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Pain Phenotype and Response to Corticosteroid Injection in Patients With Subacromial Pain Syndrome (SAPS) (NAP SAPS CSI)

31 agosto 2026 aggiornato da: Vejle Hospital

Association Between Pain Phenotype and Change in Pain Following Routine Corticosteroid Injection in Patients With Subacromial Pain Syndrome - A Prospective Cohort Study.

The goal of this prospective cohort study is to investigate whether pain phenotype is associated with subsequent change in pain intensity after corticosteroid injection given as part of routine care in patients diagnosed with SAPS.

The main question it aims to answer is:

Does change in shoulder pain from baseline to 4 weeks after corticosteroid injection differ between patients classified as having a nociplastic pain phenotype and those classified as having a non-nociplastic pain phenotype?

Panoramica dello studio

Descrizione dettagliata

This study is part of a larger study investigating the prevalence of nociplastic pain phenotype according to the International Association for the Study of Pain (IASP) clinical criteria (The NAP SAPS Study). This prospective cohort component includes participants with SAPS who receive a corticosteroid shoulder injection as part of routine clinical care.

Musculoskeletal pain poses a significant burden on individuals and society. The IASP describes different pain mechanisms, including nociceptive, neuropathic and nociplastic pain. Identification of different pain mechanisms may be relevant for understanding pain presentation and variation in treatment response among patients with musculoskeletal pain.

Shoulder pain ranks among the most prevalent musculoskeletal complaints, with subacromial pain syndrome (SAPS) ranking highest, and serves as a common diagnosis for non-traumatic shoulder pain.

Exercise and other conservative treatments, including corticosteroid injection, are commonly used in the management of SAPS. However, a substantial proportion of patients experience limited or transient treatment effects and may develop persistent shoulder pain. Differences in underlying pain mechanisms may contribute to variation in treatment response among patients with SAPS. Corticosteroid injection is primarily used to target local inflammatory and nociceptive processes, and differences in pain phenotype may therefore be associated with variation in response to treatment. Emerging evidence suggests that altered pain processing may also be present in patients with shoulder pain, supporting the investigation of whether pain phenotype is associated with treatment response.

Clinical criteria have been proposed to identify different pain mechanisms in musculoskeletal pain conditions. The IASP clinical criteria for nociplastic pain provide a structured approach to classifying patients based on clinical features.

However, the possible association between pain response following corticosteroid injection and classification according to the IASP clinical criteria for nociplastic pain has, to our knowledge, not been sufficiently investigated among patients with SAPS.

The overall objective is to investigate the association between pain phenotype, classified according to the IASP clinical criteria for nociplastic pain, and subsequent change in pain intensity four weeks after corticosteroid injection.

Primary hypothesis: Patients classified as having a nociplastic pain phenotype will demonstrate a significantly smaller mean reduction in pain intensity (VAS) from baseline to four weeks after corticosteroid injection compared with patients classified as having a non-nociplastic pain phenotype.

Secondary hypothesis: A significantly lower proportion of patients classified as having a nociplastic pain phenotype will achieve a reduction of at least 2 points on the VAS four weeks after corticosteroid injection compared with patients classified as having a non-nociplastic pain phenotype.

Tipo di studio

Osservativo

Iscrizione (Stimato)

134

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

Patients referred to and evaluated at the specialised shoulder clinic at Vejle Hospital, Denmark

Descrizione

Inclusion Criteria:

  1. Diagnosed with SAPS (dm751, dm753, dm754, dm755
  2. Shoulder pain ≥ 3 months
  3. ≥ 3 out of 5 specific shoulder test
  4. Age 18-70 years
  5. Increased pain during active arm elevation
  6. Pain during active elevation ≥ 3 (VAS)
  7. Receving a corticosteroid injection based on routine clinical proctice

Exclusion Criteria:

  1. Severe visual impairment
  2. Epilepsy
  3. Severe cognitive or physical impairment
  4. Language barrier (Danish)
  5. Receving a corticosteroid injection at a site other than the subacromial bursa (e.g. acromioclavicular joint or intra-articular injection)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
Patients diagnosed with SubAcromial Pain Syndrome (SAPS)
Patients with SAPS will be classified according to the IASP criteria for nociplastic pain as having either nociplastic or non-nociplastic pain phenotype

Participants undergo a standardised clinical assessment including medical history, specific orthopedic shoulder test, diagnostic ultrasound and x-ray of the shoulder.

Participants are included in this cohort only if they receive a corticosteroid injection as part of usual clinical care. The decision to administer the corticosteroid injection, is made part of usual clinical care and is independent of participation in the study.

All corticosteroid injections are administered by experienced clinicians under ultrasound-guidance into the subacromial bursa.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in pain between baseline and four weeks after corticosteroid injection as measured by the Visual Analog Scale (VAS)
Lasso di tempo: 4 weeks
Pain intensity will be assessed with Visual Analog Scale. Participants will score from 0 (no pain) to 100 (the worst pain they have ever experienced)
4 weeks

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in pain between baseline and ten minutes after corticosteroid injection as measured by the Visual Analog Scale (VAS)
Lasso di tempo: 10 minutes
Pain intensity will be assessed with Visual Analog Scale. Participants will score from 0 (no pain) to 100 (the worst pain they have ever experienced)
10 minutes
Change in pain between baseline and twelve weeks after corticosteroid injection as measured by the Visual Analog Scale (VAS)
Lasso di tempo: 12 weeks
Pain intensity will be assessed with Visual Analog Scale (VAS). Participants will score from 0 (no pain) to 100 (the worst pain they have ever experienced)
12 weeks
Change in Shoulder Function between baseline and four weeks after corticosteroid injection as measured by the QuickDASH
Lasso di tempo: 4 weeks
QuickDASH is a self-reported questionnaire and it will be used to assess shoulder function. Scoring range from 0 (no disability) to 100 (most severe disability)
4 weeks
Change in Shoulder Function between baseline and twelve weeks after corticosteroid injection as measured by the QuickDASH
Lasso di tempo: 12 weeks
QuickDASH is a self-reported questionnaire and it will be used to assess shoulder function. Scoring range from 0 (no disability) to 100 (most severe disability)
12 weeks
Proportion of patients with nociplastic and non-nociplastic pain phenotype achieving a Patient Acceptable Symptom State (PASS) four weeks after corticosteroid injection as measured by the PASS questionnaire.
Lasso di tempo: 4 weeks
PASS will be assessed with the following question: "Taking into account all the activities you have during your daily life, your level of pain, and also your functional impairment, do you consider that your current state is satisfactory"
4 weeks
Proportion of patients with nociplastic and non-nociplastic pain phenotype achieving a Patient Acceptable Symptom State (PASS) twelve weeks after corticosteroid injection as measured by the PASS questionnaire.
Lasso di tempo: 12 weeks
PASS will be assessed with the following question: "Taking into account all the activities you have during your daily life, your level of pain, and also your functional impairment, do you consider that your current state is satisfactory"
12 weeks
Proportion af patients with nociplastic and non-nociplastic pain phenotype reporting a clinically relevant improvement in Global Perceived Effect (GPE) four weeks after corticosteroid injection as measured by the GPE scale.
Lasso di tempo: 4 weeks
The GPE will be assessed for shoulder function and shoulder pain on a 15 point Likert scanle ranging from "a very great deal worse"(worst) to "a very great deal better"(best)
4 weeks
Proportion af patients with nociplastic and non-nociplastic pain phenotype reporting a clinically relevant improvement in Global Perceived Effect (GPE) twelve weeks after corticosteroid injection as measured by the GPE scale.
Lasso di tempo: 12 weeks
The GPE will be assessed for shoulder function and shoulder pain on a 15 point Likert scanle ranging from "a very great deal worse"(worst) to "a very great deal better"(best)
12 weeks

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Investigatori

  • Investigatore principale: Thomas Sørensen, PT, Cand.san, University of Southern Denmark
  • Direttore dello studio: kim G Ingwersen, PT, PhD, University of Southern Denmark
  • Cattedra di studio: Claus Varnum, Prof., PhD, MD, University of Southern Denmark
  • Cattedra di studio: Henrik B Vægter, Prof., PT, PhD, Odense University Hospital and University of Southern Denmark

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

15 settembre 2026

Completamento primario (Stimato)

30 settembre 2028

Completamento dello studio (Stimato)

30 novembre 2028

Date di iscrizione allo studio

Primo inviato

25 agosto 2026

Primo inviato che soddisfa i criteri di controllo qualità

25 agosto 2026

Primo Inserito (Effettivo)

28 agosto 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

2 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

31 agosto 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • The Nap SAPS CSI study
  • 2024-0039 (Altro numero di sovvenzione/finanziamento: Research Council of Lillebaelt Hospital)
  • 2024-0242 (Altro numero di sovvenzione/finanziamento: The Region of Southern Denmark)
  • 2025-0023 (Altro numero di sovvenzione/finanziamento: Research Council of Lillebaelt Hospital)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

Anonymised patient-level data for the primary objective and explorative outcome will be made available if required by the scientific journal, in which the results of the study are publiched.

Periodo di condivisione IPD

Data will be available after publication of the study.

Criteri di accesso alla condivisione IPD

Data access will be reviewed by the author group. Requestors will be required to sign a Data Access Agreement.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • ICF
  • CODICE_ANALITICO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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