Nociplastic Pain in Patients With Chronic Shoulder Pain

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.

Study Overview

• Status: Completed
• Conditions: Chronic Shoulder Pain
• Intervention / Treatment: Diagnostic test: Nociplastic Pain Criteria

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 Type: Observational
• Enrollment (Actual): 70

Contacts and Locations

Study Locations

• Greece
  • Athens, Greece
    • KAT Attica General Hospital
  • Sterea Ellada
    • Lamia, Sterea Ellada, Greece, 35100
      • Clinical Exercise Physiology and Rehabilitation Laboratory

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Paraskevi Bilika
• Investigators: Principal Investigator: Paraskevi N. Bilika, University of Thessaly; Study Director: Eleni V. Kapreli, University of Thessaly

Publications and helpful links

General Publications

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

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2022
• Primary Completion (Actual): January 10, 2025
• Study Completion (Actual): January 10, 2025

Study Registration Dates

• First Submitted: July 28, 2022
• First Submitted That Met QC Criteria: July 28, 2022
• First Posted (Actual): August 1, 2022

Study Record Updates

• Last Update Posted (Actual): June 12, 2025
• Last Update Submitted That Met QC Criteria: June 8, 2025
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: chronic pain; predictors; shoulder pain; nociplastic pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Joint Diseases; Arthralgia; Shoulder Pain
• Other Study ID Numbers: 5

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No