Tato stránka byla automaticky přeložena a přesnost překladu není zaručena. Podívejte se prosím na anglická verze pro zdrojový text.

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

31. srpna 2026 aktualizováno: 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?

Přehled studie

Detailní popis

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.

Typ studie

Pozorovací

Zápis (Odhadovaný)

134

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

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

Popis

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)

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
Intervence / Léčba
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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in pain between baseline and four weeks after corticosteroid injection as measured by the Visual Analog Scale (VAS)
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in pain between baseline and ten minutes after corticosteroid injection as measured by the Visual Analog Scale (VAS)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Vyšetřovatelé

  • Vrchní vyšetřovatel: Thomas Sørensen, PT, Cand.san, University of Southern Denmark
  • Ředitel studie: kim G Ingwersen, PT, PhD, University of Southern Denmark
  • Studijní židle: Claus Varnum, Prof., PhD, MD, University of Southern Denmark
  • Studijní židle: Henrik B Vægter, Prof., PT, PhD, Odense University Hospital and University of Southern Denmark

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

15. září 2026

Primární dokončení (Odhadovaný)

30. září 2028

Dokončení studie (Odhadovaný)

30. listopadu 2028

Termíny zápisu do studia

První předloženo

25. srpna 2026

První předloženo, které splnilo kritéria kontroly kvality

25. srpna 2026

První zveřejněno (Aktuální)

28. srpna 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

2. září 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

31. srpna 2026

Naposledy ověřeno

1. srpna 2026

Více informací

Termíny související s touto studií

Další identifikační čísla studie

  • The Nap SAPS CSI study
  • 2024-0039 (Jiné číslo grantu/financování: Research Council of Lillebaelt Hospital)
  • 2024-0242 (Jiné číslo grantu/financování: The Region of Southern Denmark)
  • 2025-0023 (Jiné číslo grantu/financování: Research Council of Lillebaelt Hospital)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu 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.

Časový rámec sdílení IPD

Data will be available after publication of the study.

Kritéria přístupu pro sdílení IPD

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

Typ podpůrných informací pro sdílení IPD

  • PROTOKOL STUDY
  • MÍZA
  • ICF
  • ANALYTIC_CODE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Předplatit