CRPS (Complex Regional Pain Syndrome) Type IMEDICUSNCT06978608
Ultrasound and Somatosensory Median Nerve Evaluation in CRPS I
An observational study of CRPS (Complex Regional Pain Syndrome) Type I, run by Azienda Ospedaliero-Universitaria Careggi.
Trial summary
Complex regional pain syndrome (CRPS) is a disorder falling within the sphere of neuropathic pain, characterised by a plethora of symptoms. Regional pain out of proportion to the triggering event is the main presentation, accompanied by allodynia, dysesthesia, thermal asymmetry, trophic changes, oedema and stiffness. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CRPS (Complex Regional Pain Syndrome) Type I
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 26 Feb 2026
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: The population will be enrolled at the primary care clinic of the hospital, diagnosed as CRPS type I.
Who may be able to join
- patients diagnosed with CRPS assessed at the AOUC's Hand Surgery and Reconstructive Microsurgery SOD
- Patients aged 18 years and over
- Signature of informed consent for participation in the study and processing of related data
Who cannot join
- patients suffering from CRPS type II and therefore with known peripheral nerve injury
- Patients under 18 years of age
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Ultrasound and Somatosensory Evaluation of the Median Nerve at the Carpal Canal in Patients With CRPS Type I and Clinical Correlation: Definition of Morphologic Patterns
Complex regional pain syndrome (CRPS) is a disorder falling within the sphere of neuropathic pain, characterised by a plethora of symptoms. Regional pain out of proportion to the triggering event is the main presentation, accompanied by allodynia, dysesthesia, thermal asymmetry, trophic changes, oedema and stiffness. Recently, preliminary observational studies have found that the management of patients with CRPS, refractory to pharmacological treatment, by carpal tunnel release may be resolving; This suggests that an irritative carpal tunnel syndrome may be masked as CRPS due to non-specific symptoms and negative electrodiagnostic studies (electromyography-EMG). Classical carpal tunnel syndrome (CTS) is a well-defined clinical condition that can be ascertained by EMG. In contrast, irritative carpal tunnel syndrome has symptoms attributable to CRPS with negative EMG that arises after trauma that required surgery or immobilisation. It is unclear how to define the presence of irritative carpal tunnel syndrome in patients diagnosed as CRPS, and thus how to make a correct diagnosis. Nor is the management of these patients defined. The aim of the research is to analyse all patients with typical symptoms for CRPS to investigate the morphological appearance of the median nerve at the level of the carpal tunnel by means of dynamic ultrasound in comparison with the healthy limb. In addition, in order to quantify the function of the median nerve, investigators will analyse patients by means of a sensory conduction velocity study (SNVC), as common EMG examinations are negative in these patients, while it is possible that the quantification of the sensory part of the nerve may be impaired. In addition, the autonomic component will be investigated by studying the Skin Sudomotor Response (SSR).The hypothesis is that some patients, after an injury that required surgery or immobilisation, develop fibrous soft tissue scarring that creates a kind of space-occupying lesion that compresses the median nerve at the level of the carpal tunnel and reduces its sliding under the transverse ligament of the carpus, a structure that is not elastic and therefore unable to adapt to the volumetric increases within it. The other hypothesis is that the fibrosis and post-traumatic oedema, which is structured, directly involves the median nerve sheath, resulting in irritation. Classical CTS develops due to mechanical trauma, high pressure and ischaemic damage affecting the median nerve and develops as a clinical condition of pure nerve suffering, with symptoms referable to a sensory and motor deficit. In CRPS, on the other hand, allodynia, hyperalgesia, sudomotor and vasomotor abnormalities and trophic changes are all symptoms that may be related, but are not specific, to nerve suffering.
Read the detailed description
This is a prospective, single-centre, non-profit observational study. The study will be carried out as follows: Patients will be recruited on the presence of positive Budapest Criteria for CRPS type I. Patients suffering from CRPS type I at the SOD of Surgery and Reconstructive Microsurgery of the Hand of the AOU Careggi of Florence (IT) will be included, aged 18 years or older. In particular, each patient will undergo dynamic bilateral wrist ultrasound and the following parameters will be recorded: median nerve sliding in terms of mm, morphological appearance of the median nerve in terms of hypertrophy/hypotrophy, hourglass lesions and relationship with adjacent soft tissues. The surrounding soft tissues will be examined, in particular the tendinous structures within the carpal canal to assess the presence of fibrosis, synovitis and degree of sliding in mm. The ultrasound examination will be performed in all patients with symptoms attributable to CRPS type I. Each patient will also undergo a Neuronographic examination recording the following parameters: Motor conduction velocity (VCM), distal latency of the M response, Sensory Conduction Speed (VCS), amplitude of the sensory action potential (SAP), latency of the sympathetic cutaneous response (SSR) and the following parameters will be recorded: Ultrasound examination will be performed.
The participation of each participant in the study will be superimposed on the performance of the ultrasound and neuronographic examination; 50 patients will be enrolled at this hospital; the study will be conducted exclusively in the Careggi University Hospital. Each patient will be analysed by ultrasound and Neuronographic examination on both healthy and diseased side defining the morphological criteria and Neuronographic parameters of the median nerve based on the findings. The aim will be to try to define specific predictive morphological patterns.
Each patient will continue to be treated both diagnostically and therapeutically, as well as post-therapy monitoring, according to normal clinical practice.
Inclusion criteria
- patients with a diagnosis of CRPS evaluated at the SOD of Hand Surgery and Reconstructive Microsurgery of the AOUC, Florence (IT)
- Patients aged 18 years or older
- Signature of informed consent to participation in the study and processing of related data
Exclusion criteria
- patients with CRPS type II and therefore with known peripheral nerve injury
- Patients under 18 years of age
Patients' clinical data (age, sex, treatment provided, clinical outcome) will be extracted from the medical records. Patients will be evaluated periodically on an outpatient basis according to the normal follow-up protocol.
- Keywords
- CRPS, MEDIAN NERVE, CARPAL TUNNEL, SENSORY, ULTRASOUND, SOMATOSENSORY
- Medical subject headings
- Complex Regional Pain Syndromes, Median Neuropathy
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 |
|---|---|---|
| Patients with Budapest Criteria positive for CRPS type I, older than 18 years old | Any specific symptoms will be recorded. Patients will undergo ultrasound examination to analyze on both the healthy and diseased side the morphological aspect of the median nerve at the carpal tunnel level, to address gliding in terms of mm, adhesion between the transverse ligament and flexor tendons. The aim will be to try to define specific predictive morphological patterns relative to the clinical appearance. Sensory nerve conduction velocity (SNCV) of the median-nerve will be evaluated to analyze the somatosensory part of the median nerve and understand the potential use of this as a diagnostic tool. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with altered gliding and/or presence of adhesion between the median nerve and the flexor tendons and/or transverse carpal ligament in patients affected by CRPS type I
Ultrasound examination will be done either to the affected and the contralateral side. The median nerve will be studied in terms of gliding of the nerve , adhesions with the flexor tendons and / or the transverse carpal ligament. The presence of hypertrophy will be addressed by measuring the median nerve thickness.
Measured: Up to 12 months. From date of recruitment until the date of clinical improvement, assessed up to 12 months
Secondary outcomes (1)
Number of patients with altered sensory nerve conduction velocity study in patients affected by CRPS type I
Patients that provide a reduction of the velocity at the sensory nerve conduction study as a result of median nerve irritation that manifests as suffering of its somatosensory part.
Measured: Up to 12 months. From date of recruitment until the date of clinical improvement, assessed up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start1 Sep 2025 (estimated)
- Primary completion26 Sep 2025 (estimated)
- Study completion26 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CRPS (Complex Regional Pain Syndrome) Type IStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria Careggi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06978608
- Sponsor's protocol ID
- Prot.: 0003733 del 2025
- Other IDs
- Rif CEAVC 28194
- Acronym
- MEDICUS
- Status last verified
- Apr 2025
- First submitted
- 23 Apr 2025
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound and Somatosensory Evaluation of the Median Nerve at the Carpal Canal in Patients With CRPS Type I and Clinical Correlation: Definition of Morphologic Patterns
- ClinicalTrials.gov ID
- NCT06978608
- Acronym / sponsor ID
- MEDICUS / Prot.: 0003733 del 2025
- Keywords
- CRPS, MEDIAN NERVE, CARPAL TUNNEL, SENSORY, ULTRASOUND, SOMATOSENSORY
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero-Universitaria CareggiUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 26 Sep 2025 (estimated)
- Study completion
- 26 Feb 2026 (estimated)
- First posted
- 18 May 2025 (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.
Complex regional pain syndrome (CRPS) is a disorder falling within the sphere of neuropathic pain, characterised by a plethora of symptoms. Regional pain out of proportion to the triggering event is the main presentation, accompanied by allodynia, dysesthesia, thermal asymmetry, trophic changes, oedema and stiffness. Recently, preliminary observational studies have found that the management of patients with CRPS, refractory to pharmacological treatment, by carpal tunnel release may be resolving; This suggests that an irritative carpal tunnel syndrome may be masked as CRPS due to non-specific symptoms and negative electrodiagnostic studies (electromyography-EMG). Classical carpal tunnel syndrome (CTS) is a well-defined clinical condition that can be ascertained by EMG. In contrast, irritative carpal tunnel syndrome has symptoms attributable to CRPS with negative EMG that arises after trauma that required surgery or immobilisation. It is unclear how to define the presence of irritative carpal tunnel syndrome in patients diagnosed as CRPS, and thus how to make a correct diagnosis. Nor is the management of these patients defined. The aim of the research is to analyse all patients with typical symptoms for CRPS to investigate the morphological appearance of the median nerve at the level of the carpal tunnel by means of dynamic ultrasound in comparison with the healthy limb. In addition, in order to quantify the function of the median nerve, investigators will analyse patients by means of a sensory conduction velocity study (SNVC), as common EMG examinations are negative in these patients, while it is possible that the quantification of the sensory part of the nerve may be impaired. In addition, the autonomic component will be investigated by studying the Skin Sudomotor Response (SSR).The hypothesis is that some patients, after an injury that required surgery or immobilisation, develop fibrous soft tissue scarring that creates a kind of space-occupying lesion that compresses the median nerve at the level of the carpal tunnel and reduces its sliding under the transverse ligament of the carpus, a structure that is not elastic and therefore unable to adapt to the volumetric increases within it. The other hypothesis is that the fibrosis and post-traumatic oedema, which is structured, directly involves the median nerve sheath, resulting in irritation. Classical CTS develops due to mechanical trauma, high pressure and ischaemic damage affecting the median nerve and develops as a clinical condition of pure nerve suffering, with symptoms referable to a sensory and motor deficit. In CRPS, on the other hand, allodynia, hyperalgesia, sudomotor and vasomotor abnormalities and trophic changes are all symptoms that may be related, but are not specific, to nerve suffering.
Detailed description
This is a prospective, single-centre, non-profit observational study. The study will be carried out as follows: Patients will be recruited on the presence of positive Budapest Criteria for CRPS type I. Patients suffering from CRPS type I at the SOD of Surgery and Reconstructive Microsurgery of the Hand of the AOU Careggi of Florence (IT) will be included, aged 18 years or older. In particular, each patient will undergo dynamic bilateral wrist ultrasound and the following parameters will be recorded: median nerve sliding in terms of mm, morphological appearance of the median nerve in terms of hypertrophy/hypotrophy, hourglass lesions and relationship with adjacent soft tissues. The surrounding soft tissues will be examined, in particular the tendinous structures within the carpal canal to assess the presence of fibrosis, synovitis and degree of sliding in mm. The ultrasound examination will be performed in all patients with symptoms attributable to CRPS type I. Each patient will also undergo a Neuronographic examination recording the following parameters: Motor conduction velocity (VCM), distal latency of the M response, Sensory Conduction Speed (VCS), amplitude of the sensory action potential (SAP), latency of the sympathetic cutaneous response (SSR) and the following parameters will be recorded: Ultrasound examination will be performed.
The participation of each participant in the study will be superimposed on the performance of the ultrasound and neuronographic examination; 50 patients will be enrolled at this hospital; the study will be conducted exclusively in the Careggi University Hospital. Each patient will be analysed by ultrasound and Neuronographic examination on both healthy and diseased side defining the morphological criteria and Neuronographic parameters of the median nerve based on the findings. The aim will be to try to define specific predictive morphological patterns.
Each patient will continue to be treated both diagnostically and therapeutically, as well as post-therapy monitoring, according to normal clinical practice.
Inclusion criteria
- patients with a diagnosis of CRPS evaluated at the SOD of Hand Surgery and Reconstructive Microsurgery of the AOUC, Florence (IT)
- Patients aged 18 years or older
- Signature of informed consent to participation in the study and processing of related data
Exclusion criteria
- patients with CRPS type II and therefore with known peripheral nerve injury
- Patients under 18 years of age
Patients' clinical data (age, sex, treatment provided, clinical outcome) will be extracted from the medical records. Patients will be evaluated periodically on an outpatient basis according to the normal follow-up protocol.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Budapest Criteria positive for CRPS type I, older than 18 years old | – | –Any specific symptoms will be recorded. Patients will undergo ultrasound examination to analyze on both the healthy and diseased side the morphological aspect of the median nerve at the carpal tunnel level, to address gliding in terms of mm, adhesion between the transverse ligament and flexor tendons. The aim will be to try to define specific predictive morphological patterns relative to the clinical appearance. Sensory nerve conduction velocity (SNCV) of the median-nerve will be evaluated to analyze the somatosensory part of the median nerve and understand the potential use of this as a diagnostic tool. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population will be enrolled at the primary care clinic of the hospital, diagnosed as CRPS type I.
Key inclusion criteria (3 listed)
- patients diagnosed with CRPS assessed at the AOUC's Hand Surgery and Reconstructive Microsurgery SOD
- Patients aged 18 years and over
- Signature of informed consent for participation in the study and processing of related data
Key exclusion criteria (2 listed)
- patients suffering from CRPS type II and therefore with known peripheral nerve injury
- Patients under 18 years of age
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
Number of patients with altered gliding and/or presence of adhesion between the median nerve and the flexor tendons and/or transverse carpal ligament in patients affected by CRPS type I
Time frame: Up to 12 months. From date of recruitment until the date of clinical improvement, assessed up to 12 months
Ultrasound examination will be done either to the affected and the contralateral side. The median nerve will be studied in terms of gliding of the nerve , adhesions with the flexor tendons and / or the transverse carpal ligament. The presence of hypertrophy will be addressed by measuring the median nerve thickness.
1 secondary outcome
Number of patients with altered sensory nerve conduction velocity study in patients affected by CRPS type I
Time frame: Up to 12 months. From date of recruitment until the date of clinical improvement, assessed up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of CRPS (Complex Regional Pain Syndrome) Type I, run by Azienda Ospedaliero-Universitaria Careggi.
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 3 inclusion and 2 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: opening soon, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chiara Suardi, MD (+39 3381032276, suardic@aou-careggi.toscana.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with altered gliding and/or presence of adhesion between the median nerve and the flexor tendons and/or transverse carpal ligament in patients affected by CRPS type I (time frame: Up to 12 months. From date of recruitment until the date of clinical improvement, assessed up to 12 months). 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 18 May 2025.