Peripheral Nerve InjuriesNCT03174665
Chronic Neuropathic Pain After Nerve Repair Hand Surgery
An observational study of Peripheral Nerve Injuries, run by Uppsala University.
Trial summary
This study intends to compare the patients with pain with those who underwent same procedure without developing pain. The patients with pain and without pain will be further analyzed in respect to clinical differences, biomarkers and genetical differences. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Peripheral Nerve Injuries
- Type of treatment
- Pill or oral medicine
- How many people
- 990 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Jan 2019
- 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients opererated with nerve suture surgery on Hand Surgery between 2006-2014
Who may be able to join
- • Female or male subjects > 18 years of age
- Provision of written informed consent
- Be able to understand and comply with the requirements of the study
- Patients with a history of persistent spontaneous and/or evoked pain (by e.g. touch, movement) interfering with daily activities of at least 3 months duration, associated with upper extremity surgery or other trauma affecting the radial, ulnar, medial or digital nerve
- Spontaneous or evoked pain upon standardized test (mechanical, movement)> 50 on a 100 mm VAS scale in the group with pain after nerve repair surgery and a group of patients with no pain
Who cannot join
- Other condition that may confound assessment of pain attributed to posttraumatic upper limb pain, as judged by the investigator
- Any condition/disease that could interfere with the study measurements, e.g. peripheral vascular disease, diabetes mellitus, polyneuropathy etc as judged by the investigator
About this study
Official title: Incidence of Chronic Neuropathic Pain and Sensory Deficits After Nerve Repair Hand Surgery (Correlation With Genotypes and Biomarkers)
This study intends to compare the patients with pain with those who underwent same procedure without developing pain. The patients with pain and without pain will be further analyzed in respect to clinical differences, biomarkers and genetical differences.
Read the detailed description
Chronic pain is a well-known complication after surgery, but the prevalence of persistent pain after upper extremity surgery or other trauma affecting the radial, ulnar or the medial nerve, or branches of these nerves such as digital nerves is unknown. The reason that some patients develop persistent neuropathic pain after surgery, while others, who have been through the exact same procedure or trauma, are pain free is still unknown. The underlying mechanisms are still largely unknown. This can lead to different responses to treatment. Whenever possible, it is important to identify and address the underlying pain mechanisms in the individual patient in order to design an optimal treatment.
The aim of this study was to determine the prevalence and the factors implicated in the development of persistent pain after nerve suture surgery investigating Clinical symptoms, standardized clinical examination for neuropathic pain, 92 biomarkers special developed for neuropathic pain, genetics.
Conditioned pain modulation and Cold pressor test is intend to be performed in all the patients.
-
- Conditions
- Peripheral Nerve Injuries
- Being tested
- No intervention
- Medical subject headings
- Peripheral Nerve Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
| Study group | Role | What they receive |
|---|---|---|
| Patients with Pain | Patients who had upper limb surgery or other trauma with a history of persistent spontaneous and/or evoked pain with duration of at least 3 months.
Patients will be recruited to the study by using a postal follow up questionnaire. Patients who judge their pain at least moderate and/or affecting daily life by will be eligible and asked to participate. Patients will visit the Pain Clinic once. Oral and written information about the study will be provided, informed consent obtained. The affected nerve will be identified and the anatomy verified by ultrasound when needed. Receives: Other: No intervention | |
| Patients with no pain | Patients operated with nerve suture surgery after a lesion of the nerves of upper extremity will be recruited to the study by using a postal follow up questionnaire. Patients with no pain will be asked to participate. Patients will visit the Pain Clinic once. Oral and written information about the study will be provided, informed consent obtained. The affected nerve will be identified and the anatomy verified by ultrasound when needed. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of neuropathic pain after trauma and nerve suture surgery
Patients with trauma and nerve suture surgery operated between 2006 and 2014 on Hand Surgery will receive a postal questionnaire (Leeds Assessment of Neuropathic Pain ). The patients with pain and without pain will be recruited to the study by using this postal follow up questionnaire. Patients who judge their pain at least moderate and/or affecting daily life by will be eligible and asked to participate.
Measured: 2016 january-2017 january
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2017
- Study startJan 2016
- Primary completionJan 2019 (estimated)
- Study completionJan 2019 (estimated)
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 Peripheral Nerve InjuriesStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 990 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet
- Responsible party
- Principal investigator, Adriana Miclescu, Uppsala University
- Investigators
- Adriana Miclescu, MD, PhD, DEAA, Principal investigator, Uppsala University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03174665
- Sponsor's protocol ID
- ICONSS
- Status last verified
- Oct 2017
- First submitted
- 30 May 2017
- Last updated
- 31 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Miclescu A, Ronngren C, Bengtsson M, Gordh T, Hedin A. Increased risk of persistent neuropathic pain after traumatic nerve injury and surgery for carriers of a human leukocyte antigen haplotype. Pain. 2024 Jun 1;165(6):1404-1412. doi: 10.1097/j.pain.0000000000003143. Epub 2023 Dec 22.
PubMed 38147413
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Chronic Neuropathic Pain and Sensory Deficits After Nerve Repair Hand Surgery (Correlation With Genotypes and Biomarkers)
- ClinicalTrials.gov ID
- NCT03174665
- Acronym / sponsor ID
- ICONSS
- Conditions
- Peripheral Nerve Injuries
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 990 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Karolinska Institutet
- Study start
- Jan 2016
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 2 Jun 2017 (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.
This study intends to compare the patients with pain with those who underwent same procedure without developing pain. The patients with pain and without pain will be further analyzed in respect to clinical differences, biomarkers and genetical differences.
Detailed description
Chronic pain is a well-known complication after surgery, but the prevalence of persistent pain after upper extremity surgery or other trauma affecting the radial, ulnar or the medial nerve, or branches of these nerves such as digital nerves is unknown. The reason that some patients develop persistent neuropathic pain after surgery, while others, who have been through the exact same procedure or trauma, are pain free is still unknown. The underlying mechanisms are still largely unknown. This can lead to different responses to treatment. Whenever possible, it is important to identify and address the underlying pain mechanisms in the individual patient in order to design an optimal treatment.
The aim of this study was to determine the prevalence and the factors implicated in the development of persistent pain after nerve suture surgery investigating Clinical symptoms, standardized clinical examination for neuropathic pain, 92 biomarkers special developed for neuropathic pain, genetics.
Conditioned pain modulation and Cold pressor test is intend to be performed in all the patients.
-
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Pain | – | Other: No interventionPatients who had upper limb surgery or other trauma with a history of persistent spontaneous and/or evoked pain with duration of at least 3 months. Patients will be recruited to the study by using a postal follow up questionnaire. Patients who judge their pain at least moderate and/or affecting daily life by will be eligible and asked to participate. Patients will visit the Pain Clinic once. Oral and written information about the study will be provided, informed consent obtained. The affected nerve will be identified and the anatomy verified by ultrasound when needed. |
| Patients with no pain | – | Other: No interventionPatients operated with nerve suture surgery after a lesion of the nerves of upper extremity will be recruited to the study by using a postal follow up questionnaire. Patients with no pain will be asked to participate. Patients will visit the Pain Clinic once. Oral and written information about the study will be provided, informed consent obtained. The affected nerve will be identified and the anatomy verified by ultrasound when needed. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients opererated with nerve suture surgery on Hand Surgery between 2006-2014
Key inclusion criteria (5 listed)
- • Female or male subjects > 18 years of age
Key exclusion criteria (2 listed)
- Other condition that may confound assessment of pain attributed to posttraumatic upper limb pain, as judged by the investigator
- Any condition/disease that could interfere with the study measurements, e.g. peripheral vascular disease, diabetes mellitus, polyneuropathy etc as judged by the investigator
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 |
|---|---|---|
| No intervention | Other | Patients with Pain, Patients with no pain |
Primary outcome
Prevalence of neuropathic pain after trauma and nerve suture surgery
Time frame: 2016 january-2017 january
Patients with trauma and nerve suture surgery operated between 2006 and 2014 on Hand Surgery will receive a postal questionnaire (Leeds Assessment of Neuropathic Pain ). The patients with pain and without pain will be recruited to the study by using this postal follow up questionnaire. Patients who judge their pain at least moderate and/or affecting daily life by will be eligible and asked to participate.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2017.
- Derived from this study: PubMed 38147413Miclescu A, Ronngren C, Bengtsson M, Gordh T, Hedin A. Increased risk of persistent neuropathic pain after traumatic nerve injury and surgery for carriers of a human leukocyte antigen haplotype. Pain. 2024 Jun 1;165(6):1404-1412. doi: 10.1097/j.pain.0000000000003143. Epub 2023 Dec 22.
- Individual participant dataSharing planned: Yes
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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.
Adriana Miclescu, MD, PhD, DEAA principal investigator
Uppsala University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Nerve Injuries, run by Uppsala University.
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 5 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: status not confirmed, as of the sponsor's last update on 31 Oct 2017. 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?
Results are not available in the source record.
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?
Prevalence of neuropathic pain after trauma and nerve suture surgery (time frame: 2016 january-2017 january). 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 NCT03174665, 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 31 Oct 2017.