Nociplastic Pain in Patients With Chronic Shoulder Pain
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
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Detailed Description
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.
Study Design
Outcome Measures
Primary Outcome Measures
- Pressure Pain Threshold (PPT) [Only one time (baseline)]
PPT will be used to assess the pain sensitivity
- Conditioned Pain Modulation (CPM) [Only one time (baseline)]
CPM will be used to examine the descending inhibition of nociceptive signals
- Nociplastic Pain Criteria [Only one time (baseline)]
The grading system for recognition of nociplastic pain will be used (Kosek et al. 2021).
Secondary Outcome Measures
- Numeric Pain Rating Scale [Only one time (baseline)]
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).
- Pain Distribution [Only one time (baseline)]
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.
- Heart Rate Variability (HRV) [Only one time (baseline)]
HRV testing will be used to assess the function of autonomic nervous system
- Range of motion [Only one time (baseline)]
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.
- Central Sensitization Inventory (CSI) [Only one time (baseline)]
CSI wiil be used to assess the CS symptoms
- Hospital Anxiety and Depression Scale (HADS) [Only one time (baseline)]
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.
- Brief Illness Perception Questionnaire (BIPQ) [Only one time (baseline)]
BIPQ will be used to estimate the perception of pain severity
- Pain Sensitivity Questionnaire (PSQ) [Only one time (baseline)]
PSQ is a self-reported tool and it will be used to assess pain sensitivity
- Pain Catastrophizing Scale (PCS) [Only one time (baseline)]
PCS is a self-reported scale which estimates the catastrophization
- Pain Self-Efficacy Questionnaire (PSEQ) [Only one time (baseline)]
PSEQ will be used to estimate the self-efficacy
- Shoulder Pain and Disability Index (SPADI) [Only one time (baseline)]
SPADI is a self-reported questionnaire and it will be used to assess the disability
- Pittsburgh Sleep Quality Index (PSQI) [Only one time (baseline)]
The Pittsburgh Sleep Quality Index (PSQI) is an effective instrument used to measure the quality and patterns of sleep in adults.
- Work Ability Index (WAI) [Only one time (baseline)]
WAI will be used to assess the work ability
- Tampa Scale Kinesiophobia (TSK) [Only one time (baseline)]
TSK is a self-reported scale and it will be used to assess the kinesiophobia
- EuroQol-5 Dimension (EQ-5D) [Only one time (baseline)]
EQ-5D will be used to assess the quality of life
- 3-Minute Step Test (3MST) [Only one time (baseline)]
3MST will be used to assess the cardiovascular capacity
- Hand Grip [Only one time (baseline)]
Hand Grip will be used to assess the strength of forearm muscles
Eligibility Criteria
Criteria
Inclusion Criteria:
The participants will be patients (men and women) with chronic shoulder pain (lasting more than 3 months, 3/10 Numeric Pain Rating Scale), aged 18-65 and mentally able to follow instructions. The study will also include healthy volunteers aged 18-65 who do not experience pain and have not received analgesic medication in the last trimester.
Exclusion Criteria:
Patients with 1) referred shoulder pain from different primary sources of pain (eg shoulder pain in women with mastectomy or stroke), (2) pain manifested by movements in the neck, (3) shoulder arthroplasty or fractures or dislocation of the shoulder, (4) diagnosis of chronic pain syndrome such as fibromyalgia, chronic fatigue syndrome, chronic regional pain syndrome, cancer diagnosis, osteoporosis, rheumatic inflammatory diseases, (5) use of medication for neurological/psychiatric disorders, (6) presence of gastrointestinal or renal disease (7) taking medication that may affect the results of the assessment, such as calcium channel blockers that could alter HRV, (8) pregnancy or childbirth before 1 year will be excluded from the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Clinical Exercise Physiology and Rehabilitation Laboratory | Lamia | Sterea Ellada | Greece | 35100 |
Sponsors and Collaborators
- Clinical Exercise Physiology and Rehabilitation Reasearch Laboratory
Investigators
- Principal Investigator: Paraskevi N. Bilika, Clinical Exercise Physiology and Rehabilitation Reasearch Laboratory
- Study Director: Eleni V. Kapreli, Clinical Exercise Physiology and Rehabilitation Reasearch Laboratory
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- 5