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NCT Number: NCT07792434

Nociplastic Pain in Patients Diagnosed With Subacromial Pain Syndrome (SAPS)

The goal of this cross-sectional study is to estimate the prevalence of 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: Prevalence of 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.

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Key information

About this study

Musculoskeletal pain poses a significant burden on both individuals and the 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) diagnosis being the most prevalent and serves as a common diagnose 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 assumption behind the treatment.

There are emerging clinical consensus statements to identify 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 among this population of shoulder patients.

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 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Exclusion criteria

  • Severe impaired vision
  • Epilepsies
  • Severe cognitive or physical impairment
  • Language barrier (danish)

Treatment and study plan

Clinical evaluation

Procedure

Participants undergo a standardiced clinical assessment including medical history, specific orthopedic shoulder test, diagnostic ultrasound and x-ray of the shoulder.

Primary outcomes

  1. Proportion of patients with chronic Subacromial Pain Syndrome (SAPS) classified as having a nociplastic pain phenotype according to the IASP classification of nociplastic pain.

    Time frame: One time (baseline)

    Grading system for nociplastic pain according to International Association for the Study of Pain (IASP) classification of nociplastic pain (Kosek et al. 2021)

Secondary outcomes

  1. Difference in shoulder function between nociplastic and non-nociplastic pain phenotypes as assessed by the QuickDASH questionnaire

    Time frame: One time (baseline)

    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)

  2. Difference in Kinesiophobia between nociplastic and non-nociplastic pain phenotypes as assessed by the Tampa Scale of Kinesiophobia (TSK) questionnaire.

    Time frame: one time (baseline)

    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.

  3. Difference in Self-efficacy between nociplastic and non-nociplastic pain phenotypes according to the Pain Self-Efficacy Questionnaire (PSEQ4)

    Time frame: one time (baseline)

    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.

  4. Difference in Overall health between nociplastic and non-nociplastic pain phenotype as assessed by the Health (WHO-5) questionnaire

    Time frame: One time (baseline)

    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.

  5. Difference in Quality of life between nociplastic and non-nociplastic pain phenotype as assessed by the EQ-5D-5L questionnaire

    Time frame: One time (baseline)

    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.

Other outcomes

  1. 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)

    Time frame: One time (baseline)

    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.

  2. 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

    Time frame: One time (baseline)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Thomas Sørensen, PT, Cand.san

CONTACT

[email protected]

+4579409871

Sponsors and collaborators

Lead sponsor

Vejle Hospital

Other

Registry information

Official study title

Identification of the Prevalence of Nociplastic Pain Phenotype in Patients Diagnosed With Subacromial Pain Syndrome (SAPS) - a Cross-sectional Study

Acronym: The NAP SAPS

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 28, 2026
Registry last updated
Aug 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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