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)

July 2, 2026 updated by: 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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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:

  1. Group I: Anatomical landmark-guided infiltration.
  2. Group UI: Ultrasound-guided infiltration performed by family physicians.
  3. 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.

Study Type

Interventional

Enrollment (Estimated)

225

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Lleida
      • Lleida, Lleida, Spain, 25100
        • Instituto Universitario de Investigación en Atención Primaria (IDIAP Jordi Gol)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Drug: Standard Oral Treatment

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:

  1. Non-steroidal anti-inflammatory drugs (NSAIDs): Ibuprofen (400 mg or 600 mg), Naproxen (500 mg or 550 mg), or Dexketoprofen (25 mg).
  2. Non-opioid analgesics: Paracetamol (500 mg, 650 mg, or 1 g) or Metamizole (575 mg).
  3. Step 2 weak opioids: Tramadol (50 mg, 100 mg, or 200 mg).
  4. Co-analgesics for neuropathic pain components: Gabapentin (300 mg, 400 mg, or 600 mg).
Active Comparator: 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.
Drug: Conventional Infiltration

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):

  1. Corticosteroid: Betamethasone (administered as 1 ml of solution).
  2. Local anesthetic: Mepivacaine (administered as 1 ml of solution).

In the Conventional Infiltration group, the solution is injected using the standard anatomical landmark technique (blind technique).
Active Comparator: 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.
Drug: Ultrasound-Guided Infiltration

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):

  1. Corticosteroid: Betamethasone (administered as 1 ml of solution).
  2. Local anesthetic: Mepivacaine (administered as 1 ml of solution). In the Ultrasound-Guided Infiltration group, 1 ml of betamethasone + 1 ml of mepivacaine are administered under real-time ultrasound guidance to ensure precise deposition in the target anatomical structure (subacromial space or carpal tunnel).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Pain Intensity using the Visual Analog Scale (VAS)
Time Frame: 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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Shoulder Function using the American Shoulder and Elbow Surgeons (ASES) Score
Time Frame: 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)
Time Frame: 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)
Time Frame: 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Collaborators

Institut Català de la Salut
Diputació de Lleida

Investigators

  • Principal Investigator: Marta Ortega Bravo, MD, PhD, Institut Català de la Salut. Instituto Universitario de Investigación en Atención Primaria (IDIAP Jordi Gol)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

June 30, 2028

Study Registration Dates

First Submitted

July 2, 2026

First Submitted That Met QC Criteria

July 2, 2026

First Posted (Actual)

July 9, 2026

Study Record Updates

Last Update Posted (Actual)

July 9, 2026

Last Update Submitted That Met QC Criteria

July 2, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • code 22/050-EOm
  • PROJ-22/13 (Other Grant/Funding Number: Jordi Gol Primary Care Research Institute (IDIAPJGol))
  • PIC-26/7 (Other Grant/Funding Number: Jordi Gol Primary Care Research Institute (IDIAPJGol))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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 Sharing Time Frame

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 Sharing Access Criteria

  • 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 Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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