NCT05062694

Brief Summary

In the literature there is still debate about the concept of central sensitization, as a pain mechanism that can support a neuromusculoskeletal pathology and which for Woolf corresponds to an amplification of neural signaling within the Central Nervous System causing hypersensitivity to pain. This mechanism is often confused with the concept of chronic pain, as in many conditions such as fibromyalgia, traumatic neck pain, low back pain or osteoarthritis, central sensitization supports its maintenance beyond 6 months. We believe it is important to investigate among Italian physiotherapists the management of the patient in which the presence of a central pain sensitization phenomenon is suspected, in order to provide consistent data to direct the education of health professionals towards more effective management of this problem. To achieve this goal we aim to:

  • Conduct a Delphi study in order to reach consensus, into a panel of experts, on the methods useful for the management, in each phase of the physiotherapy process, of the patient with neuromusculoskeletal problems with pain underlying central sensitization mechanism
  • Investigate, through a survey among Italian physiotherapists, their clinical approach to the patient in question
  • Develop a free online course available to clinical professionals and/or students who wish to deepen this issue.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2021

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

Study Start

First participant enrolled

September 20, 2021

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 21, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 30, 2021

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2021

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2021

Completed
Last Updated

November 10, 2022

Status Verified

May 1, 2022

Enrollment Period

1 month

First QC Date

September 21, 2021

Last Update Submit

November 7, 2022

Conditions

Keywords

Patient ManagementCentral SensitisationMuscoloskeletal DiseasePain

Outcome Measures

Primary Outcomes (1)

  • Physical therapists' patient management

    Exploring Italian physiotherapists' clinical approach to the patient in question through an online survey

    1 month

Interventions

SurveyOTHER

It will be created a questionnaire to investigate, among Italian physiotherapists, their clinical approach to the patient with Central Sensitisation

Eligibility Criteria

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

Physical therapists

You may qualify if:

  • Italian physiotherapists who will decide to fill in the questionnaire

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Ospedaliero-Universitaria di Ferrara

Ferrara, FE, 44124, Italy

Location

Related Publications (1)

  • Baroni A, Margelli M, Saoncella A, Toigo I, Antonellini G, Straudi S. Physiotherapy management of nociplastic pain: A Delphi study of Italian specialists. Pain Pract. 2023 Sep;23(7):734-742. doi: 10.1111/papr.13238. Epub 2023 May 4.

MeSH Terms

Conditions

Musculoskeletal DiseasesPain

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 21, 2021

First Posted

September 30, 2021

Study Start

September 20, 2021

Primary Completion

October 20, 2021

Study Completion

October 30, 2021

Last Updated

November 10, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations