Subacromial Pain SyndromeThe NAP SAPSNCT07792434
Nociplastic Pain in Patients Diagnosed With Subacromial Pain Syndrome (SAPS)
An observational study of Subacromial Pain Syndrome and Rotator Cuff Related Shoulder Pain, run by Vejle Hospital at 1 site in Denmark.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Subacromial Pain Syndrome, Rotator Cuff Related Shoulder Pain, Shoulder Pain
- What is being tested?
- Clinical evaluation
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 1 siteDenmark
- Study dates
- 19 Oct 2026to Aug 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients referred to and evaluated at the specialised shoulder clinic at Vejle Hospital, Denmark
Who may be able to join
- Diagnosed with SAPS (dm751, dm753, dm754, dm755
- Shoulder pain ≥ 3 months
- ≥ 3 out of 5 specific shoulder tests
- Age 18-70 years
- Increased pain during active arm elevation
- Pain during active elevation ≥ 3 (VAS)
Who cannot join
- Severe visual impairment
- Epilepsy
- Severe cognitive or physical impairment
- Language barrier (Danish)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Vejle Hospital
Vejle, 7100
Thomas Sørensen, PT, Cand.san, +4579409871, thomas.soerensen1@rsyd.dk
About this study
Official title: Prevalence of Nociplastic Pain Phenotype in Patients Diagnosed With Subacromial Pain Syndrome (SAPS) - a Cross-sectional Study
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.
Read the detailed description
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.
- Conditions
- Subacromial Pain Syndrome, Rotator Cuff Related Shoulder Pain, Shoulder Pain, Shoulder Impingement Syndrome, SAPS
- Being tested
- Clinical evaluation
- Keywords
- Shoulder pain, SAPS, Nociplastic pain, Rotator Cuff Related Shoulder Pain, Virtual Reality, musculoskeletal pain, pain phenotype, central sensitivation, Chronic pain
- Medical subject headings
- Shoulder Pain, Shoulder Impingement Syndrome, Nociplastic Pain, Musculoskeletal Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical evaluationProcedure or surgery
Participants undergo a standardised clinical assessment including medical history, specific orthopedic shoulder test, diagnostic ultrasound and x-ray of the shoulder.
| Study group | Role | What they receive |
|---|---|---|
| Patients diagnosed with SubAcromial Pain Syndrome (SAPS) | Not described Receives: Procedure: Clinical evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: One time (baseline)
Secondary outcomes (5)
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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: One time (baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study start19 Oct 2026
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subacromial Pain SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vejle Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Sørensen, PT, Cand.san, Principal investigator, University of Southern DenmarkKim G Ingwersen, Pt, PhD, Study director, University of Southern DenmarkClaus Varnum, Prof., PhD, MD, Study chair, University of Southern DenmarkHenrik B Vægter, Prof., PT, PhD, Study chair, Odense University Hospital and University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07792434
- Sponsor's protocol ID
- The NAP SAPS study
- Other IDs
- 2024-0242, 2025-0023, 2024-0039
- Acronym
- The NAP SAPS
- Status last verified
- Oct 2026
- First submitted
- 25 Aug 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.