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Complex Salvage Procedures for Severe Lower Extremity Nerve Pain

Schon, Lew C., MD; Lam, Peter W.-C., MD; Easley, Mark E., MD; Anderson, Claude D., MD; Lumsden, David B., MD; Shanker, Jay, MD; Levin, Gail B., RN

Clinical Orthopaedics and Related Research®: October 2001 - Volume 391 - Issue - p 171-180
SECTION I SYMPOSIUM: Complications in Foot and Ankle Surgeries
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From 1995 to 1999, the senior author did revision nerve release and vein wrapping (58 limbs in 58 patients) or peripheral nerve stimulation (62 limbs in 62 patients) to relieve intractable lower extremity nerve pain. Vein wrapping was done if the patient had temporary relief after a previous nerve release, if there was evidence of scarring around the nerve, and if nerve pain was triggered by mechanical stimulation. Peripheral nerve stimulation was done when previous nerve operations provided no relief or if the nerve pain was more constant and spontaneous without mechanical provocation. The duration of symptoms preoperatively averaged 52 months, and the number of previous peripheral neurosurgical interventions averaged 2.5. Postoperatively, the average pain improvement was rated as 60% for the patients who had vein wrapping and 41% for the patients who had peripheral nerve stimulation. Of the patients who had vein wrapping, 53% were satisfied, 14% were somewhat satisfied, and 33% were dissatisfied. Of the patients who had peripheral nerve stimulation, 61% were satisfied, 21% were somewhat satisfied, and 18% were dissatisfied. Most patients (78%) stated they would undergo the procedures again.

From the Department of Orthopaedic Surgery, The Union Memorial Hospital, Baltimore, MD.

An institutional grant has been provided by Medtronic, Inc, Minneapolis, MN.

Reprint requests to Lew C. Schon, MD, c/o Lyn Camire, Editor, Orthopaedics, The Johnston Professional Building #400, 3333 North Calvert Street, Baltimore, MD 21218.

Patients with chronic intractable lower extremity neurogenic pain may be treated nonoperatively with medication, 29,30,43,48 physical therapy with desensitization modalities, 15,17 therapeutic nerve blocks, 5,11,41 and external electrical stimulation. 25,26 When nonoperative measures fail, surgery may be indicated.

Several surgical techniques have been developed to address the chronically and intractably damaged nerve: neurolysis, 40 transection, 1,3,4,6,9,10,12,13,18–21,28,34,35,37,44,45,49,51 containment procedures, 1,2,13,22,24,37,44 barrier procedures, 6,7,14,26,27,42 and peripheral nerve stimulation. 14,23,31,32,39,47,50 The choice of best procedure for a given etiology is individualized to the patient, depends on many factors, and often is difficult to determine.

Vein wrapping and peripheral nerve stimulation have been reported to be successful in controlling chronic upper extremity nerve pain that is resistant to standard treatments. 2,14,22,27,33,36,42,46 On this basis, the indication of these procedures has been expanded to include chronic intractable lower extremity pain 16 (Gould JS, Hart TS, O’Brien TS, Winkler MV: Outcome analysis of vein wrapping for intractable painful nerves in continuity. Presented at the 12th Annual Summer Meeting of the American Foot and Ankle Society, Hilton Head, SC, June 28, 1996). The purpose of the current investigation was to review the results of these two procedures in terms of relieving intractable lower extremity nerve pain.

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MATERIALS AND METHODS

Patient Population

The current authors retrospectively reviewed the records of 120 surgeries on 104 patients at their institution between 1995 and 1999 in which vein wrapping or peripheral nerve stimulation had been used for intractable lower extremity pain secondary to various nerve injury mechanisms. All patients had undergone unsuccessful nonoperative treatment that included medical treatment with tricyclic antidepressants (amitriptyline or nortriptyline) or antiepileptic medications (carbamazepine, phenytoin, clonazepam, and Gabapentin), physical therapy, nerve blocks, transcutaneous electrical nerve stimulation, sympathetic blocks, desensitization techniques, and topical medications. All but one patient underwent one to 12 previous surgical nerve procedures.

Evaluation at the initial consultation included clinical assessment and electrodiagnostic studies. A careful history and physical examination were obtained for each patient. The history focused on evidence of systemic disease, mechanism of nerve insult, and specific nerve involvement. The results of previous surgical interventions were assessed to identify patients who had intractable lower extremity pain secondary to adhesive neuralgia (painful nerve trapped in scar tissue) who might benefit from vein wrapping rather than peripheral nerve stimulation. Physical examination identified specific nerve involvement and sites of potential nerve injury (surgical scar and trauma sites). Electrodiagnostic studies were done on each patient to help rule out a systemic peripheral neuropathy, to find more proximal areas of nerve compromise (double crush phenomenon), or to determine whether there was nerve compression or intraneural damage. Assessment included sequential nerve blocks with lidocaine and bupivacaine to help isolate the nerve or nerves involved.

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Vein Wrap Group

Indications for vein wrapping included intractable neuropathic pain and failure of the nonoperative treatment protocol. Clinical findings consistent with adhesive neuralgia included tenderness to palpation or percussion along the scar (producing dysesthesias along the nerve’s territory or course) and dysesthesias with range of motion of the joint adjacent to the scar. Patients who experienced some temporary symptomatic relief after previous neurolysis, followed by subsequent deterioration, were considered to have adhesive neuralgia. Previous infection, wound complications, or both were not contraindications to vein wrapping.

In these 58 consecutive patients (58 limbs), all had adhesive neuralgia that was a result of a combination of the original nerve insult (primary compression or entrapment, traction or stretch injury, crush injury, transection, idiopathic etiology, deep infection, compartment syndrome, and injection injury) and subsequent surgery (such as scarring after surgery). Nerves involved included the posterior tibial nerve (50 limbs in 50 patients), tibial and sural nerves (one limb in one patient), sural nerve (one limb in one patient), superficial peroneal nerve (four limbs in four patients), and superficial with deep peroneal nerve (one limb in one patient). The duration of symptoms before vein wrapping averaged 62 months (range, 11–353 months). The number of previous surgeries for the same nerve problem averaged 2.5 (range, one-seven procedures). All patients had undergone at least one neurolysis procedure, which had provided a period of complete or partial pain relief. At the time of initial evaluation at the authors’ institution, 16 patients (16 limbs) had previous intentional or unintentional transection. Other complications of previous surgery that may have contributed to the chronic neuropathic pain included two deep-space infections and six wound dehiscences.

The age of the 34 women and 21 men averaged 42 years (range, 21–66 years) at presentation to the authors’ institution.

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Peripheral Nerve Stimulation Group

The indications for peripheral nerve stimulation included patients with chronic peripheral neuralgia for intraneural compromise who underwent unsuccessful nonoperative treatment protocols, unsuccessful previous nerve release(s) combined with a containment procedure (vein, fat, or muscle graft), unsuccessful previous transection and transposition of nerve with burial into muscle or bone, unsuccessful previous nerve grafting and reanastomoses, or unsuccessful spinal cord stimulation. Patients who had did not respond to conventional surgical techniques and were being considered for either transection of the tibial, common peroneal, sciatic, or femoral nerve or a limb amputation were candidates for peripheral nerve stimulation. Previous infection or wound complications were not contraindications to peripheral nerve stimulation.

In these 62 consecutive patients (62 limbs), the intraneural disorder was a result of the initial nerve insult (crush injury, transection, traction or stretch injury, idiopathic etiology, and repetitive trauma), subsequent surgery, or both. The duration of symptoms before peripheral nerve stimulation averaged 46 months (range, 13–96 months). Of the 62 patients, 58 (94%) had undergone at least one previous peripheral neurosurgical procedure for treatment of the neuropathic pain. The number of previous peripheral neurosurgical surgeries averaged 2.8 (range, 0–12) and included neurolysis (57 patients), revision neurolysis (24 patients), vein wrapping after unsuccessful neurolysis (16 patients), transection (47 patients), and centrocentral anastomosis (three patients). Thirty-eight patients had stimulation of one nerve trunk. The remaining patients had stimulation of two to four nerves. The nerves stimulated included the tibial (28 patients), the tibial and sural (four patients), the tibial and the saphenous (three patients), the tibial and the superficial peroneal nerves (four patients), the superficial peroneal and the sural nerves (two patients), the superficial peroneal and the deep peroneal nerves (three patients), the sural (three patients), superficial peroneal (eight patients), the saphenous nerve (one patient), the deep peroneal nerve (one patient), the femoral nerve (one patient), and the tibial with at least two other nerves (four patients).

The age of these 31 females and 27 males averaged 38 years (range, 17–73 years) at presentation to the authors’ institution.

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Surgical Technique

Vein Wrap

For the vein wrap procedure, 14,27,38 (Gould JS, Hart TS, O’Brien TS, Winkler MV: Outcome analysis of vein wrapping for intractable painful nerves in continuity. Presented at the 12th Annual Summer Meeting of the American Foot and Ankle Society, Hilton Head, SC 1996) the nerve is released circumferentially over the entire course of the suspected disorder (determined by scarring or tenderness to palpation). The saphenous vein is harvested (Fig 1) or, alternatively, an umbilical vein allograft is used (Fig 2). Typically the nerve is wrapped in a barber-pole fashion (Fig 3A–B) with the autograft, or in a clamshell fashion (Fig 3C) with the allograft, to encase the nerve and affected branches.

Fig 1A–B.

Fig 1A–B.

Fig 2A–C.

Fig 2A–C.

Fig 3A–C.

Fig 3A–C.

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Peripheral Nerve Stimulation Procedure

For the peripheral nerve stimulation procedure, 38 the nerve trunk(s) proximal to the level of the disorder is/are exposed circumferentially. The fascial graft(s) harvested from adjacent fascial tissue is/are sewn to the lead(s) because it is thought to prevent the electrodes from damaging the nerve 38 (Fig 4). The wound is anesthetized, carefully avoiding nerve injection. The patient then is reversed from general anesthesia and a trial stimulation is done (Peripheral Nerve Stimulator, Medtronic, Inc, Minneapolis, MN). The trial stimulation frequency range is from 20 to 100 Hz, often starting at 40 Hz. The pulse width varies between 50 and 450 μs, often starting at 200 μs, and the range of the amplitude or strength of stimulation is .05 to 10.5 V, with the median at 2.5 V Electrode selection can be unipolar, bipolar, or multipolar and usually starts at −/+ −/+ on electrodes 0, 1, 2, and 3. Paresthesia in the zone of pain typically indicates good placement of the lead on the nerve. If this zone can be palpated or percussed during the stimulation with reduced or absent pain, the lead is secured in place over the nerve (Fig 5), the patient is reanesthetized (general), and the peripheral nerve stimulation generator is implanted. If there are still other zones of uncontrolled pain, the lead is moved around the nerve to improve the paresthesias and pain relief. If zones of uncontrolled pain still exist, intraoperative nerve blocks are done. Based on the subsequent relief of pain, a decision is made regarding additional nerve trunk stimulation versus additional nerve procedures (transection, transposition, centrocentral anastomoses, or additional nerve stimulation) in conjunction with the primary stimulation. If paresthesia in the zone of pain is obtained with minimal relief to palpation or percussion, a trial using a temporary external generator connected to the internal lead then is instituted. After 4 to 5 days, if the pain is controlled with adjustment of the external stimulator, an internal generator is implanted. If the pain has not decreased, a series of nerve blocks is done to identify the nerve producing or carrying the pain signal. Once this is determined, a second-stage procedure is done to adjust the leads, to add another lead to the other nerve(s), or to do additional nerve procedures (transection, translocation, or containment procedures).

Fig 4A–B.

Fig 4A–B.

Fig 5.

Fig 5.

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Postoperative Procedures

After surgery, each limb was placed in a splint for 2 weeks. After this time, progressive range of motion and weightbearing was allowed as tolerated. For the patients with peripheral nerve stimulation, additional electrical signal modification was done on several occasions to maximize pain control.

The same assessment was completed for every patient with nerve compromise at each office visit. Therefore, preoperative and followup values were available for review. Ten-point scales were used to evaluate pain and dysfunction. 38 On the pain scale, 0 represented no pain and 10 represented pain severe enough to prompt a request for amputation of the affected extremity. On the dysfunction scale, 0 represented unlimited function and 10 represented the necessity of a wheelchair. A team member (other than the senior surgeon) ascertained a subjective rating by asking the patient whether he or she was satisfied, satisfied with some reservation, or dissatisfied.

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RESULTS

Retrospective followup was available for all patients. The followup averaged 48.6 months (range, 12–92.6 months) after vein wrapping and 29.3 months (range, 13–61.4 months) after peripheral nerve stimulation.

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Vein Wrap Group

Pain scores improved from a preoperative average of 8.8 points (range, 6–10 points) to a postoperative average of 5.1 points (range, 0–10 points). Dysfunction scores improved from a preoperative average of 7.4 points (range, 3–10 points) to a postoperative average of 4.4 points (range, 0–9 points). Time to maximum improvement in this group averaged 12 months (range, 3–30 months). Thirty-two (55%) patients were satisfied with the procedure, eight (14%) were satisfied with reservations (gaining mild or minimal relief of symptoms), and 18 (31%) had unsatisfactory results. No patients reported worsening of the symptoms after a suitable recovery from the surgical procedure.

Of the 58 patients, 38 had saphenous vein harvested. In seven of the 38 patients, there were complications from the saphenous vein harvest: three had mild saphenous nerve symptoms, three had mild wound healing problems, two had swelling from the vein harvest incisions, and two had prolonged donor site pain. All but two of the 38 patients had resolution of the symptoms. Umbilical veins were used to wrap nerves in 20 of the 58 patients. There were no infections, rejections, or wound complications. Despite fewer complications, only seven of 20 patients who received umbilical veins were satisfied and 11 were dissatisfied. Of the patients who had saphenous vein harvesting, 25 of 38 patients were satisfied and seven were dissatisfied.

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Peripheral Nerve Stimulation Group

Pain scores improved from a preoperative average of 9 points (range, 7–10 points) to a postoperative average of 5.1 points (range, 0–8 points), and dysfunction scores improved from a preoperative average of 8 points (range, 7–10 points) to a postoperative average of 6.4 points (range, 3–10 points). The average overall percentage improvement reported by the patients was 42%. Time to maximum improvement after peripheral nerve stimulation averaged 5.2 months (range, 1–10 months). Satisfaction was reported in 38 of 62 (61%) patients, satisfaction with reservations was reported in 13 of 62 (21%) patients, and dissatisfaction was reported in 11 of 62 (18%) patients. In 48 of 58 (83%) patients who were satisfied, only one patient had complete relief of symptoms and, at 2.5 years followup, no longer uses the peripheral nerve stimulation. In these 48 patients, there were improvements in hours of sleep per night, hours of uninterrupted sleep, and average walking distance. These patients generally thought their quality of life and psychologic well-being had improved.

Of 62 patients, 29 required revisions during the 5-year study period. Major revisions with lead replacements were done in 21 of 29 patients. Of these 21, 10 required another nerve to be stimulated at a later surgery, and eight had revisions of the pulse generator for battery depletion during a lead revision. There were new pulse generators inserted in two of 29 patients. The average battery life was 2.7 years, but one patient requires a new device every 3 to 4 months. This patient has good improvement but only fair pain relief from the stimulator. She also had persistent equinovarus of the foot and ankle and clawing of the toes that have been resistant to multiple releases. She has ultimately required fusions of her hindfoot and forefoot to address these progressive contractures. Despite her need for revision surgeries, she continues to work. In four of the 29 patients, there have been minor hardware revisions.

There were revisions for postoperative infections in four of 29 patients (three already are counted in the 21 of 29 major revisions) within 6 months of implantation (one patient had a previous history of osteomyelitis) and in two of 29 for late infections, one at 1.5 years and one at 3 years (in a patient who had undergone additional lead insertion within 3 months postoperatively) that required removal of some or all of the implanted components. Four of the six patients had resolution of the infection with intravenous antibiotics and subsequently had reimplantation of the peripheral nerve stimulation with satisfactory results. The patient with a history of osteomyelitis did not have adequate relief with the initial implantation and requested an amputation. The other patient, who initially was satisfied with his pain relief for 1.3 years, did not think there was adequate functional improvement. Two months before he presented with his sudden onset of a late infection (1.5 years) he decided to undergo transtibial amputation. After his amputation, he had improvement of pain and function.

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DISCUSSION

Chronic intractable neuralgia (pain) in the distribution of a nerve(s) that does not respond to nonoperative and operative treatment presents a difficult problem in that it encompasses a wide spectrum of causes. 38 The current study sought to analyze relatively new treatment options for patients with chronic intractable neuralgia.

In general, vein wrapping with revision neurolysis, a barrier procedure designed to protect a nerve from external compromise, 7,27 can relieve symptoms and improve function in patients with adhesive neuralgia. Sotereanos et al 42 reported good and excellent results with this procedure in the upper extremity. Gould 14 and Gould et al (Gould JS, Hart TS, O’Brien TS, Winkler MV: Outcome analysis of vein wrapping for intractable painful nerves in continuity. Presented at the 12th Annual Summer Meeting of the American Foot and Ankle Society, Hilton Head, SC 1996) reported that 63% of patients had an excellent or good outcome with this technique for treatment of chronic lower extremity neurogenic pain but that 25% of patients reported an increase in symptoms.

Peripheral nerve stimulation in the lower extremity can benefit patients with intrinsic nerve compromise who have undergone unsuccessful release, transection, transposition, grafting, and/or reanastomosis. 16,33,36,46 Peripheral nerve stimulation is a neuromodulation technique based primarily on the gate mechanism of pain that theorizes that selective stimulation of large myelinated delta nerve fibers modulate afferent nociceptive input centrally or at the dorsal horn of the spinal cord. 23 There have been several reports of peripheral nerve stimulation for the treatment of intractable neurogenic pain in the upper extremity, but little has been reported for the lower extremity. In the upper extremity, Nashold et al, 33 Waisbrod et al, 46 and Cooney 8 have reported success ranging from 53% to 84%.

In patients with intraneural disorders, the alternative to peripheral nerve stimulation is transection and burial. 1,3,4,6,9,10,12,13,18–21,28,34,35,37,44,45,49,51

This is a good procedure in selected patients because it is technically easy to do and the patient does not require complex treatment after surgery. There are several potential problems with nerve transection: (1) deafferentation pain or anesthesia dolorosa; (2) motor denervation (that may result in muscle imbalance and deformities); (3) vulnerability to ulcers and infections from insensate plantar aspect of the foot; and (4) ectopic or spontaneous neuralgia. In the current series, 47 of 62 patients (the peripheral nerve stimulation group) (76%) had previously undergone transection and burial before peripheral nerve stimulation. Of these 47 patients, eight did not respond adequately to peripheral nerve stimulation and had failed results. The remainder all had allodynia that responded to some degree to peripheral nerve stimulation of the transected nerves. The current authors’ approach is to consider transection and burial or peripheral nerve stimulation if a patient presents with chronic intractable neurogenic pain of the lower extremity secondary to intraneural disorders involving nerves other than the posterior tibial nerve and if the patient has undergone unsuccessful nonoperative modalities and neurolysis. However, if the posterior tibial nerve also is involved, the patient would be offered a trial of peripheral nerve stimulation before transection. Finally, if the patient has a neuroma from a transected nerve, the first revision is usually a more proximal transection and burial. Failure after this procedure warrants consideration for peripheral nerve stimulation.

Vein wrapping and peripheral nerve stimulation can be effective surgical techniques for the treatment of intractable chronic neurogenic pain secondary to adhesive neuralgia and intraneural pathology, respectively. Ongoing analysis of a larger series of patients and a prospective study of peripheral nerve stimulation at the senior authors institution may ultimately lead to better selection criteria and better technique. Cost analysis and long-term outcome studies of these complex patients with or without these procedures are under investigation.

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Acknowledgments

The authors thank Elaine Bulson, Jennifer Shores, and Lyn Camire for assistance in preparing the manuscript.

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Section Description

Osaretin B. Idusuyi, MD; and G. James Sammarco, MD, Guest Editors

© 2001 Lippincott Williams & Wilkins, Inc.