Nociplastic Pain in Patients With Chronic Shoulder Pain

NCT05481710 | Completed

• 1 other identifier: 5
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Shoulder Pain

Keywords

chronic pain; shoulder pain; nociplastic pain; predictors

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (17)

• Numeric Pain Rating Scale

  Only one time (baseline)

• Pain Distribution

  Only one time (baseline)

• Heart Rate Variability (HRV)

  Only one time (baseline)

• Range of motion

  Only one time (baseline)

• Central Sensitization Inventory (CSI)

  Only one time (baseline)

Interventions

Nociplastic Pain Criteria DIAGNOSTIC_TEST

All participants will be assessed with the specific nociplastic pain criteria

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Paraskevi Bilika: lead

Study Sites (2)

Clinical Exercise Physiology and Rehabilitation Laboratory

Lamia, Central Greece, 35100, Greece

Location

KAT Attica General Hospital

Athens, Greece

Location

Related Publications (1)

• Miller AB. The costs and benefits of breast cancer screening. Am J Prev Med. 1993 May-Jun;9(3):175-80.

  PMID: 8347369 BACKGROUND

Related Links

• Psychometric properties of quantitative sensory testing focusing on healthy and patients with shoulder pain: a systematic review protocol

MeSH Terms

Conditions

Chronic Pain; Shoulder Pain; Nociplastic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arthralgia; Joint Diseases; Musculoskeletal Diseases

Study Officials

• Paraskevi N. Bilika

  University of Thessaly

  PRINCIPAL INVESTIGATOR

• Eleni V. Kapreli

  University of Thessaly

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Study Director

Study Record Dates

• First Submitted: July 28, 2022
• First Posted: August 1, 2022
• Study Start: July 18, 2022
• Primary Completion: January 10, 2025
• Study Completion: January 10, 2025
• Last Updated: June 12, 2025

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

GR (2)