Rotator Cuff Related Shoulder Pain, SAPS, Shoulder Impingement Syndrome, Shoulder Pain, Subacromial Pain Syndrome
Conditions
Keywords
Shoulder pain, SAPS, Nociplastic pain, Rotator cuff related shoulder pain, Musculoskeletal pain, Pain phenotype, Central sensitivation, Chronic pain, Corticosteroid injection
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 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?
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 2 points on the VAS four weeks after corticosteroid injection compared with patients classified as having a non-nociplastic pain phenotype.
Interventions
PROCEDUREClinical evaluation
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.
Sponsors
Vejle Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Diagnosed with SAPS (dm751, dm753, dm754, dm755 2. Shoulder pain ≥ 3 months 3. ≥ 3 out of 5 specific shoulder test 4. Age 18-70 years 5. Increased pain during active arm elevation 6. Pain during active elevation ≥ 3 (VAS) 7. Receving a corticosteroid injection based on routine clinical proctice
Exclusion criteria
1. Severe visual impairment 2. Epilepsy 3. Severe cognitive or physical impairment 4. Language barrier (Danish) 5. Receving a corticosteroid injection at a site other than the subacromial bursa (e.g. acromioclavicular joint or intra-articular injection)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain between baseline and four weeks after corticosteroid injection as measured by the Visual Analog Scale (VAS) | 4 weeks | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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" |
| 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. | 12 weeks | 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" |
| 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. | 4 weeks | 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) |
| 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. | 12 weeks | 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) |
| Change in pain between baseline and ten minutes after corticosteroid injection as measured by the Visual Analog Scale (VAS) | 10 minutes | 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) |
| Change in pain between baseline and twelve weeks after corticosteroid injection as measured by the Visual Analog Scale (VAS) | 12 weeks | 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) |
| Change in Shoulder Function between baseline and twelve weeks after corticosteroid injection as measured by the QuickDASH | 12 weeks | 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) |
| Change in Shoulder Function between baseline and four weeks after corticosteroid injection as measured by the QuickDASH | 4 weeks | 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) |
Countries
Denmark
Contacts
CONTACTThomas Sørensen, PT, Cand.san
PRINCIPAL_INVESTIGATORThomas Sørensen, PT, Cand.san
University of Southern Denmark
STUDY_DIRECTORkim G Ingwersen, PT, PhD
University of Southern Denmark
STUDY_CHAIRClaus Varnum, Prof., PhD, MD
University of Southern Denmark
STUDY_CHAIRHenrik B Vægter, Prof., PT, PhD
Odense University Hospital and University of Southern Denmark
Outcome results
None listed