About this trial
The goal of this cross-sectional study is to estimate the prevalence of the nociplastic pain phenotype, according to the IASP clinical criteria, among patients diagnosed with SubAcromial Pain Syndrome (SAPS).
The main question it aims to answer is: What is the prevalence of the nociplastic pain phenotype in patients diagnosed with SAPS in an outpatient clinic?
Primary outcome: Proportion of patients with SAPS meeting the IASP criteria for nociplastic pain.
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 tests
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
Cross-sectional
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.
Treatment groups
Trial outcomes
Primary outcomes
Proportion of patients with chronic Subacromial Pain Syndrome (SAPS) classified as having a nociplastic pain phenotype according to the IASP classification of nociplastic pain.
Grading system for nociplastic pain according to the International Association for the Study of Pain (IASP) classification of nociplastic pain (Kosek et al. 2021)
Secondary outcomes
Difference in shoulder function between nociplastic and non-nociplastic pain phenotypes as assessed by the QuickDASH questionnaire
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)
Difference in Kinesiophobia between nociplastic and non-nociplastic pain phenotypes as assessed by the Tampa Scale of Kinesiophobia (TSK) questionnaire.
TSK-13 is a self-reported scale and will be used to assess kinesiophobia. Scoring range from 13 to 53. A lower score indicates less kinesiophobia.
Difference in Self-efficacy between nociplastic and non-nociplastic pain phenotypes according to the Pain Self-Efficacy Questionnaire (PSEQ4)
PSEQ4 is a self-reported questionnaire and will be used to asses self-efficacy. Score range from 0 to 26. A lower score indicates less self-efficacy.
Difference in Overall health between nociplastic and non-nociplastic pain phenotype as assessed by the Health (WHO-5) questionnaire
WHO-5 is a self-reported questionnaire and will be used to assess the overall health. Score range from 0 to 100. A lower score indicates lower well-being.
Other outcomes
Explorative outcome: Change in Movement-Evoked Pain during Virtual reality (VR) between nociplastic and non-nociplastic pain phenotype as measured by the Visual Analog Scale (VAS)
A subsample of participants will complete VR-assessment. Movement evoked pain assesed during Virtual Reality tasks with manipulated visual feedback. Pain responses across VR conditions will be explored. Pain during active shoulder elevation and pain at rest after active shoulder elevation will be measured on a VAS.
Explorative outcome: Change in degrees of shoulder movement during Virtual reality (VR) between nociplastic and non-nociplastic pain phenotype as measured by Range Of Movement (ROM) in degrees
A subsample of participants will complete VR-assessment. Range Of Movement (ROM) assesed during Virtual Reality tasks with manipulated visual feedback. ROM changes across VR conditions will be explored. Maximum ROM during a shoulder elevation task, and pain onset during shoulder elevation will be measured in degree.
Sponsors and contacts
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