Chronic Neuropathic Pain After Nerve Repair Hand Surgery

NCT03174665 | Unknown

• 1 other identifier: ICONSS
• Study Type: observational
• Target: 990
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Peripheral Nerve Injuries

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

Interventions

No intervention OTHER

Patients with Pain; Patients with no pain

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Uppsala University: lead
• Karolinska Institutet: collaborator

Related Publications (1)

• 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.

  PMID: 38147413 DERIVED

MeSH Terms

Conditions

Peripheral Nerve Injuries

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Adriana Miclescu, MD, PhD, DEAA

  Uppsala University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: May 30, 2017
• First Posted: June 2, 2017
• Study Start: January 1, 2016
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: October 31, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will share