A National Center for Persistent Severe Pain After Groin Hernia Repair (Q5Y)

October 18, 2018 updated by: mads u werner, University of Copenhagen

A National Center for Persistent Severe Pain After Groin Hernia Repair: Five-year Prospective Data

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).

Study Overview

Status

Completed

Conditions

Detailed Description

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

Enrollment (Actual)

222

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with severe persistent pain after groin hernia repair with psychophysical disability referred to the dedicated tertiary center for these patients on a nationwide basis.

Description

Inclusion Criteria:

  • Severe persistent pain after groin hernia repair (activity-related or maximal pain intensity > 7 NRS-units [numeric rating scale 0-10])
  • Severe persistent pain after groin hernia repair-related serious impairment of working and social life.

Exclusion Criteria:

  • Minors or persons of legally incompetence
  • Participants, who do not speak or understand Danish
  • Participants, who cannot cooperate with the investigator or the examination procedure
  • Recurrent hernia
  • Known neurological disease or disorders in the groin area of other origin
  • Psychiatric disease
  • Abuse of alcohol or drugs - according to investigator's evaluation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity
Time Frame: 2010-2015
Numeric Rating Scale (NRS; 0-10 units)
2010-2015
Activity of Daily Living (ADL) score
Time Frame: 2010-2015
Activities Assessment Scale (AAS; 8 specified physical activities; 0-8 units each)
2010-2015

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessments of Anxiety and Depression
Time Frame: 2010-2015
Hospital Anxiety and Depression Scale (HADS; 14 item scale; 0-21 units)
2010-2015
Assessment of Pain Catastrophizing
Time Frame: 2010-2015
Pain Catastrophizing Scale (PCS; 13 item scale; 0-65 units)
2010-2015

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Copenhagen

Investigators

  • Principal Investigator: Mads U Werner, MD, PhD, Neuroscience Center, Copenhagen University Hospital, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2010

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

July 19, 2018

First Submitted That Met QC Criteria

October 18, 2018

First Posted (Actual)

October 19, 2018

Study Record Updates

Last Update Posted (Actual)

October 19, 2018

Last Update Submitted That Met QC Criteria

October 18, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-2-2011-023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Data will be made available as a supplement to the published scientific article.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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