An observational study in Subacromial Pain Syndrome, Rotator Cuff Related Shoulder Pain and Shoulder Pain, sponsored by Vejle Hospital. Recruiting at 1 site in Denmark. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Vejle Hospital · Observational
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.
Musculoskeletal pain poses a significant burden on both individuals and society. The International Association for the Study of Pain (IASP) describes different pain mechanisms, including nociceptive, neuropathic and nociplastic pain. Identification of different pain mechanisms may be relevant for understanding pain presentation and treatment response in patients with musculoskeletal pain.
Shoulder pain ranks among the most prevalent musculoskeletal complaints with subacromial pain syndrome (SAPS) being the most prevalent diagnosis and a common diagnosis for non-traumatic shoulder pain. Exercise and other conservative treatments are considered first line treatment modalities in SAPS. However, a substantial proportion of patients experience limited or transient treatment effects and may develop chronic shoulder pain. This modest effect may be explained by a potential mismatch between the pain phenotype and the mechanistic assumptions underlying the treatment.
There are emerging clinical consensus statements for identifying primary pain phenotypes in musculoskeletal pain conditions. The IASP criteria for nociplastic pain offer a structured approach for classifying patients based on clinical features. However, the IASP criteria for identifying nociplastic pain have not, to our knowledge, been sufficiently investigated among patients with SAPS to elucidate the distribution of pain phenotypes in this population of patients with shoulder pain.
Movement-evoked pain is a key feature in many patients with SAPS. Virtual Reality (VR) may provide a controlled enviroment in which visual feedback and percevied movement can be manipulated. Such manipulation may influence movement-evoked pain and could potentially provide additional information about pain responses associated with different pain phenotype. In this study, VR is therefore included as an exploratory assessment.
The primary aim of this cross-sectional study is to investigate the proportion and characteristics of patients diagnosed with SAPS who meet the IASP clinical criteria for nociplastic pain in an outpatient hospital setting.
The Primary objective is to estimate the prevalence of the nociplastic pain phenotype, according to the IASP classification, among patients with SAPS.
The exploratory objective is to investigate the relationship between movement- evoked pain responses during manipulated VR conditions and pain phenotype.
The exploratory hypothesis is that patients classified as having a nociplastic pain phenotype will demonstrate greater changes in pain intensity and movement-evoked pain responses during the VR conditions, compared with patients not classified as having a nociplastic pain phenotype.
735 studies on the registry are indexed under Shoulder Pain; 167 are open to participants now.
This study's planned enrollment of 400 is above the median of 84 across 135 observational studies indexed under Shoulder Pain.
Browse Shoulder Pain studies →Vejle Hospital is the lead sponsor of 95 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients referred to and evaluated at the specialised shoulder clinic at Vejle Hospital, Denmark
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Procedure: Clinical evaluation
Participants undergo a standardised clinical assessment including medical history, specific orthopedic shoulder test, diagnostic ultrasound and x-ray of the shoulder.
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)
Time frame: One time (baseline)
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)
Time frame: One time (baseline)
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.
Time frame: one time (baseline)
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.
Time frame: one time (baseline)
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.
Time frame: One time (baseline)
Difference in Quality of life between nociplastic and non-nociplastic pain phenotype as assessed by the EQ-5D-5L questionnaire
EQ-5D-5L, EQ-VAS is a self-reported questionnaire and it will be used to asses quality of life. Range from 0-100. A lower score indicates lower quality of health.
Time frame: One time (baseline)
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.
Time frame: One time (baseline)
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.
Time frame: One time (baseline)
Plan to share: Yes — Anonymised patient-level data for the primary objective and explorative outcome will be made available if required by the scientific journal, in which the results of the study are publiched.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code
Time frame: Data will be available after publication of the study.
Access criteria: Data access will be reviewed by the author group. Requestors will be required to sign a Data Access Agreement.
No publications or documents are linked to this record.
Started Oct 2026 (actual). Primary completion is estimated for Aug 2028, 22 months after the start.
Start moved once since we started tracking on Sep 25, 2026: Sep 2026 → Oct 2026, on Oct 6, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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