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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.
Sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Summary
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
225
Start Date
2026-06-01
Completion Date
2028-06-30
Last Updated
2026-07-09
Healthy Volunteers
No
Interventions
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).
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).
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).
Locations (1)
Instituto Universitario de Investigación en Atención Primaria (IDIAP Jordi Gol)
Lleida, Lleida, Spain