Central and Peripheral Sensitization, and Pain Contributing Factors in Shoulder Pain Patients and Healthy People

NCT05360589 | Completed

• 1 other identifier: 7757/2022
• Study Type: observational
• Target: 135
• Locations: 1 country
• Sites: 1

Brief Summary

Compared to healthy subjects, central and peripheral sensitization will be investigated in patients with non-specific shoulder pain, since no data is available at the moment. The Central Sensitization Inventory (CSI) will be administered to assess sensitization in patients and controls, and changes in the mechanosensitivity of the upper limb will be assessed by checking for mechanical allodynia, hyperalgesia, and wind-up related to peripheral sensitization. Chronic pain mediators factors such as anxiety, depression, catastrophization, self-efficacy, and kinesiophobia will be investigated through validated rating scales. The Vagus Nerve neurodynamic test (VN-NDT) will be performed to assess any HR variability reduction related to stress mechanisms typical of chronic pain conditions. Finally, to health status of participants, following the biopsychosocial model, the Generic Core Set of the International Classification of the Functioning of Disability and Health (ICF) will be assessed.

Conditions

Shoulder Pain

Keywords

Shoulder pain; Central sensistization; Peripheral sensitization; Modulating factors; ICF; Disability

Outcome Measures

Primary Outcomes (5)

• Italian Central Sensitization Inventory (CSI-I)

  It will be adopted to assess central sensitization. It consists of two sections. Part A is made up of 25 self-reported items, each rated on a scale from 0 to 5 (0=never and 4=always), for a maximum score of 100. Part B analyses the presence of commonly related symptoms. A total score \< 40 shows good sensitivity to exclude the presence of signs and symptoms related to central sensitization.

  the self-reported scale will be administered on day 1, before the clinical examination

• Numeric Pain Rating Scale

  pain intensity will be tested asking the standardized question " on a scale from 0 to 10 when 0 is no pain and 10 is the worst pain ever rate the pain intensity you feel in this moment in the body part assessed"

  The scale will be administered to assess the pain intensity during provocative tests during the clinical examination (day 1)

• Quantitative sensory testing (QST) -Tactile discrimination

  These tests will be adopted to assess peripheral and central sensitiazion phenomena. Tests will be administered once for each site, by a physiotherapist using Neuropen. -Tactile discrimination will be tested by administering an alternation of three tactile stimuli and three puncture stimuli at the level of the coracoid, the middle deltoid, the middle third of the scapula spine above and below and asking the patient to type of stimulus perceived (touch or pain).

  The outcome will be measured on day 1 for each site, by a physiotherapist during the clinical examination

• Quantitative sensory testing (QST)-Mechanical allodynia

  These tests will be adopted to assess peripheral and central sensitiazion phenomena. ests will be administered once for each site, by a physiotherapist using Neuropen. -Mechanical allodynia will be evaluated by maintaining the assessor's thumb with a standardized constant pressure for 10 seconds on the skin of middle deltoid, the anterior deltoid, the middle third of the scapular spine above and below, asking if the stimulus is painful.

  The outcome will be measured on day 1 for each site, by a physiotherapist during the clinical examination

• Pain spatial summation to assess the pain descending inhibitory system

  The wind-up phenomenon will be investigated by administering a set of 10 punctures on the skin of the middle deltoid, anterior deltoid, and middle third of the scapula above and below the scapula spine, asking if the patient to report initial and final pain rates through a Numeric Pain Rating Scale. The patient will be asked to give a verbal score on the pain intensity perceived. The score ranges from 0 (=no pain) to 10 (= maximum pain imaginable).

  Tests will be administered on day 1 for each site, by a physiotherapist using Neuropen

Secondary Outcomes (8)

• International Classification of Functioning, Disability, and Health Generic Core Set

  the self-reported scale will be administered on day 1, before the clinical examination

• Italian Shoulder Pain and Disability Index (SPADI-I)

  the self-reported scale will be administered on day 1, before the clinical examination

• Italian Pain Catastrophizing Scale (PCS-I)

  the self-reported scale will be administered on day 1, before the clinical examination

• Italian Tampa Scale for Kinesophobia (TSK-I)

  the self-reported scale will be administered on day 1, before the clinical examination

• Italian Hospital Anxiety Depression Scale (HADS-I)

  the self-reported scale will be administered on day 1, before the clinical examination

Study Arms (2)

Shoulder non-specific pain

68 adult gender-balanced subjects will be enrolled, reporting unilateral, atraumatic, and non-specific shoulder pain68 healthy subjects who regularly perform sports activities (at least one weekly session).

Controls

68 healthy subjects who regularly perform sports activities (at least one time/week) without shoulder pain will be recruited.

Eligibility Criteria

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

Study Population

Subjects with non-specific shoulder pain and healthy subjects that give their consent to be enrolled in the study.

You may qualify if:

• Subjects giving their written consent to be enrolled in the study.
• Subjects aged more than 18 years old.
• Subjects reporting unilateral, atraumatic, and non-specific shoulder pain and/or mechanosensitivity changes in the shoulder region such as burning pain, shocks, and tingling pain.

You may not qualify if:

• Subjects presenting massive lesions, fractures, joint instability following dislocations or subluxations of the shoulder.
• Subjects presenting nerve conduction deficiency
• Subjects underwent at least once in their life shoulder prostheses and/or interventions that have altered the shoulder anatomy
• Subjects undergone shoulder surgery less than 2 years before the assessment.
• Subjects reporting a history of trauma and/or dislocation less than a year before the assessment.
• Subjects presenting central neurological diseases, neurodegenerative diseases, demyelinating acute diseases (ex: Guillane Barrè), oncology and psychiatry diseases, and diabetes.

Sponsors & Collaborators

• University of Turin, Italy: lead
• Centro Medico Albese: collaborator

Study Sites (1)

Department of Biological and Clinical Science - University of Turin

Orbassano, TO, 10043, Italy

Location

MeSH Terms

Conditions

Shoulder Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Giacomo Carta, MSc, PT BSc

  University of Turin, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 14, 2022
• First Posted: May 4, 2022
• Study Start: May 2, 2022
• Primary Completion: December 30, 2022
• Study Completion: March 30, 2023
• Last Updated: February 14, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Immediately following the publication. No end date.
• Access Criteria: The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.

Locations

IT (1)