Original Investigator Generated Research Currently Under Way at IPCA
Peripheral Neurostimulation versus inguinal nerve surgical exploration
to treat chronic groin pain following hernia repair
This is a study recruiting volunteers who are at least 18 years old, had hernia repair surgery at least 3 months ago and still have pain in the groin area. The purpose of the study is to see which treatment is better, additional surgery on the nerves or a nerve stimulator that's implanted. The study lasts about 1 year and during that year study subjects will have several visits to the doctor. Should a patient qualify to be in the study all study visits, exams and procedures are provided at no cost to the patient. Only two sites are doing this study, one in Tucson and the other site in Phoenix.
For further information, please call
Outcomes Research International at (520) 514-7600
Purpose
Primary purpose: To determine whether or not one of these treatments is clearly superior in providing sustained improvement in pain and function for patients with post-herniorrhaphy inguinal neuralgia refractory to conservative management. The secondary aim of this study is to collect further data on effectiveness and safety of peripheral neurostimulation and on nerve resection and embedment for inguinal neuralgia following herniorrhaphy.
Background: Inguinal neuralgia following herniorrhaphy has recently been found to be far more common than previously thought, with an incidence recently reported as high as 54%[1]. Older and more conservative estimates found that 28.7% of patients continue to have significant pain one year after inguinal herniorrhaphy, and that one half of these have significant functional impairment [2]. Working from the more conservative statistic we can estimate that one out of every six patients who undergo hernia repair will have functionally limiting groin pain one year later. With an estimated 700,000 Americans undergoing herniorrhaphy each year[3] this translates as 116,000 new cases of chronic groin pain each year in United States. The State of Arizona has 2% of the United States population in the Greater Phoenix in Tucson metropolitan areas, and therefore there should be over 2000 new cases of functionally limiting chronic groin pain following herniorrhaphy in greater metropolitan Tucson and Phoenix combined, each year. These patients suffer compromise of their job duties, recreational activities and social activities, and home life in spite of aggressive treatment with opioid medications and anti-neuropathic medications such as tricyclic antidepressants and anticonvulsants.
There is evidence that peripheral nerve stimulation is effective and safe therapy for such patients [4], and surgical resection and embedment of the peripheral nerves involved is a well-established procedure. These are the only two "rescue" maneuvers for such patients, and there is no information available to physicians to guide them in choosing one option over the other as first-line rescue therapy. If one treatment of emerges as clearly superior in this study it should be offered as the first option. This would be a significant contribution to medical care for this population. Furthermore, success rates for surgical resection and embedment of inguinal nerves vary between 60% [5] and 70% [6] and so there will still be roughly 600-800 new patients in Arizona each year for who surgical resection and embedment will be ineffective. Even if peripheral neural stimulation becomes a second line rescue procedure, there may be up to 800 new candidates for this procedure every year in the State of Arizona. Further data on the effectiveness and safety of peripheral stimulation for this problem is needed before its use can be widely recommended.
Study overview:
POPULATION: 100 Patients with chronic post-herniorrhaphy pain randomized to one or the other treatment with the ability to cross-over if the first treatment fails to relieve pain
DATA COLLECTION PERIOD: one year
1 Poobalan AS A Review of Chronic Pain After Herniorrhaphy Clin J. Pain 2003 Jan-Feb;19(1): 48-54
2 Bay-Nielsen M Ann Surg 2001 Jan; 233(1): 1-7
3 Rutkow IM Demographic, Classificatory, and Socioeconomic Aspects of Hernia Repair in the United States Surg Clin North Am 1993; 73:413-426
4 Stinson and Davis Neuromodulation 2000; 7(3): 193-196
5 Heise CD J Am Coll Surg 1998 Nov; 187(5): 514-518
6 Starling HR World J Surgery 1989 Sept-Oct; 13(5): 586-591
Industry Sponsored Research Currently under way Trial of Peripheral Field Neurostimulation for Low Back Pain The integrative pain Center is one of a small number of sites participating in this study for treating intractable low back pain that is not responding to standard medical treatment. Patients who may qualify for this study are those - Who are 18 years of age or older
- Who have had back surgery more than 6 months ago
- But who continued to suffer from chronic intractable back pain lasting more than 6 months despite treatment with other medical optionsT
The benefits to a patient of participating include - taking an active role in health care
- helping others by contributing to the medical community knowledge of chronic intractable back pain
- having the device and procedure costs covered under the study
- receiving reasonable compensation for the patient's time spent participating in the study
In the United States, the U. S. Food and Drug Administration approves and regulates clinical studies. ANS, the study sponsor, has received an Investigational Device Exemption from the FDA for this clinical research study to evaluate peripheral nerve field stimulation (PNfS) in the treatment of chronic intractable back pain. Physicians and patients: For further information, please call
Outcomes Research International at (520) 514-7600
Recent publications of InterestEducation Generalist Pysicians About Chronic Pain: Live Experts and Online Education Can Both Provide Durable Benefits. HarrisJ, Elliot T, Davis B, et al Pain Medicine 2008;vol9(5):555-563 Subject: Educating Pimary Care Physicans in caring for painful illness. Under an National Institutes of Health grant, the investigators developed a comprehensive problem based interactive on line CME that has no ties to medical industry; they developed a pain compentency test for primary care; and they tested the on-line CME against best available live CME presentations. This is therefore the first and only Pain Medicine CME that has been tested to see how well it met its educational goals using validated knowledge, attitudes, and beliefs assessment tool; and it was also tested against typical live CME to show that it is at least as good. Click here to read the Reuters press release on the published results. The on line CME developed in this research project is continuously updated and remains available to all providers at the origina hosting sit, Virtual Home Library Know Pain 50: a Tool for Asessing Physician Pain Management Education Harris J, Fulginiti J, Gordon P, Elliot T, Davis B, et al Pain Medicine 2008;Vol 9(5):542-554 Subject: This is the report of our development of the first validated test to assess physician pain management competency.
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