A National Center for Persistent Severe Pain After Groin Hernia Repair (Q5Y)
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|ClinicalTrials.gov Identifier: NCT03713047|
Recruitment Status : Completed
First Posted : October 19, 2018
Last Update Posted : October 19, 2018
This prospective, consecutive cohort study presents nationwide 5-year outcome data on patients with severe persistent pain after groin hernia repair (SPG).
The inclusion criteria were SPG-related impairment of physical and social life. Two-hundred-four out of 222 patients (92%) were analyzed. Relevant surgical records were obtained, and examinations were by standardized clinical and neurophysiological tests. Patients demonstrating pain sensitivity to pressure algometry in the groin were evaluated regarding exploratory surgery, while patients with putative neuropathic pain received pharmacotherapy. Questionnaires at baseline (Q0) and five-year (Q5Y) were used in outcome-analyses of pain-intensity (numeric rating scale [NRS] 0-10) and the pain-related effect on the activity-of-daily-living (Activities Assessment Scale, AAS).
|Condition or disease|
|Inguinal Hernia Chronic Pain|
Severe persistent pain after groin hernia repair (SPG) causes psychophysical disability and impairs quality-of-life for a considerable number of individuals each year.1-3 In the United States, 600,000 groin hernia repairs (GHR) are performed annually, and a conservative estimate is that 2%, corresponding to 12,000 individuals, each year will develop this debilitating pain condition.4 The management of SPG remains a daunting challenge to the medical profession 5, often requiring multidisciplinary efforts.1,6 Several surgical procedures have indicated substantial pain-relieving effects in SPG1,7 however few well-powered, controlled studies have been presented.8,9 In pharmacological and neuromodulation procedures, most studies are still case-based or uncontrolled.
In 2010, the authors established a dedicated tertiary center for SPG-patients open for referral on a nationwide basis. The objectives were, first, to analyze the pathophysiological mechanism behind the pain, second, to implement optimal medical and surgical pain management and third, to perform clinical SPG-research projects. Standardized clinical and neurophysiological tests guided the management paradigm for each patient. Treatment outcomes were evaluated prospectively using baseline questionnaires (Q0) and a 5-year questionnaire (Q5Y) mailed at the end of 2014 to all patients referred to the center.
The focus of the present study is first, to present clinical, neurophysiological and psychometric data on SPG-patients at referral, and second, to evaluate and compare efficacies of exploratory surgical and non-surgical treatment, based on a consecutive follow-up cohort of 222 patients.
|Study Type :||Observational|
|Actual Enrollment :||222 participants|
|Official Title:||A National Center for Persistent Severe Pain After Groin Hernia Repair: Five-year Prospective Data|
|Actual Study Start Date :||January 1, 2010|
|Actual Primary Completion Date :||September 1, 2015|
|Actual Study Completion Date :||September 1, 2015|
- Pain intensity [ Time Frame: 2010-2015 ]Numeric Rating Scale (NRS; 0-10 units)
- Activity of Daily Living (ADL) score [ Time Frame: 2010-2015 ]Activities Assessment Scale (AAS; 8 specified physical activities; 0-8 units each)
- Assessments of Anxiety and Depression [ Time Frame: 2010-2015 ]Hospital Anxiety and Depression Scale (HADS; 14 item scale; 0-21 units)
- Assessment of Pain Catastrophizing [ Time Frame: 2010-2015 ]Pain Catastrophizing Scale (PCS; 13 item scale; 0-65 units)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03713047
|Principal Investigator:||Mads U Werner, MD, PhD||Neuroscience Center, Copenhagen University Hospital, Denmark|