Chronic Neuropathic Pain After Nerve Repair Hand Surgery

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.

Study Overview

• Status: Unknown
• Conditions: Peripheral Nerve Injuries
• Intervention / Treatment: Other: No intervention

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.

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• Study Type: Observational
• Enrollment (Actual): 990

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients opererated with nerve suture surgery on Hand Surgery between 2006-2014

Description

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:

• • 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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 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.	Other: No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2016 january-2017 january

Collaborators and Investigators

• Sponsor: Uppsala University
• Collaborators: Karolinska Institutet
• Investigators: Principal Investigator: Adriana Miclescu, MD, PhD, DEAA, Uppsala University Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Anticipated): January 1, 2019
• Study Completion (Anticipated): January 1, 2019

Study Registration Dates

• First Submitted: May 30, 2017
• First Submitted That Met QC Criteria: May 30, 2017
• First Posted (Actual): June 2, 2017

Study Record Updates

• Last Update Posted (Actual): October 31, 2017
• Last Update Submitted That Met QC Criteria: October 28, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Wounds and Injuries; Neuromuscular Diseases; Peripheral Nervous System Diseases; Trauma, Nervous System; Neuralgia; Peripheral Nerve Injuries
• Other Study ID Numbers: ICONSS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES