 3, 6, and 9 months post-intervention.
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The ASES score evaluates shoulder pain and activities of daily living.
It consists of a patient-reported section (10 items) and a clinical assessment.
The total score ranges from 0 to 100, where 100 indicates better shoulder function and less pain.
We will assess the change in this score relative to baseline.
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Baseline (Day 0), 3, 6, and 9 months post-intervention.
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Change from Baseline in Carpal Tunnel Symptoms and Function using the Boston Carpal Tunnel Questionnaire (BCTQ)
기간: Baseline (Day 0), 3, 6, and 9 months post-intervention.
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The BCTQ consists of two scales: the Symptom Severity Scale (11 items) and the Functional Status Scale (8 items).
Each item is scored from 1 (mildest) to 5 (most severe).
The final score is the average of the responses.
Higher scores indicate more severe symptoms and greater functional impairment.
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Baseline (Day 0), 3, 6, and 9 months post-intervention.
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Change from Baseline in Health-Related Quality of Life (EQ-5D-5L)
기간: Baseline (Day 0), 3, 6, and 9 months post-intervention.
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The EQ-5D-5L questionnaire assesses 5 dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) across 5 levels of severity.
It also includes a Visual Analog Scale (EQ-VAS) from 0 (worst imaginable health) to 100 (best imaginable health).
Higher index values and VAS scores represent better health status.
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Baseline (Day 0), 3, 6, and 9 months post-intervention.
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
스폰서
협력자
협력자
수사관
수사관
- 수석 연구원: Marta Ortega Bravo, MD, PhD, Institut Català de la Salut. Instituto Universitario de Investigación en Atención Primaria (IDIAP Jordi Gol)
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
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- Luime JJ, Koes BW, Hendriksen IJ, Burdorf A, Verhagen AP, Miedema HS, Verhaar JA. Prevalence and incidence of shoulder pain in the general population; a systematic review. Scand J Rheumatol. 2004;33(2):73-81. doi: 10.1080/03009740310004667.
- Silverstein BA, Viikari-Juntura E, Fan ZJ, Bonauto DK, Bao S, Smith C. Natural course of nontraumatic rotator cuff tendinitis and shoulder symptoms in a working population. Scand J Work Environ Health. 2006 Apr;32(2):99-108. doi: 10.5271/sjweh.985.
- Genova A, Dix O, Saefan A, Thakur M, Hassan A. Carpal Tunnel Syndrome: A Review of Literature. Cureus. 2020 Mar 19;12(3):e7333. doi: 10.7759/cureus.7333.
- Raja SN, Carr DB, Cohen M, Finnerup NB, Flor H, Gibson S, Keefe FJ, Mogil JS, Ringkamp M, Sluka KA, Song XJ, Stevens B, Sullivan MD, Tutelman PR, Ushida T, Vader K. The revised International Association for the Study of Pain definition of pain: concepts, challenges, and compromises. Pain. 2020 Sep 1;161(9):1976-1982. doi: 10.1097/j.pain.0000000000001939.
- Urwin M, Symmons D, Allison T, Brammah T, Busby H, Roxby M, Simmons A, Williams G. Estimating the burden of musculoskeletal disorders in the community: the comparative prevalence of symptoms at different anatomical sites, and the relation to social deprivation. Ann Rheum Dis. 1998 Nov;57(11):649-55. doi: 10.1136/ard.57.11.649.
- Roel-Valdes J, Arizo-Luque V, Ronda-Perez E. [Epidemiology of occupationally-caused carpal tunnel syndrome in the province of Alicante, Spain 1996-2004]. Rev Esp Salud Publica. 2006 Jul-Aug;80(4):395-409. doi: 10.1590/s1135-57272006000400009. Spanish.
- Cunnington J, Marshall N, Hide G, Bracewell C, Isaacs J, Platt P, Kane D. A randomized, double-blind, controlled study of ultrasound-guided corticosteroid injection into the joint of patients with inflammatory arthritis. Arthritis Rheum. 2010 Jul;62(7):1862-9. doi: 10.1002/art.27448.
- Reid KJ, Harker J, Bala MM, Truyers C, Kellen E, Bekkering GE, Kleijnen J. Epidemiology of chronic non-cancer pain in Europe: narrative review of prevalence, pain treatments and pain impact. Curr Med Res Opin. 2011 Feb;27(2):449-62. doi: 10.1185/03007995.2010.545813. Epub 2011 Jan 3.
- Teunis T, Lubberts B, Reilly BT, Ring D. A systematic review and pooled analysis of the prevalence of rotator cuff disease with increasing age. J Shoulder Elbow Surg. 2014 Dec;23(12):1913-1921. doi: 10.1016/j.jse.2014.08.001.
- Jolly M, Curran JJ. Underuse of intra-articular and periarticular corticosteroid injections by primary care physicians: discomfort with the technique. J Clin Rheumatol. 2003 Jun;9(3):187-92. doi: 10.1097/01.RHU.0000073587.90836.23.
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- Soh E, Li W, Ong KO, Chen W, Bautista D. Image-guided versus blind corticosteroid injections in adults with shoulder pain: a systematic review. BMC Musculoskelet Disord. 2011 Jun 25;12:137. doi: 10.1186/1471-2474-12-137.
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연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
연구 시작
2026년 6월 1일
기본 완료 (추정된)
기본 완료
2027년 12월 31일
연구 완료 (추정된)
연구 완료
2028년 6월 30일
연구 등록 날짜
최초 제출
최초 제출
2026년 7월 2일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2026년 7월 2일
처음 게시됨 (실제)
처음 게시됨
2026년 7월 9일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
2026년 7월 9일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 2일
마지막으로 확인됨
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- code 22/050-EOm
- PROJ-22/13 (기타 보조금/기금 번호: Jordi Gol Primary Care Research Institute (IDIAPJGol))
- PIC-26/7 (기타 보조금/기금 번호: Jordi Gol Primary Care Research Institute (IDIAPJGol))
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
Anonymized individual participant data that support the results to be published in the future will be available to qualified researchers who reasonably request them for academic research purposes.
Data sharing will be subject to a formal request to the corresponding author, approval from the Institutional Ethics Committee, and the signing of a data access agreement.
IPD 공유 기간
Data will be available beginning 12 months after publication of the main results in the scientific journal and will remain accessible for a period of 3 years.
IPD 공유 액세스 기준
- Who: Qualified academic researchers with a methodologically sound proposal and approved institutional affiliation.
- What: Anonymized individual participant data (IPDs) that support the primary results, along with the Study Protocol and Statistical Analysis Plan (SAP).
- How: Access requests must be formally submitted via email to the corresponding author. To obtain the data, the requester must obtain approval from their own Institutional Ethics Committee and sign a legally binding Data Access Agreement to ensure data confidentiality and guarantee that the data will only be used for the approved research purpose.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .