Subacromial Pain SyndromeNAP SAPS CSINCT07792421
Pain Phenotype and Response to Corticosteroid Injection in Patients 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 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. 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
- Injection or infusion, Surgery or procedure
- How many people
- 134 participants
- Where
- 1 siteDenmark
- Study dates
- 19 Oct 2026to 30 Nov 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 test
- Age 18-70 years
- Increased pain during active arm elevation
- Pain during active elevation ≥ 3 (VAS)
- Receving a corticosteroid injection based on routine clinical proctice
Who cannot join
- Severe visual impairment
- Epilepsy
- Severe cognitive or physical impairment
- Language barrier (Danish)
- Receving a corticosteroid injection at a site other than the subacromial bursa (e.g. acromioclavicular joint or intra-articular injection)
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
Thomas Sørensen, PT, Cand.san, +4579409871, thomas.soerensen1@rsyd.dk
About this study
Official title: Association Between Pain Phenotype and Change in Pain Following Routine Corticosteroid Injection in Patients With Subacromial Pain Syndrome - A Prospective Cohort Study.
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?
Read the detailed description
This study is part of a larger study investigating the prevalence of nociplastic pain phenotype according to the International Association for the Study of Pain (IASP) clinical criteria (The NAP SAPS Study). This prospective cohort component includes participants with SAPS who receive a corticosteroid shoulder injection as part of routine clinical care.
Musculoskeletal pain poses a significant burden on individuals and society. The IASP describes different pain mechanisms, including nociceptive, neuropathic and nociplastic pain. Identification of different pain mechanisms may be relevant for understanding pain presentation and variation in treatment response among patients with musculoskeletal pain.
Shoulder pain ranks among the most prevalent musculoskeletal complaints, with subacromial pain syndrome (SAPS) ranking highest, and serves as a common diagnosis for non-traumatic shoulder pain.
Exercise and other conservative treatments, including corticosteroid injection, are commonly used in the management of SAPS. However, a substantial proportion of patients experience limited or transient treatment effects and may develop persistent shoulder pain. Differences in underlying pain mechanisms may contribute to variation in treatment response among patients with SAPS. Corticosteroid injection is primarily used to target local inflammatory and nociceptive processes, and differences in pain phenotype may therefore be associated with variation in response to treatment. Emerging evidence suggests that altered pain processing may also be present in patients with shoulder pain, supporting the investigation of whether pain phenotype is associated with treatment response.
Clinical criteria have been proposed to identify different pain mechanisms in musculoskeletal pain conditions. The IASP clinical criteria for nociplastic pain provide a structured approach to classifying patients based on clinical features.
However, the possible association between pain response following corticosteroid injection and classification according to the IASP clinical criteria for nociplastic pain has, to our knowledge, not been sufficiently investigated among patients with SAPS.
The overall objective is to investigate the association between pain phenotype, classified according to the IASP clinical criteria for nociplastic pain, and subsequent change in pain intensity four weeks after corticosteroid injection.
Primary hypothesis: Patients classified as having a nociplastic pain phenotype will demonstrate a significantly smaller mean reduction in pain intensity (VAS) from baseline to four weeks after corticosteroid injection compared with patients classified as having a non-nociplastic pain phenotype.
Secondary hypothesis: A significantly lower proportion of patients classified as having a nociplastic pain phenotype will achieve a reduction of at least 20 points on the VAS four weeks after corticosteroid injection compared with patients classified as having a non-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, Musculoskeletal pain, Pain phenotype, Central sensitivation, Chronic pain, Corticosteroid injection
- 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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients diagnosed with SubAcromial Pain Syndrome (SAPS) | Patients with SAPS will be classified according to the IASP criteria for nociplastic pain as having either nociplastic or non-nociplastic pain phenotype Receives: Procedure: Clinical evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 4 weeks
Secondary outcomes (11)
Change in shoulder pain during active shoulder elevation between baseline and fifteen 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)
Measured: 15 minutes
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)
Measured: 4 weeks
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)
Measured: 4 weeks
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"
Measured: 4 weeks
Change in shoulder pain at rest 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 (VAS). Participants will score from 0 (no pain) to 100 (the worst pain they have ever experienced)
Measured: 4 weeks
Change in shoulder pain during activity between baseline and twelve weeks after corticosteroid injection as measured by the Visual Analog Scale (VAS)
Pain intensity will be assessed with Visual Analog Scale (VAS). Participants will score from 0 (no pain) to 100 (the worst pain they have ever experienced)
Measured: 12 weeks
Change in Shoulder Function between baseline and twelve 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)
Measured: 12 weeks
Proportion af patients with nociplastic and non-nociplastic pain phenotype reporting a clinically relevant improvement in Global Perceived Effect (GPE) twelve 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)
Measured: 12 weeks
Proportion of patients with nociplastic and non-nociplastic pain phenotype achieving a Patient Acceptable Symptom State (PASS) twelve 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"
Measured: 12 weeks
Change in shoulder pain at rest between baseline and twelve weeks after corticosteroid injection as measured by the Visual Analog Scale (VAS)
Pain intensity will be assessed with Visual Analog Scale (VAS). Participants will score from 0 (no pain) to 100 (the worst pain they have ever experienced)
Measured: 12 weeks
Change in shoulder pain at rest between baseline and fifteen 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)
Measured: 15 minutes
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 completion30 Sep 2028 (estimated)
- Study completion30 Nov 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
- Prospective
- Enrolment
- 134 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
- NCT07792421
- Sponsor's protocol ID
- The Nap SAPS CSI study
- Other IDs
- 2024-0242, 2025-0023, 2024-0039
- Acronym
- NAP SAPS CSI
- 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.