Chronic Neuropathic Pain After Nerve Repair Hand Surgery

Peripheral Nerve Injuries Clinical Trial

Official title:

Incidence of Chronic Neuropathic Pain and Sensory Deficits After Nerve Repair Hand Surgery (Correlation With Genotypes and Biomarkers)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03174665
• Other study ID #: ICONSS
• Status: Enrolling by invitation
• Phase: N/A
• First received: May 30, 2017
• Last updated: October 28, 2017
• Start date: January 2016
• Est. completion date: January 2019

Study information

• Verified date: October 2017
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 990
• Est. completion date: January 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Neuralgia
• Peripheral Nerve Injuries

Intervention

Other:
• No intervention

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Uppsala University	Karolinska Institutet

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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