Work-related IllnessNCT05345496
Central and Peripheral Sensitization, Pain Mediators in Thumb Pain Among Physiotherapists
An observational study of Work-related Illness, run by University of Turin, Italy at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Work-related Illness
- How many people
- 135 participants
- Where
- 1 siteItaly
- Study dates
- 2 May 2022to 30 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Physiotherapists registered in the professional register University students in physiotherapy BSc.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Biological and Clinical Science - University of Turin
Orbassano, TO, 10043
About this study
Official title: 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
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.
Read the detailed description
Introduction: Physiotherapists' work-related thumb pain is a problem recognized by the World Health Organization to be the major work-related musculoskeletal problems (WMSDs) for this profession. About 70.8% of physiotherapists experience thumb pain at least once in their life. In those who practice manual therapy, thumb pain can determine the use of compensatory strategies or the impossibility to practice wanted manipulation. It has been estimated that 1 in 6 physiotherapists end their careers because of WMSDs. The data available in the literature on biomechanics for this phenomenon do not allow to define a proper causa relation lacking to describe the impact of pain mechanisms involved, the impact of mediators of chronicity in pain, and health status.
The purpose of the present research is to investigate the relation between thumb pain and phenomena of central or peripheral plasticity among physiotherapists (exposed) and compare this data to physiotherapy students (not exposed). In particular, we aim to identify the relevance of each chronic pain mediator described in the literature (anxiety, depression, self-efficacy, kinesiophobia) in this health condition.
Methods: A case-control study will be performed. 44 physiotherapists with thumb pain and 44 physiotherapy students will be evaluated. Muscle strength and endurance of the hand will be assessed. Assessment of peripheral sensitization phenomena will be performed with validated clinical tests. It will also be assessed the health status through the minimal ICF core set, the intensity of pain, and through validated questionnaires the central sensitization, anxiety, depression, catastrophization, kinesiophobia, and self-efficacy. The sample size of 44 subjects per group (10% dropout) was estimated a priori, with a clinically relevant effect size of d= .80 and with an estimated power (1- beta )= .95 and α= 0.05.
Expected results: The results of this study can improve the knowledge of the pain mechanisms involved and the complexity of this work-related disabling condition following a multifactorial biopsychosocial model. Results could also improve the prevention of thumb pain in physiotherapists with a relevant impact on this work-related disease.
- Conditions
- Work-related Illness
- Keywords
- Thumb pain, Central sensistization, Peripheral sensitization, Modulating factors, ICF, Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
It will be used to assess the subject's health status. It consists in 7 items and includes the following subcategories: body functions (physiological functions of the body system), body structures (anatomical components such as organs, limbs, and their components), activities (execution of a task or activity by an individual), and participation (involvement in daily life).
Measured: the self-reported scale will be administered on day 1, before the clinical examination
Italian Pain Catastrophizing Scale (PCS-I)
It will be used to assess the catastrophization. This scale consists of 13 items divided into three domains. Each item can achieve a maximum of 4 points, for a maximum of 52. The higher the score, the greater the presence of thoughts of catastrophization.
Measured: the self-reported scale will be administered on day 1, before the clinical examination
Italian Tampa Scale for Kinesophobia (TSK-I)
It will be used to measure kinesiophobia and fear of movement. This scale consists of 17 items assessing the fear of movement perception, scored 1 to 4 points (1=totally disagreeing: 4= strongly agree), achieving a score that varies between 17 and 68. The higher the score, the higher the level of fear related to movement.
Measured: the self-reported scale will be administered on day 1, before the clinical examination
Italian Hospital Anxiety Depression Scale (HADS-I)
It will be used to assess anxiety and depression.This scale consists of 14 items divided into two subcategories. The first 7 items investigate General anxiety, while the other 7 items, mainly investigate the state of anhedonia. For each item the score varies from 0-3 (0= absence; 3= extreme presence). Higher scores correspond to high levels of anxiety and depression.
Measured: the self-reported scale will be administered on day 1, before the clinical examination
Italian Pain Self-efficacy Questionnaire (PSEQ-I)
It will be used to detect self-efficacy. This scale consists of 10 items, whose score varies from 0-6 (0=not safe at all, 10= completely safe), for a total of 60 points. The lower the score, the lower the self-efficacy is.
Measured: the self-reported scale will be administered on day 1, before the clinical examination
Upper Limb Neural Tension Test (ULNTT 1)
It will be used to assess mechanosensitivity of the brachial plexus and upper limb nerves. It consists of a validated combination of physiological movement of the arm (shoulder depression, wrist and finger extension, forearm supination, shoulder external rotation, and elbow extension) and a symptom discrimination maneuvers (homolateral and contralateral cervical spine inclination) to assess the physiological mechanosensitivity of the nerves of the upper limb.
Measured: the test will be administered on day 1 by a physiotherapist during the clinical examination
Vagus nerve neurodynamic test (VN-NDT)
It will be performed to assess vagus nerve sensitization due to chronic stress. It consists of a combination of physiological movements of the neck (upper cervical flexion, contralateral lateral flexion, ipsilateral rotation) and gentle movements of the upper abdomen caudally and cranially to increase tension on the thoracic tract of the vagus nerve, and it assess the physiological mechanosensitivity of the vagus nerve and its effects on heart rate at rest.
Measured: the test will be administered on day 1 by a physiotherapist during the clinical examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start2 May 2022
- Primary completion2 Mar 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Work-related IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giacomo Carta, University of Turin, Italy
- Investigators
- Giacomo Carta, MSc, PT BSc, Principal investigator, University of Turin, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05345496
- Sponsor's protocol ID
- 0169961-14/03/22
- Status last verified
- Feb 2024
- First submitted
- 19 Apr 2022
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05345496
- Acronym / sponsor ID
- 0169961-14/03/22
- Conditions
- Work-related Illness
- Keywords
- Thumb pain, Central sensistization, Peripheral sensitization, Modulating factors, ICF, Disability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- 2 May 2022 (actual)
- Primary completion
- 2 Mar 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 26 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Introduction: Physiotherapists' work-related thumb pain is a problem recognized by the World Health Organization to be the major work-related musculoskeletal problems (WMSDs) for this profession. About 70.8% of physiotherapists experience thumb pain at least once in their life. In those who practice manual therapy, thumb pain can determine the use of compensatory strategies or the impossibility to practice wanted manipulation. It has been estimated that 1 in 6 physiotherapists end their careers because of WMSDs. The data available in the literature on biomechanics for this phenomenon do not allow to define a proper causa relation lacking to describe the impact of pain mechanisms involved, the impact of mediators of chronicity in pain, and health status.
The purpose of the present research is to investigate the relation between thumb pain and phenomena of central or peripheral plasticity among physiotherapists (exposed) and compare this data to physiotherapy students (not exposed). In particular, we aim to identify the relevance of each chronic pain mediator described in the literature (anxiety, depression, self-efficacy, kinesiophobia) in this health condition.
Methods: A case-control study will be performed. 44 physiotherapists with thumb pain and 44 physiotherapy students will be evaluated. Muscle strength and endurance of the hand will be assessed. Assessment of peripheral sensitization phenomena will be performed with validated clinical tests. It will also be assessed the health status through the minimal ICF core set, the intensity of pain, and through validated questionnaires the central sensitization, anxiety, depression, catastrophization, kinesiophobia, and self-efficacy. The sample size of 44 subjects per group (10% dropout) was estimated a priori, with a clinically relevant effect size of d= .80 and with an estimated power (1- beta )= .95 and α= 0.05.
Expected results: The results of this study can improve the knowledge of the pain mechanisms involved and the complexity of this work-related disabling condition following a multifactorial biopsychosocial model. Results could also improve the prevention of thumb pain in physiotherapists with a relevant impact on this work-related disease.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Physiotherapists registered in the professional register University students in physiotherapy BSc.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Italian Central Sensitization Inventory (CSI-I)
Time frame: the self-reported scale will be administered on day 1, before the clinical examination
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.
Quantitative sensory testing (QST)
Time frame: Tests will be administered on day 1 for each site, by a physiotherapist using Neuropen
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.
7 secondary outcomes
International Classification of Functioning, Disability, and Health Generic Core Set
Time frame: the self-reported scale will be administered on day 1, before the clinical examination
Italian Pain Catastrophizing Scale (PCS-I)
Time frame: the self-reported scale will be administered on day 1, before the clinical examination
Italian Tampa Scale for Kinesophobia (TSK-I)
Time frame: the self-reported scale will be administered on day 1, before the clinical examination
Italian Hospital Anxiety Depression Scale (HADS-I)
Time frame: the self-reported scale will be administered on day 1, before the clinical examination
Italian Pain Self-efficacy Questionnaire (PSEQ-I)
Time frame: the self-reported scale will be administered on day 1, before the clinical examination
Upper Limb Neural Tension Test (ULNTT 1)
Time frame: the test will be administered on day 1 by a physiotherapist during the clinical examination
Vagus nerve neurodynamic test (VN-NDT)
Time frame: the test will be administered on day 1 by a physiotherapist during the clinical examination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- Individual participant dataSharing planned: Yes. 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
Related trials for Work-related Illness
Recruiting
Acceptability and Feasibility of Work-Oriented Social-Cognitive Skills Training for Veterans With Serious Mental Illness
Schizophrenia, Bipolar Disorder
Recruiting
Working in the Heat at Simulated Altitude: Effects of Normobaric Hypoxia on Physiological Strain
Body Temperature Changes, Heat Stress
Active, not recruiting
A Multicentre Randomised Controlled Trial of the Norwegian Health in Work Service. The NSAC Efficacy Study
Musculoskeletal Disorder, Anxiety Disorders
Active, not recruiting
A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study
Musculoskeletal Disorder, Anxiety Disorders
Active, not recruitingObservational study
Comparison of Three Treatment Strategies for Traumatic AO Type A1 Vertebral Fractures
Traumatic Vertebral Fractures, Compression Fractures of the Spine
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giacomo Carta, MSc, PT BSc principal investigator
University of Turin, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Work-related Illness, run by University of Turin, Italy at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Italian Central Sensitization Inventory (CSI-I) (time frame: the self-reported scale will be administered on day 1, before the clinical examination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2024.