Central and Peripheral Sensitization, Pain Mediators in Thumb Pain Among Physiotherapists
Assessment of Central and Peripheral Sensitization, and Pain Mediators and Health Status in the Work-related Thumb Pain Among Physiotherapists. A Case-control Study Comparing Workers and Students
1 other identifier
observational
135
1 country
1
Brief Summary
The work-related thumb pain is a common problem among physiotherapists which deal with this experience at least once in their life. Several studies analyzed the distribution of mechanical forces, kinematics, and kinesiology of the thumb in this clinical condition. However, there is no data, available in the literature, on how this pain processed is sustained and if plastic changes in the central or peripheral nervous system are involved. The research aims are to investigate the relationship between the thumb pain and pain related central and peripheral nervous sensitization phenomena among physiotherapists (exposed to work) and physiotherapy students (not exposed). The relevance of each of the pain chronification mediators, reported in the literature (anxiety, depression catastrophization, self-efficacy, kinesiophobia) will be also defined. Data on pain intensity, muscle strength, and endurance in the hand will be collected and the relation between peripheral sensitization phenomena in the hand, and central sensitization will be assessed. Also, the relevance of pain mediators and the health perceived status will be assess adopting validated questionnaires and the minimal Generic ICF core set.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2022
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 19, 2022
CompletedFirst Posted
Study publicly available on registry
April 26, 2022
CompletedStudy Start
First participant enrolled
May 2, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 2, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2023
CompletedFebruary 15, 2024
February 1, 2024
10 months
April 19, 2022
February 13, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Quantitative sensory testing (QST)
These tests will be adopted to assess peripheral and central sensitiazion phenomena.It will be tested 1cm2 of both dorsal and palmar skin. First, using the Neuropen tool patient will be asked to discriminate between a set of 3 alterante tactile and puncture stimuli. Then a mechanical pressure will be maintained on both sides for 10 seconds and asked if it was painful or not. Then 10 puncture stimuli in a row with Neuropen will be performed recording pain intensity.
Tests will be administered on day 1 for each site, by a physiotherapist using Neuropen
Secondary Outcomes (7)
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 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
Italian Pain Self-efficacy Questionnaire (PSEQ-I)
the self-reported scale will be administered on day 1, before the clinical examination
- +2 more secondary outcomes
Study Arms (2)
WORKERS GROUP
44 physiotherapists with a history of at least 1 painful episode of work-related thumb pain in the last 3 months will be enrolled.
STUDENT GROUP
44 physiotherapy students in their first academic year will be enrolled.
Eligibility Criteria
Physiotherapists registered in the professional register University students in physiotherapy BSc.
You may qualify if:
- Subjects giving their written consent to be enrolled in the study.
- Subjects aged more than 18 years old.
- Registration to the professional register or to the degree course in Physiotherapy
- History of at least 1 episode of work-related thumb pain in the last 3 months for physiotherapists
You may not qualify if:
- Recent or current pain/pathology of the upper limbs and neck;
- Pregnancy;
- Neurological disorders that increase or decrease the tone of upper limb and neck muscles;
- Rheumatic diseases
- Recent hand surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Biological and Clinical Science - University of Turin
Orbassano, TO, 10043, Italy
Study Officials
- PRINCIPAL INVESTIGATOR
Giacomo Carta, MSc, PT BSc
University of Turin, Italy
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD Candidate Experimental Medicine and Therapy, MSc in Rehabilitation Scence, BSc in Pysiotherapy
Study Record Dates
First Submitted
April 19, 2022
First Posted
April 26, 2022
Study Start
May 2, 2022
Primary Completion
March 2, 2023
Study Completion
April 30, 2023
Last Updated
February 15, 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.
There is a plan to make IPD and related data dictionaries available. All of the individual particiapnt data collected during the trial will be shared after deidentification