Central SensitisationNCT05062694
Physical Therapy Management Of The Patient With Central Sensitization
An observational study of Central Sensitisation and Musculoskeletal Diseases, run by University Hospital of Ferrara at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Central Sensitisation, Musculoskeletal Diseases, Pain
- What is being tested?
- Survey
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 20 Sep 2021to 30 Oct 2021
- 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: Physical therapists
Who may be able to join
- Italian physiotherapists who will decide to fill in the questionnaire
Who cannot join
- No exclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physical Therapy Management Of The Patient With Central Sensitization: An Observational Study Among Italian Physiotherapists
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.
Read more
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.
- Conditions
- Central Sensitisation, Musculoskeletal Diseases, Pain
- Being tested
- Survey
- Keywords
- Patient Management, Central Sensitisation, Muscoloskeletal Disease, Pain
- Medical subject headings
- Musculoskeletal Diseases, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
It will be created a questionnaire to investigate, among Italian physiotherapists, their clinical approach to the patient with Central Sensitisation
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical therapists' patient management
Exploring Italian physiotherapists' clinical approach to the patient in question through an online survey
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2021
- Study start20 Sep 2021
- Primary completion20 Oct 2021
- Study completion30 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Central SensitisationStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of Ferrara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sofia Straudi, University Hospital of Ferrara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05062694
- Sponsor's protocol ID
- Survey_CS
- Status last verified
- May 2022
- First submitted
- 21 Sep 2021
- Last updated
- 10 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37143408
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Therapy Management Of The Patient With Central Sensitization: An Observational Study Among Italian Physiotherapists
- ClinicalTrials.gov ID
- NCT05062694
- Acronym / sponsor ID
- Survey_CS
- Conditions
- Central Sensitisation, Musculoskeletal Diseases, Pain
- Keywords
- Patient Management, Central Sensitisation, Muscoloskeletal Disease, Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Hospital of FerraraUniversity, hospital or other
- Study start
- 20 Sep 2021 (actual)
- Primary completion
- 20 Oct 2021 (actual)
- Study completion
- 30 Oct 2021 (actual)
- First posted
- 30 Sep 2021 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Physical therapists
Key inclusion criteria (1 listed)
- Italian physiotherapists who will decide to fill in the questionnaire
Key exclusion criteria (1 listed)
- No exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurveyIt will be created a questionnaire to investigate, among Italian physiotherapists, their clinical approach to the patient with Central Sensitisation | Other | – |
Primary outcome
Physical therapists' patient management
Time frame: 1 month
Exploring Italian physiotherapists' clinical approach to the patient in question through an online survey
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 10 Nov 2022.
- Derived from this study: PubMed 37143408Baroni 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.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Central Sensitisation and Musculoskeletal Diseases, run by University Hospital of Ferrara 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 1 inclusion and 1 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 10 Nov 2022. 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?
Physical therapists' patient management (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05062694, which also lists 1 linked publication.
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 10 Nov 2022.