About this trial
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?
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosed with SAPS (dm751, dm753, dm754, dm755
Shoulder pain ≥ 3 months
≥ 3 out of 5 specific shoulder test
Age 18-70 years
Disqualifiers
Severe visual impairment
Epilepsy
Severe cognitive or physical impairment
Language barrier (Danish)
Trial population
Patients referred to and evaluated at the specialised shoulder clinic at Vejle Hospital, Denmark
Trial design
Cohort
Prospective
Treatments tested in this trial
Clinical evaluation
Procedure/SurgeryParticipants 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.
Treatment groups
Trial outcomes
Primary outcomes
Change in shoulder pain during activity between baseline and four weeks after corticosteroid injection as measured by the Visual Analog Scale (VAS)
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)
Secondary outcomes
Change in shoulder pain during active shoulder elevation between baseline and ten minutes after corticosteroid injection as measured by the Visual Analog Scale (VAS)
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)
Change in Shoulder Function between baseline and four weeks after corticosteroid injection as measured by the QuickDASH
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)
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.
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)
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.
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"
Sponsors and contacts
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