NCT05345496

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 19, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 26, 2022

Completed
6 days until next milestone

Study Start

First participant enrolled

May 2, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

February 15, 2024

Status Verified

February 1, 2024

Enrollment Period

10 months

First QC Date

April 19, 2022

Last Update Submit

February 13, 2024

Conditions

Keywords

Thumb painCentral sensistizationPeripheral sensitizationModulating factorsICFDisability

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

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

Location

Study Officials

  • Giacomo Carta, MSc, PT BSc

    University of Turin, Italy

    PRINCIPAL INVESTIGATOR

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

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

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