This study is enrolling participants by invitation only.
Information provided by (Responsible Party):
First received: May 30, 2017
Last updated: May 30, 2017
Last verified: May 2017
To increase our understanding of pain mechanisms related to nerve injury and to enable early clinical testing of new treatments in a frequent occurring clinical condition, we intend to evaluate patients with spontaneous and/or evoked pain associated with upper extremity surgery or other trauma affecting the radial, ulnar or the medial nerve, or branches of these nerves such as digital nerves, and to compare them with patients who underwent same procedure for same trauma without developing pain.We will determine the prevalence of neuropathic pain after trauma and nerve surgery of upper extremity nerves. The patients with pain and without pain will be further analyzed in respect to clinical differences, biomarkers and genetical differences.
|Peripheral Nerve Injuries||Other: No intervention|
|Study Design:||Observational Model: Cohort
Time Perspective: Retrospective
|Official Title:||Incidence of Chronic Neuropathic Pain and Sensory Deficits After Nerve Repair Hand Surgery (Correlation With Genetics, Fenotypes and Biomarkers)|
- 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.
|Study Start Date:||January 2016|
|Estimated Study Completion Date:||January 2019|
|Estimated Primary Completion Date:||January 2019 (Final data collection date for primary outcome measure)|
|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.
|Other: No intervention|
|Patients Without 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 whithout 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.
|Other: No intervention|
|Ages Eligible for Study:||18 Years to 85 Years (Adult, Senior)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
|Sampling Method:||Non-Probability Sample|
Patients opererated with nerve suture surgery on Hand Surgery between 2006-2014
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT03174665
|Principal Investigator:||Adriana Miclescu, MD, PhD, DEAA||Uppsala University Hospital|
|Responsible Party:||Uppsala University|
|ClinicalTrials.gov Identifier:||NCT03174665 History of Changes|
|Other Study ID Numbers:||ICONSS|
|Study First Received:||May 30, 2017|
|Last Updated:||May 30, 2017|
|Individual Participant Data|
|Plan to Share IPD:||Yes|
Additional relevant MeSH terms:
Peripheral Nerve Injuries
Nervous System Diseases
|Peripheral Nervous System Diseases
Signs and Symptoms
Trauma, Nervous System
Wounds and Injuries
ClinicalTrials.gov processed this record on June 02, 2017