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

31 sierpnia 2026 zaktualizowane przez: 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?

Przegląd badań

Szczegółowy opis

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 studiów

Obserwacyjny

Zapisy (Szacowany)

134

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

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

Opis

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)

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
Interwencja / Leczenie
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 mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change in pain between baseline and four weeks after corticosteroid injection as measured by the Visual Analog Scale (VAS)
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change in pain between baseline and ten minutes after corticosteroid injection as measured by the Visual Analog Scale (VAS)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Śledczy

  • Główny śledczy: Thomas Sørensen, PT, Cand.san, University of Southern Denmark
  • Dyrektor Studium: kim G Ingwersen, PT, PhD, University of Southern Denmark
  • Krzesło do nauki: Claus Varnum, Prof., PhD, MD, University of Southern Denmark
  • Krzesło do nauki: Henrik B Vægter, Prof., PT, PhD, Odense University Hospital and University of Southern Denmark

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

15 września 2026

Zakończenie podstawowe (Szacowany)

30 września 2028

Ukończenie studiów (Szacowany)

30 listopada 2028

Daty rejestracji na studia

Pierwszy przesłany

25 sierpnia 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

25 sierpnia 2026

Pierwszy wysłany (Rzeczywisty)

28 sierpnia 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

2 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

31 sierpnia 2026

Ostatnia weryfikacja

1 sierpnia 2026

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

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

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu 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.

Ramy czasowe udostępniania IPD

Data will be available after publication of the study.

Kryteria dostępu do udostępniania IPD

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

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA
  • SOK ROŚLINNY
  • ICF
  • ANALITYCZNY_KOD

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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