Nociplastic Pain in Patients With Chronic Shoulder Pain

Study Overview
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Brief Summary
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The aim of this study was to investigate predictors of nociplastic shoulder pain. Factors of psychological distress, functionality, fitness, quality of life, quality of sleep, functioning of the parasympathetic system, and lifestyle will be examined. Patients with nociplastic pain will be identified using the classification system proposed by the IASP.

Detailed Description
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The main part of the study will include patients with chronic shoulder pain who visit the Hand Surgery-Upper Limb and Microsurgery Department of the General Hospital KAT. The measurements will be performed in one session. Once participants have been informed of the purpose and procedure of the study and given written consent, they will complete their demographics and a series of questionnaires and questions about their pain history. They will then be examined by a doctor and finally subjected to dynamometry, a functional test and two quantitative sensory tests.

Official Title
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Investigation of the Profile of Patients With Chronic Shoulder Pain: A Cross-sectional Study

Conditions
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Chronic Shoulder Pain

Intervention / Treatment
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* Diagnostic Test: Nociplastic Pain Criteria


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients (men and women) with chronic shoulder pain (lasting more than 3 months, 3/10 Numeric Pain Rating Scale), aged 18-65 years mentally able to follow instructions or healthy volunteers aged 18-65 who do not experience pain and have not received analgesic medication in the last trimester. Exclusion Criteria: referred shoulder pain from different primary sources of pain (eg shoulder pain in women with mastectomy or stroke), pain manifested by movements in the neck, shoulder arthroplasty or fractures or dislocation of the shoulder, - diagnosis of chronic pain syndrome such as fibromyalgia, chronic fatigue syndrome, chronic regional pain syndrome, cancer diagnosis, osteoporosis, rheumatic inflammatory diseases, use of medication for neurological/psychiatric disorders, the presence of gastrointestinal or renal disease taking medication that may affect the assessment results, such as calcium channel blockers that could alter HRV, pregnancy or childbirth before 1 year will be excluded from the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Nociplastic Pain Criteria|All participants will be assessed with the specific nociplastic pain criteria|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pressure Pain Threshold (PPT) | PPT will be used to assess the pain sensitivity | Only one time (baseline) | 
| Conditioned Pain Modulation (CPM) | CPM will be used to examine the descending inhibition of nociceptive signals | Only one time (baseline) | 
| Nociplastic Pain Criteria | The grading system for recognition of nociplastic pain will be used (Kosek et al. 2021). | Only one time (baseline) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numeric Pain Rating Scale | Pain intensity will be assessed with Numeric Pain Rating Scale. Participants will score from 0 (no pain) to 10 (the worst pain they have ever experienced). | Only one time (baseline) | 
| Pain Distribution | Pain location will be recorded using the Pain Distribution App (PDA) which is a self-reported tool to assess the distribution and spread of body pain areas. The PDA has demonstrated reliability. | Only one time (baseline) | 
| Heart Rate Variability (HRV) | HRV testing will be used to assess the function of autonomic nervous system | Only one time (baseline) | 
| Range of motion | Active and passive range of motion will be measured using a goniometer. It will be assessed the flexion, abduction, and external rotation. Participants will be a standing position for flexion and abduction assessment and in prone position for external rotation. | Only one time (baseline) | 
| Central Sensitization Inventory (CSI) | CSI wiil be used to assess the CS symptoms | Only one time (baseline) | 
| Hospital Anxiety and Depression Scale (HADS) | Anxiety and depression will be measured with Hospital Anxiety and Depression Scale (HADS). HADS includes 14 items, 7 for Anxiety and 7 for Depression. The overall score range 0-42 and 0-21 for the different categories. A cut-off 8/21 has been recommended. | Only one time (baseline) | 
| Brief Illness Perception Questionnaire (BIPQ) | BIPQ will be used to estimate the perception of pain severity | Only one time (baseline) | 
| Pain Sensitivity Questionnaire (PSQ) | PSQ is a self-reported tool and it will be used to assess pain sensitivity | Only one time (baseline) | 
| Pain Catastrophizing Scale (PCS) | PCS is a self-reported scale which estimates the catastrophization | Only one time (baseline) | 
| Pain Self-Efficacy Questionnaire (PSEQ) | PSEQ will be used to estimate the self-efficacy | Only one time (baseline) | 
| Shoulder Pain and Disability Index (SPADI) | SPADI is a self-reported questionnaire and it will be used to assess the disability | Only one time (baseline) | 
| Pittsburgh Sleep Quality Index (PSQI) | The Pittsburgh Sleep Quality Index (PSQI) is an effective instrument used to measure the quality and patterns of sleep in adults. | Only one time (baseline) | 
| Work Ability Index (WAI) | WAI will be used to assess the work ability | Only one time (baseline) | 
| Tampa Scale Kinesiophobia (TSK) | TSK is a self-reported scale and it will be used to assess the kinesiophobia | Only one time (baseline) | 
| EuroQol-5 Dimension (EQ-5D) | EQ-5D will be used to assess the quality of life | Only one time (baseline) | 
| 3-Minute Step Test (3MST) | 3MST will be used to assess the cardiovascular capacity | Only one time (baseline) | 
| Hand Grip | Hand Grip will be used to assess the strength of forearm muscles | Only one time (baseline) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic pain, shoulder pain, nociplastic pain, predictors