- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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?
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienkontakt
- Name: Thomas Sørensen, PT, Cand.san
- Telefonnummer: +45 79409871
- E-Mail: thomas.soerensen1@rsyd.dk
Studienorte
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Vejle, Dänemark
- Vejle Hospital
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Kontakt:
- Thomas Sørensen, PT, Cand.san
- Telefonnummer: +4579409871
- E-Mail: thomas.soerensen1@rsyd.dk
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Probenahmeverfahren
Studienpopulation
Beschreibung
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)
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
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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
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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. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in pain between baseline and four weeks after corticosteroid injection as measured by the Visual Analog Scale (VAS)
Zeitfenster: 4 weeks
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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)
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4 weeks
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in pain between baseline and ten minutes after corticosteroid injection as measured by the Visual Analog Scale (VAS)
Zeitfenster: 10 minutes
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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)
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10 minutes
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Change in pain between baseline and twelve weeks after corticosteroid injection as measured by the Visual Analog Scale (VAS)
Zeitfenster: 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
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Change in Shoulder Function between baseline and four weeks after corticosteroid injection as measured by the QuickDASH
Zeitfenster: 4 weeks
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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)
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4 weeks
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Change in Shoulder Function between baseline and twelve weeks after corticosteroid injection as measured by the QuickDASH
Zeitfenster: 12 weeks
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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)
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12 weeks
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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.
Zeitfenster: 4 weeks
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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"
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4 weeks
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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.
Zeitfenster: 12 weeks
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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"
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12 weeks
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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.
Zeitfenster: 4 weeks
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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)
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4 weeks
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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.
Zeitfenster: 12 weeks
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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)
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12 weeks
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Thomas Sørensen, PT, Cand.san, University of Southern Denmark
- Studienleiter: kim G Ingwersen, PT, PhD, University of Southern Denmark
- Studienstuhl: Claus Varnum, Prof., PhD, MD, University of Southern Denmark
- Studienstuhl: Henrik B Vægter, Prof., PT, PhD, Odense University Hospital and University of Southern Denmark
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Schulterverletzungen
- Schmerzen
- Neurologische Manifestationen
- Erkrankungen des Bewegungsapparates
- Muskelerkrankungen
- Wunden und Verletzungen
- Gelenkerkrankungen
- Arthralgie
- Pathologische Zustände, Anzeichen und Symptome
- Anzeichen und Symptome
- Muskel-Skelett-Schmerzen
- Chronischer Schmerz
- Schulterschmerzen
- Schulter-Impingement-Syndrom
- Noziplastischer Schmerz
Andere Studien-ID-Nummern
- The Nap SAPS CSI study
- 2024-0039 (Andere Zuschuss-/Finanzierungsnummer: Research Council of Lillebaelt Hospital)
- 2024-0242 (Andere Zuschuss-/Finanzierungsnummer: The Region of Southern Denmark)
- 2025-0023 (Andere Zuschuss-/Finanzierungsnummer: Research Council of Lillebaelt Hospital)
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