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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorVejle Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosed with SAPS (dm751, dm753, dm754, dm755

Shoulder pain ≥ 3 months

≥ 3 out of 5 specific shoulder tests

Age 18-70 years

Disqualifiers

Severe visual impairment

Epilepsy

Severe cognitive or physical impairment

Language barrier (Danish)

Trial population

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

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

  • Clinical evaluation

    Procedure/Surgery

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

Treatment groups

400 Participants
are divided into 1 treatment group
Group A: Patients diagnosed with SubAcromial Pain Syndrome (SAPS)1 intervention

Trial outcomes

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

Time frame
One time (baseline)

Secondary outcomes

1

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)

Time frame
One time (baseline)
2

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.

Time frame
one time (baseline)
3

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.

Time frame
one time (baseline)
4

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.

Time frame
One time (baseline)

Other outcomes

1

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)

A subsample of participants will complete VR-assessment. Movement evoked pain assesed during Virtual Reality tasks with manipulated visual feedback. Pain responses across VR conditions will be explored. Pain during active shoulder elevation and pain at rest after active shoulder elevation will be measured on a VAS.

Time frame
One time (baseline)
2

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

A subsample of participants will complete VR-assessment. Range Of Movement (ROM) assesed during Virtual Reality tasks with manipulated visual feedback. ROM changes across VR conditions will be explored. Maximum ROM during a shoulder elevation task, and pain onset during shoulder elevation will be measured in degree.

Time frame
One time (baseline)

Sponsors and contacts

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