Pain Phenotype and Response to Corticosteroid Injection in Patients With Subacromial Pain Syndrome (SAPS)

NCT07792421 | Not Yet Recruiting

• 4 other identifiers: The Nap SAPS CSI study2024-02422025-00232024-0039
• Study Type: observational
• Target: 134
• Locations: 1 country
• Sites: 1

Brief 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 daiagnosed 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?

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; Musculoskeletal pain; Pain phenotype; Central sensitivation; Chronic pain; Corticosteroid injection

Outcome Measures

Primary Outcomes (1)

• Change in pain 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)

  4 weeks

Secondary Outcomes (8)

• Change in pain between baseline and ten minutes after corticosteroid injection as measured by the Visual Analog Scale (VAS)

  10 minutes

• Change in pain between baseline and twelve weeks after corticosteroid injection as measured by the Visual Analog Scale (VAS)

  12 weeks

• Change in Shoulder Function between baseline and four weeks after corticosteroid injection as measured by the QuickDASH

  4 weeks

• Change in Shoulder Function between baseline and twelve weeks after corticosteroid injection as measured by the QuickDASH

  12 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.

  4 weeks

Study Arms (1)

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 phenotype

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. 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 experience clinicians and are ultrasound guided into the subacromial bursa

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)
• Receving a corticosteroid injection based on routine clinical proctice

You may not qualify if:

• Severe impaired vision
• Epilepsies
• 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)

Sponsors & Collaborators

• Vejle Hospital: lead

Study Sites (1)

Vejle Hospital

Vejle, 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

+45 79409871; thomas.soerensen1@rsyd.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• 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): September 30, 2028
• Study Completion (Estimated): November 30, 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)