- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07792421
Pain Phenotype and Response to Corticosteroid Injection in Patients With Subacromial Pain Syndrome (SAPS) (NAP SAPS CSI)
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
Status
Warunki
Interwencja / Leczenie
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
Zapisy (Szacowany)
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Thomas Sørensen, PT, Cand.san
- Numer telefonu: +45 79409871
- E-mail: thomas.soerensen1@rsyd.dk
Lokalizacje studiów
-
-
-
Vejle, Dania
- Vejle Hospital
-
Kontakt:
- Thomas Sørensen, PT, Cand.san
- Numer telefonu: +4579409871
- E-mail: thomas.soerensen1@rsyd.dk
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Metoda próbkowania
Badana populacja
Opis
Inclusion Criteria:
- Diagnosed with SAPS (dm751, dm753, dm754, dm755
- Shoulder pain ≥ 3 months
- ≥ 3 out of 5 specific shoulder test
- Age 18-70 years
- Increased pain during active arm elevation
- Pain during active elevation ≥ 3 (VAS)
- Receving a corticosteroid injection based on routine clinical proctice
Exclusion Criteria:
- Severe visual impairment
- Epilepsy
- Severe cognitive or physical impairment
- Language barrier (Danish)
- Receving a corticosteroid injection at a site other than the subacromial bursa (e.g. acromioclavicular joint or intra-articular injection)
Plan studiów
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
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
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
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)?
Opis planu IPD
Ramy czasowe udostępniania IPD
Kryteria dostępu do udostępniania IPD
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
Bada produkt urządzenia regulowany przez amerykańską FDA
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 .