Subacromial Impingement SyndromePhase 4Q-EPICAPNCT07692516

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.

A Phase 4 study testing Standard Oral Treatment, Conventional Infiltration and Ultrasound-Guided Infiltration in people with Subacromial Impingement Syndrome and Carpal Tunnel Syndrome (CTS), run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Subacromial Impingement Syndrome, Carpal Tunnel Syndrome (CTS), Pain Management
What is being tested?: Standard Oral Treatment, Conventional Infiltration and Ultrasound-Guided Infiltration
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 225 participants
Where: 1 siteSpain
Study dates: 1 Jun 2026to 30 Jun 2028
Phase: Phase 4
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

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

Other trials in Spain

About this study

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.

Read the 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:

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.

Conditions: Subacromial Impingement Syndrome, Carpal Tunnel Syndrome (CTS), Pain Management
Being tested: Standard Oral Treatment, Conventional Infiltration, Ultrasound-Guided Infiltration
Keywords: Primary care, Ultrasound-guided infiltration, corticosteroid injection, Pragmatic clinical trial, Cost-effectiveness, Musculoskeletal diseases
Medical subject headings: Shoulder Impingement Syndrome, Carpal Tunnel Syndrome, Agnosia, Musculoskeletal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Standard Oral TreatmentDrug
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 InfiltrationDrug
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 InfiltrationDrug
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).

Study groups in NCT07692516
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: Drug: Ultrasound-Guided Infiltration

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
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.
Measured: 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)
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.
Measured: Baseline (Day 0), 3, 6, and 9 months post-intervention.
Change from Baseline in Health-Related Quality of Life (EQ-5D-5L)
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.
Measured: Baseline (Day 0), 3, 6, and 9 months post-intervention.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 202630 Jun 2028

First posted9 Jul 2026
Study start1 Jun 2026
Primary completion31 Dec 2027 (estimated)
Study completion30 Jun 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (21)Papers the sponsor has linked to this study.
Other trials for Subacromial Impingement SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 225 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07692516
Sponsor's protocol ID: code 22/050-EOm
Other IDs: PROJ-22/13, PIC-26/7
Acronym: Q-EPICAP
Status last verified: Jul 2026
First submitted: 2 Jul 2026
Last updated: 9 Jul 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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.

Publications

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.
PubMed 32694387
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.
PubMed 17041456
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.
PubMed 16507288
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.
PubMed 21702969
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.
PubMed 26402316
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.
PubMed 20222114
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.
PubMed 25441568
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.
PubMed 30343858
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.
PubMed 21612965
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.
PubMed 14665809
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.
PubMed 21194394
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.
PubMed 33482782
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.
PubMed 9924205
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.
PubMed 15163107
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.
PubMed 10411203

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Subacromial Impingement Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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.
ClinicalTrials.gov ID: NCT07692516
Acronym / sponsor ID: Q-EPICAP / code 22/050-EOm
Conditions: Subacromial Impingement Syndrome, Carpal Tunnel Syndrome (CTS), Pain Management
Keywords: Primary care, Ultrasound-guided infiltration, corticosteroid injection, Pragmatic clinical trial, Cost-effectiveness, Musculoskeletal diseases
Phase: Phase 4
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 225 participants (estimated)
Lead sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
Collaborators: Institut Català de la Salut, Diputació de Lleida
Study start: 1 Jun 2026 (actual)
Primary completion: 31 Dec 2027 (estimated)
Study completion: 30 Jun 2028 (estimated)
First posted: 9 Jul 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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)?

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.

Detailed description

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 3

Arm	Type	Receives
Standard Oral Treatment	Active comparator	Drug: Standard Oral TreatmentPatients 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.
Conventional Infiltration	Active comparator	Drug: Conventional InfiltrationPatients 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.
Ultrasound-Guided Infiltration	Active comparator	Drug: Ultrasound-Guided InfiltrationPatients 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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.

Key exclusion criteria (1 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Standard Oral TreatmentPrescription 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).	Drug	Standard Oral Treatment
Conventional InfiltrationLocal 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).	Drug	Conventional Infiltration
Ultrasound-Guided InfiltrationLocal 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).	Drug	Ultrasound-Guided Infiltration

Primary outcome

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.

3 secondary outcomes

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.
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.
Change from Baseline in Health-Related Quality of Life (EQ-5D-5L)
Time frame: Baseline (Day 0), 3, 6, and 9 months post-intervention.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
Background: PubMed 32694387Raja 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.
Background: PubMed 17041456Jolly 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.
Background: PubMed 16507288Lopez-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.
Background: PubMed 21702969Soh 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.
Background: PubMed 26402316Korbe 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.
Background: PubMed 20222114Cunnington 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.
Background: PubMed 25441568Teunis 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.
Background: PubMed 30343858Chesterton 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.
Background: PubMed 21612965Zufferey 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.
Background: PubMed 14665809Stewart 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.
Background: PubMed 21194394Reid 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.
Background: PubMed 33482782Garnaes 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.
Schiebinger L. Gendered Innovations in Science, Health\&Medicine, Engineering, and Environment \[Internet\]. European Union, 2011, 2020Link provided by the sponsor.
Individual participant dataSharing planned: Yes. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Marta Ortega Bravo, MD, PhD principal investigator

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07692516, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.