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Completed

NCT Number: NCT05481710

Nociplastic Pain in Patients With Chronic Shoulder Pain

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinical Exercise Physiology and Rehabilitation Laboratory, Lamia, Central Greece, Greece

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nociplastic Pain Criteria

Diagnostic Test

All participants will be assessed with the specific nociplastic pain criteria

Primary outcomes

  1. Pressure Pain Threshold (PPT)

    Time frame: Only one time (baseline)

    PPT will be used to assess the pain sensitivity

  2. Conditioned Pain Modulation (CPM)

    Time frame: Only one time (baseline)

    CPM will be used to examine the descending inhibition of nociceptive signals

  3. Nociplastic Pain Criteria

    Time frame: Only one time (baseline)

    The grading system for recognition of nociplastic pain will be used (Kosek et al. 2021).

Secondary outcomes

  1. Numeric Pain Rating Scale

    Time frame: 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).

  2. Pain Distribution

    Time frame: 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.

  3. Heart Rate Variability (HRV)

    Time frame: Only one time (baseline)

    HRV testing will be used to assess the function of autonomic nervous system

  4. Range of motion

    Time frame: 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.

  5. Central Sensitization Inventory (CSI)

    Time frame: Only one time (baseline)

    CSI wiil be used to assess the CS symptoms

  6. Hospital Anxiety and Depression Scale (HADS)

    Time frame: 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.

  7. Brief Illness Perception Questionnaire (BIPQ)

    Time frame: Only one time (baseline)

    BIPQ will be used to estimate the perception of pain severity

  8. Pain Sensitivity Questionnaire (PSQ)

    Time frame: Only one time (baseline)

    PSQ is a self-reported tool and it will be used to assess pain sensitivity

  9. Pain Catastrophizing Scale (PCS)

    Time frame: Only one time (baseline)

    PCS is a self-reported scale which estimates the catastrophization

  10. Pain Self-Efficacy Questionnaire (PSEQ)

    Time frame: Only one time (baseline)

    PSEQ will be used to estimate the self-efficacy

  11. Shoulder Pain and Disability Index (SPADI)

    Time frame: Only one time (baseline)

    SPADI is a self-reported questionnaire and it will be used to assess the disability

  12. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: 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.

  13. Work Ability Index (WAI)

    Time frame: Only one time (baseline)

    WAI will be used to assess the work ability

  14. Tampa Scale Kinesiophobia (TSK)

    Time frame: Only one time (baseline)

    TSK is a self-reported scale and it will be used to assess the kinesiophobia

  15. EuroQol-5 Dimension (EQ-5D)

    Time frame: Only one time (baseline)

    EQ-5D will be used to assess the quality of life

  16. 3-Minute Step Test (3MST)

    Time frame: Only one time (baseline)

    3MST will be used to assess the cardiovascular capacity

  17. Hand Grip

    Time frame: Only one time (baseline)

    Hand Grip will be used to assess the strength of forearm muscles

Sponsors and collaborators

Lead sponsor

Paraskevi Bilika

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Aug 1, 2022
Registry last updated
Jun 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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