Clinical trial NCT05360589: Central and Peripheral Sensitization, and Pain Contributing Factors in Shoulder Pain Patients and Healthy People
Official title: Assessment of Central and Peripheral Sensitization, and Pain Contributing Factors in Patients With Non-specific Shoulder Pain. A Case-control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Shoulder Pain
Keywords: Shoulder pain
Central sensistization
Peripheral sensitization
Modulating factors
ICF
Disability
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
Collaborators: name: Centro Medico Albese
First posted: 2022-05-04
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Detailed description: Introduction: Growing evidence shows that non-specific shoulder pain is a common musculoskeletal condition. It often involves a severe reduction in the functionality of the upper limb with a remarkable impact on daily life activities and social participation. Like back pain disorders, it is known that it has a high risk of chronification and is associated with central and peripheral sensitization phenomena. These processes are clinically detectable as hyperalgesia, allodynia, and wind-up phenomenon, but it is not yet explored if those processes are reported in shoulder pain patients. Moreover, modern clinical neuroscience had revealed that behavioral factors such as anxiety, depression, poor self-efficacy, kinesiphobia, and catastrophization contributes to pain chronification but a clear involvement of these factors has not been defined yet for shoulder pain. Considering that the relation between anatomical alterations detectable with imaging techniques is very poor when assessing chronic pain patients it is useful to explore this condition from a biopsychosocial point of view that nowadays is lacking.

To better define and treat non-specific shoulder pain patients, exploring central and peripheral sensitization, chronic pain contributing factors, and their health status is of paramount importance. Methods: A case-control study will be performed. Based on the best evidence the sample size was calculated. It was estimated 68 people with non-specific shoulder pain and 68 healthy controls are needed to be evaluated. All participants will fulfill the following validated rating scales exploring central sensitization, pain chronification factors, disability and health status. The disability will be assessed using The Shoulder Pain and Disability Index, central sensitization using the Central Sensitization Inventory (CSI), catastrophization using the Pain Catastrophizing Scale (PCS), kinesiophobia using the Tampa Scale for Kinesiophobia (TSK), anxiety and depression using the Hospital Anxiety Depression Scale (HADS) and self-efficacy using the Pain Self-efficacy Questionnaire (PSEQ). A trained physiotherapist will complete the ICF Generic Core Set, and after sharing it with the patient, a patient-clinician evaluation of the health status will be defined. Moreover, a clinical examination will be carried out to detect tactile and mechanical allodynia, wind-up phenomenon, and mechanosensitivity changes in the shoulder. A multivariate model will be considered for the statistical analysis to check for any confounding, and tests for estimating variance differences will be used.

Expected results: The study is expected to describe the relevance of processes related to central and peripheral sensitization in chronic shoulder pain patients, with a plausible difference between healthy controls. It will be possible to define the relevance of pain chronification factors and health status considering the complexity of pain from a biopsychosocial point of view. The investigators expect to identify which factors are related to disability and loss of participation in shoulder pain. Conclusion: The study is aimed to offer a multifactorial overview of patients with non-specific shoulder pain to provide tailored and precise rehabilitation programs, considering the clinical relevant factors and reducing the resource waste in less effective interventions.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Italian Central Sensitization Inventory (CSI-I)
timeFrame: the self-reported scale will be administered on day 1, before the clinical examination
measure: Numeric Pain Rating Scale
timeFrame: The scale will be administered to assess the pain intensity during provocative tests during the clinical examination (day 1)
measure: Quantitative sensory testing (QST) -Tactile discrimination
timeFrame: The outcome will be measured on day 1 for each site, by a physiotherapist during the clinical examination
measure: Quantitative sensory testing (QST)-Mechanical allodynia
timeFrame: The outcome will be measured on day 1 for each site, by a physiotherapist during the clinical examination
measure: Pain spatial summation to assess the pain descending inhibitory system
timeFrame: Tests will be administered on day 1 for each site, by a physiotherapist using Neuropen
Secondary outcomes:
measure: International Classification of Functioning, Disability, and Health Generic Core Set
timeFrame: the self-reported scale will be administered on day 1, before the clinical examination
measure: Italian Shoulder Pain and Disability Index (SPADI-I)
timeFrame: the self-reported scale will be administered on day 1, before the clinical examination
measure: Italian Pain Catastrophizing Scale (PCS-I)
timeFrame: the self-reported scale will be administered on day 1, before the clinical examination
measure: Italian Tampa Scale for Kinesophobia (TSK-I)
timeFrame: the self-reported scale will be administered on day 1, before the clinical examination
measure: Italian Hospital Anxiety Depression Scale (HADS-I)
timeFrame: the self-reported scale will be administered on day 1, before the clinical examination
measure: Italian Pain Self-efficacy Questionnaire (PSEQ-I)
timeFrame: the self-reported scale will be administered on day 1, before the clinical examination
measure: Upper Limb Neural Tension Test (ULNTT 1)
timeFrame: the test will be administered on day 1 by a physiotherapist during the clinical examination
measure: Vagus nerve neurodynamic test (VN-NDT)
timeFrame: the test will be administered on day 1 by a physiotherapist during the clinical examination
Other outcomes:
Locations:
city: Orbassano
country: Italy
facility: Department of Biological and Clinical Science - University of Turin
state: TO
Study officials:
affiliation: University of Turin, Italy
name: Giacomo Carta, MSc, PT BSc
role: PRINCIPAL_INVESTIGATOR
References: