Chronic Neuropathic Pain After Nerve Repair Hand Surgery


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This study is enrolling participants by invitation only.

Sponsor:

Collaborator:

Karolinska Institutet

Information provided by (Responsible Party):

Uppsala University

ClinicalTrials.gov Identifier:

NCT03174665

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 Type: Observational
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)

Primary Outcome Measures:

  • 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.

Enrollment: 990
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

Exclusion Criteria:

  • 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

Inclusion Criteria:

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Please refer to this study by its ClinicalTrials.gov identifier: NCT03174665

Uppsala University

Karolinska Institutet

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:

Neuralgia
Peripheral Nerve Injuries
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on June 02, 2017