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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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?
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Thomas Sørensen, PT, Cand.san
- Número de teléfono: +45 79409871
- Correo electrónico: thomas.soerensen1@rsyd.dk
Ubicaciones de estudio
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Vejle, Dinamarca
- Vejle Hospital
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Contacto:
- Thomas Sørensen, PT, Cand.san
- Número de teléfono: +4579409871
- Correo electrónico: thomas.soerensen1@rsyd.dk
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in pain between baseline and four weeks after corticosteroid injection as measured by the Visual Analog Scale (VAS)
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in pain between baseline and ten minutes after corticosteroid injection as measured by the Visual Analog Scale (VAS)
Periodo de tiempo: 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)
Periodo de tiempo: 12 weeks
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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)
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12 weeks
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Change in Shoulder Function between baseline and four weeks after corticosteroid injection as measured by the QuickDASH
Periodo de tiempo: 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
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Thomas Sørensen, PT, Cand.san, University of Southern Denmark
- Director de estudio: kim G Ingwersen, PT, PhD, University of Southern Denmark
- Silla de estudio: Claus Varnum, Prof., PhD, MD, University of Southern Denmark
- Silla de estudio: Henrik B Vægter, Prof., PT, PhD, Odense University Hospital and University of Southern Denmark
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Lesiones de hombro
- Dolor
- Manifestaciones neurológicas
- Enfermedades musculoesqueléticas
- Enfermedades Musculares
- Heridas y Lesiones
- Enfermedades Articulares
- Artralgia
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Dolor musculoesquelético
- Dolor crónico
- Dolor de hombro
- Síndrome de pinzamiento del hombro
- Dolor nociplásico
Otros números de identificación del estudio
- The Nap SAPS CSI study
- 2024-0039 (Otro número de subvención/financiamiento: Research Council of Lillebaelt Hospital)
- 2024-0242 (Otro número de subvención/financiamiento: The Region of Southern Denmark)
- 2025-0023 (Otro número de subvención/financiamiento: Research Council of Lillebaelt Hospital)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Criterios de acceso compartido de IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
- CÓDIGO_ANALÍTICO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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