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

NCT07792434 | Not Yet Recruiting

• 4 other identifiers: The NAP SAPS study2024-02422025-00232024-0039
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Subacromial Pain Syndrome; Rotator Cuff Related Shoulder Pain; Shoulder Pain; Shoulder Impingement Syndrome; SAPS

Keywords

Shoulder pain; SAPS; Nociplastic pain; Rotator Cuff Related Shoulder Pain; Virtual Reality; musculoskeletal pain; pain phenotype; central sensitivation; Chronic pain

Outcome Measures

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.

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

  One time (baseline)

Secondary Outcomes (5)

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

  One time (baseline)

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

  one time (baseline)

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

  one time (baseline)

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

  One time (baseline)

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

  One time (baseline)

Other Outcomes (2)

• 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)

  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

  One time (baseline)

Study Arms (1)

Patients diagnosed with SubAcromial Pain Syndrome (SAPS)

Procedure: Clinical evaluation

Interventions

Clinical evaluation PROCEDURE

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

Patients diagnosed with SubAcromial Pain Syndrome (SAPS)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients referred to and evaluated at the specialized shoulder clinic at Vejle Hospital, Denmark

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Vejle Hospital: lead

Study Sites (1)

Vejle Hospital

Vejle, 7100, Denmark

Location

MeSH Terms

Conditions

Shoulder Pain; Shoulder Impingement Syndrome; Nociplastic Pain; Musculoskeletal Pain; Chronic Pain

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Shoulder Injuries; Wounds and Injuries; Muscular Diseases

Study Officials

• Thomas Sørensen, PT, Cand.san

  University of Southern Denmark

  PRINCIPAL INVESTIGATOR

• Kim G Ingwersen, Pt, PhD

  University of Southern Denmark

  STUDY DIRECTOR

• Claus Varnum, Prof., PhD, MD

  University of Southern Denmark

  STUDY CHAIR

• Henrik B Vægter, Prof., PT, PhD

  Odense University Hospital and University of Southern Denmark

  STUDY CHAIR

Central Study Contacts

Thomas Sørensen, PT, Cand.san

CONTACT

+4579409871; thomas.soerensen1@rsyd.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2026
• First Posted: August 28, 2026
• Study Start (Estimated): September 15, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: August 28, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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.

Locations

DK (1)