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)
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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- フェーズ 4
連絡先と場所
研究場所
-
-
Lleida
-
Lleida、Lleida、スペイン、25100
- Instituto Universitario de Investigación en Atención Primaria (IDIAP Jordi Gol)
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：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.
|
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:
|
|
アクティブコンパレータ：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.
|
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). |
|
アクティブコンパレータ：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.
|
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):
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change from Baseline in Pain Intensity using the Visual Analog Scale (VAS)
時間枠：Baseline (Day 0), 3 months, 6 months, and 9 months post-intervention.
|
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.
|
Baseline (Day 0), 3 months, 6 months, and 9 months post-intervention.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change from Baseline in Shoulder Function using the American Shoulder and Elbow Surgeons (ASES) Score
時間枠：Baseline (Day 0), 3, 6, and 9 months post-intervention.
|
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.
|
Baseline (Day 0), 3, 6, and 9 months post-intervention.
|
|
Change from Baseline in Carpal Tunnel Symptoms and Function using the Boston Carpal Tunnel Questionnaire (BCTQ)
時間枠：Baseline (Day 0), 3, 6, and 9 months post-intervention.
|
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.
|
Baseline (Day 0), 3, 6, and 9 months post-intervention.
|
|
Change from Baseline in Health-Related Quality of Life (EQ-5D-5L)
時間枠：Baseline (Day 0), 3, 6, and 9 months post-intervention.
|
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.
|
Baseline (Day 0), 3, 6, and 9 months post-intervention.
|
協力者と研究者
捜査官
- 主任研究者：Marta Ortega Bravo, MD, PhD、Institut Català de la Salut. Instituto Universitario de Investigación en Atención Primaria (IDIAP Jordi Gol)
出版物と役立つリンク
一般刊行物
- Chesterton LS, Blagojevic-Bucknall M, Burton C, Dziedzic KS, Davenport G, Jowett SM, Myers HL, Oppong R, Rathod-Mistry T, van der Windt DA, Hay EM, Roddy E. The clinical and cost-effectiveness of corticosteroid injection versus night splints for carpal tunnel syndrome (INSTINCTS trial): an open-label, parallel group, randomised controlled trial. Lancet. 2018 Oct 20;392(10156):1423-1433. doi: 10.1016/S0140-6736(18)31572-1.
- 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.
- Lopez-Marina V, Pizarro-Romero G, Costa-Bardaji N, Mata-Navarro A, Vazquez-Blanco JR. [Evaluation of infiltrations performed in primary care]. Aten Primaria. 2005 Dec;36(10):544-9. doi: 10.1016/s0212-6567(05)70564-3. Spanish.
- 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.
- Korbe S, Udoji EN, Ness TJ, Udoji MA. Ultrasound-guided interventional procedures for chronic pain management. Pain Manag. 2015;5(6):465-82. doi: 10.2217/pmt.15.46. Epub 2015 Sep 24.
- Zufferey P, Revaz S, Degailler X, Balague F, So A. A controlled trial of the benefits of ultrasound-guided steroid injection for shoulder pain. Joint Bone Spine. 2012 Mar;79(2):166-9. doi: 10.1016/j.jbspin.2011.04.001. Epub 2011 May 25.
- Stewart WF, Ricci JA, Chee E, Morganstein D. Lost productive work time costs from health conditions in the United States: results from the American Productivity Audit. J Occup Environ Med. 2003 Dec;45(12):1234-46. doi: 10.1097/01.jom.0000099999.27348.78.
- Garnaes KK, Morkved S, Salvesen O, Tonne T, Furan L, Gronhaug G, Vasseljen O, Johannessen HH. What factors are associated with health-related quality of life among patients with chronic musculoskeletal pain? A cross-sectional study in primary health care. BMC Musculoskelet Disord. 2021 Jan 22;22(1):102. doi: 10.1186/s12891-020-03914-x.
- Franzblau A, Werner RA. What is carpal tunnel syndrome? JAMA. 1999 Jul 14;282(2):186-7. doi: 10.1001/jama.282.2.186. No abstract available.
- Witten A, Barfod KW, Thorborg K, Foverskov M, Clausen MB. [Subacromial impingement syndrome]. Ugeskr Laeger. 2019 Apr 1;181(14):V03180215. Danish.
- Burger M, Africa C, Droomer K, Norman A, Pheiffe C, Gericke A, Samsodien A, Miszewski N. Effect of corticosteroid injections versus physiotherapy on pain, shoulder range of motion and shoulder function in patients with subacromial impingement syndrome: A systematic review and meta-analysis. S Afr J Physiother. 2016 Sep 27;72(1):318. doi: 10.4102/sajp.v72i1.318. eCollection 2016.
- Karcz WM, Artigues-Barbera E, Ortega Bravo M, Pooler Perea A, Palacin Peruga JM, Gimeno Pi I. Assessment of Pain Treatments in Disorders of Upper Limbs: A Qualitative Study Protocol Based on Patients' Experiences. Nurs Rep. 2023 May 22;13(2):803-810. doi: 10.3390/nursrep13020070.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- code 22/050-EOm
- PROJ-22/13 (その他の助成金/資金番号：Jordi Gol Primary Care Research Institute (IDIAPJGol))
- PIC-26/7 (その他の助成金/資金番号：Jordi Gol Primary Care Research Institute (IDIAPJGol))
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
IPD 共有時間枠
IPD 共有アクセス基準
- 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 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。