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Chronic Shoulder PainNCT05481710

Nociplastic Pain in Patients With Chronic Shoulder Pain

An observational study of Chronic Shoulder Pain, run by Paraskevi Bilika at 2 sites in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Chronic Shoulder Pain
What is being tested?
Nociplastic Pain Criteria
How many people
70 participants
Where
2 sitesGreece
Study dates
18 Jul 2022to 10 Jan 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: The current study will include patients with chronic shoulder pain who visit the Hand Surgery-Upper Limb and Microsurgery Department of the General Hospital KAT and healthy participants who study or work at the University of Thessaly.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

Greece2 sites

  • KAT Attica General Hospital

    Athens

  • Clinical Exercise Physiology and Rehabilitation Laboratory

    Lamia, Central Greece, 35100

Other trials in Greece

About this study

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

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.

Read the 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.

Being tested
Nociplastic Pain Criteria
Keywords
chronic pain, shoulder pain, nociplastic pain, predictors
Medical subject headings
Chronic Pain, Shoulder Pain, Nociplastic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nociplastic Pain CriteriaDiagnostic test

    All participants will be assessed with the specific nociplastic pain criteria

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pressure Pain Threshold (PPT)

    PPT will be used to assess the pain sensitivity

    Measured: Only one time (baseline)

  2. Conditioned Pain Modulation (CPM)

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

    Measured: Only one time (baseline)

  3. Nociplastic Pain Criteria

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

    Measured: Only one time (baseline)

Secondary outcomes (17)

  1. 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).

    Measured: Only one time (baseline)

  2. 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.

    Measured: Only one time (baseline)

  3. Heart Rate Variability (HRV)

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

    Measured: Only one time (baseline)

  4. 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.

    Measured: Only one time (baseline)

  5. Central Sensitization Inventory (CSI)

    CSI wiil be used to assess the CS symptoms

    Measured: Only one time (baseline)

  6. 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.

    Measured: Only one time (baseline)

  7. Brief Illness Perception Questionnaire (BIPQ)

    BIPQ will be used to estimate the perception of pain severity

    Measured: Only one time (baseline)

  8. Pain Sensitivity Questionnaire (PSQ)

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

    Measured: Only one time (baseline)

  9. Pain Catastrophizing Scale (PCS)

    PCS is a self-reported scale which estimates the catastrophization

    Measured: Only one time (baseline)

  10. Pain Self-Efficacy Questionnaire (PSEQ)

    PSEQ will be used to estimate the self-efficacy

    Measured: Only one time (baseline)

  11. Shoulder Pain and Disability Index (SPADI)

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

    Measured: Only one time (baseline)

  12. 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.

    Measured: Only one time (baseline)

  13. Work Ability Index (WAI)

    WAI will be used to assess the work ability

    Measured: Only one time (baseline)

  14. Tampa Scale Kinesiophobia (TSK)

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

    Measured: Only one time (baseline)

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

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

    Measured: Only one time (baseline)

  16. 3-Minute Step Test (3MST)

    3MST will be used to assess the cardiovascular capacity

    Measured: Only one time (baseline)

  17. Hand Grip

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

    Measured: Only one time (baseline)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2022
  2. Study start18 Jul 2022
  3. Primary completion10 Jan 2025
  4. Study completion10 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05481710
Sponsor's protocol ID
5
Status last verified
Jun 2023
First submitted
28 Jul 2022
Last updated
12 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Nijs J, Lahousse A, Kapreli E, Bilika P, Saracoglu I, Malfliet A, Coppieters I, De Baets L, Leysen L, Roose E, Clark J, Voogt L, Huysmans E. Nociplastic Pain Criteria or Recognition of Central Sensitization? Pain Phenotyping in the Past, Present and Future. J Clin Med. 2021 Jul 21;10(15):3203. doi: 10.3390/jcm10153203.

    PubMed 34361986

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Shoulder Pain, run by Paraskevi Bilika at 2 sites in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pressure Pain Threshold (PPT) (time frame: Only one time (baseline)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05481710, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.

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Clinical Trial NCT05481710 | AzTrials