Ignite Creation Date:
2024-05-06 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 2:31 PM
Study NCT ID:
NCT05360589
Status:
COMPLETED
Last Update Posted:
2024-02-14
First Post:
2022-04-14
Brief Title:
Central and Peripheral Sensitization and Pain Contributing Factors in Shoulder Pain Patients and Healthy People
Sponsor:
University of Turin Italy
Organization:
University of Turin Italy
Study Overview
Official Title:
Assessment of Central and Peripheral Sensitization and Pain Contributing Factors in Patients With Non-specific Shoulder Pain A Case-control Study
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None