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Neuromodulation: Technology at the Neural Interface

Received: July 27, 2012 Revised: November 28, 2012 Accepted: January 3, 2013

(onlinelibrary.wiley.com) DOI: 10.1111/ner.12030

LETTER TO THE EDITOR


Peripheral Nerve Field Stimulation for Sacroiliac
Joint Pain

To the Editor: have at least one-year follow-up. The ages ranged from 44 to 92
Low back pain (LBP) is the fifth most common complaint for all years, with median of 72.5 years. Four patients were female and six
doctor visits (1). Studies have shown that LBP is often not confined were male. Patients presented in this paper have a follow-up of
to the spine and that sacroiliac (SI) joint is involved in 25% of the 14–29 months, with a median of 24 months. Because the group is
patients with complaints of back pain (2). The diagnosis of SI joint heterogeneous and small, statistical analysis could not be done. The
pain can be difficult because there is a significant overlap between study is therefore limited to clinical outcomes and complications.
LBP, radicular pain, and SI joint pain. Oftentimes, successful treat- All ten patients presented with pain in the SI joint(s). Eight patients
ment of SI joint pain itself serves as a diagnostic tool (3). Some of the had pain bilaterally and two had pain unilaterally. Prior treatment and
causes of SI joint pain include trauma, infection, metabolic causes, evaluation included the following: physical therapy, nonsteroidal
fracture, inflammatory processes, and arthritic processes (2,4). Con- anti-inflammatory drugs, trigger-point injections, SI joint injections,
servative treatments for SI joint pain include the following: pain and psychologic evaluation. Four patients also had prior treatment
medications, nonsteroidal anti-inflammatory drugs, steroid injec- with radiofrequency ablation, which did give patients some relief;
tion (5), physical therapy (6), and exercise program. Surgical proce- however, the effect disappeared after several months. SI joint injec-
dures include the following: radiofrequency ablation of the SI joint tion was done with 3 mL of 0.5% Marcaine (bupivacaine) (Hospira
(7,8), lumbar and sacral radiofrequency neurotomy (9,10), and Worldwide Inc., Lake Forest, IL, USA) with 20–40 mg of Depo-medrol
fusion (11,12). In a large study, the success for SI joint fusion has (methylprednisolone) (Pfizer, New York, NY, USA). A total of at least
been found to be between 60% and 75% (7). two injections were done. A good relief of pain was considered diag-
Peripheral nerve stimulation (PNS) has been used to treat chronic nostic. Usually, the effect lasted between two weeks to two to three
pain for the last 40 years and offers a minimally invasive surgical months. Physical therapy included the use of heel lift when leg-length
treatment option for many different areas of pain (13). The benefits discrepancy was detected. Those who failed conservative therapy
from the PNS system are based on the gate control theory of pain and were deemed motivated to improve (based on psychologic
proposed by Melzack and Wall in 1965; this theory hypothesizes that evaluation) were considered candidates for PNFS trial. Those who
the electric field “closes the gate” to pain transmission (14). Theories reported significant improvement in pain after the trial stimulation
on how the PNS works also propose that PNS alters endogenous for four to five days received permanent PNFS implant. Degree of pain
endorphins and ultimately alters the pain threshold, thus providing was assessed by asking the patients to rate the pain on a scale of 1–10,
subjective benefit in pain (1). PNS has been used for treatment of with 10 being the worst.
pain occipital, ilioinguinal, trigeminal, and postherpetic neuralgias
(10). More recently, investigators have placed electrodes in the sub-
cutaneous tissue in the area of the pain without targeting a specific Trial Electrode Implant
nerve to stimulate nerve endings in these areas to give pain relief. The procedure was done using sterile technique and local anes-
This technique has been called by some as “peripheral nerve field thetics. Fluoroscopic guidance was used during the lead implant.
stimulation” (PNFS) (15). It has fewer side-effects than many medi- Focal pressure was applied on the SI joint and areas around it to
cations and less risk than more invasive surgeries. It is also a good mark the painful spots. Through a Touhy needle, the trial lead, with
alternative to treating areas of pain that cannot be treated with the eight contacts, electrode diameter of 1.3 mm and length of 3 mm,
use of a spinal cord stimulator (SCS) (16) and also has been used in and interelectrode distance of 6 mm, was inserted into the subcu-
conjunction with SCS and was beneficial for patients with back and taneous tissue to place the proximal one or two electrodes around
lower extremity pain (17). It gives the patient freedom to adjust the the most painful part of the SI joint and the most distal electrode at
device in accordance with their pain and thus allows the patient to midline. The external part of the lead wire was sutured to the skin
play an active role in his or her treatment. Because PNFS has been with a strain-relief loop. The insertion site was covered with sterile
successfully used to treat LBP (15), its use, specifically for SI joint dressing. Stimulation studies were done at the time of implantation
pain, though logical, has not been previously addressed. In this to confirm that the patients had good response from stimulation. If
paper, therefore, we present our initial experience with PNFS for the
treatment of SI joint pain as a pilot study.

There are no sources of financial support to report.


MATERIAL AND METHODS The content of this manuscript represents the authors’ work/opinions and not
This study looked retrospectively at ten patients who underwent those of the sponsoring agent.
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PNS complete system implantation for treatment of SI joint pain and There are no conflicts of interest to report.

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LETTER TO THE EDITOR

tunneled to this incision and connected to the pulse generator. The


latter was then placed in the subcutaneous pocket. The integrity of
the system was then tested. The incisions were then closed.
Eight patients had bilateral leads and two patients had a unilat-
eral lead implanted. The pulse generator was usually programmed
the day after the surgery. Different combinations of stimulation
parameters were used with different combinations of bipolar lead
arrangements until optimal results were obtained. Generally,
voltage between 1 and 8, median pulse width of 360, and frequency
of 40 ⫾ 10 Hz were used.
During the follow-up, the patient was asked to rate the pain the
same way it was done during preoperative evaluation. This rating
was focused solely on the SI joint area of pain, which was the surgi-
cal target. If there was 50% or greater relief of pain over the treated
region, the improvement was considered significant. The pain medi-
cation usage and effect on sleep also was evaluated and compared
with preoperative needs.

RESULTS (TABLE 1)
The follow-up is 14–29 months, with a median of 24 months. Six
out of ten patients (60%) had significant relief of pain (improvement
of pain score by 50% or more), of which two were completely free of
pain, two (20%) had between 20% and 30% improvement in pain,
Figure 1. Bilateral lead placement. and two (20%) did not benefit from the operation. Furthermore, the
need for pain medications was reduced in six out of ten patients and
four out of ten reported improved sleep pattern. Complications
the response was unsatisfactory, the lead was repositioned. The included flipped pulse generator (one patient) and migrated lead
external part of the lead wire was then connected to an external (one patient), which had to be repositioned. No specific pattern in
pulse generator and the latter was programmed to produce pares- the history or physical examination was noted in two patients who
thesia in the painful area. The patient was then instructed on adjust- had unsatisfactory response; except that, both these patients had
ment of the pulse generator depending on the pain level. An rated their pain as 10/10.
antibiotic was prescribed for the duration of the trial to prevent
infection. After five to six days of trial stimulation, the electrodes
were removed. If the patient reported satisfactory improvement in DISCUSSION
pain, he or she was referred for permanent implantation of PNFS. Treatment of SI joint pain is often very challenging. Even after the
trial of extensive conservative treatment, some patients continue to
have disabling pain. In such situations, more aggressive treatment
Permanent Implant of PNFS options can be considered. Such options include radiofrequency
Three different permanent implant stimulator systems were uti- ablation or fusion of the SI joint (7,11). Though these procedures
lized (Medtronic, Minneapolis, MN, USA; Boston Scientific, Natick, have shown promising results, they are still being evaluated. There-
MA, USA; and St. Jude Medical, Plano, TX, USA) based on the refer- fore, another procedure that is minimally invasive was sought. PNFS
ring pain physicians’ preferences. The implantation of the perma- implantation is a minimally invasive procedure that does not violate
nent system was done under local anesthesia with sedation. The the SI joint. It has been used successfully in the treatment of
leads were inserted through small incisions using the same tech- regional pain. In addition, it has the ability to change the stimulation
nique as that used for trial lead implant under fluoroscopic guid- parameters so that if the benefits slowly fade away they can be
ance to place them over the same area as the trial leads. When changed to rejuvenate the stimulation. Therefore, patients who had
unilateral lead was indicated, it was inserted from lateral to medial. failed conservative treatment were treated with this method.
When bilateral leads were indicated, the second lead was inserted Psychologic evaluation is an important step in preoperative
through the midline with medial to lateral lead placement (Fig. 1). evaluation of a patient for PNFS implant. It helps to rule out soma-
Intraoperative stimulation studies were done to confirm that it tization, untreated depression, and tendency to seek gain that may
covered the painful areas and that it was adequate to control the adversely affect the results. It therefore helps the treating physician
pain without unpleasant sensation. If the testing showed problems, to determine the likelihood of benefit to the patient from the pro-
the lead was removed and reinserted at slightly different depth cedure and covey that information to the patient (13).
within the subcutaneous tissue and retested to make sure that sat- The stimulating electrodes were placed over the SI joint, the
isfactory results were obtained. The lead wire was then anchored to midline area at the level of SI joint, and the area between the two.
the underlying fascia by silk suture. Another incision was made in The midline area was included in the coverage because most
the flank area through which a subcutaneous pocket was created. patients had pain in this area, in addition to the SI joint. The nerve
The pocket was not more than a centimeter deep to allow proper endings covered by the electrodes were therefore, most probably,
charging of the battery. The ideal pocket location was not too super- the dorsal rami of first two or three sacral nerve roots.
ficial as to avoid erosion and not too large as to avoid movement The trial stimulation was useful to determine the likelihood
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of the generator. The connecting wires of the leads were then of benefit to the patient from the procedure. When there was a

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PATIL ET AL.

Table 1. Patient results.

Patient # Age Sex Unilateral Change in Pain scale Sleep pattern Complications
or bilateral medications Before After after surgery
after surgery surgery surgery
1 73 M Bilateral Decreased 7 0 Unchanged None
2 48 M Bilateral Unchanged 9 7 Improved None
3 80 F Bilateral Decreased 8 0 Improved None
4 74 F Bilateral Increased 10 10 Worsened No longer using system
5 68 M Unilateral Decreased 7 5 Unchanged None
6 88 M Unilateral Unchanged 10 10 Unchanged Pulse generator flipped—this was corrected surgically
7 52 F Bilateral Decreased 10 5 Improved Lead migration—this was corrected surgically
8 58 F Bilateral Decreased 9 4 Unchanged None
9 92 M Bilateral Unchanged 7 1 Unchanged None
10 44 M Bilateral Decreased 8 2 Improved None
F, female; M, male.

positive result from the trial study, permanent implant was done. excellent pain control are free of pain medication or have improve-
Therefore, to replicate the results of the trial study, it is important to ment in sleep. The reason for this finding is that they had pain in
place the permanent electrodes in the same location as those other areas too. There was nothing in the history or physical findings
during the trial studies. Therefore, intraoperative fluoroscopic that was unusual about those patients that failed this for treatment
images were obtained during permanent electrode placement and except that they had the highest pain ratings. This may suggest that
compared with those obtained with trial leads to make sure that those with very severe pain are less likely to improve.
they were in the same location as those as the trial leads. In addition,
lead placement was done under local anesthesia and intraoperative
stimulation studies were done, so that feedback could be obtained CONCLUSION
from the patient regarding the adequacy of pain relief and absence PNFS implant for SI joint pain is a simple and minimally invasive
of unpleasant sensation during stimulation. procedure to treat chronic disabling SI joint pain. Though the
The procedure for implanting PNFS is straightforward and mini- number of patients in this series is small and the follow-up is rela-
mally invasive outpatient procedure that is performed under local tively short to draw any conclusion, the result of the present series is
anesthesia with minimal sedation. The patients first receive a trial encouraging. Eighty percent of the patients benefited from the pro-
lead placement. This trial gives them and the treating physician a cedure and 60% have significant improvement. By the very nature
good indication of the likely outcome. Because the leads are placed of the procedure, the likelihood of serious complication is negli-
in the subcutaneous tissue, the SI joint is not violated, thus signifi- gible. This procedure therefore may be worth pursuing for patients
cantly reducing the risk of joint infection or injury (13). The lead can who have failed conservative treatment and want a less invasive
be inserted to the target though a Touhy needle, without the need surgical procedure.
for tissue dissection. Furthermore, because the lead is placed in the
subcutaneous tissue, there is no major risk of stimulation causing
serious side-effects. Because patients could change some of their Authorship Statements
stimulation parameters, they could adjust them based on their Drs. Patil and Otto wrote the manuscript. Ms. Otto also collected
need. In order to prevent risk of infection, new electrodes were used the data. Dr. Raikar conducted the trial procedures and also helped
for permanent implant and an interval of several weeks kept to collect the data.
between the two procedures. In addition, excessive injection of
Arun Angelo Patil, MD*, DeeAne Otto, APRN*,
local anesthesia was avoided because the local anesthetic could
Soubrata Raikar, MD†
travel along the electrode, making it difficult to do intraoperative
*Division of Neurosurgery, University of Nebraska Medical Center,
testing. In this series, the pulse generator pockets were in the flank
Omaha, NE, USA; and†Fremont, NE, USA
area because most patients preferred it and it is easy for patients to
reach it for recharging or for making minor changes in the stimula-
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