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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorVejle Hospital

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Clinical evaluation

    Procedure/Surgery

    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.

Treatment groups

134 Participants
are divided into 1 treatment group
Group A: Patients diagnosed with SubAcromial Pain Syndrome (SAPS)1 intervention

Trial outcomes

Primary outcomes

1

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)

Time frame
4 weeks

Secondary outcomes

1

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)

Time frame
10 minutes
2

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)

Time frame
4 weeks
3

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)

Time frame
4 weeks
4

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"

Time frame
4 weeks

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: