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.

NCT07692516 | Active Not Recruiting Phase 4

• 3 other identifiers: code 22/050-EOmPROJ-22/13PIC-26/7
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Carpal Tunnel Syndrome (CTS); Subacromial Impingement Syndrome; Pain Management

Keywords

Primary care; Ultrasound-guided infiltration; corticosteroid injection; Pragmatic clinical trial; Cost-effectiveness; Musculoskeletal diseases

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Pain Intensity using the Visual Analog Scale (VAS)

  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 Outcomes (3)

• Change from Baseline in Shoulder Function using the American Shoulder and Elbow Surgeons (ASES) Score

  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)

  Baseline (Day 0), 3, 6, and 9 months post-intervention.

• Change from Baseline in Health-Related Quality of Life (EQ-5D-5L)

  Baseline (Day 0), 3, 6, and 9 months post-intervention.

Study Arms (3)

Standard Oral Treatment

ACTIVE COMPARATOR

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

Conventional Infiltration

ACTIVE COMPARATOR

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

Ultrasound-Guided Infiltration

ACTIVE COMPARATOR

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

Interventions

Standard Oral Treatment DRUG

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).

Standard Oral Treatment

Conventional Infiltration DRUG

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).

Conventional Infiltration

Ultrasound-Guided Infiltration DRUG

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).

Ultrasound-Guided Infiltration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut Català de la Salut: collaborator
• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina: lead
• Diputació de Lleida: collaborator

Study Sites (1)

Instituto Universitario de Investigación en Atención Primaria (IDIAP Jordi Gol)

Lleida, Lleida, 25100, Spain

Location

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Related Links

• Schiebinger L. Gendered Innovations in Science, Health\&Medicine, Engineering, and Environment \[Internet\]. European Union, 2011, 2020

MeSH Terms

Conditions

Shoulder Impingement Syndrome; Carpal Tunnel Syndrome; Agnosia; Musculoskeletal Diseases

Condition Hierarchy (Ancestors)

Joint Diseases; Shoulder Injuries; Wounds and Injuries; Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marta Ortega Bravo, MD, PhD

  Institut Català de la Salut. Instituto Universitario de Investigación en Atención Primaria (IDIAP Jordi Gol)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Due to the nature of the interventions (ultrasound-guided infiltration versus conventional infiltration guided by anatomical landmarks versus oral pharmacological treatment), it is impossible to blind the family physicians performing the procedures. However, a single-blind design is maintained for the participants (patients), who are unaware of the alternative pharmacological or procedural strategies assigned to other groups. To minimize bias, outcome assessments and data analysis will be performed by researchers or statistical evaluators independent of the clinical intervention and unaware of the treatment groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Care Physician and Researcher

Study Record Dates

• First Submitted: July 2, 2026
• First Posted: July 9, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: July 9, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• 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.

Locations

ES (1)